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Negative compliance rate100% conformance rate (specificity) for 126 negative controls with subjects not infected with SARS-CoV-2.Positive compliance rate sensitivityEarly infection stage (day 4-10): IgM 70.0% Late infection stage (day 11 - 24): IgM 92.3% Late infection stage (day 11 -24): IgG 98.6%
When the body has been exposed to the SARS-CoV-2 virus, it produces IgM and IgG antibodies in an attempt to defend itself against infection. By measuring the concentration of these particular antibodies, the SARS-CoV-2 Rapid Test can determine in 20 minutes whether you have been exposed to the virus fast and with reliaxble results.The test is very simple.Two drops of blood are taken from a patient’s fingertip and placed in the specimen window of a test cassette, along with two drops of buffer solution.
This product is not for at-home use and is meant for health professionals following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, whole blood, or finger-prick samples. This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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