Covid 19 Neutralizing Antibodies Detection Kit

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.

Shenzhen Kisshealh Biotechnology Co., Ltd., located in the Pingshan District, Shenzhen, P.R. China. is a diagnostics company focused on the development and manufacture of IVD tests at the Point-of-Care with highly innovative proprietary technology.

We focused on the emerging markets of in vitro pathological diagnosis and immunodiagnosis. We developed, manufactured and successfully launched the in vitro immunodiagnosis platform for cancer and the POCT for infectious, genetic and chronic diseases.

<span style="color: rgb(33, 33, 33); text-transform: none; text-indent: 0px; letter-spacing: normal;" initial;"="" initial;="" 0px;="" normal;="" 255);="" 255,="" rgb(255,="" 2;="" !important;="" inline="" none;="" 600;="" 14px;="" sans-serif;="" arial,="" roboto,="" w3",="" gb="" sans="" "hiragino="" gb",="" hei",="" micro="" "wenquanyi="" sans",="" "droid="" arimo,="" freesans,="" yahei",="" "microsoft="" helvetica,="" grande",="" "lucida="" ui",="" segoe="">At Kissh we work every day to shape the future of in-vitro diagnostic testing. And our people are our best asset, the reason for our track record and our strength while we are moving forward. We live by our fundamental values and incorporate them in everything that we do. Our best asset is ‘Step Forward Every Second’