A multicentric evaluation study of an indigenously prepared cost effective prototype pregnancy test

A multicentric evaluation of an indigenously developed pregnancy detection kit (named Preglisa) based on urinary human chorionic gonadotropin (hCG) detection was carried out at 12 centres where the outcome of the kit was compared with the existing parameter (e.g., ultrasonography, clinical judgement, serum beta hCG levels) used by the centre for confirmation 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 Preglisa were compared with those of non-immunological tests. When compared 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 cost effective with a sensitivity of 300 mlU/ml and is recommended for detecting pregnancy 35 days after the last menstrual period thus fulfilling the general requirement in the Indian situation.