Medomics COMBO 8-in-1 Test is a rapid qualitative antigen test designed for self-testing at home. It enables the simultaneous detection of as many as eight of the most common pathogens responsible for respiratory infections: the SARS-CoV-2 virus, influenza A and B viruses, RSV, adenovirus (ADV), parainfluenza virus (PIV), human rhinovirus (RhV), and human metapneumovirus (hMPV). The test is performed using a nasal swab sample.

This is the most advanced COMBO self-test available on the market—a single test can simultaneously detect as many as 8 pathogens that can cause very similar symptoms. Such a broad detection range allows for the widest possible preliminary diagnosis of respiratory infections to be conducted at home.

1 swab = 8 results

The high accuracy of this test allows for reliable results as early as 15 minutes after applying the sample. The test is easy and convenient to use. All that is needed is a swab from the front of the nose, so the test can also be performed on children—under adult supervision.

This product is intended for self-testing.
This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: nasal swab
• Quick and easy testing
• Painless sample collection
• High-quality product
• Results in just 15 minutes!
• Single-use packaging
• Product intended for self-testing

Package Contents

• 1 test cassette
• 1 tube with extraction buffer
• 1 pipette tip
• 1 sterile swab
• 1 waste bag
• 1 user manual

Test Specifications

• COVID-19: specificity 100%, sensitivity 97.93%, accuracy 99.85%
• Influenza A: specificity 100%, sensitivity 96.50%, accuracy 99.75%
• Influenza B: specificity 100%, sensitivity 95.10%, accuracy 99.65%
• RSV: specificity 100%, sensitivity 94.48%, accuracy 99.75%
• ADV: specificity 100%, sensitivity 94.37%, accuracy 94.60%
• PIV: specificity 100%, sensitivity 94.48%, accuracy 99.60%
• RhV: specificity 100%, sensitivity 93.57%, accuracy 99.55%
• hMPV: specificity 100%, sensitivity 92.41%, accuracy 99.44%

How to perform the test?

1. Before performing the test, allow the kit to reach room temperature.
2. Wash your hands with warm water and soap, and dry them thoroughly.
3. Open the package and prepare all the components of the kit.
4. Remove the swab from the package, being careful not to touch the absorbent tip.
5. Insert the swab into your nostril to a depth of about 2.5 cm.
6. Carefully rotate the swab inside your nostril at least 5 times.
7. Repeat the procedure in the other nostril using the same swab.
8. Place the swab into the buffer tube and swirl it against the inner wall of the tube 10 times.
9. Squeeze the swab against the outer wall of the tube 5 times to completely dissolve the sample in the buffer.
10. Remove the swab by squeezing the sides of the tube to leave as much of the sample in the tube as possible.
11. Close the tube with the pipette tip.
12. Dispense 4 drops, approximately 100 µL, into each of the 3 wells on the test cassette.
13. Wait 15 minutes and read the result according to the test line markings.

The result should not be interpreted after 20 minutes.

Indications for testing

• fever
• cough
• sore throat
• runny nose
• fatigue
• muscle aches
• chills
• suspected upper respiratory tract infection
• contact with an infected person
• need to differentiate between COVID-19, influenza A, influenza B, RSV, adenovirus, parainfluenza virus, rhinovirus, and metapneumovirus

Application

• Detection of respiratory infections: The test enables qualitative, differential detection of antigens from eight respiratory pathogens.
• Support for rapid diagnosis: Simultaneous testing for multiple pathogens can facilitate the initial assessment of the cause of infection symptoms.
• Differentiation of the most common pathogens: The test detects the presence of SARS-CoV-2, influenza A, influenza B, RSV, adenovirus, PIV, HRV, and hMPV.
• Support for health monitoring: The test may be helpful for people with symptoms of respiratory tract infections, such as fever, cough, sore throat, or a runny nose.
• Quick assessment at home: The product is intended for self-testing and allows you to perform the test using a nasal swab sample.

Product identification details and responsible entities

EAN code: 6974167892263