Covid 19 Ag Card

Intended Use

Covid 19 Ag Card Test is designed for in vitro qualitative detection of Covid 19 antigen in human nasopharyngeal, nasal swab specimens. The kit is intended for professional use and as a screening test and is an aid in early diagnosis of SARS COV-2 infection in patients with clinical symptoms.

Salient Features

Rapid Visual Test for the Qualitative Detection of Covid-19 (SARS-COV-2) antigen in Human nasopharyngeal and nasal swab specimens.

• Based on Sandwich Immunoassay principle.
• Results within 20 minutes.
• Single step test procedure.
• Evaluated & Validated by ICMR Centre ; Sensitivity -91.5% (<30 CT) & Specificity -100% against RT-PCR.
• Long Shelf life:30 months at 2-30° C.
• No Instruments required.
• Convenient pack sizes . 10T,25T,50T,100T & 200T.

Principle

Covid 19 Ag Card is an immunoassay based on “Sandwich” principle. The test contains two pre-coated lines, “C” Control line and “T” test line. SARS-CoV-2 specific Antibody is immobilized on nitrocellulose membrane at “T” Line. Colloidal gold is conjugated to another antibody specific for SARS-CoV-2 Antigen. The test sample treated with extraction buffer when added to the device, interacts with the Colloidal gold Conjugate.

If the specimen contains a novel Coronaviruses antigen, it will form a complex with the Colloidal gold-labelled with SARS-CoV-2 antibody. The complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of corresponding immobilized antibody, the complex is trapped forming a pink purple band which confirms a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result. A red procedural control line should always develop at “C” region to indicate that the test has been performed properly.

Ordering Information

Performance Characteristics

The performance of 3 different lots of Covid 19 Ag Card has been evaluated and validated by ICMR validation Centre using RT-PCR confirmed positive (112) and negative samples (106).

The results obtained on are as follows:

• Sensitivity (in samples ≤ 30 ct) = 91.51%
• Specificity = 100%
• Positive Predictive Value: 100%
• Negative Predictive Value : 92.17%