Resumen

GARCIA DAFONTE, Gema E. et al. Validation of a kit of reagents (CUALINEN-HCG) for the qualitative detection of human chorionic gonadotropin in pregnancy. Rev Cubana Endocrinol [online]. 2002, vol.13, n.3. ISSN 1561-2953.

The results of the standardization of a Kit of reagents (CUALINEN-HCG), for the detection of the Human Chorionic Gonadotropin (HCG) in urine and their diagnostic validation at primary level are presented. CUALINEN-HCG is a double capture micro ELISA that involves the participation of a specific monoclonal antibody for the b subunit of the hCG (AcM-bhCG-IG1) and the enzymatic conjugated with the corresponding colorimetric substrate, obtained and purified in the National Institute of Endocrinology. The results of the analytic validation of the CUALINEN-HCG showed that it was able to distinguish between positive and negative urines samples, with a ratio positive/negative of 10; it was obtained coefficients of variation of 6 % in studies of precision (inter and intra assays) carried out for the positive control. 91 samples of matutinal urine from women who had been with amenorrhea between 4 and 16 weeks, starting from the last date of menstruation, were processed. Pregnancy was diagnosted later among these women. We performed the validation at primary level of the CUALINEN-HCG with a diagnostic sensibility and specificity of 85 % and 95 % respectively and a diagnostic accuracy of 90 %. Their use is recommended as auxiliary tool for the diagnostic of the pregnancy to primary level starting from the first week of absence of the menstruation (5 weeks of amenorrhoea).

Palabras clave : GONADOTROPINS; CHORIONIC; ENZYME-LINKED IMMUNOSORBENT ASSAY; ANTIBODIES, MONOCLONAL; URINE; DIAGNOSTIC TECNIQUES, OBSTETRICAL AND GYNECOLOGICAL; PREGNANCY.