Professional Covid-19 antigen rapid test, Clungene. Box of 25 units

IMPORTANT NOTE: This kit is for exclusive use by healthcare professionals and online sales are not enabled. If you want more information, write to us here or contact us at 93 864 37 07.

The rapid self-diagnosis of antigens Covid-19 test from Clungene is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigens using samples from both the nasal cavity, and the nasopharyngeal or oropharyngeal during the active phase of the infection.

It also detects coronavirus mutations, such as the beta, delta, and omicron variants, among others.

The test result can be read in just 15 minutes. 

Certificates:
- Approved by the European Commission's Health Safety Committee on February 17, 2021.
- CE Class IVD - Self-test medical product.

Technical Specifications: 
- Test type: qualitative. 
- Sample type: nasal, nasopharyngeal or oropharyngeal swab.
- Specificity: 
    • Nasopharyngeal sample collection: 99.7%.
    • Nasal sample collection: 99.4%.
- Sensitivity:
    • Nasopharyngeal sample collection: 98.0%.
    • Nasal sample collection: 97.1%.
- Reading time: 15 minutes. 
- Storage temperature: 4-30°C.

Test Procedure:
1. Remove the swab from the package and place the test cassette on a flat surface.
2. Sample collection can be performed in the nasal, nasopharyngeal or oropharyngeal cavity:
- Nasal cavity: insert the swab approximately 2.5 cm into the nostril and rotate the swab around several times against the nasal wall. Repeat the process in the other nostril using the same swab.
- Nasopharyngeal cavity: Tilt the patient's head back about 70º, introduce the swab through the nostril parallel to the palate (not upwards) until resistance is detected or the distance is equivalent to that from the patient's ear to the nostril and gently rub and roll the swab. The sample can be collected in both cavities using the same swab, but this step is not necessary if the swab tip is sufficiently impregnated with the liquid from the first collection.
- Oropharyngeal cavity: insert the swab into the posterior area of the pharynx and the tonsils. Rub the swab over the tonsillar pillars and the posterior oropharynx and avoid touching the tongue, teeth, and gums.
3. Carefully remove the sealed aluminum layer from the extraction reagent tube. Then, place it in the tube holder.
4. Insert the swab sample into the extraction tube that contains the reagent. Rotate the swab at least 5 times while pressing the tip against the bottom and side of the tube. Leave the swab in the extraction tube for one minute.
5. Remove the swab while squeezing both sides of the tube in order to extract the liquid from the swab. The extracted solution will be used as a test sample. Seal the extraction tube well with the tip of a dropper.
6. Remove the test cassette from the sealed bag. Invert the sample extraction tube, holding it in an upright position and transfer 3 slow drops to the sample area (S).
7. Wait for the color lines to appear and interpret the test results approximately 15 minutes after. Do not read the results after 20 minutes.

Interpretation of Results: 
- Positive: Two color lines appear, one in the control region (C) and another in the test region (T), regardless of the intensity of the test line.
- Negative: A color line appears in the control region (C) and none in the test region (T).
- Invalid: No color line appears in the control line (C), this may be due to an insufficient sample or an incorrect procedure. Review the process and repeat the test with another test strip.

Includes:
- 25 test cassettes.
- 25 tubes of extraction reagent containing 0.3ml of solution.
- 25 sterile single-use nasal swabs.
- 1 reagent tube holder.
- Instruction manual.

Each box contains the necessary materials to perform 25 tests.