SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex
particle-enhanced turbidimetric immunoassay)
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.
False positive results forSARS-CoV-2 Neutralizing Antibodies Test
Kit(Latex particle-enhanced turbidimetric immunoassay) may occur
due to cross-reactivity from pre-existing antibodies or other
possible causes
Product information
Principe | Latex Particle- Enhanced Turbidimetric Turbidimetric |
Specimen | Plasma,Serum |
Sample Volume | 10µL |
Package | 300 tests/kit |
Storage | 2-8°C |
Shelf Life | 12 months |