Multigrip rapid nasal combi-test for the detection of coronavirus antigens, influenza A and B viruses No. 1

Rapid test for the qualitative determination of SARS-CoV-2 nucleoside protein and influenza A and influenza B nucleoprotein antigens detected in a nasal swab specimen.

The product is intended for self-testing. In vitro diagnostic medical device.

Indications for use

MULTIFLU rapid nasal combi-test for the detection of coronavirus antigens, influenza A and B viruses is a single-use test kit intended for the detection of SARS-CoV-2, influenza A and influenza B viruses, which cause COVID-19 and/or influenza, in a self-collected nasal swab specimen. The test is intended for use in symptomatic/asymptomatic individuals with suspected COVID-19 and/or influenza A+B infection. The results are intended for the detection of SARS-CoV-2 nucleocapsid protein, influenza A and influenza B nucleoprotein antigens. The antigen can usually be detected in upper respiratory tract specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with medical history and other diagnostic data is necessary to determine the infectious status. Positive results indicate the presence of SARS-CoV-2 and/or influenza A+B. Individuals who test positive should self-isolate and seek further medical attention from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 and/or influenza A+B. Individuals who test negative and continue to experience COVID- or influenza-like symptoms should contact their healthcare provider for further follow-up.

Please read all information in this manual before performing the test.

Method of application

Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

STEP 1

Remove the cap from the extraction buffer tube and place the tube in the tube holder in the box.

STEP 2. Collect nasal swab samples

1. Remove the sterile specimen swab from the package without touching the soft tip of the swab.
2. Insert the swab into your nostril until you feel a slight resistance (about 2 cm up your nose). Slowly twist the swab, rub it along the inside of your nostril against the nasal wall 5-10 times, and carefully remove the swab.

Note:

This may cause discomfort. Do not insert the swab deeper if you feel strong resistance or pain. If the nasal mucosa is damaged or bleeding, it is not recommended to take nasal swabs. When collecting a sample from other people, please wear a mask. When collecting a sample from children, it is not necessary to insert the swab so deep into the nostril. For very young children, another person may be needed to hold the child’s head while taking the swab.

3. Repeat step 2 in the other nostril using the same swab.

STEP 3. Sample preparation

1. Place the swab in the tube with the buffer solution, make sure it touches the bottom, and mix (rotate the swab for 10-15 seconds in the tube).
2. Remove the swab by pressing the swab head against the inside of the tube to obtain the maximum amount of sample from the swab. Place the swab in a plastic bag for used materials.
3. Close the cap or put the tip on the tube.

STEP 4. Testing

1. Remove the test cassette from the packaging and use it within one hour. For best results, perform the test immediately after opening. Place the test cassette on a flat surface.
2. Shake the sample tube, open the cap, holding it vertically, and add 3 drops of extracted sample to each well (S) of the test cassette and start the timer. Do not move the test cassette during the test development.
3. Read the result after 10 minutes. Do not read the result after 20 minutes.

Note:

After completing the test, place all components in a plastic bag for used materials and seal it tightly, then dispose of as medical waste.

STEP 5. Reading the results

Please share your test results with your doctor and carefully follow local COVID guidelines/requirements.

POSITIVE RESULT SARS-CoV-2:*
Two colored lines appear in the COVID-19 result window.

One colored line should be in the control region (C) and the other colored line should be in the test region (T).

POSITIVE FLU A RESULT:*

Two colored lines appear in the FLU A+B result window. One colored line should be in the control region (C) and the other colored line should be in the flu A region (A).

POSITIVE FLU B RESULT:*

Two colored lines appear in the FLU A+B result window. One colored line should be in the control region (C) and the other colored line should be in the influenza B region (B).

POSITIVE RESULT FLU A and FLU B:*

*NOTE: The intensity of the color in the test line region (T/B/A) will vary depending on the amount of SARS-CoV-2 antigen and/or influenza A+B antigen present in the specimen. Therefore, any shade of color in the test region (T/B/A) should be considered positive. A positive result means that there is a high probability that you have COVID-19 and/or influenza A/influenza B, but laboratory confirmation is required. Immediately self-isolate according to local guidelines and contact your GP/physician or local health department immediately according to the instructions of your local authority. Your test result will be verified by PCR confirmation and you will be advised of the next steps.

NEGATIVE RESULT:

One colored line appears in the control line region (C). No visible colored line appears in the test line region (T/B/A). It is unlikely that you have COVID-19 and/or influenza A/influenza B. However, in some people with COVID-19 and/or influenza A/influenza B, this test may give a false negative result (false negative). This means that you may have COVID-19 and/or influenza A/influenza B even if the test is negative.

You can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus/flu virus cannot be accurately detected at all stages of infection. Even if the test result is negative, it is necessary to follow the rules of distance and hygiene, migration/travel, attending events, etc. according to local recommendations/requirements regarding COVID/flu.

INVALID RESULT:

Control line does not appear. Insufficient specimen volume or incorrect test technique are the most likely reasons for the absence of a control line.

Review the procedure and repeat the test with a new test or contact a COVID-19 and/or flu testing center.

Reservation

The product is intended for self-testing. In vitro diagnostic medical device. Do not eat, drink or smoke in the area where specimens or kits are handled. Do not drink the buffer solution. Handle the buffer solution with care and avoid contact with skin or eyes, in case of contact, rinse immediately with plenty of running water. Do not use if the packaging is damaged. This test kit is for preliminary testing only, and repeated invalid results should be discussed with a doctor. Strictly follow the specified test time. Do not reuse. Do not disassemble or touch the test wells of the test cassette. The kit cannot be frozen or used after the expiration date stated on the package. Children should perform the test under adult supervision. Wash hands thoroughly before and after handling the kit. Please ensure that sufficient specimen is used for testing. Too much or too little specimen may result in invalid results.

Storage conditions

Store in the original packaging at a temperature of 2°C to 30°C in a dry place and out of reach of children. The test cassette should remain in the sealed pouch until use.

Packaging

Test cassette packed in a sealed package with a desiccant, buffer solution in a tube with a dispenser cap, a disposable swab for sample collection, a plastic bag for used materials, and instructions for use.

Test Cassette Components: Well pad contains chemicals and detergents, as well as SARS-CoV-2 antibody conjugate particles, influenza A antibody conjugate particles, influenza B antibody conjugate particles, and mouse IgG conjugate particles. Result window (nitrocellulose membrane): Control line contains IgG antibodies. Test line: contains SARS-CoV2 antibodies, mouse influenza A antibodies, and mouse influenza B antibodies. Absorbent pad is made of highly absorbent paper.

Additional required materials for the test that are not provided: timer.

Producer

Delta Medical Promotions AG, 26 Oetenbachgasse, Zurich, CH-8001, Switzerland/Delta Medical Promotions AG, Oetenbachgasse 26, Zurich, CH-8001, Switzerland. At the production site at: 550#, Yinhai Street, Hangzhou Economic and Technological Development Area, Hangzhou – 310018, PR China/№550, Yinhai Street, Hangzhou Economic and Technological Development Area, Hangzhou – 310018, PR China.

Authorized representative in Ukraine:

Representative office of Delta Medical Promotions AG, 08132, Vyshneve, Chornovola St., 43.

Expiration date

2 years.