A MULTICENTRIC EVALUATION STUDY OF AN INDIGENOUSLY PREPARED COST-EFFECTIVE PROTOTYPE PREGNANCY TEST

A multicentric evaluation of an indigenously developed pregnancy detec tion kit (named Preglisa) based on urinary human chorionic gonadotropi n (hCG) detection was carried out at 12 centres where the outcome of t he kit was compared with the existing parameter (e.g. ultrasonography, clinical judgement serum beta hCG levels) used by the centre for conf irmation of the pregnancy. The specificity sensitivity and accuracy of the kit were 98.05, 98.7 and 98.69 per cent (n=382) when results of P reglisa were compared with those of non-immunological tests. When comp ared with commercially available kits, sensitivity was 97.9 per cent, specificity was 97.2 per cent and accuracy was 97.94 per cent (n=155). The kit is cast effective with a sensitivity of 300 mlU/ml and is rec ommended for detecting pregnancy 35 days after the last menstrual peri od thus fulfilling the general requirement in the Indian situation.