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KMID : 0377619970620090776
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Korean Jungang Medical Journal
1997 Volume.62 No. 9 p.776 ~ p.776
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Clinical usefulness of an improved AFP monoclonal antibody kit in the diagnosis of preterm premature rupture of the membranes
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Tatsuro, Kisida
Yamada, Hideto/Sagawa, Tadashi/Fujimoto, Seiichiro
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Abstract
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Objective : We developed a new AFP kit for detecting AFP in the leaked amniotic fluid. Later, we have developed an improved AFP monoclonal antibody kit, utilizing the same AFP monoclonal antibody. In this study, we evaluate the clinical usefulness of this improved AFP kit in the diagnosis of preterm premature rupture of the membranes(PROM).
Methods : In 14 institutions throughout Japan, 1,057 women less than 37th weeks of gestation were enrolled in the study from July 1995 to January 1996. We compared this improved AFP kit test with the nitration test for 421 women. Statistical analysis was performed using y 2 test with Yates´ continuity correction. A p-value less than 0.05 was considered significant.
Results : In 1,000 women(18 cases of PROM and 982 cases of no PROM) excluding 57 inadequate ones, the accuracy of diagnosis of the improved AFP kit was 99.3%, sensitivity 72.2%, specificity 99.8%, positive predictive value 86.7% and negative predictive value 99.5 %, these values were significant(p<0.0001). In 421 women(16 cases of PROM and 405 cases of no PROM), the improved AFP kit test showed the accuracy of 98.6%, sensitivity of 75.0%, specificity 99.5%, positive predictive value of 85.7% and negative predictive value of 99.0%, in contrast the nitration test had 89.3%, 81.3%, 89.6%, 23.6 and 99.2%, respectively. The diagnostic accuracy, specificity and positive predictive value for the improved AFP kit were significantly superior to those for the nitration test (p<0.0001). The reaction time using the kit is 90 seconds.
Conclusion : This study has confirmed a high clinical efficacy of the improved AFP kit as a method of PROM diagnosis.
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KEYWORD
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