cPass™ SARS-CoV-2

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 Details

• 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 of GenScript’s cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit
  
  
  

  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 Detection 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:

  pTitle border="0" cellspacing="0" cellpadding="0" class="basicTable" width="100%"> PRNT₅₀ Result Interpretation Positive: > 1:20 Negative: < 1:20 PRNT₉₀ Result Interpretation Positive: > 1:10 Negative: < 1:10

  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:

  pTitle border="0" cellspacing="0" cellpadding="0" class="basicTable" width="100%"> PRNT₅₀ Clinical Agreement PPA: 100% NPA: 100% PRNT₉₀ Clinical Agreement PPA: 100% NPA: 100%

  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:

  pTitle border="0" cellspacing="0" cellpadding="0" class="basicTable" width="100%"> PRNT₅₀ Clinical Agreement PPA: 95.7% NPA: 97.8%

  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):

  	cPass Analyte Level Categories	cPass Titers Sub-Categories	PRNT50 Dilution Titers
  				Low Titer	High Titer
  			Target Not Detected <1:20	1:40-1:320	1:640-1: 5120
  cPass SARS-CoV-2 Neutralization Antibody Detection Kit interval of numerical values in U/mL	Negative	Negative	91	2	0
  	Low Titer	< 100 U/mL	2	22	1
  	High Titer	>100 U/mL	0	5	17
  Total			93	29	18
  Exact Agreement per Neutralization Titer Category	Equation			22/29=75%	17/18=94.4%
  	Acceptance Criteria			60%	60%
  +/- Agreement per Neutralization Titer Category	Equation			27/29=93%	18/18=100%
  	Acceptance Criteria			80%	80%
  	95% Score CI			78-98.1%	82.4-100%
  Negative Percent Agreement (NPA)	Equation		91/93=98%
  	Acceptance Criteria		95%
  	95% Score CI		92.5-99.4%

• Documents

  Protocols

  COAs

  SDS

  Dislaimer

• Fact Sheets
  

  Fact sheet for healthcare providers

  FACT SHEET FOR HEALTHCARE PROVIDERS GenScript USA Inc.November 12, 2021

  Free Download

  

  Fact sheet for recipients

  FACT SHEET FOR RECIPIENTS GenScript USA, Inc.November 06, 2020

  Free Download
• Resource
  

  Detect COVID-19 Neutralizing Antibodies in 1 hour!

  Test with cPass™ SARS-CoV-2 Neutralization Antibody Kit.

  Free Download

  

  SARS-CoV-2 Neutralizing Antibody Calibrator

  Instruction for Use

  Free Download

  

  cPass Test Labels for Updated Semi-Quantitation Authorization

  cPass Test Labels for Updated Semi-Quantitation Authorization

  Free Download

Features

Isotype Independent

High Specificity

High Sensitivity

Safe & Scalable