Flu A/B + Covid-19/RSV combo test – product description
Combination test kit for SARS-CoV-2, influenza A/B and RSV virus antigens (Chromatographic immunoassay using colloidal gold. Combo test designed to detect the presence of the nucleocapsid protein antigen of influenza A and B virus, RSV virus and/or SARS-CoV-2 virus.
The kit is used for the simultaneous qualitative detection and differentiation of coronavirus (SARS-CoV-2 antigen), influenza A virus antigen, influenza B virus antigen and/or
RSV antigen in nasal swab samples in vitro.
It can be used to aid in the diagnosis of infectious disease called coronavirus (COVID-19), caused by SARS-CoV-2 in patients with
symptoms within 7 days of their onset. It can also be used to aid in the diagnosis of disease caused by influenza A/B or RSV.
The combo test is intended for people over 2 years of age.
Action
The combined test kit for the presence of SARS-CoV-2, influenza A/B and RSV antigens is intended for the diagnosis and differentiation of infection.
- Positive COVID-19 or RSV antigen test result: Two purple lines.
- Positive Influenza A/B Test Result: The A line and quality control line (line C) appear, indicating a positive result for influenza A. The B line and quality control line (line C) appear, indicating a positive result for influenza B. The A line, B line and quality control line (line C) are colored, indicating a positive result for both influenza A and influenza B.
How to do the test?
Before starting the test, please read the instruction manual carefully, return the test kit and samples to room temperature (20-25℃) before use. The test should be performed at 20~25℃. If the kit has been taken out of the refrigerator before starting the test, please leave it at room temperature (20-25℃) for 5 minutes.
- Wash your hands using disinfectant.
- Clean the countertop on which the test will be performed.
- Unscrew the cap of the tube and remove the inner blue stopper. The purpose of the blue stopper is to prevent leakage of the product during transport. The blue stopper must be removed before use! Insert the tube into the opening in the kit or use other means to hold the tube in place.
- Tear open the foil pouch, remove the test card and use as soon as possible within 1 hour.
- Sample collection: nasal swab method:
- Carefully remove the sterile nasal swab from the package. (Avoid touching the cotton tip of the swab.) Insert the swab into the left nostril to a depth of 2.5 cm (1 inch) from the edge of the nostril.
- Rotate the swab on the nostril wall (mucosa) 5 times to ensure adequate sample collection.
- Repeat the process in the right nostril using the same swab, sampling from both nasal passages to ensure adequate sample collection.
- Place the swab sample in the tube, then break the swab at the swab node and leave the lower half in the tube. Close the lid.
- Press the swab 10 times into the tube. Then wait 1 minute for reaction. Unscrew the clamp located on the top of the lid. If the clamp on the top of the lid is not unscrewed and the blue stopper inside the tube is not removed, the liquid will not be able to drip.
- Each well on the test card requires 2 drops (approximately 60 μL) of sample treatment solution. The wells marked with the letter “S” under the COVID-19. Influenza A/B or RSV signs are sample wells. You can add up to 3 sample wells at a time to detect 3 different types of antigens or add only to one sample well to detect one type of antigen. Only 2 drops of sample treatment solution can be added to each well! Adding too much or too little sample treatment solution may cause incorrect test results!
- After adding the sample, the stopper. the top end of the stopper and the blue stopper should be re-capped in the tube for analysis and treated as contaminants.
- The test card should be kept at room temperature for 15 minutes to observe the test results; the observation results beyond 20 minutes will be invalid. If you read the test results after 20 minutes, the test results may be incorrect or invalid. You cannot touch the test card or pick it up from the desk while waiting.
Warnings
This is a medical device. Use it according to the instructions for use or label.
- This set is suitable for ages 2 and up.
- Persons aged 2-14 years old are not allowed to operate this set independently.
- This sample collection and testing kit should be used by adults or parents (aged 18-60).
- People aged 14-17 years can use this kit to collect and test samples under the supervision of an adult or parent (aged 18-60 years).
- Supervisors should ensure that users fully understand the requirements of the instructions and verify that their actions are correct.
- For people over the age of 75, it is recommended that a family member or caregiver (aged 18-60) performs the test.
- The test kit should be stored at 2-30℃ in a dry place and protected from light. The test kit is valid for 18 months.
- The test card must remain tightly closed until use. Once the test card pouch is opened, the test should be performed within 1 hour.
Contents: Test card (including drying agent), sterile nasal swab, pre-filled processing tube, instructions for use.
Storage method: 15°C – 25°C
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