KISSH Covid-19 Neutralizing Antibodies Detection Kit (Latex particle-enhanced turbidimetric immunoassay)

Test principle

The SARS-CoV-2 Neutralizing Antibodies Test Kit is a Latex particle - enhanced turbidimetric immunoassay and Intended for qualitative and direct detection of total neutralizing antibodies to SARS-CoV-2 spike (S)protein receptor binding domain (RBD) in human serum and plasma. It is intended for use as an aid in identifying individuals with adaptive immune response to SARS - CoV - 2 , indicatingrecentorpriorinfection.

Product information

Intended use

SARS-CoV-2 Neutralizing Antibodies Test Kit(Latex particle-enhanced turbidimetric immunoassay) is intended for qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum. The kit is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. It should not be used to diagnose acute SARS-CoV-2 infection.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

Results are for the detection of SARS-CoV-2 antibodies. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

The sensitivity of the SARS-CoV-2 Neutralizing Antibodies Test Kit(Latex particle-enhanced turbidimetric immunoassay) early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.