• English
  • Sign In
  • Contact Us
×

cPass™ SARS-CoV-2
Neutralization Antibody Detection Kit (FDA EUA)

cPass™ Technology » cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (FDA EUA)

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.

Watch the cPass video to learn how it works

Placing an Order

cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit

Authorization
FDA EUA
Size
96 Test
Quantity
Get A Quote

Customers should be aware that they may receive product with original packaging prior to the Dec 16, 2021 FDA EUA approval. Such packaging retains the original 6 month expiration. The current inventory is qualified for the 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.

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

Features

Isotype Independent

High Specificity

High Sensitivity

Safe & Scalable

Technology

Featured Video | Learn about COVID-19 and the importance of serology investigation in viral disease outbreak.

Fill in The Form to View Video

Dr. Linfa Wang, Ph.D., FTSE, is the director of the Program in Emerging Infectious Diseases at Duke-NUS Medical School in Singapore. His team at Duke-NUS, worked together with Diagnostics Development Hub and GenScript co-developed cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit.

Resources