Revista Cubana de Medicina
On-line version ISSN 1561-302X
TORRES GOMEZ, Edel et al. Validación clínica del inmunoensayo rápido BioLine-hCG para el diagnóstico precoz del embarazo BioLine-hCG. Rev cubana med [online]. 1998, vol.37, n.3, pp. 131-135. ISSN 1561-302X.
The clinical validation of the rapid and easy immunoassay for the early diagnosis of BioLine-hGC pregnancy was made at the Provincial Gynecoobstetrical Hospital of Sancti Spiritus. 397 urine samples were analyzed. 150 of them were from patients attending the Menstrual Regulation Department. The results obtained were compared with the ABBOT Test Pack+Plus chromatographic reference diagnosis, with the physical examination finished by the gynecologist, and with the histopathological analysis made by the pathology laboratory of the hospital. 99.07 % of sensitivity, 100 % of specificity and 99.3 % of accuracy were attained in the BioLINE-hCG system compared with the reference diagnosis. This fast and simple diagnosis allows the pregnant woman to know the result and to avoid the risks derived from an abortion.
Keywords : PREGNANCY TESTS, IMMUNOLOGIC [methods]; GONADOTROPINS, CHORIONIC [urine].