A lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The sample material can be obtained by using a nasal swab during the acute phase of the infection.
The single packed antigen tests allows for easier home testing with nasal sampling – Confirm with your local authority if self-testing is approved in your region.
Benefits
Clinical performance of FORA COVID-19 Antigen Rapid Test was determined by testing 100 positive and 242 negative specimens for SARS CoV-2 antigen (Ag) to have a sensitivity of 95.7% (95% CI: 89.3% – 98.3%) and specificity of 99.3% (95% CI: 96.1%-99.9%).
| PCR Test Result | |||||
|---|---|---|---|---|---|
| Positive | Negative | Subtotal | |||
| FORA COVID-19 Antigen Rapid Test | |||||
| Positive | 93 | 1 | 94 | ||
| Negative | 7 | 141 | 148 | ||
| Subtotal | 100 | 142 | 242 | ||
| Sensitivity | 95.7% (95% CI: 89.3% – 98.3%) | ||||
| Specificity | 99.3% (95% CI: 96.1%-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.
Single Test / Box:
| Test Principle | Lateral Flow Chromatographic Immunoassay |
| Target Antigen | SARS-CoV-2 Nucleocapsid Protein |
| Sample Type | Fresh Nasal Specimen |
| Limit of Detection (LoD) | 1.26 x 10^2 TCID50 per mL |
| Storage Condition | 2~30°C |
| Cross-reactivity & Interferences | Viruses, Bacteria and Interferences tested do not cross-react or interfere |
| Reaction Time | 15 minutes |
