The KOVIFAST™ Antigen Rapid Test is based on Lateral Flow Detection (LFD) intended for the in-vitro qualitative detection of the SARS-CoV-2 virus antigen nucleocapsid (N) protein in the human nasal swab, nasopharyngeal swab, oropharyngeal swab, and deep throat sputum samples. N protein is an important structural protein of the SARS-CoV-2 virus and plays a critical role in enhancing the efficiency of virus transcription and assembly.

Product Specifications:

• Sample collection method: deep throat sputum as the preferred method; or throat and tonsil (oropharyngeal) swab as an alternative method if sputum cannot be produced
• Test kit contents: disposable swab (one); dropper tube (one); diluent vial (one); sputum dish (one); test cassette (one)
• Storage conditions: 2 to 30°C away from direct sunlight; use within 12 months from date of manufacture
• Packing: One Test (single boxed test kit); Twenty Test Shipping Box (twenty single boxed test kits in one shipping box); Twenty Test (twenty individual single test kits in one bulk box)

Validated by Clinical Study：

The KOVIFAST™ Covid-19 (SARS CoV-2) Antigen Rapid Test Kit has been validated by a comprehensive clinical study in which 62 clinical samples were selected.  Using this kit, 35 cases out of 38 PCR test confirmed cases are positive, with a sensitivity of 92.1%; 50 out of 50 PCR test excluded cases are negative, the specificity was 100%. The overall consistency is 96.6%.