FORA Covid-19 Antigen Test

Single-Packed
FORA Covid-19 Antigen Test

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 FORA COVID-19 Antigen Rapid Test is clinically validated for testing with nasal and nasopharyngeal sample.

 

Benefits

  • NEW: Now available as an individual test for home use (Confirm with your local authority if self-testing is approved within your region)
  • More comfortable sampling from the front of the nose
  • High quality rapid test in just 15 minutes

 

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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
  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%

Test in 3 Simple Steps
Test in 3 Simple Steps
Clear Results Interpretation
Positive COVID-19 Reading

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 COVID-19 Reading

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 Covid-19 Reading

Invalid

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.
All necessary test components within the box
FORA Covid-19 Antigen Single-Packed Kit Components
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 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
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