Immupass VivaDiag™ SARS-CoV-2 IgM / IgG Rapid Test is an in Vitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood (from vine or fingertip), serum or plasma.
Each test kit contains:
Test devices 40T
Buffer
Pipettes (optional)
Package insert.
It is only suitable for in Vitro diagnostics as a point-of-care application or in laboratories. The test kit is based on immunoassay technology.
Performance data
It can be confirmed from the results of 200 negative and positive samples that Immupass VivaDiag ™ SARS-CoV-2 IgM / IgG Rapid Test shows good clinical performance.
Limitations
Please do not use highly hemolytic samples.
The test cards cannot be reused.
The test kit can only be used with whole blood (venous or capillary), serum or plasma (all common anticoagulants). Using other sample materials can cause incorrect results.
Make sure you read the results after 15 minutes. Shorter or longer evaluation times can lead to incorrect results.
Please read the instructions before carrying out the test.
Steps for a single test
Specification
Product name
Immupass VivaDiag™ SARS-CoV-2 IgM / IgG Rapid Test
Test Principle
Colloidal gold
Sample Type
Whole blood (from vein or fingertip), serum or plasma