FORA COVID-19 ANTIGEN RAPID TEST

FORA COVID-19 ANTIGEN RAPID TEST

FORA COVID-19 ANTIGEN RAPID TEST

FORA ANTIGEN Rapid Test

FORA COVID-19 Antigen Rapid Test

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.

Benefits


Clinical Performance

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
PositiveNegativeSubtotal
FORA COVID-19 Antigen Rapid Test
Positive39140
Negative3 (2 subject Ct > 30)220223
Subtotal42221263
Sensitivity96.3%
(95% CI: 81.7% – 99.3%)
Specificity99.5%
(95% CI: 97.5%-99.9%

Test in 5 Simple Steps
Clear Results Interpretation

Positive

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*.

Negative

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*.

Invalid

If no line appears in the Control zone (C), the test is invalid.

All necessary test components within the box
Box content

20-Test Kits / Box:

  • Individually Foil Packaged Test Cassettes *20
    Each cassette includes:

    • Conjugate pad: Anti SARS-CoV-2 N protein IgG CGC
    • Test line (T Line): Anti-SARS-CoV-2 N protein IgG
    • Control line (C Line): Control line antibody
  • Extraction Buffer (6ml/bottle) *2: Detergent, salts, and non-reactive ingredients
  • Extraction Tube *20
  • Nozzle Cap *20
  • Sterile Nasopharyngeal Swab *20
  • User Manual *6 (EN/DE/FR/IT/NL/ES/PT)
  • Quick Reference Guide *1
kit
Specifications

Test PrincipleLateral Flow Chromatographic Immunoassay
Target AntigenSARS-CoV-2 Nucleocapsid Protein
Sample TypeFresh Nasopharyngeal Swab Specimen
Limit of Detection (LoD)1.26 x 10^2 TCID50 per mL
Storage Condition2~30°C
Cross-reactivity & InterferencesViruses, Bacteria and Interferences tested do not cross-react or interfere
Reaction Time15 minutes
Information

Instruction for Use

Frequently Asked Questions (FAQ)

COVID-19 General Information

Information for Healthcare Professionals

Infection Control Guidance for Healthcare Professionals