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 103 positive and 268 negative specimens for SARS CoV-2 antigen (Ag) to have a sensitivity of 94.2% (95% CI: 87.9% – 97.3%) and specificity of 99.6% (95% CI: 97.9%-99.9%).
|PCR Test Result|
|FORA COVID-19 Antigen Rapid Test|
(95% CI: 87.9% – 97.3%)
(95% CI: 97.9%-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.
*No test is ever perfect. All tests occasionally result in false-positive or false-negative results. Sometimes the results are not definitive. For this and other reasons, results should always be reviewed by healthcare professionals.
Reference: CDC(2020). Guidance on Interpreting COVID-19 Test Results.
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|