A lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The sample material is obtained by using a nasopharyngeal swab during the acute phase of the infection.
Clinical performance of FORA COVID-19 Antigen Rapid Test was determined by testing 42 positive and 221 negative specimens for SARS CoV-2 antigen (Ag) to have a sensitivity of 96.3% (95% CI: 81.7% – 99.3%) and specificity of 99.5% (95% CI: 97.5%-99.9%).
|PCR Test Result|
|FORA COVID-19 Antigen Rapid Test|
|Negative||3 (2 subject Ct > 30)||220||223|
(95% CI: 81.7% – 99.3%)
(95% CI: 97.5%-99.9%
Two colored lines appear: One line in the control line region (C) and one in the test line region (T). The result is positive regardless of the intensity of the T-line.
The patient is most likely INFECTED with the COVID-19 infection*.
A line in the Control line region (C) appears. No line in the Test line region (T).
The patient is most likely NOT INFECTED with the COVID-19 infection*.
If no line appears in the Control zone (C), the test is invalid.
20-Test Kits / Box:
|Test Principle||Lateral Flow Chromatographic Immunoassay|
|Target Antigen||SARS-CoV-2 Nucleocapsid Protein|
|Sample Type||Fresh Nasopharyngeal Swab Specimen|
|Limit of Detection (LoD)||1.26 x 10^2 TCID50 per mL|
|Cross-reactivity & Interferences||Viruses, Bacteria and Interferences tested do not cross-react or interfere|
|Reaction Time||15 minutes|