PERFORMANCE CHARACTERISTICS
a) In-House Evaluation
The performance of Covid 19 (IgM + IgG + IgA) Microlisa has been evaluated inhouse with the panel of 345 clinical serum/ plasma samples. The sensitivity was checked with 60 positive samples of patients with confirmed COV-SARS-2 infection.The specificity is checked with a panel of 263 negative samples and 22 cross-reacting samples with other diseases; HIV, HCV, HBV, Dengue, Chikungunya, Leptospira,Malaria, Typhi, Rheumatoid factor positive, CRP positive and ASO positive samples.The results obtained are as follows:
PERFORMANCE CHARACTERISTICS
No. of Samples
|
Status
|
Covid 19 (IgM + IgG + IgA) Microlisa |
Positive |
Equivocal |
Negative |
60 |
Covid Positive |
59 |
0 |
1 |
263 |
Covid Negative |
0 |
0 |
263 |
22 |
Covid Reacting |
0 |
0 |
22 |
Sensitivity : 96.72% Specificity : 100%
b) External Evaluation
The performance of 3 batches of Covid 19 (IgM + IgG + IgA) Microlisa has also been validated by ICMR, NARI, Pune. The results obtained are as follows:
Sensitivity : 94.04% Specificity : 100%
Precision : Within-run and between-run precisions have been determined by testing 10 replicates of seven specimens : two negative and five weak covid positive. The C.V.(%) of negative and weak positive values were within 15%.