Covid Kawach IgG Microlisa

Intended Use

Covid Kawach IgG Microlisa is intended for qualitative detection of IgG antibodies in serum/
plasma of patients presenting clinical signs and symptoms consistent with SARS CoV-2 infection.

Caution: The laboratory results alone should not form the basis of medical report for individual
patient. The clinical history and any other test performed must be taken into account. The
presumptive diagnosis by SARS CoV-2 Human IgG ELISA may be confirmed by Neutralization
assay.

Salient Features

• ELISA TEST for detection of IgG Antibodies to COVID-19 in Human serum/plasma.
• Based on Indirect ELISA principle.
• Ready to use Enzyme Conjugate .
• Test results within 130 minutes.
• Color coded reagent to monitor procedural steps.
• Shelf life :12 months at 2-8°C.
• Excellent Sensitivity 96.33% & Specificity 100%
• Evaluated by ICMR NIV, Pune.
• Convenient pack sizes- 96 Test.

Principle

IgG antibodies from serum / plasma of human will bind to the SARS CoV-2 virus whole cell antigen coated on to the Microtitre plate (ELISA wells). In the next step, anti Human IgG HRP binds to captured human IgG antibodies. Subsequently, chromogenic substrate (TMB/H2O2) is added, the reaction is stopped by 1N H2SO4. The intensity of color / optical density is measured at 450 nm. The kit is for in- vitro use for monitoring anti-SARS CoV-2 IgG antibodies in human only.

Performance Characteristics

The performance of 3 batches of Covid Kawach IgG Microlisa has been validated by ICMR, NIV, Pune. The results obtained are as follows:

Sensitivity : 96.33% Specificity : 100%

Precision : Within-run and between-run precisions have been determined by testing 10 replicates of five specimens : two negative and three weak covid IgG positive. The C.V.(%) of negative and weak positive values were within 10%.

Ordering Information