VivaDiag SARS-CoV-2 Ag Fast Check relies 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 check generates a end result inside 15 minutes figuring out individuals contaminated with COVID-19 rapidly serving to to comprise the unfold of the virus.
The package comprises all gadgets required together with swab, extraction tube, extraction resolution and lateral circulation check system. No specialised gear or personnel is required to make use of this check. The assessments may be carried out in any setting at any time by educated personnel, i.e for skilled use solely
This lateral circulation Covid-19 Fast 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 stuffed 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 check, a optimistic or detrimental result’s clearly indicated.
This Covid-19 Fast Antigen Check Equipment has an general 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 must be used as a part of a totally built-in COVID-19 technique, serving to determine these contaminated to cut back the unfold of the virus. VivaDiag™ SARS-CoV-2 Ag Fast Check has ONLY been designed to behave as a supplementary check for suspected instances of detrimental coronavirus nucleic acid detection or along with nucleic acid detection within the analysis of suspected instances. Outcomes from nucleocapsid protein antigen testing shouldn’t be used as the only real foundation to diagnose or exclude SARS-CoV-2 (COVID-19) an infection or to tell an infection standing.
VivaDiag SARS CoV 2 Ag Fast Check
Precept and meant use
Immupass VivaDiag SARS-CoV-2 Ag Fast Check is meant for medical laboratories and healthcare skilled use just for point-of-care testing. Not for at-home testing.
Immupass VivaDiag™ SARS-CoV-2 Ag Fast Check relies on immunoassay know-how. Every check 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 properly, it should react with the labeled antibody to type a posh, the combination then migrates by way of the membrane by capillary motion and interacts with the coated anti-SARS coronavirus monoclonal antibody on the detection line. If the specimen comprises SARS-CoV-2 antigen, the detection line will seem purplish-red indicating the SARS-CoV-2 antigen is optimistic. In any other case, the check end result shall be detrimental. The check system additionally comprises a top quality management line C which ought to seem purplish-red for all legitimate assessments. If the standard management line C doesn’t seem, the check end result shall be invalid even when the detection line seems.
Composition
Every check package comprises: 25 check 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:Â timer.
Specification
Check Precept
Colloidal gold
Pattern Kind
Nasal swab, oropharyngeal swab or nasopharyngeal swab
Description: This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
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
Description: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.
SARS-CoV-2 and Influenza A+B Antigen
Combo Rapid Test
