This document provides instructions for using the Novel Coronavirus (COVID-19) RT-PCR Kit for detecting SARS-CoV-2. The kit contains reagents for extracting viral RNA from patient samples and performing real-time PCR to detect ORF1ab, N, and/or E genes. The procedure involves extracting RNA from respiratory samples, preparing a master mix, adding samples and controls to PCR tubes, and running PCR with specified cycling conditions. Positive and negative controls are included to validate the results. Precautions are described to handle samples and reagents safely and avoid contamination.
Care start access bio antigen test covid 19 biotechh commerceHafsaWadood1
The care start covid-19 antigen test is a lateral flow immuno-chromatographic assay, for the qualitative detect of the SARS coronavirus nucleo-capsid protein (major antigen). It is a rapid, easy, diagnostic test for the qualitative detection of Covid-19 antigen. This device is intended for use at Point of Care (POC) testing services.
The document discusses quality assurance and regulatory control in the pharmaceutical industry. It describes key aspects of quality assurance including regulatory drug analysis and interpretation of data. Regulatory authorities like the FDA and DDA in Nepal establish rules and regulations to ensure safety, efficacy and quality of drugs. The FDA oversees drug approval and manufacturing inspections through centers like CDER. It also works with other agencies on issues like advertising claims (FTC), environmental protection (EPA), and workplace safety (OSHA). Similarly, Nepal's DDA regulates drug production, import/export, storage and consumption to implement the objectives of the Drug Act 2035.
The document provides an overview of current good manufacturing practices (cGMP) regulations for pharmaceutical manufacturing. It discusses the history of drug regulation in response to safety issues. cGMP regulations aim to ensure quality, safety and efficacy and are enforced through inspections by the FDA. Inspections follow a systems-based approach and aim to determine compliance with cGMP regulations.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
Care start access bio antigen test covid 19 biotechh commerceHafsaWadood1
The care start covid-19 antigen test is a lateral flow immuno-chromatographic assay, for the qualitative detect of the SARS coronavirus nucleo-capsid protein (major antigen). It is a rapid, easy, diagnostic test for the qualitative detection of Covid-19 antigen. This device is intended for use at Point of Care (POC) testing services.
The document discusses quality assurance and regulatory control in the pharmaceutical industry. It describes key aspects of quality assurance including regulatory drug analysis and interpretation of data. Regulatory authorities like the FDA and DDA in Nepal establish rules and regulations to ensure safety, efficacy and quality of drugs. The FDA oversees drug approval and manufacturing inspections through centers like CDER. It also works with other agencies on issues like advertising claims (FTC), environmental protection (EPA), and workplace safety (OSHA). Similarly, Nepal's DDA regulates drug production, import/export, storage and consumption to implement the objectives of the Drug Act 2035.
The document provides an overview of current good manufacturing practices (cGMP) regulations for pharmaceutical manufacturing. It discusses the history of drug regulation in response to safety issues. cGMP regulations aim to ensure quality, safety and efficacy and are enforced through inspections by the FDA. Inspections follow a systems-based approach and aim to determine compliance with cGMP regulations.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
Accredited Consultants Pvt Ltd provides regulatory consulting services for new drug approval in India. The Drug Controller General of India regulates drugs and medical devices through the Central Drugs Standard Control Organization. New drug approval involves submitting a Common Technical Document with information on quality, non-clinical studies, and clinical studies. Approval takes approximately one year and involves fees of Rs. 50,000. After approval, an import license must be obtained through additional documents and fees in order to import the drug. The import license process takes about one month.
The document discusses Thailand's drug control and registration system. It outlines the organization of the Drug Control Division within the Thai Food and Drug Administration and describes the drug licensing and registration processes. The drug registration system classifies drugs into new drugs, new generic drugs, and generic drugs and details the review process for new drug and new generic drug registration applications. It also discusses Thailand's safety monitoring program for new drugs and efforts to harmonize regulations with ASEAN standards.
Binax now home users guide by hafsa wadoodHafsaWadood1
The document provides instructions for using the BinaxNOW COVID-19 antigen card home test kit. It explains how to perform the test with a nasal swab sample, read the test results, and interpret the results. A negative result means COVID-19 proteins were not detected, while a positive result means proteins were detected and COVID-19 is very likely. An invalid result occurs if no lines or unexpected lines appear. Results will be sent via the NAVICA app and patients should consult their healthcare provider for next steps.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The document discusses regulatory requirements for ABM Medical's StopLoss surgical hemostat product in the United States, European Union, and Canada. Key points include:
1) StopLoss is a class III medical device in the US and will require premarket approval (PMA) due to its potential high risk and use of biological components.
2) In the EU, StopLoss will be classified as a class III device and require review by a Notified Body for conformity assessment.
3) In Canada, StopLoss will be a class IV device due to the extremely high consequences if it stops working or malfunctions, and will require a medical device license from Health Canada.
The document outlines the drug registration process in India. It describes the regulatory bodies like the Drug Controller General of India and its subordinate offices. It provides details on the fees, various required documents like legal forms, manufacturing licenses, quality certificates, and technical documents like plant master files, device master files, labels, and inserts. It explains the submission and processing procedure that takes around 2-3 months to scrutinize the documents and issue a registration certificate. It also describes the subsequent import license application process.
This document provides an overview of Good Distribution Practices (GDP) for pharmaceutical products. It discusses that GDP aims to ensure quality and identity of pharmaceuticals during distribution by establishing adequate controls over handling, storage and distribution. It outlines key requirements for GDP certification including personnel training, documentation, storage and transportation procedures to prevent issues like contamination or mixing of products. Obtaining GDP certification demonstrates a company's commitment to quality and safety standards across its entire pharmaceutical supply chain.
Dr. Eric Gordon - Discussion on the Veterinary Feed Directive Integration in ...John Blue
Discussion on the Veterinary Feed Directive Integration in Small Ruminant - Dr. Eric Gordon, The Ohio State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
This document discusses Schedule M, which outlines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing in India. Schedule M was first implemented in 1988 and further amended in 2001. It describes requirements for factory premises, plants, and equipment for manufacturing drugs, pharmaceuticals, homeopathic preparations, cosmetics, and medical devices. The document outlines specific GMP requirements for sterile products, oral solid dosages, oral liquids, topical products, metered dose inhalers, and active pharmaceutical ingredients. It also references additional sources that provide more information on intellectual property rights and drug regulatory affairs in relation to Schedule M.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
There are three systems for registering pesticides in Pakistan - Form 17, Form 16, and Form 1. Form 17 allows registration of new pesticides without trials, while Form 16 allows registration of certain pre-approved pesticides without trials. Form 1 requires trials and is the only system that allows registration of any pesticide. The document outlines the requirements and process for registration under each form. Registration certificates must be renewed every three years by submitting the prescribed form and payment of fees.
M. Suresh is an analytical chemist seeking a position to further develop his skills in research. He has over 4 years of experience in method development and validation, instrument calibration and maintenance, and analysis of samples using techniques like ICP-OES, UV-Vis, FT-IR, GC-MS, and HPLC. He is trained in quality management systems and has experience ensuring compliance with standards like ISO/IEC 17025, REACH, and RoHS.
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include application forms, fees, certificates and other documentation depending on the IVD classification. If the application is complete, an import license will be issued within three months. The document provides contact information for Accredited Consultants Private Limited, the organization assisting with IVD imports to India.
The document discusses quality control procedures for a microbiology laboratory. It outlines monitoring, evaluating, and record keeping for equipment, reagents, media, and test procedures to ensure accurate and reproducible results. Reference strains are listed for quality control testing of Gram stains, culture media, antibiotic disks, and other reagents. Acceptance and rejection criteria are provided for specimens to ensure only suitable samples are tested.
This document provides instructions for using the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) for the qualitative detection of SARS-CoV-2 in respiratory specimens. The kit uses real-time RT-PCR to detect SARS-CoV-2 RNA and includes positive and negative controls. Test results along with clinical observations are needed for accurate patient diagnosis and management. Strict laboratory procedures and biosafety precautions must be followed when handling specimens and performing the test.
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by...HK HuZef
The document provides instructions for using the CareStart COVID-19 Antigen rapid diagnostic test. It is a lateral flow test intended to qualitatively detect SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swabs. The test involves extracting the swab in buffer, adding drops of extracted sample to the test cassette, and reading results at 10 minutes. Positive results require lines in both the test and control lines, while negative results have only a control line.
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 µg/mL were
tested in a separate study. Biotin concentrations up to 1.25 µg/ml did not lead to false results.
Biotin concentrations ≥2.5 µg/ml can cause false-negative COVID-19 results with the
CareStart™ COVID-19 Antigen.
High-dose Hook Effect
The CareStart™ COVID-19 Antigen was tested up to 105 TCID50/ml of heat-inactivated SARSCoV-2 strain and no high-dose hook effect was observed.
Point of Care Use
The CareStart™ COVID-19 Antigen was demonstrated at near patient or Point of Care (POC)
testing that non-laboratory personnel can perform the test accurately in the intended use
environment. In addition, the robust use of the CareStart™ COVID-19 Antigen for near patient
or Point of Care (POC) testing was demonstrated by thirteen (13) Flex studies.
Technical Support
For questions, or to report a problem, please call Technical Support at +1-888-898-1270
(Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or TShelp@accessbio.net (24/7 available).
Test system problems may also be reported to the FDA using the MedWatch reporting system
(phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch)
For Emergency Use Authorization (EUA) Only
The CareStartTM COVID-19 Antigen test is a lateral ow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within ve days of symptom onset.
IMPORTANT!
- Refer to the Package Insert for Warnings and Precautions, Specimen Collection Procedures, Storage and Handling Conditions, and Quality Control Recommendations.
- Warning and Precautions - All kit components can be discarded as Biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information.
- Biotin Interference: False negative results may occur in patients who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
- The extracted sample must be used within 4 hours of preparation when stored at room temperature.
- Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
Accredited Consultants Pvt Ltd provides regulatory consulting services for new drug approval in India. The Drug Controller General of India regulates drugs and medical devices through the Central Drugs Standard Control Organization. New drug approval involves submitting a Common Technical Document with information on quality, non-clinical studies, and clinical studies. Approval takes approximately one year and involves fees of Rs. 50,000. After approval, an import license must be obtained through additional documents and fees in order to import the drug. The import license process takes about one month.
The document discusses Thailand's drug control and registration system. It outlines the organization of the Drug Control Division within the Thai Food and Drug Administration and describes the drug licensing and registration processes. The drug registration system classifies drugs into new drugs, new generic drugs, and generic drugs and details the review process for new drug and new generic drug registration applications. It also discusses Thailand's safety monitoring program for new drugs and efforts to harmonize regulations with ASEAN standards.
Binax now home users guide by hafsa wadoodHafsaWadood1
The document provides instructions for using the BinaxNOW COVID-19 antigen card home test kit. It explains how to perform the test with a nasal swab sample, read the test results, and interpret the results. A negative result means COVID-19 proteins were not detected, while a positive result means proteins were detected and COVID-19 is very likely. An invalid result occurs if no lines or unexpected lines appear. Results will be sent via the NAVICA app and patients should consult their healthcare provider for next steps.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The document discusses regulatory requirements for ABM Medical's StopLoss surgical hemostat product in the United States, European Union, and Canada. Key points include:
1) StopLoss is a class III medical device in the US and will require premarket approval (PMA) due to its potential high risk and use of biological components.
2) In the EU, StopLoss will be classified as a class III device and require review by a Notified Body for conformity assessment.
3) In Canada, StopLoss will be a class IV device due to the extremely high consequences if it stops working or malfunctions, and will require a medical device license from Health Canada.
The document outlines the drug registration process in India. It describes the regulatory bodies like the Drug Controller General of India and its subordinate offices. It provides details on the fees, various required documents like legal forms, manufacturing licenses, quality certificates, and technical documents like plant master files, device master files, labels, and inserts. It explains the submission and processing procedure that takes around 2-3 months to scrutinize the documents and issue a registration certificate. It also describes the subsequent import license application process.
This document provides an overview of Good Distribution Practices (GDP) for pharmaceutical products. It discusses that GDP aims to ensure quality and identity of pharmaceuticals during distribution by establishing adequate controls over handling, storage and distribution. It outlines key requirements for GDP certification including personnel training, documentation, storage and transportation procedures to prevent issues like contamination or mixing of products. Obtaining GDP certification demonstrates a company's commitment to quality and safety standards across its entire pharmaceutical supply chain.
Dr. Eric Gordon - Discussion on the Veterinary Feed Directive Integration in ...John Blue
Discussion on the Veterinary Feed Directive Integration in Small Ruminant - Dr. Eric Gordon, The Ohio State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
This document discusses Schedule M, which outlines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing in India. Schedule M was first implemented in 1988 and further amended in 2001. It describes requirements for factory premises, plants, and equipment for manufacturing drugs, pharmaceuticals, homeopathic preparations, cosmetics, and medical devices. The document outlines specific GMP requirements for sterile products, oral solid dosages, oral liquids, topical products, metered dose inhalers, and active pharmaceutical ingredients. It also references additional sources that provide more information on intellectual property rights and drug regulatory affairs in relation to Schedule M.
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.
There are three systems for registering pesticides in Pakistan - Form 17, Form 16, and Form 1. Form 17 allows registration of new pesticides without trials, while Form 16 allows registration of certain pre-approved pesticides without trials. Form 1 requires trials and is the only system that allows registration of any pesticide. The document outlines the requirements and process for registration under each form. Registration certificates must be renewed every three years by submitting the prescribed form and payment of fees.
M. Suresh is an analytical chemist seeking a position to further develop his skills in research. He has over 4 years of experience in method development and validation, instrument calibration and maintenance, and analysis of samples using techniques like ICP-OES, UV-Vis, FT-IR, GC-MS, and HPLC. He is trained in quality management systems and has experience ensuring compliance with standards like ISO/IEC 17025, REACH, and RoHS.
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include application forms, fees, certificates and other documentation depending on the IVD classification. If the application is complete, an import license will be issued within three months. The document provides contact information for Accredited Consultants Private Limited, the organization assisting with IVD imports to India.
The document discusses quality control procedures for a microbiology laboratory. It outlines monitoring, evaluating, and record keeping for equipment, reagents, media, and test procedures to ensure accurate and reproducible results. Reference strains are listed for quality control testing of Gram stains, culture media, antibiotic disks, and other reagents. Acceptance and rejection criteria are provided for specimens to ensure only suitable samples are tested.
This document provides instructions for using the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) for the qualitative detection of SARS-CoV-2 in respiratory specimens. The kit uses real-time RT-PCR to detect SARS-CoV-2 RNA and includes positive and negative controls. Test results along with clinical observations are needed for accurate patient diagnosis and management. Strict laboratory procedures and biosafety precautions must be followed when handling specimens and performing the test.
buy carestart covid-19 Antigen test by bio Access Inc, EUA Approvel Letter by...HK HuZef
The document provides instructions for using the CareStart COVID-19 Antigen rapid diagnostic test. It is a lateral flow test intended to qualitatively detect SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swabs. The test involves extracting the swab in buffer, adding drops of extracted sample to the test cassette, and reading results at 10 minutes. Positive results require lines in both the test and control lines, while negative results have only a control line.
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 µg/mL were
tested in a separate study. Biotin concentrations up to 1.25 µg/ml did not lead to false results.
Biotin concentrations ≥2.5 µg/ml can cause false-negative COVID-19 results with the
CareStart™ COVID-19 Antigen.
High-dose Hook Effect
The CareStart™ COVID-19 Antigen was tested up to 105 TCID50/ml of heat-inactivated SARSCoV-2 strain and no high-dose hook effect was observed.
Point of Care Use
The CareStart™ COVID-19 Antigen was demonstrated at near patient or Point of Care (POC)
testing that non-laboratory personnel can perform the test accurately in the intended use
environment. In addition, the robust use of the CareStart™ COVID-19 Antigen for near patient
or Point of Care (POC) testing was demonstrated by thirteen (13) Flex studies.
Technical Support
For questions, or to report a problem, please call Technical Support at +1-888-898-1270
(Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or TShelp@accessbio.net (24/7 available).
Test system problems may also be reported to the FDA using the MedWatch reporting system
(phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch)
For Emergency Use Authorization (EUA) Only
The CareStartTM COVID-19 Antigen test is a lateral ow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within ve days of symptom onset.
IMPORTANT!
- Refer to the Package Insert for Warnings and Precautions, Specimen Collection Procedures, Storage and Handling Conditions, and Quality Control Recommendations.
- Warning and Precautions - All kit components can be discarded as Biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information.
- Biotin Interference: False negative results may occur in patients who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
- The extracted sample must be used within 4 hours of preparation when stored at room temperature.
- Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
TNO Triskelion BSL-3 lab tests anti-viral drugs in newly developed H7N9 influenza model
Human infections with a new avian influenza A (H7N9) virus were first reported in China in 2013, with the loss of 46 lives. In order to meet the growing needs to test new drugs against H7N9, TNO Triskelion has recently developed an H7N9 mouse model. This H7N9 model is suitable for testing new anti-virals such as vaccines, monoclonal antibodies and small molecules in our BSL-3 lab, in conformity with Good Laboratory Practice. TNO Triskelion has proven to be a successful partner in the development of new anti-viral and anti-bacterial vaccines for many years. Understanding the pressures on time lines, we support companies and institutes during the preclinical and clinical stages of drug development.
The MHRA has sent a letter to Peter Wei of Lotus Global Co Ltd confirming registration of Xiamen Jiqing Biomedical Technology Co., Ltd. as a manufacturer of in vitro diagnostic medical devices based on the information provided by Wei as their authorized representative. The letter notes that registration does not represent endorsement of the manufacturer's device classifications and that any changes to the registration information must be reported.
ePI – Electronic Product Information Use Case | Topic #3 of PharmaLedger's 1s...PharmaLedger
Learn more about ePI | Electronic Product Information through PharmaLedger’s Use Case presentation during our #1 Open Webinar about a Trust-Centric Healthcare Journey.
In this ePI | Electronic Product Information Use Case presentation, you will find:
An introduction to the ePi use case presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Current paper product information leaflets and the disadvantages
Advantages of digitising product information leaflets using blockchain
Current product information (leaflet) lifecycle
EMA/HMA key principles
PharmaLedger future vision with blockchain
Connecting the supply chain through the 2D data matrix
PharmaLedger project roadmap
Stakeholder and value proposition
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
This document discusses the importance of blood cultures for diagnosing bloodborne pathogens and the need for optimal blood collection and culture methods. It outlines the current process for blood culture collection and identifies areas for improvement, including faster detection times and greater automation. New technologies like the BacT/AlerT 3D culture system aim to continuously monitor blood cultures and detect pathogens more quickly through non-invasive means.
neoplex pcr test kit [genematrix]genematrix fda_eua -convertedHK HuZef
This letter provides an Emergency Use Authorization from the FDA to GeneMatrix, Inc. for their NeoPlex COVID-19 Detection Kit. The kit is authorized for qualitative detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens from individuals suspected of COVID-19 by a healthcare provider. The authorization allows testing to be performed in CLIA certified laboratories. Numerous conditions are outlined for GeneMatrix, authorized distributors, and laboratories regarding product distribution, labeling, performance monitoring, and reporting of results.
Foregene's detection solution to covid 19Maggie Ma
In response to the Covid-19, Foregene developes the RT-PCR kit within 3 days.Based on Direct PCR tech, test centers needn't buy extra nucleic acid extraction kit and machine, just do PCR directly.It's so economical way. This kit is CE certificated, and welcomed by 10+ countries with stable quality and competitive prices.
The variant nucleic acid detection kit for Brazil, UK,India,and South Africa is also available with high specificity and sensitivity.
Are you a medical device importer?
Welcome your enquiry. E-mail:maggie@foregene.com
2- Pre Requirements for registration of MD.pdfssusercbd395
This document provides information on the pre-requirements for registering medical devices in Oman. It discusses medical device definitions, classifications, and categories. It outlines three stages for medical device registration: before importing, during supply/marketing, and after supplying/marketing. For each stage, it lists specific requirements like manufacturer and product authorization, storage licensing, clearance requirements, and commitments around after-sales support, modifications, disposal, and safety reporting. The overall document serves as a guideline for medical device registration in Oman from import to post-market obligations.
The COVID-19 pandemic, also known as the corona virus pandemic, is an ongoing pandemic of corona virus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome corona virus 2 (SARS‑CoV‑2).
Though several trials for candidate vaccines and potential therapies are underway, there is currently no cure, and in the absence of either proven effective therapy or a vaccine, diagnostic testing becomes a valuable tool. Testing is our window onto the pandemic and how it is spreading. Without data on who is infected by the virus we have no way of understanding the pandemic. Without this data we cannot know which countries are doing well, and which are just underreporting cases and deaths.
At IntellectPeritus, we have collected around 100 diagnostic kits (used in SARS-COV-2 diagnosis) and around 50 patent documents as sample report and have tried to put value added technology categories to generate specific insights quickly using our deliverable “Innovigence Corona”.
If you are interested in detailed or any customized report for SARS-COV-2 diagnostic kits please feel free to write to us at sales@intellectperitus.com
Access bio care antigen US=FDA EUA Approvel LetterHK HuZef
est Principles
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
This document discusses point-of-care and point-of-impact molecular diagnostic testing from a European perspective. It describes how molecular diagnostics is moving towards more commercial multiplex assays and automation. Near-patient testing provides results faster but challenges include defining quality indicators for new rapid assays and ensuring clinical relevance. Standards like ISO15189 and ISO22870 provide guidelines for quality control of centralized and decentralized testing. The changing regulatory landscape in Europe aims to improve safety and transparency for in vitro diagnostics.
The document discusses medical devices and in vitro diagnostics. It provides definitions and classifications of medical devices according to risk levels. It describes types of medical devices including diagnostic, therapeutic, and prosthetic devices. It discusses notified and non-notified in vitro diagnostic kits/reagents in India and examples. The regulation of medical devices in India is discussed along with the Drugs and Cosmetics Act. Manufacturers must comply with quality system regulations.
A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st ...PharmaLedger
In this #1 Open Webinar | A trust-centric healthcare journey presentation, you will find:
An introduction to the PharmaLedger project presented by Lynn Wang (Johnson & Johnson)
Topic 1 | Clinical Supply Traceability presented by Francesco Spoto (Novartis) and Chad Sklodosky (Pfizer)
Topic 2 | Finished Goods Traceability presented by Dr Jan Wortmann (Bayer) and Bernhard Salb (Roche)
Topic 3 | ePI – Electronic Product Information presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Topic 4 | Anti-Counterfeiting presented by Daniel Fritz (Novartis) and Alberto Lòpez (Imprensa Nacional Casa da Moeda)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
This document discusses practical approaches for diagnosing viral diseases in poultry, including clinical diagnosis, rapid field diagnostic tests, serological diagnosis, molecular diagnosis, and isolation/characterization. Clinical diagnosis is based on case history, clinical signs, examination of live/dead birds, and gross lesions. Rapid field tests can detect viruses but require high viral titers. Serological tests detect antibodies but have delays. Molecular diagnosis using PCR technologies can sensitively and specifically detect pathogens. The document emphasizes that clinical signs alone are not confirmatory and that multiple diagnostic approaches should be used to accurately diagnose poultry viral diseases.
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Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
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6. Describe the flow of current around the heart during the cardiac cycle
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9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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1. COVID-19 RT-PCR Kit
(Ultra Sensitivity)
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B3, No. 2054 West Wengjiao Rd.,
Haicang, Xiamen 361028, China
Tel/Fax: +86 592 5210 772
Email: minfenglin@merlinbio.com.cn
www.merlinbio.com.cn
Lotus NL B.V.
Contact person: Peter
Address: Koningin Julianaplein 10,1e Verd,2595AA, The
Hague, Netherlands.
Telephone: +31644168999
E-mail: peter@lotusnl.com
2.
3.
4.
5. Farmatec
Bezoekadres:
Hoftoren
Rijnstraat 50
2515 XP Den Haag
T 070 340 6161
http://hulpmiddelen.farmatec.nl
Inlichtingen bij:
T.I. van Langeveld - Baas
medische_hulpmiddelen@
minvws.nl
Ons kenmerk:
CIBG-20202030
Bijlagen
-
Uw aanvraag
10 mei 2020
Correspondentie uitsluitend
richten aan het retouradres met
vermelding van de datum en
het kenmerk van deze brief.
Pagina 1 van 2
> Retouradres Postbus 16114 2500 BC Den Haag
Lotus NL B.V.
T.a.v. de heer X. Wei
Koningin Julianaplein 10
2595 AA 's-Gravenhage
Datum: 2 juni 2020
Betreft: aanmelding In-vitro diagnostica
Geachte heer Wei,
Op 10 mei 2020 ontving ik uw notificatie krachtens artikel 4, eerste lid van het
Nederlandse Besluit in-vitro diagnostica (BIVD) om onder de bedrijfsnaam Merlin
Biomedical (Xiamen) Co., Ltd met Europees gemachtigde Lotus NL B.V.
onderstaand product als in-vitro diagnosticum op de Europese markt te brengen.
Het product staat geregistreerd als in-vitro diagnosticum onder nummer:
Novel Coronavirus (COVID19) RTPCR Kit,2019nCoV IgG/IgM Rapid
Test Cassette,Single Use Specimen Container
(geen merknaam) (NLCA002202051178)
Hiermee heeft u voldaan aan uw verplichting op grond van artikel 4, BIVD.
In alle verdere correspondentie betreffende bovenvermeld product verzoek ik u dit
nummer te vermelden. Aan dit nummer kunnen geen verdere rechten ontleend
worden, het dient alleen om de notificatie administratief te vergemakkelijken.
De registratie van in-vitro diagnostica als medisch hulpmiddel op grond van de
Classificatiecriteria (Bijlage II) bij Richtlijn 98/79/EG betreffende medische
hulpmiddelen voor in-vitro diagnostiek is onderhevig aan mogelijke revisies van
Europese regelgeving inzake de classificatie van medische hulpmiddelen en aan
voortschrijdend wetenschappelijk inzicht (zie artikel artikel 10, eerste lid van
Richtlijn 98/79/EG).
6. Pagina 2 van 2
Notificatie van in-vitro diagnostische medische hulpmiddelen impliceert dat de
fabrikant, Merlin Biomedical (Xiamen) Co., Ltd de CE-conformiteitsmarkering heeft
aangebracht op het desbetreffende product alvorens het in een EU-lidstaat in de
handel te brengen. Zodoende garandeert Lotus NL B.V. dat het in-vitro
diagnosticum voldoet aan de essentiële eisen zoals opgenomen in bijlage I bij
Richtlijn 98/79/EG (en in het daarmee corresponderende onderdeel 1 bij het
besluit)
Volledigheidshalve wijzen wij u erop dat een in-vitro diagnosticum moet voldoen
aan de eisen uit het BIVD. Het BIVD is gebaseerd op Richtlijn voor in-vitro
diagnostiek, 98/79/EG. Met name wijzen wij u op de Nederlandse-taaleis zoals
deze in Nederland geldt, de eisen voor het ter beschikking houden van de
technische documentatie en de plicht tot het hebben van een Post Marketing
Surveillance- en vigilantiesysteem.
Tot slot merk ik op dat met uw notificatie - de administratieve notificatie als
fabrikant - en deze brief geen sprake is van een oordeel over de status of
kwalificatie van uw product: notificering betekent niet dat daadwerkelijk sprake is
van een in-vitro diagnosticum in de zin van de onderhavige wet- en regelgeving.
In voorkomende gevallen kan de Inspectie Gezondheidszorg en Jeugd (IGJ),
belast met het toezicht op de naleving van het bij of krachtens de wet bepaalde,
een standpunt innemen over de status van een product, waarbij het volgens vaste
jurisprudentie uiteindelijk aan de nationale rechter is om te bepalen of een
product onder de definitie van in-vitro diagnosticum valt.
De Minister voor Medische Zorg en Sport,
namens deze,
Afdelingshoofd
Farmatec
Dr. M.J. van de Velde
7. Acknowledgment Letter
10/20/2020
Pearl Chen
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B3, 2054 West Wengjiao Rd., Haicang
Xiamen 361028
CHINA
Dear Pearl Chen:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has received your submission. This submission has been assigned the unique document
control number below. All future correspondence regarding this submission should be identified
prominently with the number assigned and should be submitted to the Document Control
Center at the above letterhead address. Failure to do so may result in processing delays. If you
believe the information identified below is incorrect, please contact the Office of Product
Evaluation and Quality (OPEQ) submission support at (301) 796-5640 or
OPEQSubmissionSupport@fda.hhs.gov.
Submission Number: EUA202911
Received: 10/20/2020
Applicant: Merlin Biomedical (Xiamen) Co., Ltd.
Device: Novel Coronavirus (COVID-19) RT-PCR Kit
We will notify you when the review of this document has been completed or if any additional
information is required. For information about CDRH review regulations and policies, please
refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
Sincerely yours,
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
8.
9. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
1 / 3
Novel Coronavirus (COVID-19)
RT-PCR Kit
Instruction for Use
Product:
Novel Coronavirus (COVID-19) RT-PCR Kit
Specification:
Cat No Target Gene Size
CP01020011 ORF1ab/N 50T
CP01980011 ORF1ab/N/E 50T
CP02400011 ORF1ab/N 96T
CP02410011 ORF1ab/N/E 96T
Intended Use:
The kit is a qualitative in vitro diagnostic test for nucleic acid detection of
SARS-CoV-2 ORF1ab, E and N gene from human respiratory tract
secretion samples of suspected SARS-CoV-2-infected pneumonia cases,
suspected clustered infection cases, and others who need SARS-CoV-2
infection diagnosis or differential diagnosis. The test results are only used
for auxiliary diagnosis.
Summary:
Coronaviruses are a large family of viruses that are enveloped single
stranded positive sense RNA viruses which cause illnesses in both
human and animals. The illness has ranged from common cold (e.g.
respiratory syndrome, fever, cough, etc.) to more severe diseases such
as pneumonia and severe acute respiratory syndrome.
Test Principle:
The kit is based on real-time PCR method and technology of fluorescent
probes to detect specific nucleic acid sequences of SARS-CoV-2
ORF1ab, E and N gene from human respiratory tract secretion samples
which indicates the infection of the above pathogens.
The PCR reagent of the kit contains UDG enzyme to selectively cleave
the uracil glycosidic bond of uracil-containing PCR fragment for effectively
reducing false positives caused by PCR product contamination.
Kit Contents:
The kit contains the following materials.
For CP01020011, CP01980011:
Tube
No.
Contents Volume (μL/tube) Quantity
① Freeze-dried Buffer Mix
780μL after
reconstituted
1 vial
② Diluent 1000μL 1 vial
③ Buffer PC
50μL after
reconstituted
1 vial
④ Buffer NC 100μL 1 vial
For CP02400011, CP02410011:
Tube
No.
Contents Volume (μL/tube) Quantity
① Freeze-dried Buffer Mix
PCR 8-tube,
50μL/Well after
reconstituted
96 vials
② Diluent 1000μL 1 vial
③ Buffer PC
200μL/vial after
reconstituted
5 vials
④ Buffer NC 1000μL 1 vial
Storage and Stability:
Store at 2~8℃ in dark.
Transport at 2 ~28℃ within 15 days.
Shelf life: 12 months.
Note: Freeze-dried Buffer Mix should be stored at -20 ± 5℃ after reconstituted, valid for 48 hours.
Buffer PC should be stored at -20 ± 5 ℃ after reconstituted, valid for 6 months. Repeated thawing and
freezing reagents more than 3 times should be avoided as this may affect performance.
Materials Required (but not provided):
1) Compatible PCR instruments:
Agilent Mx-3000p, Agilent Mx-3005p, ABI QuantStudio 3, ABI7500,
Molarray MA-6000, Hongshi SLAN-96, Tianlong Gentier 96E, Gentier 48S,
Gentier 48E, LightCycler480II.
2) Viral RNA extraction kit.
3) Biosafety cabinet.
4) Vortex.
5) Mini centrifuge with rotor for centrifuge tubes.
6) Personal Protective Equipment (PPE): Disposable powder-free gloves,
goggles/face shield, respirators (NIOSH-certified N95 is recommended.)
7) Nuclease-free centrifuge tubes.
8) Nuclease-free PCR tubes and caps.
9) Adjustable pipettors and sterile, nuclease-free pipet tips.
10) Biohazard waste container.
11) Tube racks.
12) RNase-Free ddH2O.
Precautions and Warnings:
General Precautions
• For in vitro test only. Please read the instruction carefully and become
familiar with all components of the kit prior to use, and strictly follow the
instruction during operation.
• Please check the compatible real-time PCR instruments prior to use.
• DO NOT use the kit or any kit component after expiry date.
• DO NOT use any other reagents from different lots in the tests.
• DO NOT use any other reagent in this kit.
• Thaw reagents shall be stored at -20℃ for use within 2 days avoiding
repeated freezing and thawing.
Handling Precautions
• Handle all specimens and components of the kit as potentially infectious
material according to safe laboratory procedures.
• Only trained professionals can use this kit. Wear appropriate personal
protective equipment (PPE) when working with clinical specimens.
• Specimen processing should be performed in a certified Class II
biosafety cabinet following biosafety level 2 or higher guidelines.
• Avoid skin, eyes and mucous membranes contact with the chemicals. In
case of contact, flush with water immediately.
• DO NOT pipet by mouth.
• Avoid aerosols.
Safety Precautions
• The kit contains positive control; strictly distinguish the positive control
from other reagents to avoid contamination which may cause false
positive.
• PCR amplification is extremely sensitive to cross-contamination. The
flow of tubes, racks, pipets and other materials used should be from pre-
amplification to post-amplification, and never backwards.
• Gloves should be worn and changed frequently when handling samples
and reagents to prevent contamination.
• Using separate, dedicated pipettes and nuclease-free filtered pipette tips
when handling samples and reagents to prevent exogenous RNA
contamination to the reagents.
• Please pack the post-amplification tubes with two disposable gloves and
discard properly. DO NOT open the post- amplification PCR tubes.
• All disposable materials are for one time using. DO NOT reuse.
• The unused reagents, used kit, and waste must be disposed of properly.
• After the experiment, wipe down the work area, spray down the pipettes
and equipment with 75% ethanol or 10% hypochlorous acid solution.
Specimen Collection and Preparation:
10. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
2 / 3
• Viral RNA extracted from human respiratory specimens should be
collected, including upper respiratory specimen (nasopharyngeal or
pharyngeal extracts, washes or swabs) and lower respiratory
specimens (bronchoalveolar lavage samples, tracheal extracts or deep
cough sputum).
• Swab specimens should be collected only on swabs with a synthetic tip
with aluminum or plastic shafts. Swabs with calcium alginate or cotton
tips with wooden shafts are not acceptable.
• The samples should be extracted RNA immediately. For short-term
storage of up to 24 hours, the sample should be stored at 2~8℃. For
long-term storage of over 24 hours, the sample should be stored at -
70℃ and avoid repeated freezing-thawing.
Assay Procedure:
For CP01020011, CP01980011
RNA Extraction
1)Add 50μLRNase-Free ddH2O to dissolve Buffer PC(Positive
Control), vortex and centrifuge briefly. Add 5μL of Buffer PC for RNA
extraction.Please refer to operation manual of RNA extraction or
purification reagents for detailed procedure.
2)Viral RNA extraction or purification reagents are not included in this
kit.
Viral RNA Detection
1) Take the Freeze-dried Buffer Mix and Diluent out of the kit from the
freezer.
2) Add 780μL Diluent to dissolve Freeze-dried Buffer Mix and ensure it is
evenly blended.
3) Prepare enough Master Mix in separate sterile centrifuge tube
according to the ratio in below Table. The volume of Master Mix should
be sufficient for tests of <n> samples, positive control and negative
control.
Content Volume per test
Buffer Mix 15μL
Note: Every PCR run must contain one Positive Control and one Negative
Control (Buffer NC).
4) Prepare PCR tubes for Sample/PC/NC, dispense 15μL Master Mix into
each PCR tube respectively.
5) Add 15μL Buffer NC (vortex and centrifuge before use) to the reaction
tube, cap the tube.
6) Add 15μL sample RNA to the reaction tube, cap the tube.
7) Add 15μL Positive Control to the reaction tubes, cap the tube.
Note: Suggest following below adding order: NC → samples → PC,
and use filtered tips for all pipetting steps to avoid cross-contamination.
8) Briefly centrifuge the PCR strips to collect all liquid at the bottom of
each PCR tube.
9) Place the PCR strips into the real-time PCR instrument.
10) Setup the PCR Protocol using the cycling parameters in below
Table.
Stage Cycles Temp. Time Data
Reverse
Transcription
1 48℃ 15min /
Initial
denaturation
1 93℃ 2 min /
Cycle Reaction 45
93℃ 15s /
58℃ 40s
Fluorescence
Collection
Device Cooling 1 30℃ 30s /
For CP01020011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
For CP01980011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
E Cy5 None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
11) Start the PCR run immediately.
12) When the PCR run is finished, analyze the data according to the
“Results Interpretation” procedures.
For CP02400011, CP02410011
RNA Extraction
1) Add 200μLDiluent to dissolve Buffer PC(Positive Control), vortex and
centrifuge briefly. Add 200μL of Buffer PC for RNA extraction.Please refer
to operation manual of RNA extraction or purification reagents for detailed
procedure to samples and Positive Control /Negative Control RNA
extraction.
2) Viral RNA extraction or purification reagents are not included in this kit.
Viral RNA Detection
1) Take the Freeze-dried Buffer Mix out of the kit from the freezer.
2) Prepare enough Freeze-dried Buffer Mix for tests of <n> samples,
positive control and negative control.
Note: Every PCR run must contain one Positive Control and one Negative
Control (Buffer NC).
3) Add 50μL Buffer NC (vortex and centrifuge before use) to the reaction
tube, cap the tube.
4) Add 50μL sample RNA to the reaction tube, cap the tube.
5) Add 50μL Positive Control to the reaction tubes. Cap the tube.
Note: Suggest following below adding order: NC → samples → PC, and
use filtered tips for all pipetting steps to avoid cross-contamination.
6) Briefly centrifuge the PCR strips to collect all liquid at the bottom of each
PCR tube.
7) Place the PCR strips into the real-time PCR instrument.
8) Setup the PCR Protocol using the cycling parameters in below Table.
Stage Cycles Temp. Time Data
Reverse
Transcription
1 48℃ 15min /
Initial
denaturation
1 93℃ 2 min /
Cycle Reaction 45
93℃ 15s /
58℃ 40s
Fluorescence
Collection
Device Cooling 1 30℃ 30s /
For CP02400011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
For CP02410011:
Target Channel Quencher
ORF1ab FAM None
N HEX/VIC/JOE None
E Cy5 None
Internal
Control
Cal Red 610/ROX/TEXAS RED None
9) Start the PCR run immediately.
10) When the PCR run is finished, analyze the data according to the
“Results Interpretation” procedures.
Calculation:
Baseline setting: Adaptive baseline.
Threshold setting: Threshold line should be set just above the peak of the
normal negative control amplification curve (irregular noise line).
Quality Control:
Before data analysis, the result of control items should be checked in
following Table:
For CP01020011/CP02400011:
Result of Control
Negative
Control
Positive
Control
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin) Ct≥42
or No Ct
Ct<42
FAM (ORF1abGene)
HEX/VIC/JOE (N Gene)
For CP01980011/CP02410011:
Result of Control
Negative
Control
Positive
Control
FAM (ORF1ab gene) Ct≥42 or No Ct Ct<42
11. Rx Only Merlin Biomedical (Xiamen) Co., Ltd.
3 / 3
HEX/VIC/JOE (N gene)
Cy5 (E gene)
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin)
Results Interpretation:
If the negative/positive control results meet the above "Quality Control ",
Interpretation of Ct value of the target gene detection according to below
Table:
For CP01020011/CP02400011:
Result of
Sample
ROX (Inner
Control, β-actin)
FAM (ORF1ab
Gene)
HEX
(N Gene)
Negative Ct<40, with good
amplification curve
Ct≥42 or No Ct
Ct≥42 or No
Ct
Positive Ct<42 Ct<42
Suspicious results: for FAM or HEX, 42≤Ct<45, repeat experiment. If Ct
<42 with good amplification curve, the sample is judged to be positive;
otherwise, it is negative.
For CP01980011/CP02410011:
Test result Negative (-) Positive (+)
FAM (ORF1ab gene)
Ct≥42 or No Ct Ct<42
HEX/VIC/JOE (N gene)
Cy5 (E gene)
Cal Red 610/ROX/TEXAS RED
(Inner Control, β-actin)
Based on the above test results, the sample result interpretation is as
follows:
Result of Sample Result interpretation
ORF1ab, N gene and E gene
are all (+)
SARS-CoV-2 positive
ORF1ab (+) and N gene (+)
ORF1ab (+) and E gene (+)
Only ORF1ab gene (+) Repeat the test. If it is still (+), it will be
interpreted as SARS-CoV-2 positive.
Only ORF1ab gene (-) Repeat the test. If ORF1ab, and N
gene and/or E gene are (+), interpret
the result as SARS-CoV-2 positive;
Otherwise interpret the result as
suspect who need to be retested the
other time.
ORF1ab (-) and N gene (+)
ORF1ab (-) and E gene (+)
ORF1ab, N gene and E gene
are all (-)
SARS-CoV-2 negative
Limitation:
• The test result of this product is positive, which can indicate the
presence of SARS-CoV-2 in the tested samples. The clinical diagnosis
and treatment of patients should be considered in combination with
other symptoms/signs, medical history, other laboratory tests and
treatment responses.
• The test results are related to the process of sample collection, transfer,
storage and processing, and any mistakes may lead to inaccurate
results. If cross-contamination is not properly controlled during sample
processing, false positive results may occur.
• The test is limited to the specified extraction reagents, specimen types,
and applicable instruments. Other unverified situations require
laboratory verification before use.
• During the design of this product, relatively conservative fragments of
viral nucleic acids were selected for amplification and detection, but the
virus gene is possible to mutate. Although the mutation rate in the
conservative region which selected for amplification detection is very
small, but the possibility cannot be completely avoided theoretically.
• This product cannot be used for the differential diagnosis of SARS.
• Test results shall be determined according to the “result interpretation”.
Performance Characteristics:
Appearance: Clean, clearly marked, no leakage.
Sensitivity:
For CP01020011/CP01980011: 200 copies/mL.
For CP02400011/CP02410011: 100 copies/mL.
Coincidence rate of positive reference: 100%.
Coincidence rate of negative reference: 100%.
Precision: CV≤5%.
Reference:
1. Heid, C. A., Stevens, J., Livak, K. J., et al. Real time quantitative
PCR[J]. Genome Research,1996,6(10), 986–994.
Merlin Biomedical (Xiamen) Co., Ltd.
Add: 4th Floor, Building B3,
2054 West Wengjiao Rd.,
Haicang, Xiamen, 361028, China
Tel: 86-592-5210772; 86-592-5210773
Fax: 86-592-5210772
Email: info@merlinbio.com.cn
Website: http://www.merlinbio.com.cn
Lotus NL B.V.
Contact person: Peter
Address: Koningin Julianaplein 10,1e Verd,2595AA,
The Hague,Netherlands.
Telephone: +31644168999
E-mail:peter@lotusnl.com
Instruction Approval and Revision Date:
Approval Date: 05 Jun 2020
Revision Date: 03 Nov 2021
Date of Issue: 03 Nov 2021
Catalogue number Temperature limit
Consult instructions for use Batch code
In vitro diagnostic medical
device
Use-by date
Manufacturer Biological risks
This way up Keep dry
Warning
Avoid overexposure to the
sun
Don't use the product when the
package is damaged
Authorized representative
in the European
Community
Date of manufacture
Contains sufficient for <n>
tests
Do not re-use Rx Only
CAUTION!
US Federal Law restricts
this device to sale by or on
the order of a physician.
12. Certificate
No. Q5 106286 0001 Rev. 01
Page 1 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Holder of Certificate: Merlin Biomedical (Xiamen) Co., Ltd.
Unit 01, 4th Floor, Building B3
Xiamen Biological Medicine Industrial Park
2054 West Wengjiao Road, Haicang
361028 Xiamen
PEOPLE'S REPUBLIC OF CHINA
Certification Mark:
Scope of Certificate: Design and Development, Production and
Distribution of In Vitro Diagnostic Medical
Devices for Detection Kit of 5 Urogenital
Tract Pathogens Nucleic Acid
(Fluorescence PCR method), Single Use
Specimen Container, DNA/RNA Extraction
Kit, IVD Equipment for Nucleic Acid
Purification integrated with Amplification
based on Fluorescence PCR Method
The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system, which meets the
requirements of the listed standard(s). All applicable requirements of the testing and certification
regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see:
www.tuvsud.com/ps-cert?q=cert:Q5 106286 0001 Rev. 01
Report No.: GZ2135501
Valid from: 2021-08-02
Valid until: 2023-06-08
Date, 2021-08-02 Christoph Dicks
Head of Certification/Notified Body
13. Certificate
No. Q5 106286 0001 Rev. 01
Page 2 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Applied Standard(s): EN ISO 13485:2016
Medical devices - Quality management systems -
Requirements for regulatory purposes
(ISO 13485:2016)
DIN EN ISO 13485:2016
Facility(ies): Merlin Biomedical (Xiamen) Co., Ltd.
Unit 01, 4th Floor, Building B3, Xiamen Biological Medicine
Industrial Park, 2054 West Wengjiao Road, Haicang, 361028
Xiamen, PEOPLE'S REPUBLIC OF CHINA
Design and Development, Production of IVD Equipment for
Nucleic Acid Purification integrated with Amplification based on
Fluorescence PCR Method.
Production of In Vitro Diagnostic Medical Devices for Detection Kit
of 5 Urogenital Tract Pathogens Nucleic Acid (Fluorescence PCR
method), Single Use Specimen Container, DNA/RNA Extraction Kit
Merlin Biomedical (Xiamen) Co., Ltd.
4th Floor, Building B11, Xiamen Biological Medicine Industrial
Park, 2070 West Wengjiao Road, Haicang, 361028 Xiamen,
PEOPLE'S REPUBLIC OF CHINA
Design and Development, Production and Distribution of Detection
Kit of 5 Urogenital Tract Pathogens Nucleic Acid (Fluorescence
PCR method), Single Use Specimen Container, DNA/RNA
Extraction Kit.
Production and Distribution of IVD Equipment for Nucleic Acid
Purification integrated with Amplification based on Fluorescence
PCR Method.
.