Testsealabs COVID-19 Antigen Test Cassette
Short Description:
Testsealabs COVID-19 Ag is an immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in anterior nasal swab specimens from human.
Fast & Accurate：Achieve reliable results in minutes.
Simple Operation：No complex equipment required.
High Accuracy：Lab-grade precision you can trust.
Clear Visual Readout：Results are easy to read and interpret.
Certified Quality Systems：Compliant with ISO 13485 and MDSAP.
Room-Temperature Stability：No cold chain needed—easy to transport and store.
Product Specification
| Principle | Chromatographic Immunoassay | Specimen | nasal swab |
| Reading Time | 15 minutes | QMS Certification | ISO 13485、MDSAP |
| Storage Temperature | 4-30°C | Shelf life | 2 years |
| Format | Cassette | Specification | 1T/5T/20T |
Intended Use
COVID-19 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab specimens.
Summary
The COVID-19 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab specimens from individuals with suspected COVID- 19 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of COVID-19 antigen. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude COVID-19 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a
molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Test Cassette is intended for use by trained clinical laboratory personne.
