The Fluorecare® SARS-CoV-2, Influenza A/B, and RSV Combination Test Kit (MF-71) is a colloidal gold immunochromatographic test for the qualitative detection and differentiation of four viruses:

SARS-CoV-2 (COVID-19),
Influenza A,
Influenza B, and
RSV (respiratory syncytial virus).

This is a self-test for in vitro diagnostic use. The test can help diagnose respiratory infections in symptomatic patients within 7 days of symptom onset.

Indications

The test is intended to:

detect COVID-19 (caused by SARS-CoV-2)
detect influenza A and B (Influenza A/B)
differentiate RSV infections

Its use is intended as an aid to diagnosis and not as the sole basis for medical decisions.

Instructions

This test is suitable for individuals over the age of 2:

2-14 years: The test must be performed by an adult.

14-17 years: Can be tested under supervision.

>75 years: It is recommended that an adult perform the test.

The test is performed using a nasal swab:

Nasal swab: Insert the cotton swab 2.5 cm deep into each nostril, then rotate it five times.
Place the sample in the tube containing the pre-filled solution.
Add 2 drops of the sample solution to the test card (in the well marked “S”).
Wait 12 minutes at room temperature (20-25°C).
Read the results between 12 and 20 minutes:
Two lines = positive
One line (C) = negative
No control line (C) = invalid

The test material is then disposed of as contaminated waste.

Composition

Each test kit contains:

Test card(s) with desiccant
Sterile nasal swabs
Sample processing tube(s) pre-filled with 0.5 ml of saline solution
Instructions for use

The test strip contains:

A cellulose membrane coated with antibodies against SARS-CoV-2, influenza A/B, and RSV.

A conjugate pad containing the same antibodies labeled with colloidal gold.

Other components: polyester pad and absorbent paper.