Rapid SARS-CoV BOSON 2 Antigen Test Card

Rapid SARS-CoV-2 Antigen single-phase immunochromatographic in vitro assay.

Characteristics

It is designed for the rapid qualitative detection of SARS-CoV-2 virus antigens on anterior (anterior part of the nose) nasal swab specimens from individuals with suspected COVID-19 infection within the first seven days of symptom onset.

The SARS-CoV-2 Antigen Rapid Test Cassette should not be used as the sole basis for diagnosis or to rule out a SARS-CoV-2 infection.

Children under 14 must be supervised by an adult.

How to use

1. Prepare a flat, clean and dry surface.
2. Check the contents of the package. Make sure nothing is damaged or broken.
3. Take the timer.
4. Blow your nose several times before taking the sample. To wash hands.
5. Open the extraction solution. Open it away from your face and make sure you don't spill the liquid. Pour the entire contents of the extraction solution into the extraction tube. Avoid contact between the two containers.
6. The swab is in the sealed package. Locate the soft fabric tip. Open the swab package and carefully remove the swab. Try not to touch the soft fabric tip with your hands.
7. Carefully insert the swab into one nostril. The tip of the swab should be inserted no less than 2.5 cm deep from the edge of the nostril. Rotate the swab along the mucosa inside the nostril to ensure that both mucus and cells are collected. Rotate the swab 3-4 times. Leave the swab in the nostril for a few seconds.
8. Repeat the procedure with the same swab in the other nostril. This operation can be unpleasant. Do not insert the tampon deeper if you feel severe resistance or pain.
9. Insert the swab with the sample into the extraction tube. Now rotate the swab three to five (3-5) times. Leave the swab in the extraction buffer solution for 1 minute. Press the extraction tube with your fingers trying to remove the solution from the swab as best you can, while withdrawing and discarding the swab. Place the cap with the dropper on the extraction tube.
10. Before testing, leave kit components at room temperature. Open the pouch and remove the test cassette. Place the test cassette on a flat, straight surface. After opening, the test cassette should be used immediately.
11. Rotate the extraction tube and pour 3 drops (75 mcL) of the sample onto the well (S) by gently pressing the extraction tube. Avoid the formation of air bubbles in the well (S).

The result is displayed after 15-20 minutes.

ATTENTION: after more than 20 minutes the result may be wrong.

The used product can be disposed of with normal household waste in accordance with applicable local regulations.

Interpretation of the results

• Positive: If two colored lines appear within 15-20 minutes, a line in the control area (C) and a line in the test area (T), the test is valid and positive. The result is considered positive, no matter how faint the colored line is in the test area (T). A positive result does not exclude packaging with other pathogens.
• Negative : If within 15-20 minutes a colored line appears in the control area (C) but no colored line is seen in the test area (T), the test is valid and negative. A negative result does not rule out a SARS-CoV-2 viral infection and should be confirmed by molecular diagnostics if the presence of COVID-19 is suspected.
• Invalid: If no colored line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test cassette.

Warnings

• Read these instructions carefully.
• Do not use the product if the pouch is damaged or the seal is broken.
• The product must be used at room temperature (15 ° C to 30 ° C). If the product has been stored in a colder environment (temperature below 15 ° C), leave it at normal room temperature for 30 minutes before use.
• Treat all specimens as potentially infectious.
• Inappropriate or inaccurate specimen collection, storage, and transport can lead to inaccurate test results.
• Use the swabs provided in the package to ensure optimal test performance.
• The correct sampling is of fundamental importance for the execution of the test. Be sure to collect enough sample material for analysis (nasal secretions) with the swab, especially for the nasal sample collection in the front.
• Blow your nose several times before taking the sample.
• Samples should be examined as soon as possible after collection.
• Introduce the drops of sample to be analyzed into the well (S) only.
• Too many or too few drops of the extraction solution can make the test result invalid or incorrect.
• Children under 14 must be supervised by an adult.

storage

Store the test at 4 to 30 ° C in the original sealed pouch. Do not freeze.

Do not use the product after the expiration date.

Validity for intact packaging: 12 months.

Format

The kit contains:

• SARS-CoV-2 Antigen Test Cassette (sealed foil pouch);
• sterile swab;
• extraction tube;
• extraction solution;
• Instructions for Use;
• test tube holder.