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cPass™ Coronavirus SARS-CoV-2 Neutralizing Antibody

Test Code: 33026

Patients, you must contact your physician to order Coronavirus COVID-19 testing.
Eurofins Viracor will not see patients at our facility or collect samples on site.

An account must be set up to order testing. See the Specimen Information section for more information.

cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody is available with a self-pay price for patients who do not have health insurance or for those who intentionally choose not to submit a claim to their insurance company. The cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody self-pay price is $70. Additional charges may apply for specimen collection, logistics or expedited turnaround testing.

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Clinical Utility

The cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody test is a Blocking Enzyme-Linked Immunosorbent Assay (ELISA) intended for qualitative direct detection of total neutralizing antibodies to SARS-CoV-2 in human serum and K2-EDTA plasma. The cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody test should not be used to diagnose acute SARS-CoV-2 infection.

About cPass™ Coronavirus SARS-CoV-2 Neutralizing Antibody Assay
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is a 3 enveloped non-segmented positive-sense RNA virus. It is the causative agent of coronavirus disease 2019 (COVID-19), which is contagious in humans.

SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The spike protein (S) contains a receptor-binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2). It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells of the deep lung and viral replication.

Infection with SARS-CoV-2 initiates an immune response, which includes the production of antibodies, or binding antibodies, in the blood. Not all binding antibodies can block cellular infiltration and replication of the SARS-CoV-2 virus. The subpopulation of the binding antibodies that can block cellular infiltration and replication of the virus are named neutralizing antibodies. It is unknown how long it takes for neutralizing antibodies to be produced, and if they are always produced after SARS-CoV-2 infection. While individuals infected with SARS-CoV-2 develop binding antibodies to the virus, not all of them develop neutralizing antibodies to SARS-CoV-2. The cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit is specific to SARS-CoV-2 neutralizing antibodies.

Aside from evaluating the natural immune response of neutralizing antibodies to SARS-CoV-2, the cPass™ Coronavirus SARS-CoV-2 Neutralizing Antibody Assay could also aid in evaluating vaccine efficacy. The goal of most currently available vaccines is to induce neutralizing anti-S antibodies. Individuals typically have detectable antibodies for weeks to months after infection regardless if mild or no clinical signs were present. Neutralizing antibodies have been shown to appear approximately 3-4 weeks after infection or vaccination and the length of persistence varies by the patient’s immune response.

Procedure

The cPass™ Coronavirus (COVID-19) SARS-CoV-2 Neutralizing Antibody test is a blocking ELISA detection tool. Using purified receptor binding domain (RBD), protein from the viral spike (S) protein and the host cell receptor ACE2, this test is designed to mimic the virus-host interaction by direct protein-protein interaction in a test tube or a well of an ELISA plate. The highly specific interaction can then be neutralized, the same manner as in a conventional Virus Neutralization Test (VNT). Recent studies demonstrated that the cPass test does not detect binding antibodies such as those typically detected in conventional indirect ELISA tests, but rather the presence of neutralizing antibodies.4

The kit contains two key components: the Horseradish peroxidase (HRP) conjugated recombinant SARS-CoV-2 RBD fragment (HRP-RBD) and the human ACE2 receptor protein (hACE2). The protein-protein interaction between HRP-RBD and hACE2 can be blocked by neutralizing antibodies against SARS-CoV-2 RBD.

Samples and controls diluted with sample dilution buffer and pre-incubated with the HRP-RBD to allow the binding of the circulating neutralization antibodies to HRP-RBD. The mixture is then added to the capture plate, which is pre-coated with the hACE2 protein. The unbound HRP-RBD as well as any HRP-RBD bound to non-neutralizing antibody will be captured on the plate, while the circulating neutralization antibodies HRP-RBD complexes remain in the supernatant and are removed during washing. Following a wash cycle, TMB substrate solution is added followed by the Stop Solution and the reaction is then quenched and the color turns yellow. The absorbance of the final solution can be read at 450 nm in a microtiter plate reader.

This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA to perform high complexity tests.

Package Insert

HCP Fact Sheet

Recipient Fact Sheet

Specificity

Please refer to the Package Insert

3-5 business days from receipt of specimen

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Serum 33026 86408 Yes

1 mL (min. 0.5 mL)

Qualitative, "Positive / Negative"

  • Collect whole blood in red top tube.
  • Allow blood to clot at room temperature for 30 minutes then centrifuge at 10,000 x g for 10 minutes to recover serum. Remove serum from cells within 30 minutes and transfer 1 mL to a clean, screw top tube.
  • Samples are stable ambient, refrigerated or frozen for 14 days.
  • Can be shipped ambient, refrigerated or frozen. Recommend shipping at frozen temperature, -20°C, Monday through Friday and must be received within 14 days of collection.
Plasma 33026 86408 Yes

1 mL (min. 0.5 mL)

Qualitative, "Positive / Negative"

  • Collect whole blood in EDTA tube.
  • Centrifuge at 10,000 x g for 10 minutes and transfer 1 mL plasma from cells within 30 minutes to clean, screw top tube.
  • Samples are stable ambient, refrigerated or frozen for 14 days.
  • Can be shipped ambient, refrigerated or frozen. Recommend shipping at frozen temperature, -20°C, Monday through Friday and must be received within 14 days of collection.
Shipping

To Setup an Account:
Prior to sending samples for the first time, all new clients must set up a Eurofins Viracor Account. Please visit our Account Setup page to begin this process.

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. For additional testing, please send a separate specimen. Refer to our website for accepted specimen types. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed. Hyperlipemic and moderate to grossly hemolyzed specimens.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency.

References
  1. Chinese Center for Disease Control and Prevention (2020) Public protection guidelines for Novel coronavirus pneumonia, People's Medical Publishing House (PMPH).
  2. ZHOU Peng, YANG Xinglou. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature, 2020.
  3. XUE Xiongyan, ZHU Changlin, HUANG Shaozhen, Inactivation of 2019 new coronary virus before antibodies detection by different methods. Journal of Southern Medical University, 2020.
  4. SHI Heshui, HAN Xiaoyu, FAN Yanqing. Radiologic Features of Patients with 2019-n Co V Infection. Journal of Clinical Radiology, 2020.
  5. NCCLS. 1991. National Committee for Clinical Laboratory Standard. Internal Quality
  6. Testing of Reagent Water in the Clinical Laboratory. NCCLS Publication C3-A3.
  7. NCCLS. 1997. National Committee for Clinical Laboratory Standard. Preparation and Testing of Reagent Water in the Clinical Laboratory. NCCLS Publication C3-A3.
  8. Melissa L.Tuck et al. Standard Operating Procedures for Serum and Plasma Collections: Early Detection Research Network Consensus Statement Standard Operating Integration Working Group. J Proteome Res 2009.
  9. Chee Wah Tan et al. A SARS-CoV-2 surrogate virus neutralization test (sVNT) based on antibody-mediated blockage of ACE2-spike (RBD) protein-protein interaction. 2020. Preprint on ResearchSquare : doi: https://dx.doi.org/10.21203/rs.3.rs-4574/v1.
  10. Tan et al Nat Biotechnol (2020) 38, 1073-1078 https://doi.org/10.1038/s41587-020-0631-z

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