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The rapid non-invasive antigenic swab CE certificate for Covid-19 allows you to identify in 4 simple steps (15 minutes) the presence of Coronavirus (SARS-CoV-2). This test it is not invasive, it is not painful and it is highly accurate. The tampon is made in the superficial part of the nose and it does not cause pain. In Austria, Germany and South Tyrol these pads are used as "self-administered tests" (self-diagnostics / do-it-yourself) to test schoolchildren and students before entering the classroom. The test is done by children / teenagers in complete autonomy (without the presence of health personnel), for this reason it is called "self-administered test" (do it yourself).
The Covid-19 Rapid Antigen Test is a rapid chromatographic immunoassay test for the qualitative detection of the antigen SARS-CoV-2 in the nasopharynx (superficial part of the nose) responsible for the disease COVID-19. The test is performed on nose pharyngeal swab, And the result is read after 15 minutes. Test officially registered at the Italian Ministry of Health (nr. 2004469).
Due to a lack of regulation in Italy these tests are still sold "for professional use"and not as a self-test, although in other European countries and in some Italian regions they are used as self-administered tests (self-diagnostics). Dolomiti Medical assumes no responsibility for any unauthorized use or purchases by non-medical personnel. Read carefully the instruction manual. This product is intended for use by healthcare professionals.
2. Remove the swab and insert it into the test tube with the liquid that stabilizes the antigen. Then close the tube.
3. Apply 2-3 drops of the tube liquid on the Covid Test holder.
4. After alone 15 minutes you can read the result of the Covid Test.
The Quick Covid Test presents two lines: one of check (C) and one of test (T). The control line must turn pink to consider the test valid. The T line, on the other hand, will only be colored pink if you are positive for Coronavirus. The result should be read exactly 15 minutes after the application of the drops on the support.
- Positive (+): There are purple stripes in both the quality control area (C) and the test area (T).
- Negative (-): There is only a purple stripe in the area of quality control (C), and no purple streaks in the test area (T).
- Invalid: There is no purple stripe in the quality control area (C), or there is a blue stripe in the quality control area (C), thereby indicating incorrect operating procedures or that the test card has already deteriorated. In this condition, dethe instructions for use must be read carefully again, and then use the new test card to perform a new test. If the problem persists, stop using products with the same lot number and contact your local suppliers immediately.
Positive test results do not rule out co-infections with other pathogens. In case of positivity to the rapid test in question, it is necessary to perform the confirmation molecular test by RT-PCR, to search for SARS-CoV-2 RNA.
- Specificity: 99.62%
- Sensitivity Ct ≤32: 96.60%
- Sensitivity Ct ≤25: 98.54%
- Total coincidence rate 97.44% sensitivity
1. The test results of this product should be fully judged by the physician in combination with other clinical information, and should not be used as the sole criterion;
2. The product is used to test the clinical specimen SARS-COV-2 antigen.
1. The test is suitable only to professionals for an auxiliary in vitro diagnosis. Do not use expired products.
2. Do not freeze or use after the expiration date (see package for expiration date.
3. Avoid excessive temperatures and humidity in the laboratory environment. The tempreaction rate should be 15-30 ° C and humidity it should be below 70%.
4. The test card pouch contains desiccant and must not be taken orally.
5. During the test phase wear protective clothing, medical mask, gloves and goggles.
6. Do not use test cards with a single broken package, unclear marks, or after the expiration date.
7. Discard used samples, test cards and other waste according to local regulations and laws.
8. The test card must be used within 1 hour after being removed from the foil pouch. 9. Users must take samples according to the Instructions for Use.
10. Before testing the double-sided adhesive protection layer must be removed in advance to avoid splashing of liquid. If the double-sided adhesive protective layer is removed after adding the diluent, it is easy to cause liquid splashes.
11. Do not pour the thinner In the wrong sump.
12. During the test the test card must be placed on the horizontal plane. The test card must be fixed and must not be removed.
- Pack of 25 tests
- User manual
- Non invasive, simple to use
- Practical, does not require any device
- Quick, gives results in 15 minutes
- Stable and very accurate
- Economical and convenient
- Shelf life of 12 months from date of manufacture
- Ministry of Health registration: 2004469
- Storage conditions: 4 ~ 30 ° C