These assessments needs to be used as a part of a totally built-in COVID-19 methodology, serving to seek out out these contaminated to cut once more the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Fast Confirm has ONLY been designed to behave as a supplementary look at for suspected conditions of detrimental coronavirus nucleic acid detection or along with nucleic acid detection all through the analysis of suspected conditions. Outcomes from nucleocapsid protein antigen testing shouldn’t be used because the one precise foundation to diagnose or exclude SARS-CoV-2 (COVID-19) an an an infection or to tell an an an infection standing.
VivaDiag SARS-CoV-2 Ag Fast Confirm is dependent upon 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 look at generates a end consequence inside 15 minutes figuring out folks contaminated with COVID-19 rapidly serving to to comprise the unfold of the virus.
The bundle accommodates all gadgets required together with swab, extraction tube, extraction resolution and lateral circulation look at system. No specialised gear or personnel is required to make the most of this look at. The assessments is also carried out in any setting at any time by educated personnel, i.e for knowledgeable use solely
This lateral circulation Covid-19 Fast Antigen Confirm Instruments is for easy for educated personnel to deal with delivering acceptable outcomes quickly utilizing the oropharyngeal or nasopharyngeal swab specimen.
With the specimen collected insert the swab into the extraction tube filled with extraction resolution. Having eradicated a testing system from the sealed pouch apply three drops of the reply and wait 15 minutes before discovering out the look at, a optimistic or detrimental consequence’s clearly indicated.
This Covid-19 Fast Antigen Confirm Instruments has an regular accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% offering full assurance of quick, acceptable, dependable outcomes.

Precept and meant use
Immupass VivaDiag SARS-CoV-2 Ag Fast Confirm is meant for medical laboratories and healthcare knowledgeable use just for point-of-care testing. Not for at-home testing.
Immupass VivaDiag™ SARS-CoV-2 Ag Fast Confirm is dependent upon immunoassay know-how. Every 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 same old administration line (C line).
When extracted specimen is added to the specimen accurately, it must react with the labeled antibody to type a flowery, the combination then migrates by the use of the membrane by capillary motion 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 seem purplish-red indicating the SARS-CoV-2 antigen is optimistic. In one other case, the look at end consequence shall be detrimental. The look at system furthermore accommodates a top quality administration line C which must look purplish-red for all skilled assessments. If the same old administration line C wouldn’t seem, the look at end consequence shall be invalid even when the detection line seems.
Composition
Every look at bundle accommodates: 25 look at gadgets, 25 extraction tubes (prefilled with extraction resolution 300 μL / tube), filtered nozzles, 1 tube stand, 25 sterile swabs and 1 bundle insert.
Supplies required however could not supplied: timer.
Specification
Confirm Precept | Colloidal gold |
Pattern Kind | Nasal swab, oropharyngeal swab or nasopharyngeal swab |
Pattern Quantity | 60 μL |
Confirm Time | 15 min |
Operation Temperature | 15-30℃ |
Storage Temperature | 2-30℃ |
Shelf Life (Unopened) | 24 months |
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