These assessments must be used as part of a completely built-in COVID-19 methodology, serving to hunt out out these contaminated to chop as soon as extra the unfold of the virus. VivaDiag SARS-CoV-2 Ag Quick Affirm has ONLY been designed to behave as a supplementary have a look at for suspected situations of detrimental coronavirus nucleic acid detection or together with nucleic acid detection all via the evaluation of suspected situations. Outcomes from nucleocapsid protein antigen testing should not be used as a result of the one exact basis to diagnose or exclude SARS-CoV-2 (COVID-19) an an an an infection or to inform an an an an infection standing.

The bundle accommodates all devices required along with swab, extraction tube, extraction decision and lateral circulation have a look at system. No specialised gear or personnel is required to profit from this have a look at. The assessments can also be carried out in any setting at any time by educated personnel, i.e for educated use solely

This lateral circulation Covid-19 Quick Antigen Affirm Devices is for straightforward for educated personnel to cope with delivering acceptable outcomes rapidly using the oropharyngeal or nasopharyngeal swab specimen.

With the specimen collected insert the swab into the extraction tube crammed with extraction decision. Having eradicated a testing system from the sealed pouch apply three drops of the reply and wait 15 minutes earlier than discovering out the have a look at, a optimistic or detrimental consequence’s clearly indicated.

This Covid-19 Quick Antigen Affirm Devices has an common accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% providing full assurance of fast, acceptable, reliable outcomes.

VivaDiag SARS-CoV-2 Ag Rapid Test

VivaDiag SARS-CoV-2 Ag Fast Take a look at

Principle and meant use

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

Immupass VivaDiag™ SARS-CoV-2 Ag Quick Affirm depends upon immunoassay know-how. Each have a look at 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 identical previous administration line (C line).

When extracted specimen is added to the specimen precisely, it should react with the labeled antibody to sort a flowery, the mixture then migrates by way of the membrane by capillary movement and interacts with the coated anti-SARS coronavirus monoclonal antibody on the detection line. If the specimen accommodates SARS-CoV-2 antigen, the detection line will appear purplish-red indicating the SARS-CoV-2 antigen is optimistic. In a single different case, the have a look at finish consequence shall be detrimental. The have a look at system moreover accommodates a high quality administration line C which should look purplish-red for all expert assessments. If the identical previous administration line C would not appear, the have a look at finish consequence shall be invalid even when the detection line appears.

Composition

Each have a look at bundle accommodates: 25 have a look at 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 provided: timer.

 

 

Specification

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

 

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