Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test

Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab or throat swab specimen. The test is for in vitro diagnostic use only. For professional use only.

Principle and intended use

Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test is intended for clinical laboratories and healthcare professional use only for point-of-care testing. Not for at-home testing.

Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test is based on immunoassay technology. Each test device has one line of anti-SARS coronavirus monoclonal antibody on the detection line (T line) and one line of anti-mouse IgG polyclonal antibody on the quality control line (C line).

When extracted specimen is added to the specimen well, it will react with the labeled antibody to form a complex, the mixture then migrates through the membrane by capillary action and interacts with the coated anti-SARS coronavirus monoclonal antibody on the detection line. If the specimen contains SARS-CoV-2 antigen, the detection line will appear purplish-red indicating the SARS-CoV-2 antigen is positive. Otherwise, the test result will be negative. The test device also contains a quality control line C which should appear purplish-red for all valid tests. If the quality control line C does not appear, the test result will be invalid even if the detection line appears.

Composition

Each test kit contains: 25 test devices, 25 extraction tubes (prefilled with extraction solution 300 μL / tube), filtered nozzles, 1 tube stand, 25 sterile swabs and 1 package insert.

Materials required but may not provided: timer.

Advanced Technical Features

Steps for Simple Test — Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test — www.sk-telemed.co.at

Steps for Simple Test

Steps for Simple Test — Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test — www.sk-telemed.co.at

**Warning**

NOT FOR AT-HOME TESTING. VivaDiag ™ SARS-CoV-2 Ag Rapid Test has ONLY been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in the diagnosis of suspected cases. Results from nucleocapsid protein antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.

Result Interpretation

Result Interpretation — Immupass VivaDiag™ SARS-CoV-2 Ag Rapid Test — www.sk-telemed.co.at

Specification

Test PrincipleColloidal gold
Sample TypeNasal swab, oropharyngeal swab or nasopharyngeal swab
Sample Volume60 μL
Test Time15 min
Operation Temperature15-30℃
Storage Temperature2-30℃
Shelf Life (Unopened)24 months
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