Rapid Antigen Test SARS-CoV-2 LEPU MEDICAL

Rapid Antigen Test SARS-CoV-2 LEPU MEDICAL - Medical Device

This product is a lateral flow rapid immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs self-collected from an individual aged 18 years or older or collected from an adult from an individual aged under the age of 18. This test is intended for use in individuals with symptoms or other epidemiological reasons where a COVID-19 infection is suspected. This product is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

USEFUL MATERIAL FOR PERFORMING 1 TEST / SELF-TEST

How does it work

• For the sampling, insert the swab EXCLUSIVELY inside the vestibule of the Nostril and gently rotate 5 times.
• Repeat the operation in the second Nostril to ensure sufficient collection of material. ATTENTION: the swab must ONLY be inserted into the wall of the nostril and not up to the upper pharynx.
• Once the sample has been collected, insert the swab in the space provided inside the card, so that it fits into its special section.
• Apply 6 drops of reagent solution to the swab.
• Remove the adhesive protection strip and close the card.
• Wait 15 minutes for the result to be highlighted on the outside of the card.

Description

The Rapid Antigen Test Kit for SARS-CoV-2 (Immunochromatography with colloidal gold) is an immunoenzymatic test for professional use, of great speed and ease of use (15 minutes), intended for the qualitative determination of the antigen of SARS-CoV -2 starting from nasopharyngeal swab.
Diagnostic sensitivity: 92.00% (percentage of correctly identified sick subjects)
Diagnostic specificity: 99.26% (percentage of healthy subjects correctly identified)

Characteristics

The product consists of Test Cards, Instructions for Use, Sample Treatment Solution. In addition, there is a SARS-COV-2 Antigen Detection Card and desiccant packet in each Test Card Bag. The test card consists of a gold standard mat (coated with monoclonal antibody of the SARS-CoV-2N protein with colloidal gold label), sample mat, nitrocellulose membrane. (The test area (T) is coated with a monoclonal antibody of the SARS-COV-2 N protein; the control area (C) is coated with goat anti-mouse antibody), blotting paper and hydrophobic stiff paper.

Clinical Performance

Diagnostic sensitivity: 92.00% (percentage of correctly identified sick subjects)

Diagnostic specificity: 99.26% (percentage of healthy subjects correctly identified)

Indications

The test is only suitable for professionals for an auxiliary in vitro diagnosis. Do not freeze or use after the expiry date (stated on the package). The card test must be used within one hour of opening the sealed foil pouch. Avoid excessive temperatures and humidity in the laboratory environment. The reaction temperature should be 15-30 ° C and the humidity should be below 70%. During the test phase, wear protective clothing, medical mask, gloves and goggles. Do not use test cards with a single broken package, unclear marks, or after the expiration date. During the test the test card must be placed on the horizontal plane. The test card must be fixed and must not be removed. Dispose of used samples, test cards and other waste in the unsorted collection bin inside a plastic bag. Store at 4 ° C ~ 30 ° C, C, in a dry environment, away from direct sunlight. Expiry date equal to 12 months.

Interpretation of the results

Test results are available within 15 minutes, with the result displayed by means of a test strip. Evaluation of the LEPU Rapid Antigen Test is particularly easy and avoids the risk of misinterpreted test results.

Coronavirus nucleocapsid (N) protein is detected with the LEPU antigen rapid test. The test result is displayed on a test strip. The greater the volume of this protein, the darker the color of the test strip.

Carefully read the instructions for use contained in the package.

Format

The pack contains 1 test.