VivaDiag SARS-CoV-2 Ag Rapid Test

VivaDiag SARS-CoV-2 Ag Rapid Test

Principle and meant use

Immupass VivaDiag SARS-CoV-2 Ag Quick Examine is supposed for medical laboratories and healthcare expert use only for point-of-care testing. Not for at-home testing.

Immupass VivaDiag™ SARS-CoV-2 Ag Quick Examine depends on immunoassay know-how. Each test system 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 usual administration line (C line).

When extracted specimen is added to the specimen correctly, it ought to react with the labeled antibody to kind a fancy, the mix then migrates by means of the membrane by capillary movement 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 optimistic. In some other case, the test finish end result shall be detrimental. The test system moreover contains a high quality administration line C which ought to appear purplish-red for all official assessments. If the usual administration line C does not appear, the test finish end result shall be invalid even when the detection line appears.

 

VivaDiag SARS-CoV-2 Ag Quick Examine depends on immunoassay know-how for the speedy, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human oropharyngeal or nasopharyngeal swab specimens. The test generates a finish end result inside 15 minutes determining people contaminated with COVID-19 quickly serving to to comprise the unfold of the virus.

The bundle contains all devices required along with swab, extraction tube, extraction decision and lateral circulation test system. No specialised gear or personnel is required to utilize this test. The assessments could also be carried out in any setting at any time by educated personnel, i.e for expert use solely

This lateral circulation Covid-19 Quick Antigen Examine Tools is for simple for educated personnel to handle delivering right outcomes rapidly using the oropharyngeal or nasopharyngeal swab specimen.

With the specimen collected insert the swab into the extraction tube full of extraction decision. Having eradicated a testing system from the sealed pouch apply three drops of the reply and wait 15 minutes sooner than learning the test, a optimistic or detrimental end result’s clearly indicated.

This Covid-19 Quick Antigen Examine Tools has an basic accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% providing full assurance of fast, right, reliable outcomes.

These assessments should be used as part of a completely built-in COVID-19 approach, serving to find out these contaminated to chop again the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Quick Examine has ONLY been designed to behave as a supplementary test for suspected situations of detrimental coronavirus nucleic acid detection or together with nucleic acid detection throughout the evaluation of suspected situations. Outcomes from nucleocapsid protein antigen testing should not be used as the one actual basis to diagnose or exclude SARS-CoV-2 (COVID-19) an an infection or to inform an an infection standing.

VivaDiag SARS CoV 2 Ag Rapid Test
VivaDiag SARS CoV 2 Ag Fast Check

 

Composition

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

Provides required nonetheless couldn’t equipped: timer.

Specification

Examine Principle Colloidal gold
Sample Sort Nasal swab, oropharyngeal swab or nasopharyngeal swab
Sample Amount 60 μL
Examine Time 15 min
Operation Temperature 15-30℃
Storage Temperature 2-30℃
Shelf Life (Unopened) 24 months

 

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