Covid 19 Ag Microlisa

Intended Use

Covid 19 Ag Microlisa is designed for in vitro qualitative detection of Covid 19 nucleocapcid antigen in human nasopharyngeal, nasal, oropharyngeal swab specimen collected in VTM or in Sample diluent from individuals who are suspected of COVID-19 . The test is a screening test only and is an aid for the early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. More specific and alternate diagnostic method should also be performed for confirmation of SARS -CoV-2 infection.

Salient Features

Microwell ELISA Test for the Qualitative Detection of Covid-19 (SARS-COV-2) nucleocapsid antigen in Human nasopharyngeal, nasal swab and VTM specimens.

• Based on Sandwich ELISA principle.
• Use of both VTM Specimen & Swab collected in Sample Diluent.
• Ready to use Enzyme conjugate.
• Total Test Time : 120 minutes.
• Sensitivity 100% & Specificity 100% (against RT-PCR).
• Shelf life :12 months at 2-8°C
• Breakaway Microwells provided in 24 test pack.
• Color coded reagents to monitor procedural steps.
• Convenient pack size :96 Test.
• ICMR Evaluated.

Principle

Covid 19 Ag Microlisa test is an enzyme immunoassay based on “Sandwich ELISA”.Anti-Covid 19 antibodies specific to nucleocapsid antigen are coated onto microtiter wells.

Specimens and controls are added to the microtiter wells and incubated. Covid antigen if present in the specimen, will bind to the Anti-Covid-19 antibodies absorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRP) conjugated with Anti-Covid-19 antibodies is added to each well. This conjugate will bind to covid antibody-antigen complex present in the microwells. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of Covid antigen present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm and 630 nm. If the sample does not contain Covid antigen then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colour develops.

Ordering Information

Performance Characteristics (In House Evaluation) Of Covid 19 Ag Microlisa

The performance of Covid 19 Ag Microlisa has been evaluated in-house with the 2 VTM positive and 2 nasal swab positive samples of patients with confirmed COVSARS-2 infection for sensitivity. The specificity is checked with 10 each of nasal swab and nasopharyngeal swab sample of patient negative for COV-SARS-2 infection.
Sensitivity : 100% Specificity : 100%