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Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

Packaging size: 25 Tests

SKU 11BH888889
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Description

Product Description

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and venous whole blood (heparin, K2-EDTA, and sodium citrate). The Biohit SARS-CoV-2 IgM/IgG Antibody Test is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N-protein antigen and mouse anti human IgM/IgG antibody. SARS-CoV-2 IgM/IgG in the sample reacts with SARS-CoV-2 recombinant N-protein antigen bound to gold particles. This complex migrates along the membrane and reaches the IgM/IgG test line (T) which contains mouse anti human IgM/IgG antibody against SARS-CoV-2 IgM/IgG complex. The sample diluent is supplied for the lateral chromatography process, to provide a suitable environment for the reaction of antigen and antibody. When the result is positive, the gold-labelled SARS-CoV-2 recombinant antigen-antibody complex binds to the IgM/IgG test line (T) and a purplish red color develops. When the result is negative, the sample does not contain any SARS-CoV-2 recombinant N-protein antigen-antibody complex that can bind to the IgM/IgG test line (T) so no color becomes visible. Development of a purplish red control line (C) guarantees that sample application and migration have taken place correctly and that the test was properly performed.

Usage Statement

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 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. It 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 that 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.

Negative results do not preclude SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 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 a second, different IgG or IgM assay.

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization. For prescription use only. For in vitro diagnostic use only.

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit has not been FDA cleared or approved; it has been authorized by the FDA under an EUA for use by authorized laboratories. MP Biomedicals cannot make any claims suggesting that the test is safe or effective for the detection of SARS-CoV-2. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2 and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Key Applications

For COVID-19 antibodies IgG/IgM rapid screening

Specifications
SKU 11BH888889
Base Catalog Number BH888889
Components Instruction For Use, 25 Cassettes, Test Card, 1 Vial Sample Diluent, 25 Droppers.
Pack Size 25 Tests
Usage Statement <p>The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 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. It 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.</p><p>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 that antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.</p><p>Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.</p><p>Negative results do not preclude SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.</p><p>False positive results for Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 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 a second, different IgG or IgM assay.</p><p>The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization. For prescription use only. For in vitro diagnostic use only.</p><p>The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit has not been FDA cleared or approved; it has been authorized by the FDA under an EUA for use by authorized laboratories. MP Biomedicals cannot make any claims suggesting that the test is safe or effective for the detection of SARS-CoV-2. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2 and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.</p>