Meril Life has created ABFind, India's first post-covid-19 vaccine antibody test kit. Here's where you can learn about home testing for fast neutralising antibodies.
Risk Analysis of igg/igm Rapid Test Kits by healgenHK HuZef
1. Introduction
1.1. Overview
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma).
1.2. Intended Use/Purpose
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in
human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive
specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed
with alternative testing method(s) and clinical findings.
1.3. Scope
This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the
operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma), which references the standard of ISO 14971:2012.
Accuracy report of Healgen IgG/IgM Rapid Test kits AntibodyHK HuZef
1. Accuracy
1.1 Purpose
To evaluate the equivalence of COVID-19 IgG/IgM Rapid Test result and clinical diagnosis.
1.2 Method
By testing clinical samples with known results, to evaluate the accuracy of COVID-19 IgG/IgM
Rapid Test (Whole blood/Serum/Plasma).
1.3 Material
COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)
Cassette Lot1: 2002155,Lot2:2002156,Lot3:2002157
Clinical samples
1.4 Test Procedure
1) Prepare specimens: tests were taken to clinical partner to evaluate, totally 113 specimens.
2) Perform the test according to the test procedure in the package insert
1.5 Result
1) IgM
A Fully Automated Sample-to-result PCR System for Detecting Infectious DiseasesSimon Chung - genereach
This document describes GeneReach Biotechnology Corporation's POCKIT Central system, a fully automated sample-to-result PCR system for infectious disease detection. The POCKIT Central can detect multiple pathogens from a single sample in less than 2 hours, including dengue virus serotypes. It has been validated against qPCR with equivalent sensitivity and specificity for dengue virus detection and subtyping. The portable and easy-to-use POCKIT Central provides a rapid and accurate molecular diagnostic solution for point-of-care infectious disease testing.
1) The document describes an IgG/IgM rapid test cassette that uses a lateral flow immunochromatographic assay to detect antibodies in whole blood, serum, or plasma that are produced in response to COVID-19 infection.
2) The test works by detecting IgG and IgM antibodies that bind to COVID-19 antigens conjugated with colloid gold, which migrate through the cassette to test lines containing immobilized antibody. Positive results indicate recent or past COVID-19 infection.
3) The test cassette has received FDA Emergency Use Authorization as a qualitative detection tool to aid in identifying individuals with an adaptive immune response to COVID-19. However, clinical diagnosis requires consideration of additional factors and follow-up testing may
This document provides information about Tests For Life's COVID-19 IgM/IgG Rapid Antibody Test. The test is a point-of-care test that can detect both IgM and IgG antibodies in 10-15 minutes using a small blood sample without any instrumentation. It has a combined sensitivity of 100% and specificity of 98.75%. The document describes the test's applications, protocols, validation studies, packaging, and contact information for the company.
This document summarizes a seminar presentation on laboratory diagnosis of HIV. It discusses specimen collection, storage and transport. Screening tests covered include ELISA and rapid tests. Confirmatory tests discussed are Western blot and nucleic acid-based tests like PCR. Molecular assays for detecting HIV RNA are also summarized, including quantitative PCR and viral load determination. National testing strategies, reference laboratories, legal and ethical issues are also briefly covered.
RT PCR is too slow for effective control of spread of cov 2 infection, rapid antigen test by giving results in less than 30 minutes can help identify infected persons leading to quick isolation.Lack of sensitivity can be compensated by repeating RAT after a day or so.
The document discusses laboratory diagnosis of HIV infection and its treatment. [1] Several specific tests are used to detect HIV infection including antigen detection, virus isolation, viral nucleic acid detection and antibody detection. [2] Non-specific tests like complete blood count and CD4/CD8 ratio are also used. [3] Opportunistic infections are diagnosed using microscopy, culture and specific tests. HIV treatment involves the use of several classes of antiretroviral drugs that target different stages of the viral lifecycle alone or in combination therapy.
Risk Analysis of igg/igm Rapid Test Kits by healgenHK HuZef
1. Introduction
1.1. Overview
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma).
1.2. Intended Use/Purpose
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in
human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive
specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed
with alternative testing method(s) and clinical findings.
1.3. Scope
This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the
operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma), which references the standard of ISO 14971:2012.
Accuracy report of Healgen IgG/IgM Rapid Test kits AntibodyHK HuZef
1. Accuracy
1.1 Purpose
To evaluate the equivalence of COVID-19 IgG/IgM Rapid Test result and clinical diagnosis.
1.2 Method
By testing clinical samples with known results, to evaluate the accuracy of COVID-19 IgG/IgM
Rapid Test (Whole blood/Serum/Plasma).
1.3 Material
COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)
Cassette Lot1: 2002155,Lot2:2002156,Lot3:2002157
Clinical samples
1.4 Test Procedure
1) Prepare specimens: tests were taken to clinical partner to evaluate, totally 113 specimens.
2) Perform the test according to the test procedure in the package insert
1.5 Result
1) IgM
A Fully Automated Sample-to-result PCR System for Detecting Infectious DiseasesSimon Chung - genereach
This document describes GeneReach Biotechnology Corporation's POCKIT Central system, a fully automated sample-to-result PCR system for infectious disease detection. The POCKIT Central can detect multiple pathogens from a single sample in less than 2 hours, including dengue virus serotypes. It has been validated against qPCR with equivalent sensitivity and specificity for dengue virus detection and subtyping. The portable and easy-to-use POCKIT Central provides a rapid and accurate molecular diagnostic solution for point-of-care infectious disease testing.
1) The document describes an IgG/IgM rapid test cassette that uses a lateral flow immunochromatographic assay to detect antibodies in whole blood, serum, or plasma that are produced in response to COVID-19 infection.
2) The test works by detecting IgG and IgM antibodies that bind to COVID-19 antigens conjugated with colloid gold, which migrate through the cassette to test lines containing immobilized antibody. Positive results indicate recent or past COVID-19 infection.
3) The test cassette has received FDA Emergency Use Authorization as a qualitative detection tool to aid in identifying individuals with an adaptive immune response to COVID-19. However, clinical diagnosis requires consideration of additional factors and follow-up testing may
This document provides information about Tests For Life's COVID-19 IgM/IgG Rapid Antibody Test. The test is a point-of-care test that can detect both IgM and IgG antibodies in 10-15 minutes using a small blood sample without any instrumentation. It has a combined sensitivity of 100% and specificity of 98.75%. The document describes the test's applications, protocols, validation studies, packaging, and contact information for the company.
This document summarizes a seminar presentation on laboratory diagnosis of HIV. It discusses specimen collection, storage and transport. Screening tests covered include ELISA and rapid tests. Confirmatory tests discussed are Western blot and nucleic acid-based tests like PCR. Molecular assays for detecting HIV RNA are also summarized, including quantitative PCR and viral load determination. National testing strategies, reference laboratories, legal and ethical issues are also briefly covered.
RT PCR is too slow for effective control of spread of cov 2 infection, rapid antigen test by giving results in less than 30 minutes can help identify infected persons leading to quick isolation.Lack of sensitivity can be compensated by repeating RAT after a day or so.
The document discusses laboratory diagnosis of HIV infection and its treatment. [1] Several specific tests are used to detect HIV infection including antigen detection, virus isolation, viral nucleic acid detection and antibody detection. [2] Non-specific tests like complete blood count and CD4/CD8 ratio are also used. [3] Opportunistic infections are diagnosed using microscopy, culture and specific tests. HIV treatment involves the use of several classes of antiretroviral drugs that target different stages of the viral lifecycle alone or in combination therapy.
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.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
The document discusses HIV testing procedures for adults and children. It outlines the objectives of HIV testing, general principles, types of diagnostic tests, and strategies for testing. It also covers tests for diagnosing HIV in children under 18 months, including DNA PCR. Guidelines for monitoring disease progression and ART response via CD4 count and viral load testing are presented. The key aims of HIV testing are diagnosis, monitoring, and surveillance to help control the HIV epidemic.
ReaMetrix is a life science technology company founded in 2003 with facilities in San Carlos, CA and Bangalore, India. It is committed to developing high-quality, affordable diagnostic solutions for resource-limited settings. ReaMetrix has expertise in assay development, protein expression and labeling, instrumentation, and developing integrated diagnostic solutions. It currently offers products like conjugates for flow cytometry-based tests and is working on projects like affordable point-of-care tests for bacterial detection and disease monitoring.
By titrating the First WHO International Standard for Anti-SARS-CoV-2 immunoglobulin and the NIBSC Anti-SARS-CoV-2 Diagnostic Calibrant, TestLine responded to the requirement to accurately determine the level of antibodies after vaccination and monitor the sensitivity of serological tests. Results from testing the Anti-SARS-CoV-2 Verification Panel show that MBA COVID-19 kits have comparable results to other commercially available assays, and in some cases even better results. This allows the kits to be used for monitoring antibody concentration after vaccination thanks to harmonization with International Standards.
Lyme disease is caused by the bacterium Borrelia burgdorferi and its symptoms include a characteristic rash called erythema migrans. If left untreated, later symptoms can include joint pain, heart palpitations, and shooting pains. Diagnosis is made through ELISA testing which detects antibodies produced by the immune system against Borrelia antigens like OspC, Crasp, and VIsE. The Borrelia IgM ELISA uses recombinant antigens for high sensitivity and specificity in detecting IgM antibodies in serum or plasma samples, with results available in under two hours.
Detecting neutralization antibodies to covid 19Melvin Alex
A robust serological test to detect neutralizing antibodies to SARS Cov-2 is needed to determine not only the infection rate, herd immunity, and predicted humoral protection, but also vaccine efficacy during clinical trials after large-scale vaccination.
This document discusses affordable reagent alternatives for CD4 T-lymphocyte counting and HIV viral load testing in resource-poor settings. It introduces several reagents developed by ReaMetrix for CD4 enumeration on various flow cytometry platforms, including single- and multi-color reagents for common platforms like BD FACScan, BD FACSCalibur, and Guava. The reagents aim to provide accurate CD4 testing through simple workflow and are extensively validated. ReaMetrix also develops customized solutions and continues to expand platform compatibility.
The Widal test is a serological method used to diagnose typhoid or enteric fever caused by Salmonella typhi, Salmonella paratyphi A, B, and C. It detects antibodies in patient serum that agglutinate specific antigens prepared from Salmonella species. A positive result indicates a recent or past infection. While it has low specificity and can be difficult to interpret, the Widal test remains useful for diagnosing typhoid fever in developing countries due to its low cost. More specific tests such as Typhidot and PCR are also used but are more expensive. The document provides details on how to perform and interpret the Widal test as well as alternative diagnostic methods for typhoid fever.
Rapid HIV tests can be performed outside laboratory settings using whole blood, saliva, or urine samples. They provide results within 20-40 minutes and do not require specialized equipment, electricity, or running water. Two common testing methods are serial testing, where two different rapid tests are used sequentially, and parallel testing, where two tests are run simultaneously on the same sample. A positive result requires counseling, while a negative result could mean the person is not infected or is in the early "window period" before antibodies form. Further testing is needed to confirm an initial positive or indeterminate result.
Immunology lab manual for MLT students
Ethics of Laboratory
Collection of the blood sample by vein puncture, separation and preservation of serum
Widal Test
VDRL (including Antigen Preparation)
ASO (Anti streptolysin ‘O’)
C-Reactive Protein (Latex agglutination)
Rheumatoid factor (RF) Latex agglutination
Demonstration of antigen / antibody, determination by Immuno fluorescence (IF), Immuno diffusion, precipitation
in Agarose gel (Ouchterlony)
Demonstration of ELISA
Demonstration of SDS – PAGE
Preparation of Vaccination schedule
This document summarizes various laboratory tests used in the diagnosis of HIV infection. It describes the purpose and types of HIV tests, including specific tests like antigen detection, antibody detection using ELISA, rapid tests, and confirmatory tests like Western Blot. It also discusses viral load tests, CD4 counts, and the use of PCR in diagnosis. The temporal sequence of biomarkers in HIV infection is outlined.
The document discusses specimen management in clinical microbiology. It covers topics like the roles of clinical microbiologists, appropriate specimen collection and transport, use of holding media to maintain viability, different types of culture media, and atmospheric conditions required by different microorganisms. It also addresses direct examinations, identification of clinically significant isolates, quantitative urine plating using a calibrated loop, and immediate reporting of positive blood cultures.
This document summarizes various laboratory tests used for HIV diagnosis and management. It describes enzyme immunoassays (EIAs) and rapid tests for detecting HIV antibodies. It also discusses tests for detecting the p24 antigen for early infant diagnosis, and CD4 and viral load tests for monitoring disease progression and response to antiretroviral therapy (ART). The document provides details on different formats of rapid tests including immuno-concentration, immuno-chromatography, and particle agglutination, and emphasizes the importance of proper training, supervision and monitoring for reliable HIV testing.
The role of the clinical lab in diagnosis of hivAyman Allam
The document discusses the role of clinical laboratories in diagnosing and monitoring HIV infection. It describes that initial diagnosis involves screening tests like ELISA or rapid tests, followed by confirmatory tests like Western Blot or nucleic acid amplification tests. Monitoring involves regular CD4 counts to track immune status and viral load tests to monitor response to antiretroviral treatment. It also discusses additional tests like drug resistance and co-receptor tropism tests to help guide treatment decisions.
Medical Microbiology Laboratory (Antibiotics Sensitivity Testing)Hussein Al-tameemi
This document discusses antibiotic sensitivity testing, specifically the Kirby-Bauer test method. It provides terminology for antibiotics and their modes of action. The Kirby-Bauer test involves growing bacteria on Muller-Hinton agar, placing antibiotic disks on the plate, incubating, and measuring inhibition zones to determine antibiotic sensitivity or resistance. The Stokes method compares inhibition zones of test and control organisms.
A Fully Automated POCKIT Central PCR System for Evaluation of the Infectious ...Simon Chung - genereach
This document discusses using PCR to evaluate the uniformity of infectious bronchitis vaccination in chickens. It finds:
1) A POCKIT Central PCR system can detect the IB vaccine virus in tracheal swabs up to 4 weeks after spraying vaccination at hatcheries.
2) Sequence analysis showed nucleic acids detected by the PCR system matched the vaccine used in the study.
3) A PCR positive rate of 40% or higher on day 7 after vaccination could be used as a cutoff for evaluating uniformity, with regular monitoring needed below that threshold.
The study demonstrates PCR is an effective quality control tool for checking IB vaccination uniformity. The portable POCKIT system makes this feasible for poultry grow
This document summarizes the new features and capabilities of the VITEK 2 Compact system for microbial identification. Key points include:
- The system has redesigned test cards with 64 wells, pre-inserted straws, and barcodes for improved accuracy, fewer manual steps, and full traceability.
- Four new test cards (GN, GP, BCL, YST) have been developed to identify different types of microorganisms, achieving identification rates of 85-100% within 10-18 hours.
- The system features an intuitive interface, automated functions to reduce manual steps and increase productivity, and software compliant with regulatory standards.
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
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.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
The document discusses HIV testing procedures for adults and children. It outlines the objectives of HIV testing, general principles, types of diagnostic tests, and strategies for testing. It also covers tests for diagnosing HIV in children under 18 months, including DNA PCR. Guidelines for monitoring disease progression and ART response via CD4 count and viral load testing are presented. The key aims of HIV testing are diagnosis, monitoring, and surveillance to help control the HIV epidemic.
ReaMetrix is a life science technology company founded in 2003 with facilities in San Carlos, CA and Bangalore, India. It is committed to developing high-quality, affordable diagnostic solutions for resource-limited settings. ReaMetrix has expertise in assay development, protein expression and labeling, instrumentation, and developing integrated diagnostic solutions. It currently offers products like conjugates for flow cytometry-based tests and is working on projects like affordable point-of-care tests for bacterial detection and disease monitoring.
By titrating the First WHO International Standard for Anti-SARS-CoV-2 immunoglobulin and the NIBSC Anti-SARS-CoV-2 Diagnostic Calibrant, TestLine responded to the requirement to accurately determine the level of antibodies after vaccination and monitor the sensitivity of serological tests. Results from testing the Anti-SARS-CoV-2 Verification Panel show that MBA COVID-19 kits have comparable results to other commercially available assays, and in some cases even better results. This allows the kits to be used for monitoring antibody concentration after vaccination thanks to harmonization with International Standards.
Lyme disease is caused by the bacterium Borrelia burgdorferi and its symptoms include a characteristic rash called erythema migrans. If left untreated, later symptoms can include joint pain, heart palpitations, and shooting pains. Diagnosis is made through ELISA testing which detects antibodies produced by the immune system against Borrelia antigens like OspC, Crasp, and VIsE. The Borrelia IgM ELISA uses recombinant antigens for high sensitivity and specificity in detecting IgM antibodies in serum or plasma samples, with results available in under two hours.
Detecting neutralization antibodies to covid 19Melvin Alex
A robust serological test to detect neutralizing antibodies to SARS Cov-2 is needed to determine not only the infection rate, herd immunity, and predicted humoral protection, but also vaccine efficacy during clinical trials after large-scale vaccination.
This document discusses affordable reagent alternatives for CD4 T-lymphocyte counting and HIV viral load testing in resource-poor settings. It introduces several reagents developed by ReaMetrix for CD4 enumeration on various flow cytometry platforms, including single- and multi-color reagents for common platforms like BD FACScan, BD FACSCalibur, and Guava. The reagents aim to provide accurate CD4 testing through simple workflow and are extensively validated. ReaMetrix also develops customized solutions and continues to expand platform compatibility.
The Widal test is a serological method used to diagnose typhoid or enteric fever caused by Salmonella typhi, Salmonella paratyphi A, B, and C. It detects antibodies in patient serum that agglutinate specific antigens prepared from Salmonella species. A positive result indicates a recent or past infection. While it has low specificity and can be difficult to interpret, the Widal test remains useful for diagnosing typhoid fever in developing countries due to its low cost. More specific tests such as Typhidot and PCR are also used but are more expensive. The document provides details on how to perform and interpret the Widal test as well as alternative diagnostic methods for typhoid fever.
Rapid HIV tests can be performed outside laboratory settings using whole blood, saliva, or urine samples. They provide results within 20-40 minutes and do not require specialized equipment, electricity, or running water. Two common testing methods are serial testing, where two different rapid tests are used sequentially, and parallel testing, where two tests are run simultaneously on the same sample. A positive result requires counseling, while a negative result could mean the person is not infected or is in the early "window period" before antibodies form. Further testing is needed to confirm an initial positive or indeterminate result.
Immunology lab manual for MLT students
Ethics of Laboratory
Collection of the blood sample by vein puncture, separation and preservation of serum
Widal Test
VDRL (including Antigen Preparation)
ASO (Anti streptolysin ‘O’)
C-Reactive Protein (Latex agglutination)
Rheumatoid factor (RF) Latex agglutination
Demonstration of antigen / antibody, determination by Immuno fluorescence (IF), Immuno diffusion, precipitation
in Agarose gel (Ouchterlony)
Demonstration of ELISA
Demonstration of SDS – PAGE
Preparation of Vaccination schedule
This document summarizes various laboratory tests used in the diagnosis of HIV infection. It describes the purpose and types of HIV tests, including specific tests like antigen detection, antibody detection using ELISA, rapid tests, and confirmatory tests like Western Blot. It also discusses viral load tests, CD4 counts, and the use of PCR in diagnosis. The temporal sequence of biomarkers in HIV infection is outlined.
The document discusses specimen management in clinical microbiology. It covers topics like the roles of clinical microbiologists, appropriate specimen collection and transport, use of holding media to maintain viability, different types of culture media, and atmospheric conditions required by different microorganisms. It also addresses direct examinations, identification of clinically significant isolates, quantitative urine plating using a calibrated loop, and immediate reporting of positive blood cultures.
This document summarizes various laboratory tests used for HIV diagnosis and management. It describes enzyme immunoassays (EIAs) and rapid tests for detecting HIV antibodies. It also discusses tests for detecting the p24 antigen for early infant diagnosis, and CD4 and viral load tests for monitoring disease progression and response to antiretroviral therapy (ART). The document provides details on different formats of rapid tests including immuno-concentration, immuno-chromatography, and particle agglutination, and emphasizes the importance of proper training, supervision and monitoring for reliable HIV testing.
The role of the clinical lab in diagnosis of hivAyman Allam
The document discusses the role of clinical laboratories in diagnosing and monitoring HIV infection. It describes that initial diagnosis involves screening tests like ELISA or rapid tests, followed by confirmatory tests like Western Blot or nucleic acid amplification tests. Monitoring involves regular CD4 counts to track immune status and viral load tests to monitor response to antiretroviral treatment. It also discusses additional tests like drug resistance and co-receptor tropism tests to help guide treatment decisions.
Medical Microbiology Laboratory (Antibiotics Sensitivity Testing)Hussein Al-tameemi
This document discusses antibiotic sensitivity testing, specifically the Kirby-Bauer test method. It provides terminology for antibiotics and their modes of action. The Kirby-Bauer test involves growing bacteria on Muller-Hinton agar, placing antibiotic disks on the plate, incubating, and measuring inhibition zones to determine antibiotic sensitivity or resistance. The Stokes method compares inhibition zones of test and control organisms.
A Fully Automated POCKIT Central PCR System for Evaluation of the Infectious ...Simon Chung - genereach
This document discusses using PCR to evaluate the uniformity of infectious bronchitis vaccination in chickens. It finds:
1) A POCKIT Central PCR system can detect the IB vaccine virus in tracheal swabs up to 4 weeks after spraying vaccination at hatcheries.
2) Sequence analysis showed nucleic acids detected by the PCR system matched the vaccine used in the study.
3) A PCR positive rate of 40% or higher on day 7 after vaccination could be used as a cutoff for evaluating uniformity, with regular monitoring needed below that threshold.
The study demonstrates PCR is an effective quality control tool for checking IB vaccination uniformity. The portable POCKIT system makes this feasible for poultry grow
This document summarizes the new features and capabilities of the VITEK 2 Compact system for microbial identification. Key points include:
- The system has redesigned test cards with 64 wells, pre-inserted straws, and barcodes for improved accuracy, fewer manual steps, and full traceability.
- Four new test cards (GN, GP, BCL, YST) have been developed to identify different types of microorganisms, achieving identification rates of 85-100% within 10-18 hours.
- The system features an intuitive interface, automated functions to reduce manual steps and increase productivity, and software compliant with regulatory standards.
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
User Menual How To USE Covid-19 Antibody Tests By Healgen HK HuZef
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is
a lateral flow immunoassay intended for the qualitative detection and differentiation
of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma
from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or
serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
is intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. At this time, it is
unknown for how long antibodies persist following infection and if the presence of
antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute
SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform
moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to
SARS-CoV-2 are generally detectable in blood several days after initial infection,
although the duration of time antibodies are present post-infection is not well
characterized. Individuals may have detectable virus present for several weeks
following seroconversion.
Laboratories within the United States and its territories are required to report all
positive results to the appropriate public health authorities.
The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) early after infection in unknown. Negative results do not
preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing
for SARS-CoV-2 is necessary.
False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing
antibodies or other possible causes. Due to the risk of false positive results,
confirmation of positive results should be considered using second, different IgG or
IgM assay.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only
for use under the Food and Drug Administration’s Emergency Use Authorization.
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.
This document discusses laboratory diagnosis of COVID-19. It describes how the disease spreads and appropriate sample types and collection methods. Molecular RT-PCR tests targeting SARS-CoV-2 genes like E, RdRp, N and ORF1ab are recommended for diagnosis. Serological and antigen tests can also be used but have limitations. Proper sample handling and accurate test interpretation are important for diagnosis. Laboratory networking is important for managing the COVID-19 pandemic.
This project report summarizes the process of blood culture testing. The purpose is to detect bloodborne microorganisms in patients with sepsis. Blood samples are inoculated into culture bottles and incubated for 5 days. The system monitors for increases in fluorescence that indicate growth. Positive bottles are subcultured onto agar plates and identified using staining techniques like Gram stain and Vitek 2 compact system. Identification of bacteria and reporting of antibiotic sensitivities helps in diagnosis and treatment of septic patients.
This document discusses diagnostic tests for COVID-19. It describes how samples are collected, typically nasopharyngeal or oropharyngeal swabs. Real-time reverse transcription polymerase chain reaction (RT-PCR) is the preferred testing method, using RNA extraction and fluorescent markers to detect viral DNA. Lateral flow and ELISA tests detect antibodies produced in response to infection. Treatment options discussed include chloroquine and favilavir. Several vaccine candidates are under development at universities and companies.
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 document describes a rapid test kit for detecting canine parvovirus antigen in dog feces. Canine parvovirus causes inflammation of the intestines and other symptoms like vomiting and diarrhea. The test uses lateral flow immunoassay to detect parvovirus antigen in a fecal sample in 5-10 minutes. It has a sensitivity of 98.5% and specificity of 98% compared to ELISA tests. A positive result confirms parvovirus infection while a negative result does not rule it out, as virus shedding may be short.
Adult HIV: Skills workshop screening tests for HIVPiLNAfrica
Adult HIV was developed by doctors and nurses with wide experience in the care of adults with HIV, under the auspices of the Desmond Tutu HIV Foundation at the University of Cape Town. It covers: introduction to HIV infection, management of HIV-infected adults at primary-care clinics, preparing patients for antiretroviral (ARV) treatment, ARV drugs, starting and maintaining patients on ARV treatment, opportunistic infections
The document discusses HIV/AIDS, including:
- HIV was identified as the cause of AIDS in 1983.
- HIV is transmitted through unprotected sex, contaminated blood, and from mother to child.
- India's HIV epidemic began in the 1980s, with over 2 million new infections globally in 2013.
- HIV diagnosis involves antibody and antigen tests, while treatment and monitoring involves CD4 counts and viral load tests.
COVID Testing and ICMR strategy and vaccinesRishikaThakur9
The document discusses COVID-19 testing strategies and vaccines in development in India. It provides details on appropriate specimen collection, storage and transport for COVID-19 testing. It outlines the types of COVID-19 tests - molecular, antigen and antibody - and provides guidance on using the different tests for various testing scenarios. It also summarizes the status of several COVID-19 vaccines in clinical trials in India, including Covishield, ZyCoV-D, Sputnik V and others.
Introduction to coviself antibody testing kitAnneHathaway6
Meanwhile, the RT-PCR test requires a healthcare provider to take a sample and send it to a laboratory for analysis. In the sample, the analysis can find evidence of the virus's genetic material. If it detects two distinct SARS-CoV-2 genes, this test can confirm a COVID-19 diagnosis. It will yield an inconclusive result if it only finds one.
1. HIV is a retrovirus that infects and destroys CD4+ T cells, weakening the immune system.
2. It is spherical and enveloped, around 90-120nm in size, with a genome containing two identical RNA strands and enzymes like reverse transcriptase.
3. HIV is primarily transmitted through unprotected sexual intercourse, contaminated blood transfusions, needle sharing, and from mother to child during pregnancy, childbirth or breastfeeding.
4. Diagnosis involves screening tests like ELISA and rapid tests that detect antibodies to HIV. Supplemental tests like Western blot and viral load tests are used to confirm results.
5. Antiretroviral therapy with combinations of drugs can effectively suppress HIV
This document provides instructions for using a Canine Leptospira Antibody Test Kit to determine a dog's antibody levels to Leptospira bacteria. The kit uses a comb-shaped plastic card to test serum samples in 12 wells for antibodies against 4 common Leptospira serovars. Results appear within 23 minutes as purple-grey dots on the comb, which are then compared to color standards to determine antibody levels and interpret as negative, low positive, or high positive based on a scale equivalent to common Leptospira antibody tests. The instructions provide details on sample collection and preparation, performing the test over multiple incubation steps, and interpreting results using the supplied color scale.
Validation of the Q - Preven HIV 1 2 DBS Immunoenzyme Kit REPORT FIN 11012012Terra Vivos
The Q-Preven HIV 1+2 DBS kit was validated for detecting HIV antibodies in dried blood spot specimens. Controls tested acceptably on multiple runs. Precision and accuracy testing over five days found coefficient of variation within acceptable ranges for negative controls but outside ranges for some positive controls. Sensitivity and specificity testing of known samples found 100% concordance with initial test results. Additional new controls also tested acceptably. The validation demonstrated that the kit performed as expected but had some limitations.
Corona is here to stay and it is predicted that over 70% of population will get the infection (fortunately not all will fall sick or very sick). (Recovery rate of over 74% & Death rate around 2%).
A lot of confusion exists regarding testing for covid and what test to do, when and how to interpret these tests.
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Ab find, an antibody test after covid 19 vaccination by meril life
1.
2. WHAT’S IN THE BOX?
1 Test device
1 Assay buffer
1 Capillary tube
1 Alcohol swab
1 Lancet
1 Disposal bag
1 User guide
C
T
1
3. HOW TO USE?
TAKE THE TEST IN 5 EASY STEPS:
PREPARE
01
COLLECT SAMPLE
02
RUN TEST
03
INTERPRET RESULTS
DISPOSE
04
05
2
4. STEP 1: PREPARE
Wash your hands.
Make sure they are dry
before starting the test.
Remove the test components
from the box and place them
on a flat surface.
Remove the test device
from the pouch and keep
it ready.
Peel the aluminium foil from
the pre-filled buffer tube and
secure the cap on top of
the buffer tube.
Push the buffer tube on to
the perforated circle of the box.
1
2
3
4
5
3
C
T
5. Choose your ring or the
middle finger and clean the
tip of the finger with the
alcohol swab and let it dry for
5 -7 seconds.
Twist & pull the tip of
the Lancet.
Position the lancet
over your finger tip and push
it against the skin until you
hear a click.
Wait for a good size of a drop
of blood to form. If it doesn't,
squeeze the sides of the
finger for it to form.
Squeezing the top of the
capillary tube, bring the
capillary tip in contact with
the blood drop and release
the top of the capillary tube,
allowing blood to flow into
the tube.
STEP 2: COLLECT SAMPLE
1
2
3
4
5
4
6. STEP 3: RUN TEST
STEP 4: INTERPRET RESULTS
2
Squeeze the top of the
capillary tube to transfer the
blood into the sample well of
the test device.
Add 3 drops of the buffer on
to the sample well of the
test device.
Wait for 15-20 mins to
interpret the test results.
Results post 20 mins should
not be considered valid.
1
3
Neutralizing Antibody
Negative result
If only the control (C) band is
developed, the test indicates that
the result is negative.
C
T
5
20 min
3 drops
7. Positive result
If control (C) and test (T) bands are
developed, the test indicates for the
presence of COVID-19 Neutralizing
antibody in the sample. The result
is positive.
Different possibilities of
Positive result
Invalid result
If no control (C) band is developed,
then the assay is invalid regardless
of colour development on test (T)
band as indicated below. Repeat the
assay with a new device.
If none of the bands are developed,
then the assay is invalid. Repeat the
assay with a new device.
C
T
C
T
C
T
C
T
Look very closely!
Even a faint line
at “T” indicates
a positive result.
C
T
C
T
C
T
C
T
C
T
OR
OR
6
Neutralizing Antibody
8. 1
2
3
STEP 5: DISPOSE
Place used lancet, alcohol
swab, capillary tube, assay
buffer tube and test device into
the disposal bag. Seal the
disposal bag and dispose
the bag in a waste bin.
All the used materials should
be put inside the waste
disposal bag and thrown in the
household waste.
Disinfect all surfaces that
the specimen may have
touched and wash your hands
after disposal.
7
DISPOSAL BAG
DISPOSAL BAG
DISPOSAL BAG
9. THE DO’S
• Store the test device at 2°C- 30° C.
• Check the expiry date printed on the kit packaging.
• Stand up so that your hand is below your heart level.
This will also help your blood flow better.
• Follow standard local procedure and guidelines
for handling and disposal of used kits.
THE DONT’S
• Do not refrigerate.
• Do not use if expiry date has passed.
• Do not interpret the result after 30 minutes.
(Interpret the results after 20 minutes of test.)
• Do not dispose the used material anywhere
except the disposal bag.
8
10. FAQS
How does Neutralizing Antibody Test work?
COVID-19 Neutralizing Antibody Test detects the
neutralizing antibodies to SARS-CoV-2 in human whole
blood specimens. When the presence of neutralizing
antibody in the blood specimens binds with the
Spike-RBD Antigen coated on the device, the
complexion will react and form a color band at test
region, indicating a positive test.
What are the dierences between COVID-19 Antigen
Test, Antibody and NAB Test ?
COVID-19 Antigen Tests detects the coronavirus
proteins. COVID-19 Antibody tests detect antibodies
produced by your body’s immune system in response
to a previous COVID-19 infection. ABFIND COVID-19
Neutralizing Antibody Test is a NAB test. NAb tests are
used to detect the immune system post COVID-19
infection or immune response to vaccination.
Who should have the COVID-19 (Coronavirus)
NAB Test?
This can be used by individuals who want to find the
presence of Neutralising Antibodies post vaccination
or post SARS-CoV2 infection.
This kit should not be used by individuals with bleeding
or clotting disorders, those taking anti-coagulants,
or by patients taking immunosuppressive drugs or
undergoing chemotherapy.
9
11. Why do we need NAb testing?
There are 2 main uses for Neutralizing Antibody
(NAB) Tests:
1. Confirms if an individual has developed an immune
response post SARS-CoV2 infection.
2. Confirms if an individual has developed an immune
response post vaccination.
Does a positive antibody test mean I am immune?
There is not enough scientific evidence to confirm if
having antibodies means you are definitely immune.
As per research, some human reinfections with
SARS-CoV-2 have been confirmed in patients who had
antibodies but this is extremely rare. This suggests the
body usually develops significant immunity as antibody
levels seem to rise in patients as viral counts drop and
reinfections are very uncommon.
Research showed, following the 2002 SARS virus
outbreak the responsible virus SARS-CoV, patients with
antibodies were immune over a 3 year period.
COVID-19 (SARS-CoV-2) is closely related to SARS-CoV,
both viruses having originated in bats.
When to use antibody test?
It is recommended to use ABFIND Neutralizing
Antibody Test 2 weeks after the Second dose of
vaccine or 2 weeks after SARS-CoV-2 infection.
It can also be used at regular intervals post vaccination
or infection to check for the presence of neutralising
antibodies.
Who can use antibody test?
Persons vaccinated against SARS-CoV-2 virus and
persons infected by SARS-CoV-2 infection.
10
12. INTENDED USE AND
TEST PRINCIPLE
Intended Use:
ABFIND COVID-19 Neutralizing Antibody Rapid Test is
a qualitative in-vitro diagnostic immunochromatography
assay. This test is designed for use to detect the circulating
SARS-CoV-2 neutralizing antibodies in whole blood. This
test is intended for use in any laboratory & non-laboratory
setting to check immune response in subjects post
COVID-19 vaccination & or infection with the SARS-CoV-2
initiates by the healthcare professional and individual’s
with self collected specimen.
ABFIND COVID-19 Neutralizing Antibody Rapid Test is
a qualitative membrane-based immunoassay for the
detection of SARS- CoV-2 Neutralizing Antibody in whole
blood. This test consists of two components, test region
(T) coated with Recombinant Spike-RBD Antigen, and
control region (C) coated with Goat Anti-Chicken IgY.
The Recombinant Spike-RBD Antigen and Goat
Anti-Chicken IgY labeled by colloidal gold are
as tracers.
When specimens are processed and added to the test
device, neutralizing antibodies present in the specimen
will bind to the colloidal gold labeled Spike-RBD Antigen,
Antigen-Antibody complex further bind with coated
Recombinant Spike-RBD Antigen test region, form
a color band at test region (T).
11
Principle:
13. The colloidal gold labeled Chicken IgY antibody is
bound to the Goat Anti-Chicken IgY antibody coated on
the control line (C), forms a color band. The control
band is used for procedural control and should always
appear if the test procedure is performed correctly.
Disclaimer:
Meril ABFIND detects IgG antibodies against the
receptor binding domain (RBD) of the spike protein of
SARS-CoV-2.
A positive result indicates anti-RBD IgG at or above the
limit of detection of the test. A positive result indicates
past SARS-CoV-2 infection and / or COVID-19
vaccination. Studies indicate that individuals with
Anti-RBD IgG have a lower risk of future SARS-CoV-2
infection, symptomatic COVID-19 and severe COVID-19
compared to individuals without Anti-RBD IgG.
ABFIND may give negative result when an individual
doesn’t have Anti-RBD IgG or if the antibody titers are
too low to be detected by the test. Some individuals
who test negative may develop antibodies later or may
have antibodies other than Anti-RBD IgG.
IFU/RPDSNA01/00,
Date:
03/09/2021
12
14. Manufacturer:
Meril Diagnostics Pvt Ltd
Second Floor, D1-D3, Meril Park,
Survey No. 135/2/B & 174/2,
Muktanand Marg, Chala, Vapi 396191,
Gujarat, India.
Tel: +91 260 2408000
Fax: +91 260 2408025
Customer Care: 1800 266 3745
E-mail: diagnostics@merillife.com,
Web: www.merillife.com
Scan QR Code
for video instructions
on how to use ABFIND
at home
IFU/RPDSNA01/00,
Date:
16/09/2021