SARS Antigen card

Method: Colloidal Gold Immunochromatography

SARS CoV-2 Antigen Test is a colloidal gold enhanced double antibody sandwich immunoassay for the qualitative determination of SARS-CoV-2 antigen. Anti-SARS-CoV-2 antibody are immobilized in the test region on nitrocellulose membrane. If the specimen contains SARS-CoV-2 nucleocapsid proteins, during the assay specimen is allowed to react with the colored conjugate (SARS-CoV-2 antibody-colloidal gold conjugate); the mixture then migrates chromatographically on the membrane by the capillary action. An SARS-CoV-2 positive specimen produces a distinct color band in the test region, formed by the specific antibody antigen colored conjugate complex"(Au-SARS-CoV-2-Ab)-(SARS-CoV-2-Antigen)-(SARS-CoV-2-Ab)". Absence of this colored band in the test region suggests a negative result. A colored band always appears in the control region serving as procedural control regardless of the specimen contains SARS-CoV-2 nucleocapsid proteins or not.

1. Performance
1.1 The coincidence rate of positive controls
Tested with 5 positive controls, the results were all positive, and the coincidence rate (+ / +) was 5/5.
1.2 The coincidence rate of negative controls
Tested with 10 negative controls, the results were all negative, and the coincidence rate (+ / +) was 10/10.
1.3 Repeatability
Tested with repeatable control for 10 times, the results were all positive and consistent.
1.4 Limit of detection
Use 3 different concentration LoD controls to test, L1 is negative, L2 ~ L3 are positive.

2. Clinical Performance
Positive coincidence rate:97.0%,95%CI (94.2%-98.7%);
Negative,coincidence rate,:99.6%,95%CI(98.0%-99.9%)
Total coincidence rate:=98.4% ,95%CI (97.0%-99.2%).