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.
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.
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.
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.
| Test Principle | Colloidal gold |
| Sample Type | Nasal swab, oropharyngeal swab or nasopharyngeal swab |
| Sample Volume | 60 μL |
| Test Time | 15 min |
| Operation Temperature | 15-30℃ |
| Storage Temperature | 2-30℃ |
| Shelf Life (Unopened) | 24 months |
Declaration of Conformity (CE)
EN ISO13485: 2016
UK MHRA
Approval from Holland’s Ministry of Health
Usage Manual
Clinical Report
