FORA COVID-19 ANTIGEN RAPID TEST (Single Packed)

FORA COVID-19 ANTIGEN RAPID TEST (Single Packed)

FORA COVID-19 ANTIGEN RAPID TEST (Single Packed)

 

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 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

  • Extra comfort – Clinically validated for testing with nasal sample
  • Test in 3 simple steps without specific training
  • Results in 15 minutes


Clinical Performance

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
PositiveNegativeSubtotal
FORA COVID-19 Antigen Rapid Test
Positive93194
Negative7141148
Subtotal100142242
Sensitivity95.7%
(95% CI: 89.3% – 98.3%)
Specificity99.3%
(95% CI: 96.1%-99.9%

Test in 3 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

Single Test / Box:

  • Individually Foil Packaged Test Cassette (1)
    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 Tube (0.5 mL per bottle) (1)
  • Sterile Swab (1)
  • User Manual (1)
  • Quick Reference Instruction (1)
Specifications

Test PrincipleLateral Flow Chromatographic Immunoassay
Target AntigenSARS-CoV-2 Nucleocapsid Protein
Sample TypeFresh Nasal 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
Useful Information

User manual

Quick user guide

Frequently asked questions (FAQ)

COVID-19 General information

Information for healthcare professionals

Infection Control Guidance for healthcare professionals