VivaDiag SARS-CoV-2 Ag Rapid Test

VivaDiag SARS-CoV-2 Ag Rapid Test

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 verify 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 package deal includes all devices required along with swab, extraction tube, extraction decision and lateral circulation verify system. No specialised gear or personnel is required to utilize this verify. 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 Gear 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 filled with extraction decision. Having eradicated a testing system from the sealed pouch apply three drops of the reply and wait 15 minutes sooner than finding out the verify, a optimistic or detrimental end result’s clearly indicated.

This Covid-19 Quick Antigen Examine Gear 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 have to 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 verify for suspected situations of detrimental coronavirus nucleic acid detection or together with nucleic acid detection inside 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 Speedy Check

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 verify 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 complicated, the mixture then migrates by the use of the membrane by capillary movement and interacts with the coated anti-SARS coronavirus monoclonal antibody on the detection line. If the specimen includes SARS-CoV-2 antigen, the detection line will appear purplish-red indicating the SARS-CoV-2 antigen is optimistic. In some other case, the verify finish end result shall be detrimental. The verify system moreover includes a high quality administration line C which ought to look purplish-red for all professional assessments. If the usual administration line C does not appear, the verify finish end result shall be invalid even when the detection line appears.

Composition

Each verify package deal includes: 25 verify 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 Form 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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Description: The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in human nasal swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or self-collection under the supervision of a healthcare worke

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