Covid 19 Neutralizing Antibody Microlisa

Test Kit Type: ELISA Test Kit
Specificity: 100%
Sensitivity: 95.90%
Feature: Single Washing Step

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%.

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