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 FORA COVID-19 Antigen Rapid Test is clinically validated for testing with nasal and nasopharyngeal sample.
|PCR Test Result|
|FORA COVID-19 Antigen Rapid Test|
|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.
|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|
|Cross-reactivity & Interferences||Viruses, Bacteria and Interferences tested do not cross-react or interfere|
|Reaction Time||15 minutes|