VALIDATION OF IGM-ELISA KIT FOR THE DETECTION OF LETOSPIROSIS ANTIBODY IN HUMAN SERUM SAMPLESMALLIKARJUNA REDDY CHINTHAPARTHI, T.M. CHOZHAVEL RAJANATHAN, PRUDHVI CHAND MALLEPADDI, REVATHI POONATI, SRIHARI MANCHIKALAPUDI, RATHNAGIRI POLAVARAPU AND VIJAYARAGHAVAN R.
Leptospira, a zoonotic disease causes clinical as well as subclinical infections in man and animals, many a times resulting in mortality. Most of the available diagnostic tools use live serovars as antigens and is time consuming and laborious requiring experienced personnel. In the present study, we have developed an ELISA kit which used the cell membrane proteins as antigens and this was compared with the gold standard MAT test, commercial ELISA and lateral flow agglutination test. 220 samples (Positive n= 123, Negative n=97) which were tested for leptospira antigens with the gold standard method- Microscopic Agglutination Test (MAT) were tested with Genomix ELISA test, commercial ELISA test and Lateral flow agglutination test. Our Genomix ELISA test showed a specificity and sensitivity of 95.88% and 95.12% respectively, with the false negative rate of 5.69% and false positive rate of 5.15%. The positive predictive value was 95.87% and negative predictive value was 92.93%. The sensitivity and specificity was considerably higher than that of the commercial ELISA and the LFA which were 91.75% & 77.24% and 94.85% and 94.31% respectively. Our Genomix ELISA kit is highly specific and sensitive compared to similar available tests in the market. It is not only an easy diagnostic tool, but also does not require live leptospiral antigens.
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