SARS-Cov-2 Antibody Test PACK OF 20 TESTS

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The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).

20 Kits are included along with pipettes/dropper, buffer solution, and lancets.

Cross-reactivity: This test device has no cross reactivity with endemic human coronavirus OC43 antibody, influenza A virus antibody, influenza B virus antibody, respiratory syncytial virus antibody, adenovirus antibody, EB virus antibody, measles virus antibody, cytomegalovirus antibody, rotavirus antibody, norovirus antibody, mumps virus antibody, varicella-zoster virus antibody, and mycoplasma pneumoniae antibody.

Clinical Performance of the test

220 Clinical samples based on the nucleic acid detection method (PCR) test results were obtained including 93 positive and 127 negative samples.  The Sars-CoV-2 Antibody Test was compared with nucleic acid method (PCR) using the collected clinical samples.  The results are summarized below:

Diagnostic Sensitivity: 98.9%

Diagnostic Specificity: 97.6% 

Results in 15 minutes

INSTRUCTIONS FOR USE

 

Disclaimer: 

  • This test has not been reviewed by the FDA.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.

Link to FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

 

 

  • Disclaimer of Warranty

    No warranties or representations. Sellers and purchaser specifically acknowledge that except as otherwise set forth in this purchase agreement, sellers are selling and purchaser is purchasing the purchased equipment / tools “as is, where is”. Seller is not providing any warranty for the product and not making any warranty, express or implied. Purchaser has inspected the equipment/tool, and is not relying on any representations or warranties of any kind.

    Purchaser agrees and understands that it is solely the responsibility of the purchaser to know and understand the training and regulatory requirements of the state in which she/he is operating in order to use the product. Purchaser agrees to defend and indemnify seller for any misuse of the product and seller shall in no way be responsible for any injury, accident, malfeasance or misfeasance related to purchasers use of the product.

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