In case any one was interested ... it appears as though there is only 1 covid neutrilizing antibody test out there. I could not nail down a price for each test. Things to keep in mind when we compare PMN' s covid serology test
- this test has only received Emergency Use Approval
- it is a ELISA test
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Nov 2020
Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the
cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody.
Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans it is still being researched.
“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.” ____________________________________________________ SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit (RUO)
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. This kit would be instrumental in vaccine and therapeutic development as it is suitable for all antibody isotypes and can be used to determine neutralizing antibodies in animal models without modification. The kit will also help in current COVID-19 investigations of sero-prevalence, assessment of herd immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection in animals.
- Global patent protection for the kit will be firmly implemented.
- 96 well ELISA format test with ACE2 protein attached to the plate and HRP labeled RBD is used for detection.
- Can be used with serum and plasma samples.
- The kit comes with positive and negative controls.
- 4 wells are typically used for the controls, so 92 wells can be used for samples.
High sensitivity, specificity To support the EUA, Genscript provided the FDA with data comparing Cpass’ performance with a real-time polymerase chain reaction (RT-PCR) test and with two plaque reduction neutralization test titers, PRNT
50 and PRNT
90. Using RT-PCRF as the comparator, Cpass demonstrated sensitivity of 94% and specificity of 96.5%. The Cpass test showed 100% sensitivity and specificity when using the PRNT titers.
The testing strategy was also validated in two COVID-19 patient cohorts in Singapore and China, with sample sizes of 375 and 250, respectively. The
study, published in
Nature Biotechnology in July, directly compared the clinical performance of Cpass and a cell- and virus-based detection test, with results showing Cpass was able to detect neutralizing antibodies from patients with 95% to 100% sensitivity and 99.93% specificity.
Piscataway, N.J.-based Genscript has already launched Cpass for countries that accept the CE mark, including all countries in Europe and many in Asia Pacific and Africa, Martz told
BioWorld. It also has regulatory approval from Singapore’s Health Sciences Authority.
With COVID-19 cases again rising globally, the company has “the capacity to produce millions of tests per month, and we can quickly scale up as needed,” he said