Overview

cPass Neutralization Antibody Detection kit detects circulating neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE2 cell surface receptor. The cPass test is now authorized for semi-quantitative detection that provides a relative concentration result of an adaptive immune response to recent SARS-CoV-2 infection.

       - This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories;

       - This product has been authorized only for detecting the presence of neutralizing antibodies to SARS-CoV-2, not for any other viruses or pathogens;

       - The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Product Introduction

GenScript cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit, is faster, easier, more scalable and automatable alternative to the traditional neutralizing antibody tests, such as virus neutralization test (VNT), pseudo-virus neutralization test (pVNT) and plaque reduction neutralization test (PRNT). The kit has the capability of measuring functional neutralizing antibodies (NAbs) within an hour instead of the days required by the traditional tests. cPass Neutralization Antibody detection kit does not require live biological materials or strict biosafety containment for testing (i.e. BSL3 containment). All aspects of the quality management system are certified to ISO 13485. GenScript has acquired CE mark (Europe) and HSA provisional approval (Singapore) and has been issued Emergency Use Authorization (EUA) by U.S. FDA. CPT code for the cPass kit is 86409. Please find more information here.

Basic Knowledge

A new coronavirus, SARS-CoV-2, has recently emerged to cause a human pandemic. There is an urgent need for a robust serological test to detect neutralizing antibodies to SARS-CoV-2. There are two types of antibody tests that aim for detecting COVID-19 infection with sufficient specificity and sensitivity. The first type is the virus neutralization test (VNT) which detects neutralizing antibodies (NAbs) in a patient's blood. VNT requires handling live SARS-CoV-2 in a specialized biosafety level 3 (BSL3) containment facility which is tedious and time consuming, taking 2-4 days to complete. Pseudovirus-based virus neutralization test (pVNT) is similar, but still requires the use of live viruses and cells although handled in a BSL2 laboratory. The second assay type includes ELISA and lateral flow (rapid tests) for antibody detection. However, most of these assays only detect binding antibodies that have been generated to various epitopes of the whole virus and do not differentiate for the virus blocking Nabs. GenScript cPass™ SARS-CoV-2 Neutralization Antibody Detect\ion Kit is based on the Surrogate virus neutralization test (sVNT) established in Professor Lin-Fa Wang's lab at Duke-NUS Medical School. This test detects NAbs, but without the need to use any live virus or cells and can be completed in 1-2 hours in a BSL2 lab. Using purified receptor binding domain (RBD) protein from the viral spike (S) protein and the host cell receptor ACE2, the test is designed to mimic the virus-host interaction by direct protein-protein interaction in a test tube or an ELISA plate well. This highly specific interaction can then be neutralized, i.e., blocked by highly specific NAbs in patient or animal sera in the same manner as in a conventional VNT.

Performance

Two clinical performance studies were conducted to validate the performance of the cPass SARS-CoV-2 Neutralization Antibody Detection Test using the Plaque Reduction Neutralization Test (PRNT) and SARS-CoV-2 virus WA01/2020 isolate. The cutoff for the PRNT comparator tests was established as indicated below:
 

Study 1:

The first study evaluated the clinical agreement of 114 samples (n=114) from previously determined RT-PCR positive or negative patients. Samples were run in the cPass™ Test and PRNT as the comparator The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated for each PRNT₅₀ and PRNT₉₀:

Study 2:

The second study evaluated the clinical agreement of 140 samples (n=140) whereby the corhort consisted of 93 PRNT50 negative and 47 PRNT50 positive samples. The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated:

Additional semi-quantitative data analysis show concordance between the cPass SARS-CoV-2 Neutralization Antibody Detection Kit results and the titers obtained with the neutralization comparator method (PRNT₅₀):

A02087 SARS-CoV-2 Neutralizing Antibody Calibrator is now FDA authorized under Emergency Use Authorization with cPass SARS-CoV-2 Neutralization Antibody Detection Kit for semi-quantitative results. ^New

Notice! Customers should be aware that they may receive product with original packaging prior to the updated FDA EUA authorization November 12, 2021. Such packaging retains the original 6 month expiration, manufacturer address, and IFU for qualitative use. The current inventory is qualified for the expiration extension to 9 months. Should you have questions about your order's expiration, do not hesitate to contact us to provide updated information related to your order. All kit lots manufactured after February 1, 2022 will include the new authorized labeling.

See below additional details related to a list of kit lots with original packaging. An outline of label changes can be found in the Resources section.

Kit lots with packaging prior to November 12, 2021*:

*Expiration extension applies to current GenScript inventory. If your order includes one of these kit lots, you will be informed that they include the original labels and they are eligible for the updated expiration per the updated FDA authorization dated November 12, 2021. The new expiration will be included on your quote and order.

Please email us at cs@medikonia.com for any enquiry. To place an order, please include the catalog number(s) of the product(s) in the email. Thank you

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