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

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

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.

*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

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Covid Antigen Test

FORA COVID-19 ANTIGEN RAPID TEST (Single Packed)

Positive

Negative

Invalid

User manual

Quick user guide

Frequently asked questions (FAQ)

COVID-19 General information

Information for healthcare professionals

Infection Control Guidance for healthcare professionals