The document describes a proposed study to evaluate the effectiveness of the SMARTubeTM device in India. The SMARTubeTM is designed to enable earlier detection of HIV and HCV infections by stimulating antibody production in blood samples. The study would involve collecting blood samples from various clinical sites and incubating portions in the SMARTubeTM device before testing for antibodies. The goals are to validate using the SMARTubeTM in Indian settings and to estimate the rate of additional HIV/HCV detections made possible by the technology. Participating organizations would benefit from thought leadership, contributing to medical research, and gaining experience evaluating new diagnostic technologies.
Breaking the barriers in the management of neovascular AMDAjayDudani1
The document summarizes key details from two phase 3 clinical trials called HAWK and HARRIER that compared the anti-VEGF drug brolucizumab to aflibercept for treating neovascular age-related macular degeneration (nAMD). The trials involved over 1700 patients across multiple international sites. Patients were randomly assigned to receive either brolucizumab 3mg or 6mg, or aflibercept 2mg. The primary endpoint was change in vision from baseline at week 48, with assessments continuing through week 96. Brolucizumab demonstrated non-inferiority to aflibercept and an ability to be dosed as infrequently as every 12 weeks after the initial
This case presentation discusses a patient with normal tension glaucoma. Key details include a past ocular history of high myopia and elevated intraocular pressure in both eyes. Visual field testing over several years using Humphrey 24-2 and 24-2C grids showed progressive visual field loss. The presenter reviews visual field test patterns, parameters, and how to integrate visual field tests with ganglion cell complex scans. A journal article is summarized that compares the 24-2 and 24-2C grids' ability to detect central visual field defects and evaluate structure-function concordance in glaucoma.
This document summarizes information from an instruction course on glaucoma and visual field testing. It discusses when visual field tests are recommended, how the tests work, what the results show, and how to interpret them. Key points include that visual field tests measure retinal sensitivity, central 30 degrees of vision represent most ganglion cells, and results are analyzed for reliability, patterns of defects, and correlation to glaucoma diagnosis.
The document is a 38-page test report from Bay Area Compliance Laboratories Corp. that analyzes samples of LED high bay lights for OK LED Lighting Limited. The report tests the samples for 163 substances of very high concern and finds concentrations of all substances to be <0.1%. The samples tested include various plastic, metal, and PCB parts of the LED lights.
For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website https://www.visiongain.com/Report/1272/Ophthalmic-Devices-Market-Forecast-2014-2024
1) The document summarizes results from the ESTABLISH 2 Phase 3 clinical trial comparing tedizolid to linezolid for the treatment of acute bacterial skin and skin structure infections.
2) The primary and secondary efficacy endpoints were met as tedizolid demonstrated non-inferiority to linezolid. Tedizolid also showed a favorable safety profile.
3) Upcoming milestones include presentations at conferences, regulatory filings for approval in the US and EU, and initiation of a Phase 3 study in ventilated nosocomial pneumonia.
How conductive keratoplasty is impacting the presbyopic practiceSM2 Strategic
CK is a procedure that uses radio frequency waves to alter the cornea shape and improve near vision in presbyopes. A survey of 20 surgeons found that the "LightTouch" technique for CK has dramatically improved outcomes. Surgeons have much higher confidence in CK results compared to the original pressure technique. The typical CK patient is between 48-52 years old, frustrated by their inability to see up close, but not yet in the market for reading glasses or other vision correction options. Successful doctors have adjusted their protocols to attract, counsel, and manage this different type of patient.
Pan Pacific Clinical Practice Guideline For The Prevention And Management Of ...GNEAUPP.
This document provides a summary of the Pan Pacific Clinical Practice Guideline for the Prevention and Management of Pressure Injuries, which was published in 2012. The guideline was developed through an extensive review process and in collaboration with experts from Australia, New Zealand, Hong Kong, and Singapore. It aims to optimize the prevention, assessment, and treatment of pressure injuries across the healthcare systems of these regions. The guideline provides evidence-based recommendations on topics such as risk assessment, prevention, wound assessment and classification, interventions, and organizational considerations.
Breaking the barriers in the management of neovascular AMDAjayDudani1
The document summarizes key details from two phase 3 clinical trials called HAWK and HARRIER that compared the anti-VEGF drug brolucizumab to aflibercept for treating neovascular age-related macular degeneration (nAMD). The trials involved over 1700 patients across multiple international sites. Patients were randomly assigned to receive either brolucizumab 3mg or 6mg, or aflibercept 2mg. The primary endpoint was change in vision from baseline at week 48, with assessments continuing through week 96. Brolucizumab demonstrated non-inferiority to aflibercept and an ability to be dosed as infrequently as every 12 weeks after the initial
This case presentation discusses a patient with normal tension glaucoma. Key details include a past ocular history of high myopia and elevated intraocular pressure in both eyes. Visual field testing over several years using Humphrey 24-2 and 24-2C grids showed progressive visual field loss. The presenter reviews visual field test patterns, parameters, and how to integrate visual field tests with ganglion cell complex scans. A journal article is summarized that compares the 24-2 and 24-2C grids' ability to detect central visual field defects and evaluate structure-function concordance in glaucoma.
This document summarizes information from an instruction course on glaucoma and visual field testing. It discusses when visual field tests are recommended, how the tests work, what the results show, and how to interpret them. Key points include that visual field tests measure retinal sensitivity, central 30 degrees of vision represent most ganglion cells, and results are analyzed for reliability, patterns of defects, and correlation to glaucoma diagnosis.
The document is a 38-page test report from Bay Area Compliance Laboratories Corp. that analyzes samples of LED high bay lights for OK LED Lighting Limited. The report tests the samples for 163 substances of very high concern and finds concentrations of all substances to be <0.1%. The samples tested include various plastic, metal, and PCB parts of the LED lights.
For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website https://www.visiongain.com/Report/1272/Ophthalmic-Devices-Market-Forecast-2014-2024
1) The document summarizes results from the ESTABLISH 2 Phase 3 clinical trial comparing tedizolid to linezolid for the treatment of acute bacterial skin and skin structure infections.
2) The primary and secondary efficacy endpoints were met as tedizolid demonstrated non-inferiority to linezolid. Tedizolid also showed a favorable safety profile.
3) Upcoming milestones include presentations at conferences, regulatory filings for approval in the US and EU, and initiation of a Phase 3 study in ventilated nosocomial pneumonia.
How conductive keratoplasty is impacting the presbyopic practiceSM2 Strategic
CK is a procedure that uses radio frequency waves to alter the cornea shape and improve near vision in presbyopes. A survey of 20 surgeons found that the "LightTouch" technique for CK has dramatically improved outcomes. Surgeons have much higher confidence in CK results compared to the original pressure technique. The typical CK patient is between 48-52 years old, frustrated by their inability to see up close, but not yet in the market for reading glasses or other vision correction options. Successful doctors have adjusted their protocols to attract, counsel, and manage this different type of patient.
Pan Pacific Clinical Practice Guideline For The Prevention And Management Of ...GNEAUPP.
This document provides a summary of the Pan Pacific Clinical Practice Guideline for the Prevention and Management of Pressure Injuries, which was published in 2012. The guideline was developed through an extensive review process and in collaboration with experts from Australia, New Zealand, Hong Kong, and Singapore. It aims to optimize the prevention, assessment, and treatment of pressure injuries across the healthcare systems of these regions. The guideline provides evidence-based recommendations on topics such as risk assessment, prevention, wound assessment and classification, interventions, and organizational considerations.
This document discusses several online accounts for communication and sharing content. It mentions accounts for messaging (My Accounts), blogging (Blogger), customizing desktops (eMac), creating wikis, and various Google services (I google). The accounts allow sending and receiving messages, sharing songs, photos, videos and text, customizing desktop settings, safely adding pictures to wikis, and accessing features like Google Reader through multiple linked accounts.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses CodeStringers, an outsourcing company that offers web and mobile app development, server and database development, agile project management, user experience design, and quality assurance services. It notes that CodeStringers was founded as a product development company, not a typical outsourcer, and that it is nimble, innovative, and financially stable. It then provides brief bios of several leaders at CodeStringers, and indicates the company is headquartered in San Francisco with development operations in Ho Chi Minh City, Vietnam.
Creativity in the language classroom with Animotomickstout
For EFL instructors looking to help their learners engage with English in creative ways, Internet-based applications offer numerous exciting possibilities to provide learners with authentic reasons for using English. This presentation introduces Animoto, an easy to use web-based application ideal for creating professional looking short videos and demonstrates its efficacy in two different EFL learning contexts.
CDVE 2011 - A Model for Collaborative Scheduling Based onCompetenciesTomasz Kajdanowicz
The document proposes a model for collaborative scheduling based on competencies. The model (1) quantifies the competencies required for tasks and those possessed by employees, (2) uses decision variables to represent how employee time is allocated to tasks based on competencies over time periods, and (3) aims to optimize an objective function that measures the increase in competency expertise across employees over the planning horizon. The model is constrained to ensure employee capacity is not exceeded, tasks are completed on time, and effective work time per task and competency is limited.
This document discusses how communities work and brands' participation in communities. It provides an overview of how tribal behavior has evolved from pre-industrial to post-industrial to today. People now belong to many online tribes through social media. Communities fulfill various needs like education, finding a sense of belonging, and gaining social currency. Brands can participate by feeding a community's common interests but should never pose as regular contributors. The best practices for brands engaging with communities include observing communities first before initiating any programs and ensuring community engagement is a long-term relationship.
This document shows a pattern where multiplying a number by 8 or 9 and adding another number produces a new number with the digits in increasing or descending order. For example, 123456 x 8 + 6 = 987654. It also includes some larger examples that extend this pattern to longer numbers with more digits.
This document discusses the challenges of incorporating new biomaterials into medical devices. It notes that including new biomaterials often requires joint ventures or in-house research given regulatory and industrialization hurdles. Specifically, biomaterials suppliers must provide technical and regulatory support to bridge the gap between research and medical device companies. While there is commercial pressure, clinicians agree on the potential of regenerative therapies. Key challenges include developing regulatory strategies for customized degradable materials, industrializing production processes, and facilitating the transfer of technologies from research to industry.
La composición de una fotografía es importante para captar la atención del espectador. Una regla básica es utilizar el encuadre de las "líneas de tercio", donde se divide la imagen en tercios horizontales y verticales, y se colocan los puntos de interés a lo largo de estas líneas o en sus intersecciones. Esto ayuda a crear un equilibrio visual agradable y dinámico.
CodeStringers provides outsourced software development services using an "upsourcing" model that aims to seamlessly augment clients' internal development teams. They offer agile development resources, product consulting, and a blended onshore-offshore model to improve clients' development velocity and quality while extending their budgets. Key attributes include offshore costs with onshore quality, a product development culture, cloud service technical expertise, and proven execution of agile methodologies like Scrum.
The biography discusses the person's life from birth to high school. They were born on August 30, 1963, the same day the US-Soviet hotline was established. Their childhood involved moving schools frequently, but high school years were enjoyable as they joined a band and had their first love, though it ended in heartbreak.
Network, Technology, and Data: Missing Pieces of the Puzzle for Clinical Tria...Health Catalyst
There is a massive shortfall in the enrollment and accrual of patients for clinical trials. Identifying the “right patients for the right trials at the right time” is a growing concern for providers, pharmaceutical companies, and clinical research organizations. In this webinar, we will discuss the evolution of clinical trials, including how to break barriers to enable successful clinical research as a care option, how clinical research impacts patient satisfaction and revenue, and more.
By: Fiona Fitzgerald, GE Healthcare Canada
At Sherbrooke International Life Sciences Summit - 2nd edition | September 28/29/30 2015
www.sils-sherbrooke.com
This document discusses several online accounts for communication and sharing content. It mentions accounts for messaging (My Accounts), blogging (Blogger), customizing desktops (eMac), creating wikis, and various Google services (I google). The accounts allow sending and receiving messages, sharing songs, photos, videos and text, customizing desktop settings, safely adding pictures to wikis, and accessing features like Google Reader through multiple linked accounts.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses CodeStringers, an outsourcing company that offers web and mobile app development, server and database development, agile project management, user experience design, and quality assurance services. It notes that CodeStringers was founded as a product development company, not a typical outsourcer, and that it is nimble, innovative, and financially stable. It then provides brief bios of several leaders at CodeStringers, and indicates the company is headquartered in San Francisco with development operations in Ho Chi Minh City, Vietnam.
Creativity in the language classroom with Animotomickstout
For EFL instructors looking to help their learners engage with English in creative ways, Internet-based applications offer numerous exciting possibilities to provide learners with authentic reasons for using English. This presentation introduces Animoto, an easy to use web-based application ideal for creating professional looking short videos and demonstrates its efficacy in two different EFL learning contexts.
CDVE 2011 - A Model for Collaborative Scheduling Based onCompetenciesTomasz Kajdanowicz
The document proposes a model for collaborative scheduling based on competencies. The model (1) quantifies the competencies required for tasks and those possessed by employees, (2) uses decision variables to represent how employee time is allocated to tasks based on competencies over time periods, and (3) aims to optimize an objective function that measures the increase in competency expertise across employees over the planning horizon. The model is constrained to ensure employee capacity is not exceeded, tasks are completed on time, and effective work time per task and competency is limited.
This document discusses how communities work and brands' participation in communities. It provides an overview of how tribal behavior has evolved from pre-industrial to post-industrial to today. People now belong to many online tribes through social media. Communities fulfill various needs like education, finding a sense of belonging, and gaining social currency. Brands can participate by feeding a community's common interests but should never pose as regular contributors. The best practices for brands engaging with communities include observing communities first before initiating any programs and ensuring community engagement is a long-term relationship.
This document shows a pattern where multiplying a number by 8 or 9 and adding another number produces a new number with the digits in increasing or descending order. For example, 123456 x 8 + 6 = 987654. It also includes some larger examples that extend this pattern to longer numbers with more digits.
This document discusses the challenges of incorporating new biomaterials into medical devices. It notes that including new biomaterials often requires joint ventures or in-house research given regulatory and industrialization hurdles. Specifically, biomaterials suppliers must provide technical and regulatory support to bridge the gap between research and medical device companies. While there is commercial pressure, clinicians agree on the potential of regenerative therapies. Key challenges include developing regulatory strategies for customized degradable materials, industrializing production processes, and facilitating the transfer of technologies from research to industry.
La composición de una fotografía es importante para captar la atención del espectador. Una regla básica es utilizar el encuadre de las "líneas de tercio", donde se divide la imagen en tercios horizontales y verticales, y se colocan los puntos de interés a lo largo de estas líneas o en sus intersecciones. Esto ayuda a crear un equilibrio visual agradable y dinámico.
CodeStringers provides outsourced software development services using an "upsourcing" model that aims to seamlessly augment clients' internal development teams. They offer agile development resources, product consulting, and a blended onshore-offshore model to improve clients' development velocity and quality while extending their budgets. Key attributes include offshore costs with onshore quality, a product development culture, cloud service technical expertise, and proven execution of agile methodologies like Scrum.
The biography discusses the person's life from birth to high school. They were born on August 30, 1963, the same day the US-Soviet hotline was established. Their childhood involved moving schools frequently, but high school years were enjoyable as they joined a band and had their first love, though it ended in heartbreak.
Network, Technology, and Data: Missing Pieces of the Puzzle for Clinical Tria...Health Catalyst
There is a massive shortfall in the enrollment and accrual of patients for clinical trials. Identifying the “right patients for the right trials at the right time” is a growing concern for providers, pharmaceutical companies, and clinical research organizations. In this webinar, we will discuss the evolution of clinical trials, including how to break barriers to enable successful clinical research as a care option, how clinical research impacts patient satisfaction and revenue, and more.
By: Fiona Fitzgerald, GE Healthcare Canada
At Sherbrooke International Life Sciences Summit - 2nd edition | September 28/29/30 2015
www.sils-sherbrooke.com
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
The document discusses HIV self-testing in South Africa. It notes that from 2005-2015 there was a sharp increase in HIV diagnoses in Africa, and from 2010-2014 over 600 million people received HIV testing services in low- and middle-income countries, nearly half of all tests in Africa. However, there remains a testing gap as only 45% of people living with HIV know their status. HIV self-testing is proposed as an innovative way to help close this gap and reach key populations by making testing more accessible and private. The document outlines several HIV self-testing implementation and research programs currently underway in South Africa, and barriers to introducing HIV self-testing in the country such as regulatory issues.
Program Presentation Advance Program In Clinical Trial, Research & Data Man...biinoida
The document summarizes an advance program in clinical trial research and data management offered by the Bioinformatics Institute of India. The 6-month weekend program provides theoretical and practical training in clinical trial design, conduct, analysis and regulation. It includes classroom lectures, guest speakers and a clinical site visit. The program aims to prepare students for careers in the growing field of clinical research.
This document summarizes a workshop on mapping the UK diagnostics landscape. The workshop included sessions on industry views, clinicians' views, the current diagnostics system, how diagnostic pathways can be achieved, and the role of health technology assessment in diagnostics. Speakers discussed topics like the potential for rapid diagnostics in community healthcare, barriers to diagnostic usage, tackling antimicrobial resistance, and how industry is driving greater diagnostic uptake. The goal of the workshop was to evaluate how fit the current diagnostics system is for purpose and identify ways to improve it.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
The Pistoia Alliance is examining the challenges of the Faster Safe Companion Diagnostics (CDx) by Aligning Discovery & Clinical Data in the Regulatory Domain.
The slides discuss whether the data standards used in the research environment be aligned better with the data standards used in the regulated environment? If so, the time and cost of the development of NGS-based CDx could be reduced.
The document describes the development of a dashboard to measure the impact of Innovation Units at Massachusetts General Hospital. It outlines the dashboard development process, including selecting metrics, collecting data from various sources, and using visual displays and benchmarks to show performance over time. The goal is to use data to drive improvement through testing changes and spreading improvements. Sample metrics in the dashboard include falls, pressure ulcers, central line infections, and patient and staff satisfaction measures.
Healthcare is undergoing a technological transformation, and it is imperative for the industry to leverage new technologies to generate, collect, and track novel data. Panel chaired by Ralf Reilmann of the George Huntington Institut, Muenster.
A LEAN SIX SIGMA APPROACH TO REDUCE WAITING AND REPORTING TIME IN THE RADIOLO...Joe Andelija
This document summarizes a research paper that used Lean Six Sigma to reduce waiting and reporting times in the radiology department of a tertiary care hospital in Kolkata, India. The researchers mapped the process from patient entry to report generation and identified areas of delay. Root causes of delay were found to be lack of patient preparation and disorganized operations. Recommendations included improving patient orientation to decrease pre-test wait times and streamlining operations to reduce post-test reporting delays. Implementing these changes statistically significantly reduced both pre-test and post-test waiting times.
Operational research aims to apply analytical methods to improve decision-making and resource allocation in various fields, including health care. It originated during World War II to study military problems scientifically. Now, operational research techniques are used to identify issues in health programs, test solutions to address those issues, and evaluate changes made to programs. The goal is to generate practical evidence to improve implementation, effectiveness, efficiency and sustainability of programs. Common methods include simulation, optimization, and data analysis. Operational research requires collaboration between managers and researchers throughout the research process.
Opportunities and Challenges of Mobile Health, Wearables and Sensors for PharmaJohn Reites
This document discusses opportunities and challenges of using mobile health technologies, wearables, and sensors in pharmaceutical research. It describes a vision for the clinical research of the future where patients can be directly dosed, monitored, and engaged through digital tools from their home. Examples are provided of how electronic patient-reported outcomes, biosensors, medical records, drug delivery, and a study companion app could be integrated into a direct-to-patient research model over the course of a day. The document also outlines considerations for determining whether a particular digital health approach or device is well-suited for integration into a patient registry.
Mobile CRAs: Transforming Clinical Monitoring Processes through Mobile Techno...Xiu Wei Lim
This document summarizes a presentation on how mobile applications can transform clinical monitoring processes.
The objectives were to investigate current CRA on-site processes to identify areas for improved efficiency through mobile technology, and to explore if mobile apps could improve a CRA's productivity and the quality of their work.
Four mobile apps were tested: 1) a subject visit scheduler, 2) an investigational product calculator, 3) a mobile camera/scanner, and 4) an app to check prohibited concomitant medications. Results showed these apps saved CRAs significant time, such as 23 hours per year using the camera/scanner app while maintaining or improving quality.
The conclusion is that implementing mobile tools in clinical trials through identifying large
Program Presentation Advance Program In Clinical Trial, Research & Data Man...biinoida
The document advertises an advance program in clinical trial research and data management offered by the Bioinformatics Institute of India. The 12-month weekend program provides theoretical and practical training in clinical trial design, conduct, analysis, and management. It aims to prepare students for careers in the growing clinical research industry in India. The program fee is Rs. 35,000 and includes classroom lectures, guest speakers, research projects, and placement assistance.
The document discusses biometric scan technologies as a more advanced and reliable authentication method compared to passwords and passcodes. Biometric scans use unique physical attributes like fingerprints, iris scans, or facial recognition for authentication. This helps overcome weaknesses of passwords, like being forgotten or shared. The document argues biometric scans provide stronger authentication through unique physical traits, improving security for computers, phones, and other devices.
The document describes an advanced 12-month weekend program in clinical trials, research, and data management offered by the Bioinformatics Institute of India. The program provides theoretical and practical understanding of clinical trials design, conduct, analysis and interpretation. It covers topics like statistics, data management, contract research, regulatory affairs, ethics, and medical writing. The program includes weekend classes, e-learning, guest lectures, research study, and clinical site visits. It aims to help students participate in and manage global clinical trials and contribute to drug development.
This document outlines a proposal for producing a 15-minute documentary film about the potential of solar energy in Madhya Pradesh, India. It details the objectives to create awareness of the excellent solar work being done in MP and the benefits of solar energy. The production will be handled professionally to international standards, with interviews and footage presented in an easy to understand way. The budget is Rs. 6,75,000 for the Hindi version, with additional costs for dubbing and social media promotion.
The document appears to be a portfolio from a production company listing various works they have produced including documentary films, training films, television serials, corporate films, and films promoting government departments and initiatives. The works cover a wide range of topics from health to the Indian Army to crime investigation. The production company also lists some prestigious works and appreciations they have received for their film and video productions.
In rain or sunshine... we deliver – always & every time. We provide strategic communication services through multiple online and offline platforms to reach diverse target audiences. When the local administration and media were trying to demolish a temple believed to be a historical site, we conducted an investigation, activated key influencers from religious leaders to politicians, approached senior officials and filed a PIL. Through a multi-pronged approach using various media and leveraging different relationships, we were able to prevent the demolition of the potentially important archaeological site.
The document discusses strategies to defend a temple site in Chandigarh that was threatened with demolition to make way for commercial development. Experts were consulted who identified the site as having Harappan artifacts. Local media supported the administration's plans. Alternative approaches were then employed, including notifying senior officials, political leaders, and religious figures; filing a public interest litigation; and activating media in Delhi that was independent of local influence. This pressure led the administration to back down from demolishing the temple.
This document provides an overview of digital crimes and cybersecurity issues on a global scale. It discusses the large economic costs of digital crimes to nations and organizations, provides several case studies of significant cyber attacks and data breaches, and outlines types of digital crimes committed against governments, organizations, property, society, and individuals. The case studies illustrate how digital criminals have used viruses, spoofing, hacking, data theft, and other techniques to inflict major impacts. Overall, the document examines the changing nature of crimes in the digital age and some of the most serious cybersecurity incidents occurring worldwide.
Alvitina is a multi-vitamin and mineral syrup containing L-lysine and protein hydrolysate. It supports the body's natural defenses and regulates biochemical reactions. Vitamins and minerals are essential nutrients obtained from food and support health. L-lysine is an amino acid that helps build protein and support bone, skin, and tissue health. Alvitina is prescribed to boost nutrition during conditions like general debility, convalescence, or impaired digestion. It should be taken as directed by a physician and can cause side effects if taken in excess or without supervision.
Product Name: Indoler APS
This medication contains aceclofenac, paracetamol, and serratiopeptidase. Aceclofenac is an anti-inflammatory similar to indomethacin and diclofenac but is safer for the gastrointestinal and cardiovascular systems. Paracetamol is a pain reliever and fever reducer. Serratiopeptidase reduces swelling and improves microcirculation. The medication is prescribed for pain and inflammation and should be taken as directed by a physician, avoiding other medications containing paracetamol.
This document provides information about the drug Remoxid DCL. It is a combination of amoxicillin and dicloxacillin, which are penicillin-class antibiotics used to treat bacterial infections. Remoxid DCL works by inhibiting cell wall synthesis in bacteria. It is prescribed to treat many infections caused by bacteria, and the usual dosage for adults is 250-500mg every 6 hours. Side effects may include nausea, diarrhea, and allergic reactions.
This document provides information on the antibiotic drug Alcepid, including its:
- Active ingredients of Cefpodoxime Proxetil 100mg/200mg
- Mechanism of action as a third generation oral cephalosporin antibiotic that fights bacteria
- Pharmacokinetic properties of being absorbed in the intestines and having activity against some beta-lactamase producing bacteria
- Use for treating various bacterial infections like pneumonia when prescribed by a physician.
Amikacin is an aminoglycoside antibiotic used to treat severe gram-negative bacterial infections. It works by binding to the bacterial ribosome and inhibiting protein synthesis. Amikacin is prescribed for infections like pneumonia, bone/joint infections, bloodstream infections, and more. It is administered via intravenous or intramuscular injection and the dosage is based on the patient's condition, weight, and lab tests. Common side effects include nausea, vomiting, and pain at the injection site.
This document proposes a new health management tool called the Strategic Win-Win America Project (SWAP) for Smart Health & Prosperous Economy (SHAPE) that aims to provide affordable, high-quality healthcare globally through an "inside-out" solution. Key aspects include streamlining operations across medical facilities to provide treatments near patients' homes at lower costs than traveling abroad, and investing savings into the US healthcare system to spur economic growth and jobs. The goal is universal access to on-demand medical care and advice from around the world to benefit America, India, and humanity overall through knowledge sharing and a recession-proof healthcare industry.
The document provides a communications monthly report for Baxter Asia Pacific from January 2008. It outlines key activities in bioscience, medication delivery, and renal areas including PR initiatives awaiting final clearance. It also discusses corporate communications including an internal note, story bank, and layout for an internal magazine. Emerging issues on CSR in India are noted along with recent media coverage. Priorities for the next month include launching an internal communication survey and stories on APD, HAI, Tisseel, and Baxter corporate.
Bill Austin, the 65-year-old founder and CEO of Starkey, a $700 million hearing aid manufacturer, will visit Delhi from October 22-23, 2007 to donate over 2,000 hearing aids to needy children. As the head of Starkey Hearing Foundation, Austin's mission is to help people around the world gain access to hearing aids, regardless of their ability to pay. Since 2000, the Foundation has donated over 200,000 hearing aids. Austin started his career in the hearing aid industry after discovering his calling while working for his uncle's company to pay for medical school.
Core Group is a pharmaceutical company known for developing high quality and safe medicines at low costs for a variety of medical conditions. It produces a wide range of products including antibiotics, analgesics, gynecological supplements, pediatric medicines, gastrointestinal drugs, and injectables. All products are manufactured according to stringent WHO and FDA standards to ensure quality and safety. Core Group aims to improve people's health and quality of life through innovative and affordable pharmaceutical solutions.
SMARTube is a new medical technology for early detection of HIV and HCV infections. It works by stimulating the body's immune response in a small blood sample to produce antibodies within days, rather than waiting weeks or months. This allows detection of infections during the "window period" before other tests can detect it. SMARTube has been tested on over 10,000 patients and is in use in several countries. It provides a simple, affordable way to more accurately diagnose infections and help reduce the spread of HIV/HCV.
The document introduces the Society for Medicare, an Indian NGO focused on health education, advocacy, and awareness. It aims to extend healthcare access to underprivileged communities through various communication mediums like print, television, radio, and the internet. The organization believes that healthcare should be consumer-centric and available to all. It hopes to coordinate with other groups, stimulate medical tourism, and set globally reputed medical institutions to provide quality and affordable healthcare.
The document summarizes information about the Indian pharmaceutical industry and Core Group, a pharmaceutical company operating in India. Key points:
- The Indian pharmaceutical industry is large and growing, ranking 4th globally in volume and supplying many generic medicines at low prices.
- Core Group is an ISO-certified pharmaceutical company that develops and markets affordable, high-quality medicines, supplements and surgical products in India.
- Core Group has state-of-the-art facilities, a large sales network, and over 26 products across therapeutic areas aimed at improving patients' quality of life.
The document discusses some common questions that new employees may have, including what companies expect from employees and what employees can expect from companies. Specifically:
[1] Companies expect employees to help the business make or save money through their contributions. Good employees are hardworking, take initiative, and strive to exceed expectations.
[2] Employees can expect opportunities for training, career growth, and rewards from companies in return. Companies also provide a supportive work environment and culture of innovation.
[3] Both employees and companies benefit when there is a relationship of mutual trust and respect, with open communication and feedback about performance. Good employees make long-term investments in their skills and the company's success.
The story describes four episodes of races between a hare and tortoise where they are reborn each time. In the first race, the tortoise wins by moving slowly and steadily while the hare sleeps. In the second race, the hare wins after being ashamed of losing previously. In the third race, the tortoise cheats by changing the track to include a river knowing the hare cannot swim. The fourth race ends with them realizing neither can win on their own and working as a team by helping each carry the other across the land and river, allowing both to win. The moral is that teamwork is essential for win-win situations.
The document discusses the concept of discipline from several perspectives:
- Discipline involves acting in an orderly manner according to set rules or codes of conduct through systematic instruction and self-control.
- Examples of discipline can be seen throughout nature and in various human systems and organizations like the military, where order is necessary.
- Maintaining discipline at work involves following rules, policies, instructions from leaders, and focusing on tasks and goals rather than distractions.
- Self-discipline is important for success and can be developed through commitment, practice, and establishing healthy habits while avoiding harmful ones.
- Countries like Japan recovered strongly after World War II due to the disciplined work ethic of their
Co-Chairs, Val J. Lowe, MD, and Cyrus A. Raji, MD, PhD, prepared useful Practice Aids pertaining to Alzheimer’s disease for this CME/AAPA activity titled “Alzheimer’s Disease Case Conference: Gearing Up for the Expanding Role of Neuroradiology in Diagnosis and Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/AAPA information, and to apply for credit, please visit us at https://bit.ly/3PvVY25. CME/AAPA credit will be available until June 28, 2025.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
1. CORP OFFICE: 10160 MEDLOCK BRIDGE ROAD, DULUTH, GA 30097 (USA)
PH: 770-495-0011, FAX: 770-495-0012
INDIA OFFICE: C-33A SHASTRI NAGAR, GHAZIABAD-201002 (UP) INDIA
MOB: 9999989066, 9818666863
2. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Index
S.No Description Page No.
TM
1 Introduction to SMARTube 3
2 Back Ground 4
3 Purpose and Scope of the Study 4
4 Study Design 5
5 Expected results 7
6 Outcome of studies 7
7 Benefits to the participating organization 8
8 Research Procedures 9
9 Methodology 10
10 Comments & Notes 12
Administrative and Financial Issues
11 Economic/ Financial Implications 14
12 Equipment and Material Required 15
13 Defining of Responsibilities 15
Additional Inputs for Clinical Trial
14 Instructions for Use 18
15 Guidelines for Running a laboratory evaluation 19
16 Notes & Tips 20
17 Trouble Shooting 25
18 Extracts of Clinical Trials in different parts of the word 27
19 Case Histories – Applications & Benefits 30
2
Page
20 Follow up questions and clarifications 33
3. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Introduction to SMARTubeTM
SMARTubeTM being introduced for the first time in India – is a first of its kind, innovative medical
diagnostic product that will revolutionize HIV & HCV detection. Stimulating Maximal Antibody
Response Tube – SMARTube™ enables earlier, better and complete detection of HIV/HCV just a
week after exposure. SMARTube™ not only enables the detection of all the patients who are
diagnosed in the conventional testing - but also enables detection in additional patients that are
infected, but otherwise would have gone undetected at that testing time. As a cost effective
method that increases the SENSITIVITY and SPECIFICITY of other known HIV & HCV detection
devises—with very little additional training or cost input, it will help in saving millions of lives.
SMARTube™ is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulations and the
highest global Quality Control, R&D and professional standards. SMARTube™ has been awarded--
CE Mark—the regulatory stamp of approval in the whole of Europe (the EU countries) and is
certified for public and individual use in Germany, Russian Federation, South Africa, Israel,
Romania, Nigeria, and Turkey. It is being used in these countries in hospitals, diagnostic labs,
blood banks, health or life insurance uses—anywhere blood samples need to be tested for HIV.
SMARTube™ Benefits include:
• Enables early detection than any other existing methods, within days of exposure
• Simple, affordable and reliable
• Requires no changes to the existing testing procedure
• Saves lives and suffering
• Proven effective
• Increased sensitivity
• Increased specificity
• Cost effective – Saves: Money, Time, Resources
SMARTube™ has been tested in controlled clinical trials on over 10,000 patients/individuals in
several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most of these
clinical trials and tests were done by reputed government agencies, blood banks, reference
3
Page
laboratories, academic and professional bodies.
4. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Background:
The window period of HIV and HCV infection is a major concern for the governments, health
authorities and professionals, blood banks, vaccine and drug developers all over the world, as
many infected individuals test negative for HIV or HCV antibodies, and are thus misdiagnosed.
A simple process, called Stimmunology, for stimulating the antibody production in-vitro in the
blood sample, prior to testing it for HIV (and/or HCV) antibodies, has been developed, to solve the
window period. This has been implemented in the SMARTube™ HIV&HCV, a blood pre-treatment
device, which enables the detection of HIV and HCV infections (during the window period) by
overcoming, in vitro, the specific immune suppression exerted by the virus, and which is the cause
for the window period.
This process involves placing 1ml of blood sample inside the SMARTube™ for a 3-5 day incubation
period, leading to the formation of HIV and/or HCV antibodies in detectable levels in all those
infected, including those in the window period. The detection of the antibodies is done by the
current serological assays and antibody detection kits (ELISA, WB), following the same procedures
and algorithms, just with an improved sample – the SMART-plasma.
1. Purpose & Scope: To evaluate the effectiveness of SMARTubeTM under Indian conditions.
1.1 The purpose of this study is to evaluate the feasibility of using SMARTube™ in India, in
different settings such as hospitals, clinical and diagnostic laboratories, VCT clinics, blood
transfusion centers, AIDS centers, epidemiological and research institutes by conducting
short term studies validating the usefulness of the SMARTube™ in Indian Conditions.
1.2 By participating in the study, the investigators will be able to have early access to on an
innovative technology, and collect data within the Indian health, scientific, and public
settings, gaining important scientific insight into the early stages of infection, confirmed
diagnosis, true measure of prevalence and incidence rate, and more.
1.3 Based on the results obtained in this study, the participating investigators will be able to
4
evaluate the feasibility of using the SMARTube™ technology in the Indian settings,
Page
become opinion leaders on this issue for curtailing the HIV and HCV epidemics in India.
5. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
2. Study Design:
2.1 - Design Rational
Previous testing of thousands of individuals and blood donors in different countries have
shown that pre-treating the blood sample using SMARTube™ HIV&HCV (a technology
which drives primed HIV and/or HCV immune cells to complete their proliferation and
differentiation and secrete HIV and /or HCV specific antibodies in culture, at levels
detectable by current antibody detection assays and kits) leads to the detection of
additional antibody positives, currently missed by regular serology. [All positive results
confirmed by the local algorithms using the locally used kits, cutoff points, controls,
practices, and guidelines. These seronegative yet infected individuals are infected, yet
missed by current serology, as they are at the very early stages of the infection, when they
are potentially infectious and undetectable (i.e. in the window period).
The rate of additional positives is dependent on several factors including:
• Incidence in the regular population,
• Incidence in the donor population (if different from the above due to donor
• selection, where applicable),
• Length of the window period in that population.
• Length of the asymptomatic period in that population.
These factors are not always known, and thus estimates can be done based on the
seroprevalence and the known (if any information available and provided) dynamics of the
spread of the HIV and/or HCV epidemic in that population/area/nation.
The aim of this study is to test the feasibility of using Stimmunology (as embodied in the
SMARTube™) for use in routine settings of HIV and/or HCV testing, and thus enabling the
detection of HIV and/or HCV infections among the seronegative individuals prior to the
appearance of anti-HIV or anti-HCV antibodies in the serum, in different settings in India.
The end point is either the detection of an additional HIV (and/or HCV) carrier, or the
‘routine’ implementation of the SMARTube™ incubation step in the testing center’s setting
5
for 1-3 months, testing 500-2000 samples.
Page
6. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
The study shall include ‘all’ blood samples, collected on the site, and brought to the
laboratory for testing, for a set time (1-3 months). A small heparin tube (or blood collected
in heparin washed syringe) will be collected from each individual (or donor) to be tested for
HIV and/or HCV antibodies. The blood sample will be sent to the laboratory at room
temperature. In the laboratory, one ml of blood will be aseptically transferred into a
labeled SMARTube™ and incubated in a humidified 5% CO2 incubator set at 370 C for 5
days (3 days in blood banks). The rest of the plasma will be stored after the routine testing
for HIV and/or HCV antibodies.
Following the incubation step, the supernatant = SMART-plasma will be collected and also
tested for HIV and/or HCV antibodies, using the same kits and algorithms as the regular
plasma is/was tested. The remaining volume of SMART-plasma is stored for repeat or
confirmatory testing and for future research work.
The results for HIV (and HCV) antibodies in plasma and in SMART-plasma will be compared.
2.2 - Population size, basic outline, and end point.
The study will have two types of end points:
I. Completion of a 1-3 months validation of implementation protocol for entering it into
the center’s/ laboratory’s routine testing.
II. Having an initial estimate of the rate of hidden / missed infection among the blood
donors achieved by the detection of one or more additional positive (defined as
routine plasma negative, SMART-plasma positive), or greyzone/ indeterminate
/discrepant readings in plasma that turn clear positive in the SMARTplasma.
6
Page
7. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
3. Expected results:
• All seropositive samples will also be SMART-plasma positive. – No loss of sensitivity.
• There might be (pending sample size and incidence rate in the tested populations) – additional
positives, i.e. seronegative yet antibody positive in the SMART-plasma –
Increase in sensitivity,
More confirmed diagnosis
Marked improvement of blood safety,
More true prevalence rates,
A good measure of incidence rates.
• There might be (pending sample size and incidence rate in the tested populations) –
Seropositives, which will have increased levels of antibodies in the SMART-plasma. These
individuals are recent sero-converters. - A measure of the incidence levels.
• Some low positives or borderline/gray-zone positives might become clear positives (or clear
negatives) after the incubation in the SMARTube™. – Increase in sensitivity and specificity.
• Some plasma false positives might be clear negative in the SMART-plasma, reducing the false
positive rate. -Increase in specificity.
Note: General sensitivity and specificity of the results are dependent on the antibody testing kits
used and their intrinsic qualities.
4. Outcome of studies:
Following validation and implementation steps, the criteria for diagnosing an HIV or HCV infection,
based on antibodies, or for releasing a blood unit based on SMART-Plasma results should follow
the same guidelines as those for plasma results for HIV and/or HCV antibody screening – leading to
a healthier society and safer blood supply.
The studies will be the initiation of an implementation plan, initially in the participating institutes
and eventually in others in the city, district and eventually the country, with the first users offering
7
leadership and guidance to others.
Page
8. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
5. Benefits to the participating organization:
• Thought Leadership-- Prestige of being part of a handful of organizations in different
regions across India
• First mover Advantage: The organization can claim credit, if so desired, for being involved
in trying out a new technology for the first time in the country
• Corporate Social Responsibility & Contribution for a noble cause: Any organization which
volunteers to participate in this research is obviously contributing towards the noble cause
of understanding and removing the barriers in the eradication/containment of lethal HIV-
HCV combine.
• Contribution to medical research and sharing of information for better and complete
diagnosis of HIV & HCV
• Credit for international collaborative research at a justifiable yet negligible cost, effort,
manpower and material expense
• Valuable experience for the staff, research associates, students and technicians towards
tackling the window period
• Key Opinion Leaders: After the completion of the study select individuals in different
organizations will be identified as key opinion leaders for this new technology for
participation as special invitees in various national-international medical forums and
conferences and if they do so agree their interviews/ opinions will be published in national-
international media besides assisting them in getting their study findings published in
reputed medical journals and websites.
8
Page
9. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
6. Research Procedures:
All procedures are performed at room temperature except for the incubation of the SMARTube™
with the blood samples performed at 36.5-37.5°C.
6.1 Work Instructions (using regular SMARTube™)
At Site:
6.1.1 Mark a (Lithium) Heparin coated vacuum tube with the donor code. Record date
and time. [If syringes are used, rinse the syringe with heparin]
6.1.2 Fill, aseptically, the labeled vacuum tube, (best, using a G21 sterile needle). Mix the
blood by inverting gently the tube 8 times.
6.1.3 If using other means for blood collection, use heparin as the anti-coagulant.
Note: Blood should be transferred to the SMARTube™ and put into incubation the same
day (within 24 hours, at room temperature).
In the Laboratory:
6.1.4 Record the incoming blood samples in Blood Sample Log-in Book.
6.1.5 Label the SMARTube™ accordingly.
6.1.6 Set up the culture in the SMARTube™ by mixing the blood and then, aseptically,
adding 1 ml blood to SMARTube™ with a sterile disposable pipette. Re-cap the
SMARTube™ lightly (’one click’ not two)
6.1.7 Incubate SMARTube™ with blood in 36.5-37.5C, 5% CO2 humidified incubator for
3-4 days as described in Table 1.
Note: Be careful not to close the cap tightly, in order to allow gas exchange.
Note: Record draw time and incubation time in “Laboratory Sheet”.
9
Page
10. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
6.1.8 Spin down, or let the RBC settle to the bottom of the tube and then transfer some
of the plasma (~1 ml) into an eppendorf tube, mark it accordingly and keep for future
testing (refrigerated for several days or frozen <-20oC for longer periods.).
Use the rest of the plasma for testing for HIV and/or HCV antibodies using the current
routine and testing algorithms (ELISA, WB).
6.1.9 At the end of the incubation period of the sample in the SMARTube™ (5 days, with
minimum 3 days in a blood bank) aspirate the upper phase (ST supernatant fluid with
plasma = “SMART-plasma”) and transfer to sterile, screw cap, Eppendorf tubes (or other
small test tubes), mark accordingly.
6.1.10 Write the incubation stop date and time in the “Laboratory Sheet”*.
6.1.11 Test the SMART-plasma and the plasma for HIV (and/or HCV) antibodies using the
routine ELISA kits (compensate for the dilution – see "instructions for use", and “notes and
tips”). If positive, confirm result by repeat ELISA testing (on a different kit?), and WB where
relevant.
6.1.12 Freeze all the remaining SMART-plasma immediately at -80C (or > 20C), for future
testing.
6.1.13 The Optical Density (OD) results, the Cut Off (CO), the positive control value(s), the
kit’s name, and the plate number will be recorded together with the OD of the plasma and
/or the SMART-Plasma.
6.2 Methodology to be adopted:
6.2.1 HIV and/or HCV antibodies detection:
6.2.1.1 The level of HIV and/or HCV antibodies in plasma and in SMART-Plasma after
incubation of blood in SMARTube™ will be detected using the same ELISA kits used
routinely by the laboratory and/or blood bank. The loading conditions of the samples will
be modified to achieve a final plasma concentration as recommended in the kit. To this
end, when possible, 5 times the recommended volume of ST-Plasma will be loaded on the
10
plates. Diluent should be adjusted to obtain the same final volume, as mentioned in the
instructions for use.
Page
11. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
6.2.1.2 The volume of SMART-Plasma used on the ELISA will be adjusted as described in
6.2.1.1. Examples for correction for the dilution of the plasma in the SMARTube™,
depending on the kit used and the volume of plasma it requires:
Full compensation:
10ul plasma + 100ul diluent = 50ul ST-Plasma + 60ul diluent
10ul plasma + 90ul diluent = 50ul ST-Plasma + 50ul diluent
Partial compensation
20ul plasma + 80ul diluent = 100ul ST-Plasma + 10ul diluent
50ul plasma + 50ul diluent = 100ul ST-Plasma + 10ul diluent
No compensation
100ul plasma = 100ul ST-Plasma
Stimmunology has been tried using different ELISA kits and different plasma volumes required. In
all settings, plasma positives were also positive after the SMARTube™.
6.3 Culture Incubation days
Day in Day out (day 3) Day Out (day 4)
Sunday Wednesday Thursday
Monday Thursday Friday
Tuesday Friday Saturday
Wednesday Saturday Sunday
Thursday Sunday Monday
Friday Monday Tuesday
Saturday Tuesday Wednesday
6.4 Interpretation of results:
Any sample, with or without the SMARTube™ pre-treatment, which tests positive for HIV or HCV
antibodies according the site’s algorithm, is positive for HIV or HCV infection respectively.
11
Sensitivity and specificity of the results are dependent on the kit itself and its intrinsic qualities.
Page
12. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
7. Comments and notes:
1. The SMARTube™ is simple to use and no complex training is required. A CO2 incubator is a
must as the incubation in the SMARTube™ is a tissue culture step requiring “body-like”
conditions for the proliferation and differentiation of the relevant lymphocytes leading to
antibody production in-vitro, against the HIV and/or the HCV virus which was encountered in-
vivo.
2. The above outline is a minimal one. Based on the interests of the principal investigator(s)
many additional questions can be addressed, both immunological and epidemiological. These
can be incorporated into the basic initial study, or be designed as a complementary or
continuation study. Many questions can be asked using the same initial blood draw, with
specific tests run either in parallel or following the initial study. Others might require follow-
up samples, on later dates, parallel to and following the conclusion of the initial study.
12
Page
13. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Administrative and Financial Issues
13
Page
14. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
8. Economic/ Financial Implications
Since the SMARTube™ is implemented within the existing testing and laboratory set-up, the
additional expenses are only:
1. Pipettes for 1ml blood transfer.
2. Test tubes for storing SMART-plasma for future testing and research.
3. The additional testing of SMART-plasma, (as it is done parallel to the regular plasma
testing) for HIV and/or HCV antibodies.
• Each site should have a (5%) CO2 incubator set to 37oC for the culture step in the
SMARTube™.
• Training is minimal and the additional technician time is very small and can be calculated
as per the additional work listed above.
• The total additional cost, per sample, can be calculated based on the local cost of testing
kits, with the additional (minimal) expenses for a pipette and two test-tubes.
Scope of study –
8.1 Basic Study - testing, for antibodies only for HIV and/or HCV. (Sample size 1-200)
8.2 Medium Study – testing, for antibodies only for HIV and/or HCV. (Sample size 201-500)
8.3 High Level Study – testing, for antibodies for HIV and/or HCV. (Sample size 501-above)
14
Page
15. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
9. Equipment and Materials Required:
9.1 ELISA kits for HIV and/or HCV.
9.2 SMARTube™ HIV&HCV (stored refrigerated, brought to room temp prior to use)
9.3 Humidified CO2 incubator set at 370C and 5% CO2
9.4 Sterile plastic Pasteur pipettes (1 ml)
9.5 Sterile Eppendorf tubes (or other small test tubes), screw cap, for repeat testing,
confirmation testing, and for freezing samples for future testing.
10. Sharing of Responsibilities
10.1 What we Eternal Well Foundation will provide?
• Eternal Health & Wellness Foundation will provide technical support to the research site for
data analysis and use of SMARTubeTM
• Eternal Health & Wellness Foundation will facilitate the research site wherever possible with
information/ research and scientific insight from the experiences gained in the other
countries
• Eternal Health & Wellness Foundation will not fund the research/ efficacy study but will be
happy to provide SMARTubeTM (s) required for the research at the following highly
subsidized and special concessional rates:
• Basic Study (Sample size 1-200)
o Eternal Health & Wellness Foundation will provide 75 SMARTubeTMs FREE
• Medium Level Study (Sample Size 201-500)
o Eternal Health & Wellness Foundation will provide 125 SMARTubeTMs FREE
• High Level Study (Sample Size 501 – Upwards)
o Eternal Health & Wellness Foundation will provide 200 SMARTubeTMs FREE
15
• Additional number of SMARTubeTM s required for the trails/ efficacy studies will be provided
Page
at the rate of 3 Euro per SMARTubeTM
16. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
10.2 What is expected of you (Research Site)?
• To conduct feasibility studies for implementation of SMARTube™ in India, and to measure
the rate of new infections in the studied populations using SMARTube™ HIV&HCV for
indentifying the HIV and HCV infections during the window-period leading to a healthier
society and a safer blood supply in India.
• The site will be responsible for the collection of the blood, the incubation in the
SMARTube™, and the antibody testing as per mutually agreed time line for initiation of the
study, its completion, conclusions, and future recommendations.
• The site will be responsible for the data management, as per the agreed protocols and
format, and for the storage of the samples for future use
• The site will be responsible for timely completion of the study as per agreed schedule.
• All data will be shared in an open and cooperative form. Eternal Health & Wellness
Foundation shall have access to information about the progress of the study and its
direction.
• The research institute will provide copy of the data, final report and recommendations to
Eternal Health & Wellness Foundation before releasing it to any third party.
• The final report and recommendation will be published only in consultation and with the
consent of Eternal Health & Wellness Foundation.
16
Page
17. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Additional Inputs for Clinical Trial
17
Page
18. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
11. Instructions for Use:
For using SMARTube™ HIV&HCV as a blood pre-treatment prior to HIV or HCV antibody testing
of a blood sample.
1. Limit exposure of SMART media to fluorescent lights (refrigerators for SMARTubeTM store
should not be with glass doors).
2. Blood should be collected into heparin and transferred to the laboratory within 20 hours at
room temperature (RT) (15-25oC).
3. Transfer 1ml of blood (mixed well) into a properly marked SMARTube™ at RT under
aseptic/clean conditions. (See “Notes and Tips” #6).
4. Re-cap the SMARTube™ in the loose position (one click instead of two), and put into 5% CO2
incubator, at 37 oC (CO2 gas phase in the incubator can be anywhere between 5% and 7%, best
set at 5%). Write the date on the tray. (You might want to already mark the planned “out” date
also on it so it is easier to follow).
5. After 3-5 days (best results are obtained on day 5), take the SMARTube™ samples out of the
incubator, and use the supernatant as the sample on the ELISA antibody test used in the lab.
6. Keep the remaining sample volume refrigerated for repeat or further testing within that day. For
later repeat testing, transfer the supernatant fluid to another, properly marked sterile test tube to
prevent hemolysis, and keep refrigerated. For future reference and long term storage, freeze at -
20oC.
7. Since the plasma has been diluted in the SMARTube™ (1ml of blood = ~0.5 ml of plasma, was
put into 2ml of SMART medium), it is best, when possible, to Compensate for this dilution (x5) in
the sample volume used on the ELISA (See “Notes and Tips” #8).
18
Page
19. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
12. Guidelines for running a laboratory evaluation:
For using SMARTube™ HIV&HCV as a blood pre-treatment prior to HIV or HCV antibody testing
of a blood sample.
1. Clear objectives should be set. These may be either an increase in detection level, or
reduction of false positive/noise, in the HIV and / or HCV antibody testing at the site.
2. Based on the objectives, the scope of the testing to be done, and your time frame, chose
the populations/samples to be tested for evaluation, and number of samples to be run.
3. SMARTube™ enhanced blood samples will be the only samples tested for HIV and/or HCV
antibodies once SMARTube™ is introduced into the routine work of the laboratory, thus
no additional ELISA assays will need to be purchased or preformed. However, during the
evaluation period each blood sample will get tested twice, on the same ELISA -- once with
untreated plasma and once with the SMARTube™ enhanced sample.
4. The key points one could look at during an evaluation:
a. All (true) seropositives are positive also after the SMARTube™.
b. In a few seropositives, elevated antibody levels might be measured after the
SMARTube™ enhancement step (due to early seroconversion status of the
donor/patient). Conclusion: Increased sensitivity of your assay and enabling
evaluation of incidence levels.
c. In a population with a high incidence level, and with the right population size to be
tested, additional antibody positive(s) will be detected. Conclusion: Increased
sensitivity of your assay by detecting those previously missed, enabling the detection
of those in the window period, and giving a more true indication of the current state
of the epidemic, for both prevalence and incidence information.
d. When using an assay system with a high false positive rate, some false positives
(mostly those due to noise or interfering materials), will test negative after the
SMARTube™ enhancement step, thus increasing specificity of your assays.
REMEMBER:
19
• Every infection missed, means tens of lives risked.
• Every infection diagnosed means saving the life of just as many, if not more.
Page
20. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
13. Notes and Tips:
For using SMARTube™ HIV&HCV as a blood pre-treatment prior to HIV or HCV antibody testing
of a blood sample.
The CO2 incubator:
1. Use a SMARTube™ (with no blood in it) constantly monitor CO2 levels in incubator by
observing the color daily (color should correspond to 6.6-7.0).
2. Use a thermometer in the incubator to monitor the temperature.
3. A CO2 cylinder of 27kg should last for 4-6 months. It is best to have a backup cylinder.
4. Since the osmolality of culture media can rise as a result of evaporation CO2 incubators
must be well humidified in order to prevent evaporation from SMARTube™.
Transferring blood into the SMARTube™:
5. Take out of the refrigerator the SMARTube™(s) to be used during the day, and keep at
Room Temperature (RT 18-30oC), as SMARTube must be at RT before adding the blood.
6. The blood transfer should be done aseptically.
a. Use only fresh blood drawn within the last 20 hours into heparin, and kept at RT.
b. Do not open the SMARTube™ in an unclean environment. This could lead to
contamination, which could affect the results.
c. If a hood is not available and work is done at the bench then:
Clean and disinfect the area/bench/table which you plan to work on, and your
gloves/hands.
Lite a flame (gas Bunsen, spirit flame, or candles) to provide semi-sterile
20
environment for the transfer of the blood into the SMARTube™. Work close to the
Page
flame.
21. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
d. Before adding blood to the SMARTube™ mixes the sample well and check that there is NO
coagulation.
e. Use a sterile pipette/tip for blood transfer, and a new pipette for each blood sample.
f. Immediately after transferring the blood of all samples into the SMARTubes™, incubate the
SMARTube™ with cap in the loose / ventilating position (one “click” of the cap and not two).
Using the SMARTube™ enhanced sample for HIV or HCV antibody testing:
7. At the end of the incubation (day 5) the ST-supernatant is tested for antibodies. The tubes
can be kept in the cold for immediate testing and repeat testing. It is recommended that
you keep the samples for additional testing you might want to perform in the future. For
that you should collect the ST-supernatants to a sterile test tube, seal, and freeze at -20oC
or -80oC (best). Once the samples inside the SMARTube™ are out of the incubator, it is best
to close the cap.
8. To test for the antibodies in the sample after the SMARTube™ incubation step
(STsupernatant), follow the instructions of the ELISA kit. However, when applying the
sample to the ELISA one should take into account the 1:4 = X5 dilution of the plasma which
has already occurred when 1ml of blood, i.e. ~0.5 ml of plasma, was put into 2ml of
SMARTmedium.
Full compensation:
10ul plasma + 100ul diluent = 50ul ST-Plasma + 60ul diluent
10ul plasma + 90ul diluent = 50ul ST-Plasma + 50ul diluent
Partial compensation
20ul plasma + 80ul diluent = 100ul ST-Plasma + 10ul diluent
50ul plasma + 50ul diluent = 100ul ST-Plasma + 10ul diluent
No compensation
100ul plasma = 100ul ST-Plasma
21
The SMARTube™ has been tested using different ELISA and different plasma volumes
Page
required. In all settings, plasma positives were also positive using the SMARTube™.
22. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
9. The SMARTube™ should become the blood pre-treatment of choice in testing for HIV and
HCV to enable more complete detection of HIV and HCV infected individuals.
10. However, should you choose to run the two assays in parallel, these are the results you can
expect to see:
All true plasma positives will be SMARTube™ positives.
Some of the plasma positive samples will have higher antibody levels following the
SMARTube™ incubation (= earlier months after seroconversion).
Seeing a higher O.D. reading will depend on the level of compensation for the
dilution of 1:4 (=5x) when putting sample on the ELISA.
Some plasma negatives will be SMARTube™ positive (= very early infection, still in
the window period).
Most plasma-negatives will also be SMARTube™ negatives (that is, not-infected).
Some samples which fall into the “gray zone” reading would be cleared in the
SMARTube™ sample as either a true positive (reading above the “grey zone”) or a clear
(low) negative. Also some false positive plasma readings (which will not be repeat
positive) could read negative from the start in the ST-supernatant This is because using
SMARTube™ reduces the false positives reported by some kits).
22
Page
23. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Table 1. O.D. HIV readings with FULL dilution compensation.
Table of O.D. readings as example of SMARTube™ enabled results using an HIV antibody ELISA
with full compensation for the dilution by using a larger volume of sample on the ELISA. The cutoff
was 0.140
Sample # (for Plasma O.D. (10ul+ SMARTube™ O.D. Diagnosis & [comment]
ref. only) 90ul diluents) (50ul+50ul diluents)
001 0.012 0.016 Negative
002 0.090 0.020 Negative [less noise]
003 0.138 0.026 Negative [an almost false positive–
cleared]
004 0.142 0.030 Negative [false positive due to
noise – cleared]
005 0.157 0.280 Positive [increase in antibody
levels to a clear positive-> early
seroconversion]
006 0.508 0.783 Positive [increase in antibody
levels -> early seroconversion]
007 1.882 2.701 Positive [increase in antibody
levels -> early seroconversion]
008 2.850 3.000 Positive [increase in antibody
levels -> early seroconversion]
008 2.678 2.640 Positive [ no increase in antibody
levels -> later seroconversion]
009 2.898 2.752 Positive [ no increase in antibody
levels -> later seroconversion]
010 1.703 1.112 Positive [ decrease in antibody
levels -> immuno-deficient state]
011 0.087 0.178 Positive [window period]
012 0.026 0.250 Positive [window period]
013 0.043 0.600 Positive [window period]
23
014 0.077 0.822 Positive [window period,
probably close to seroconversion]
Page
24. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Table 2. O.D. HIV readings WITHOUT full dilution compensation.
Table of OD readings as example of SMARTube™ enabled results using an HIV antibody ELISA with
no complete compensation for the dilution by using a larger volume of sample on the ELISA. The
cutoff was 0.142
Sample # Plasma O.D. (100ul SMARTube™ O.D. Diagnosis & [comment]
(for ref. only) + no diluent) (100ul+no diluent)
001 0.012 0.016 Negative
002 0.090 0.020 Negative [less noise]
003 0.138 0.026 Negative [an almost false positive – cleared]
004 0.142 0.030 Negative [false positive due to noise – cleared]
005 0.157 0.152 Low Positive [increase in antibody levels most
probably hidden in the X5 dilution factor.->
early seroconversion]
006 0.508 0.370 Positive [increase in antibody levels most
probably hidden in the X5 dilution factor ->
early seroconversion]
006a 0.508 0.502 Positive [increase in antibody levels hidden in
the X5 dilution factor -> early seroconversion]
007 1.882 1.701 Positive [increase in antibody levels hidden in
the X5 dilution factor->probably early
seroconversion]
008 2.850 2.822 Positive [increase in antibody
levels might be hidden in the X5 dilution factor
]
008 2.678 2.400 Positive [no info on stage of
seroconversion]
009 2.898 2.598 Positive [no info on stage of
seroconversion]
010 1.703 1.033 Positive [decrease in antibody levels -> either
late seroconversion or early immunodeficient
state]
011 0.087 0.172 Positive [window period]
012 0.026 0.202 Positive [window period]
013 0.043 0.300 Positive [window period]
24
014 0.077 0.377 Positive [window period, maybe
close to seroconversion]
Page
25. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
14. Trouble-shooting:
For using SMARTube™ HIV&HCV as a blood pre-treatment prior to HIV or HCV antibody testing
of a blood sample.
1. Blood sample is (even partially) coagulated. This occurs when the tube has not been mixed
well at the collection site, or not enough heparin was used. Do not use such blood.
2. Blood sample is very hemolytic. It can be used, but severe hemolysis may affect the results.
3. Blood sample collected in an anticoagulant other then heparin. The current formulation
only accepts blood in heparin. If this is problem at your facility, please inquire about other
versions of the SMARTube™.
4. Medium in SMARTube™ is not clear. Do not use.
5. After incubation the supernatant is not clear. Can use with caution as it indicates either a
high lipid content in the plasma or contamination; the latter may affect results.
6. After incubation there are white aggregates close to the red cells but supernatant is clear:
no problem.
7. Longer than 5 days incubation. Supernatant from the SMARTube™ should be tested after 3-
5 days (best on day 5). If cannot be read on day 5, remove the supernatant from
SMARTube™ and put into a sterile, empty test tube, seal and store refrigerated at 2-10oC.
To store more than a few days, freeze at -20oC. Incubation of over 5 days may lead to
reduction in the antibody levels in the sample.
8. When comparing plasma and SMARTube™ results, no additional positives were detected.
The prevalence of individuals in the window period depends on the incidence and the
length of the window period in the tested population. (See #10, below.)
25
9. When comparing plasma and SMARTube™ results, antibody levels in the SMARTube™ are
Page
the same or lower(and not higher) than in the plasma. An increase in antibody levels
26. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
following stimulation in the SMARTube™ is observed only when antibody production in the
body is not at its full capacity. This is so especially during the early stages of the
seropositive state, or in a state of partial tolerance or suppression of the immune response.
The prevalence of individuals in the early sero-conversion period depends on the incidence
and prevalence of the HIV or HCV infection in the tested population. (See # 10, below).
10. Factors that affect the performance of the SMARTube™: While the instructions for use of
SMARTube™ are relatively simple and should lead to expected results, some factors that
could interfere with the performance of the SMARTube™ and affect the results include:
• Contamination of the sample.
• Strong hemolysis of red blood cells.
• Blood sample conditions from collection to SMARTube™ were longer than 24 hours at
room temperature (RT) [15-30oC], or were too hot or too cold.
• Blood sample not mixed well before collecting 1ml for adding to SMARTube™.
• Blood too “old” prior to incubation in the SMARTube™.
• SMARTube™ was not at RT when blood was added.
• Incubation time was outside the recommended range in the SMARTube™ (less than 3
days or longer than 5 days).
• CO2 levels were outside the recommended range (too high or too low).
• SMARTube™ cap was not in half closed (ventilation) position during incubation.
• Freeze-thaw cycles reduce the levels of antibodies in the sample.
• Storage of the SMART supernatant in the SMARTube™ for too long after incubation
period causes exposure to high levels of proteolytic enzymes.
• Kits that are of poor quality or analytically less sensitive.
• Kkit does not detect IgM-- a main component of early antibodies, both in vitro and vivo.
• When looking for the stimulation for additional antibodies (higher O.D. readings) in the
SMARTube™ supernatant, the dilution (1:4 i.e.X5) of the plasma was not taken into
account.
26
Page
27. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
15. Extracts of Clinical Trials in different parts of the world
Clinical studies of the HIV&HCV SMARTube™ for HIV/HCV have been performed in
• China
• USA.
• South Africa,
• Mexico,
• Israel,
• Kenya
China:
Clinical Trials in China were conducted, executed and reported by the Department of Cell
Biology, National Institute for Control of Pharmaceutical and Biological Products. The trials
were done in 5 different regions in China (Total samples tested: approximately 6,000).
1. Trial in high risk population (IVD) in Sichuan District:
HIV
• 653 individuals tested.
• 149 Seropositive.
• 151 Seropositive after pre-treatment in the SMARTube™.
HCV
• 653 individuals tested.
• 389 Seropositive.
• 391 Seropositive after pre-treatment in the SMARTube™.
2. Trials in blood banks:
HIV
• Beijing Blood Bank: 2000 low risk samples, no positives.
• Clearance of false positives by the SMARTube™.
U.S.A
Studies were performed in monkeys. naïve monkeys were infected with a very low dose of
SIV virus (the equivalent to HIV in monkeys).
• 4 monkeys tested.
• 4 seronegative (one week from infection).
• 4 Seropositive after pre-treatment in the SMARTube™ (one week from infection).
27
All monkeys seroconverted between 1-5 months from infection.
Page
28. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
South Africa
Clinical trials were carried out in South Africa among high risk population (blood donors):
HIV
• 90 individuals tested.
• 3 Seropositive.
• 4 Seropositive after pre-treatment in the SMARTube™.
Mexico
Clinical trials were carried out in Mexico, by an approved government agency.
HIV
• 200 Individuals tested, very high risk, multiple, current exposures.
• 20 Seropositive.
• 25 Seropositive after pre-treatment in the SMARTube™.
Israel
Several high risk populations were screened using the SMARTube™ as a blood pre-treatment
device in a number of trials (total: over 2,000 individuals).
1. Immigrants from High risk areas:
HIV
• 537 individuals tested.
• 26 Seropositive.
• 28 Seropositive after pre-treatment in the SMARTube™.
HCV
• 67 individuals tested.
• 1 Seropositive
• 4 Seropositive after pre-treatment in the SMARTube™.
2. Low risk populations were screened using the SMARTube™:
HIV
• Over 1,500 individuals tested – no positives.
28
HCV
Page
• Over 600 individuals tested – no positives.
29. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Kenya
Clinical trials were carried out in Kenya.
1. Screening of high risk population:
HIV
• 555 individuals tested.
• 28 Seropositive.
• 42 Seropositive after pre-treatment in the SMARTube™.
2. Additional trials conducted in the blood bank in Kenya for complete detection of HIV
infected blood units:
HIV
Adults:
• 513 individuals tested.
• 45 Seropositive.
• 66 Seropositive after pre-treatment in the SMARTube™.
Youth:
• 332 individuals tested.
• 12 Seropositive.
• 22 Seropositive after pre-treatment in the SMARTube™.
HCV
• Over 300 individuals tested.
• 13 Seropositive.
• 14 Seropositive after pre-treatment in the SMARTube™.
3. A study was conducted on pregnant women:
HIV
• 40 Seronegative women tested.
• 8 out of the 40 Seronegative women, were positive after pre-treatment in the
SMARTube™. 29
Page
30. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
16. Case Histories – Applications & Benefits
A baby saved:
Mayama was 22 when she came to the antenatal clinic. This was her third pregnancy, yet her fist
visit to that clinic. She has come because her friend told her that she could save her baby if would
go there. She was five months pregnant, and the nurse explained the risks of transmitting HIV to
the un-born baby, and that there was medicine that could save the baby form getting AIDS.
Mayama was tested for HIV, using a rapid test, which was negative. The nurse explained that such
a result does not mean that she is not infected for sure, as she could have been infected in the last
few months, and then the test will not detect it yet. Mayama was worried. She was sure one of her
regular clients on the truck route was sick with AIDS and seeing she got pregnant… When she
shared her fears with the nurse she was told that she could come back in 3 months or so and re-
test. Mayama wanted to know. She was worried, and she really wanted to give that baby the best
chance possible. “I cannot wait for 3 months; if I am infected I want to take the medicine now. In
three months I will give birth, it will be too late. Plus, I cannot come back here heavy with
pregnancy – everyone will talk! The nurse shrugged her shoulders. “There is nothing we can do for
you now. We cannot see the infection during the window period, when the virus is hiding and the
tests are negative. Mayama started crying. The head nurse took her into her office. “There is a new
way we can use to see if you are infected, even if it happened recently. But for that we need to
draw blood and send it to the laboratory in town. The results will come back next week. You will
need to come back then, and if you're positive we will give you the ART.” Mayama agreed to come
back. A test tube with her blood was sent to the laboratory. There they treated the blood with the
SMARTube™, an innovative blood pre-treatment which closes the window period and thus
eliminates the false negative results in the early stages of the infection. On the fifth day, the lab
sent the results back to the clinic. While negative on the tests using the regular methods,
Mayama was clearly positive after the SMARTube™ step that was added in the laboratory to the
testing. When Mayama came back, she got the results with tears of fear and a smile of relief.
She was going to save her baby; she was going to get the drugs to protect him from the virus
that has invaded her. As she was walking out of the clinic, holding on to the medicine for both her
and for the baby, when it will be born, she turned around and ask the head nurse “How do they do
it, there in the laboratory? How can see what is still hidden”. “Well” answered the nurse, “ it is as
if they go behind the stage and peak into the dressing rooms, this way they know about the actors
even before they get on stage”. Mayama gave birth to healthy baby girl.
30
Page
31. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
If we only knew!
Katub had her fifth child less than a year after she immigrated to Israel. Upon arrival her whole
family had their blood tested for different things, including HIV. Her husband was the only one
that tested positive for HIV. He figured he must have gotten it in the camp on route to Israel.
Katub was upset, but relieved for herself and the unborn baby. The baby was born slightly
underweight, but pink and beautiful. When he was six months old he had a bad cold that would
not go away. Then, the doctor said it was probably some infection in the lungs. The antibiotics did
not help. The baby was hospitalized, but could not be saved. In the blood tests, he was found to
be HIV positive, but it was too late, he died of lung infection typical to AIDS patients. The doctors
were upset. “ If only you would have told your doctor that you are HIV positive, you could have
saved that baby. We know how to treat these type of infections, we just do not suspect it in a baby
without an HIV record.” Katub was very bewildered. How could she transmit HIV to her baby if she
is not infected? Did they not tell her in the immigration center that she tested negative? She told
the doctors it must be a mistake. “No”, said the young doctor, “it is not a mistake. Unfortunately
we cannot detect the HIV infection in the first few months. You must have gotten infected shortly
before the pregnancy, this is why the results were negative, but it was not a true negative result.
A year later, in a scientific-medical conference, An immunologist presented some interesting
results with a new method which enables the detection of those infected even when still missed
by regular testing in the first months of infection. She called the method “Stimmunology”, as it
stimulates the immune system in the blood sample to “tell” us about the infection “right away”. “I
would like to share with you some alarming results we got when studying some families with one
seropositive HIV carrier. We used the Stimmunology process for stimulating antibody production
even in blood samples form infected individuals during the window period. This was we can detect
them using the regular diagnostic antibody tests.” On the screen appeared results showing
seronegative wives who were actually infected, and their infected babies. The doctors in the
audience sighed “If only we would have known”.
Building a new relationship.
Seth and Diane decided to move in together and formalize their relationship. They both went
together for HIV testing, and, to their relief, both tested negative. Because of their lifestyle, Seth’s
doctor recommended to do an additional blood test using an experimental pre-treatment of the
31
blood in the university laboratory. They agreed. The following week the doctor called them in for
consultation and told then that using the experimental new technology; Seth was found to be
Page
infected with HIV. “It must be a recent encounter, in the last half a year or so” said the doctor.
32. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
“But it is still experimental, right” said Seth hopefully… Diane was silent all the way home. They
have been together for some time now, she wanted to believe Seth that “it could not be”, yet she
insisted that for their future they should use precaution “Just for the next few months. The
window period is not forever, right?” Three months later, Seth tested positive in a routine
testing.
Organ donor
Sheila has been waiting for a kidney transplant for 2 years. The phone finally rang with the news –
we have a donor. The young motorcyclist was brain dead and his family agreed to donate his
organs. A battery of tests was run, including HIV and HCV antibody tests. All came negative.
Additional testing was using very sensitive molecular biology techniques to detect the virus even
before the antibody tests detect the infection. They were negative for both HIV and HCV. Sheila
got the kidney, and stayed on immunosuppressive drugs to reduce the risk of rejection of the
transplanted kidney. Less than a year later, Sheila was diagnosed with HIV and HCV infection.
The source of the infection was the transplanted kidney. All the recipients from that donor were
now positive for HIV and HCV. When Sheila sued the hospital the doctors testified that they have
used all known measures for testing the donor for these infectious and deadly viruses. “But even
with the most sensitive tests, there is a window period in which we cannot detect the infection,
and this window period can take three to six months and sometimes even longer” testified the
laboratory expert. “So there is nothing that could have been done?” asked Sheila’s lawyer. “Well,
responded the expert “there is a way to eliminate that window period. It is a simple system of pre-
treating the blood in a way that expresses the antibodies prior to their appearance in the body. It
works like magic; it exposes those early infections we currently miss.” “So if you would have used
that method, you would have been able to prevent all those terrible infections! Why did you not
use it?!”. “We do, but only experimentally, and unlinked, as it has not yet been approved for use in
our country...” responded the expert.
32
Page
33. Corp Office: 10160 Medlock Bridge Road, Duluth, GA 30097 (USA)
Ph: 770-495-0011, Fax: 770-495-0012
India Office: C-33A Shastri Nagar, Ghaziabad-201002 (UP) INDIA
Mob: 9999989066, 9818666863
Follow Up Questions / Clarifications:
Finally, please do not hesitate to contact us with whatever technical or practical
questions or comments you might have. When you send us the data from these
evaluations, we can assist with the data analysis, sharing thoughts and ideas as to
the implications of the data which come up during the evaluation period.
For More Details Contact:
Eternal Health & Wellness Foundation (USA)
India Branch Office
Mob: 9999989066, 9818666863
33
Page