Khatkhatay M I, Desai M P, Donde U M
Institute for Research in Reproduction (ICMR), Bombay.
Indian J Med Res. 1996 Mar;103:150-4.
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.
在12个中心对一种自主研发的基于尿液人绒毛膜促性腺激素（hCG）检测的妊娠检测试剂盒（名为Preglisa）进行了多中心评估，将该试剂盒的检测结果与各中心用于确认妊娠的现有参数（如超声检查、临床判断、血清β-hCG水平）进行了比较。当将Preglisa的结果与非免疫检测结果进行比较时，该试剂盒的特异性、敏感性和准确性分别为98.05%、98.7%和98.69%（n = 382）。与市售试剂盒相比，敏感性为97.9%，特异性为97.2%，准确性为97.94%（n = 155）。该试剂盒成本效益高，敏感性为300 mIU/ml，建议在末次月经后35天检测妊娠，从而满足印度的一般需求。
