The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic is a public health emergency of international concern. At present, the SARS-CoV-2 is spreading all over the world. Due to the the emergence of vaccines, people’s risk of contracting the virus has been reduced, but it is still impossible to completely avoid contracting the virus.Thus,it is necessary for people to conduct a rapid self-test.
The test utilizes the lateral flow immunoassay technology for the detection of nucleocapsid protein antigen in individuals with symptoms or suspected symptoms of SARS-CoV-2 infection.The self-testing cassette is suitable for people aged 15-70. People aged 15 to 70 who cannot test themselves can use it with help of other adults.
Store at 4-30°C in the sealed pouch until the expiration date printed on the package. Do not freeze.
1. Clinical performance
The SARS-CoV-2 Antigen Test Cassette was compared with a commercially available gold standard reagent (PCR), the results showed that the clinical sensitivity and specificity.
Clinical Sensitivity (Positive coincidence rate): 98.18%
Clinical Specificity (Negative coincidence rate): >99.00%
98.18% Sensitivity: In total 110 PCR confirmed positive samples: 108 PCR confirmed positive samples were correctly detected by SARS-CoV-2 Antigen Test Cassette. There are 2 false negative cases.
>99.00% Specificity: In total 456 PCR confirmed negative samples: 456 PCR confirmed negative samples were correctly detected by SARS-CoV-2 Antigen Test Cassette. There are 0 false positive case.
2. Limit of Detection (LoD)
The detection limit of SARS-CoV-2 Antigen Test Cassette has been examined. The LOD of the test for the NP-protein of SARS-CoV-2 is approximately 100pg/ml. The LOD of the test for the SARS-CoV-2 virus (inactivated) is approximately 50 TCID50/ml.
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