Covid 19 Neutralizing Antibody Microlisa

Intended Use

Covid 19 neutralizing Antibody Microlisa is designed for in vitro semi-quantitative detection of neutralizing antibodies developed against SARS-CoV-2 in human serum/ plasma that prevent the interaction between receptor binding domain viral spike glycoprotein (RBD) and cell surface receptor angiotensin converting enzyme-2 (ACE2).

Salient Features

• Semi Quantitative Detection of COVID-19( SARS- COV -2) neutralizing antibodies in Human serum/plasma
• Based on Blocking ELISA principle
• Test results within 75 minutes
• Color coded reagent to monitor procedural steps
• Single washing step.
• Long shelf life :12 months at 2-8°C
• Excellent Sensitivity 95.90% & Specificity 100%
• Convenient pack size- 96 Test

Principle

Covid 19 neutralizing antibody Microlisa test is an enzyme immunoassay based on “Blocking ELISA”. Specimen and controls are pre-incubated with HRPO conjugated recombinant SARS-CoV-2 RBD protein in tube, and added to the microtiter wells coated with recombinant hACE2 proetin , incubated and then washed to remove the unbound HRP-RBD –neutralizing Antibodies complex. Finally substrate solution containing chromogenic and hydrogen peroxide is added to the wells and incubated. A blue color reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. Antibodies against SARS-CoV2 if present in the specimen, will bind to recombinant SARS-CoV-2 RBD protein and block the protein-protein interaction between HRPO conjugated RBD and cell receptor protein hACE2 .The absorbance of the sample is inversely proportional to the titre of neutralizing antibodies against SARS-CoV-2.

Performance Characteristics

The performance of Covid 19 neutralizing Antibody Microlisa has been evaluated by ICMR approved Lab /Institute for COVID-19 with the Positive (Vaccinated persons) and negative samples (not vaccinated). The Inhibition rate was checked for all negative and positive samples. The result obtained of 3 different lots are as follows:

Lot Details	No. of Positive samples	No. of Negative samples	Sensitivity	Specificity
LOT 1	66	16	96.99%	100%
LOT 2	47	9	95.7%	100%
LOT 3	60	8	95.0%	100%

Precision : Within-run and between-run precisions have been determined by testing 5 replicates of five specimens : two negative and three (high, medium & weak) covid antibody positive. The C.V.(%) of negative and weak positive values were within 15%.