DIATHER Test SARS-CoV-2/Flu A/Flu B+ADV/RSV Antigen Combo

DIATHER Test SARS-CoV-2/Flu A/Flu B+ADV/RSV Antigen Combo  is a rapid test (LFIA) that uses a sandwich immunoassay with double antibodies to detect SARS-CoV-2, Influenza A virus, Influenza B virus, adenovirus (ADV), and respiratory syncytial virus (RSV) using colloidal gold immunochromatography

APPLICATION

The SARS-CoV-2/Flu A/Flu B+ADV/RSV Antigen Combo test – a rapid (LFIA) one-step in vitro test based on immunochromatography. It is intended for qualitative detection of SARS-CoV-2, Influenza A virus, Influenza B virus, adenovirus, and respiratory syncytial virus in nasal swab samples collected from humans. The test results are used as an aid in diagnosing respiratory pathogen infections and are suitable for individuals with clinical symptoms such as fever, sore throat, cough, and runny nose. The test kit is designed for self-administration. Individuals aged 18 and over can use this test kit independently. For those under 18, use of the kit should be supervised by an adult. This test kit should not be used in conjunction with other devices and is not automated.

HOW TO PERFORM THE TEST?

1. Preparation for the test
   Before starting, ensure all test components have reached room temperature. Wash and dry your hands thoroughly.

2. Check expiry date and prepare the test cassette
   Verify the expiry date on the packaging or foil pouch – do not use the test after this date. Place the test cassette on a dry, flat surface and open the pouch immediately before use.

3. Prepare the tube
   Open the buffer tube seal and place it securely in the designated station.

4. Collect the sample
   Open the sterile swab packaging, avoiding touching the tip. Collect the sample by holding the swab by the plastic handle.

5. Swab collection
   Gently insert the swab into the nostril (about 2.5 cm). Rotate it five times, touching the nasal walls. Leave it in for a few seconds to absorb an adequate amount of secretion.

6. Place the sample in the buffer
   Insert the swab into the buffer tube. Rotate it at least 10 times, pressing the tip against the tube walls to thoroughly mix the sample with the liquid.

7. Extract the sample
   Squeeze the outside of the tube to expel all contents from the swab into the buffer.

8. Remove the swab
   Slowly remove the swab while pressing the tube to extract as much liquid as possible.

9. Close the tube
   Attach the dropper tip to the tube and press until you hear a 'click' sound.

10. Apply the sample and read the result
    Add 4 drops of the solution (about 100 μl) into the test well of the cassette. Read the result after 15 minutes. Results after 20 minutes are invalid.
    Tip: If bubbles appear in the drops, add an extra drop.

11. Disposal of materials
    Place used test components in a biological waste bag and dispose of in a sealed trash bin.

PACKAGE CONTENTS

1 foil pouch with test panel

Instructions for use

STORAGE

The test kit should be stored away from direct sunlight at temperatures between 2 °C and 30 °C with a shelf life of 24 months. Do not freeze. The test kit should be used within 1 hour of opening the foil pouch.

WARNINGS AND PRECAUTIONS

• This test kit is intended for self-testing (Layman test).
• This test kit is for in vitro diagnostic use only.
• Individuals aged 18 and over can use this kit independently. For those under 18,
use under adult supervision.
• Before testing, bring all components to room temperature.
• During testing, take appropriate precautions to avoid splashes when adding the sample.
• The lysis buffer contains: Tris, NaCl, EDTA, SDS, Triton X-405, Triton X-100, Proclin 300, purified water. Safety information – warnings regarding the lysis buffer (use only as directed; do not swallow; do not immerse the swab in the provided lysis buffer or other liquids before inserting into the nose; avoid contact with skin and eyes; keep out of reach of children and pets before and after use. If the lysis buffer contacts skin or eyes, rinse thoroughly with water. If irritation persists, consult a doctor or local medical centre).
• A positive SARS-CoV-2 test result indicates a current COVID-19 infection. Follow local health department guidelines for confirmatory testing if necessary. Seek medical help if feeling unwell.
• A positive Influenza A/B test result suggests possible infection; individuals with positive results or feeling unwell should consult a doctor for further clinical care.
• A positive ADV test result indicates a possible adenovirus infection; individuals with positive results or feeling worse should seek medical advice for further care.
• A positive RSV test result suggests possible respiratory syncytial virus infection; individuals with positive results or feeling worse should consult a healthcare provider for further care.
• Do not reuse the test kit.
• Do not use the test kit if the pouch is damaged, the seal is broken, or the cassette is wet or contaminated.
• Do not use the contents after the expiry date printed on the external box.
• When collecting a nasal front swab, only use the swab provided in the kit.
• If the result is invalid, repeat the test.
• Do not mix components from different batches.
• After testing, place used test components, sterile swab, lysis buffer, and pipette tip in a biological waste bag to prevent potential infection risk from the sample.

This is a medical device. Use it according to the instructions or label.

Manufacturer: W.H.P.M Bioresearch & Technology Co., Ltd. China, No. 2 Zhongxin Street, LouZIZhuang, Jinzhanxiang, Chaoyang District, Beijing 100018

Responsible entity:  Diather Petrusewicz Sp. K. Ku Ujściu 19 80-701 Gdańsk

Advertising entity: Bionic sp. z o.o., al. Grunwaldzka 415, 80-309 Gdańsk