VivaDiag SARS-CoV-2 Ag Rapid Test

VivaDiag SARS CoV 2 Ag Rapid Test

VivaDiag SARS-CoV-2 Ag Speedy Check is predicated on immunoassay expertise for the speedy, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human oropharyngeal or nasopharyngeal swab specimens. The take a look at generates a end result inside 15 minutes figuring out individuals contaminated with COVID-19 rapidly serving to to include the unfold of the virus.

The equipment accommodates all gadgets required together with swab, extraction tube, extraction resolution and lateral circulate take a look at system. No specialised gear or personnel is required to make use of this take a look at. The assessments may be carried out in any setting at any time by educated personnel, i.e for skilled use solely

This lateral circulate Covid-19 Speedy Antigen Check Equipment is for easy for educated personnel to manage delivering correct outcomes quickly utilizing the oropharyngeal or nasopharyngeal swab specimen.

With the specimen collected insert the swab into the extraction tube crammed with extraction resolution. Having eliminated a testing system from the sealed pouch apply three drops of the answer and wait 15 minutes earlier than studying the take a look at, a optimistic or damaging result’s clearly indicated.

This Covid-19 Speedy Antigen Check Equipment has an total accuracy of 98.79%, a specificity of 99.12% and a sensitivity of 90.90% offering full assurance of quick, correct, dependable outcomes.

These assessments ought to be used as a part of a completely built-in COVID-19 technique, serving to establish these contaminated to cut back the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Speedy Check has ONLY been designed to behave as a supplementary take a look at for suspected instances of damaging coronavirus nucleic acid detection or along with nucleic acid detection within the prognosis of suspected instances. Outcomes from nucleocapsid protein antigen testing shouldn’t be used as the only foundation to diagnose or exclude SARS-CoV-2 (COVID-19) an infection or to tell an infection standing.

 

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

Precept and meant use

Immupass VivaDiag SARS-CoV-2 Ag Speedy Check is meant for scientific laboratories and healthcare skilled use just for point-of-care testing. Not for at-home testing.

Immupass VivaDiag™ SARS-CoV-2 Ag Speedy Check is predicated on immunoassay expertise. Every take 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 standard management line (C line).

When extracted specimen is added to the specimen effectively, it’s going to react with the labeled antibody to type a posh, the combination then migrates via 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 any other case, the take a look at end result shall be damaging. The take a look at system additionally accommodates a high quality management line C which ought to seem purplish-red for all legitimate assessments. If the standard management line C doesn’t seem, the take a look at end result shall be invalid even when the detection line seems.

Composition

Every take a look at equipment accommodates: 25 take a 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

Check Precept Colloidal gold
Pattern Kind Nasal swab, oropharyngeal swab or nasopharyngeal swab
Pattern Quantity 60 μL
Check Time 15 min
Operation Temperature 15-30℃
Storage Temperature 2-30℃
Shelf Life (Unopened) 24 months

 

SARS-CoV-2 Rapid Antigen Test Nasal

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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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