Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes.

PURPOSE: To determine the diagnostic accuracy of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) compared with traditional clinical assessment (TCA) of nitrazine, ferning and pooling for the diagnosis of prelabor rupture of membranes (PROM). METHODS: A double-blinded, multicenter clinical study was conducted between February 2015 and August 2015 among pregnant women presenting with symptoms or features suggestive of PROM between 24 and 42 weeks gestation. Confirmation of PROM was done after delivery based on the presence of any two of these criteria: delivery within 48 h to 7 days, evidence of chorioamnionitis, membranes explicitly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Sensitivity, specificity and accuracy were outcome measures assessed. RESULTS: Two hundred and thirty-six women were recruited. Three women were excluded from the final analysis due to lack of follow-up data and failure to meet inclusion criteria. Two hundred and thirty-three women had complete data for analysis. The specificity and sensitivity values for TCA were 76.2% and 85.2%, which were lower than those of Amnioquick duo+, which were 97.6% and 97.9%, respectively. The accuracy of Amnioquick duo+ was statistically higher (97.9% vs. 83.7%; RR=1.17; 95%CI=1.10-1.24; P<0.001). In equivocal cases (pooling=negative), the accuracy of Amnioquick duo+ vs. TCA was 98.4% vs. 69.4% (RR=1.42; 95%CI=1.20-1.68; P<0.001) at ≥34 weeks gestation and 100.0% vs. 71.4% (RR=1.40; 95%CI=1.07-1.83; P=0.021) at <34 weeks gestation. CONCLUSION: The performance matrix of Amnioquick duo+® was superior to that of TCA for diagnosing PROM even in equivocal cases.

Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor.

PURPOSE: To determine values of combinations of interleukin-6 (IL-6)/cervical native insulin-like growth factor-binding protein-1 (IGFBP-1)/total IGFBP-1 (Premaquick©) in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in women with threatened preterm labor. METHODS: Women with singleton pregnancies between gestation age (GA) of 24 weeks and 36 weeks and 6 days with preterm labor were recruited during a prospective multicenter study. Premaquick© was positive when at least two of three biomarkers were positive. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were estimated for both prediction of spontaneous deliveries and spontaneous exclusive preterm deliveries. RESULTS: Ninety-seven (99.0%) out of 98 women enrolled were analyzed. Based on delivery status 7/14 days post-enrollment of general study population, Premaquick© had a sensitivity of 87.1/85.7%, a specificity of 92.4/96.8%, a PPV of 84.4/93.8% and a NPV of 93.9/92.3% for prediction of spontaneous delivery. Predictive accuracy of Premaquick© test in relation to days of enrollment were: 90.7% (≤7 days) and 92.8% (≤14 days). For women enrolled at GA <35 weeks, Premaquick© had a sensitivity of 100.0/87.5%, a specificity of 94.1/96.9%, a PPV of 70.5/87.5%, a NPV of 100.0/96.9% and an accuracy of 95.0/95.0% for prediction of preterm delivery within 7/14 days of enrollment, respectively. PPV was most significantly different in both groups when outcomes were compared between 2 days and 14 days post-enrollment (P<0.001). CONCLUSION: This novel triple biomarker model of native and total IGFBP-1 and IL-6 appears to be an accurate test in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in threatened preterm labor in singleton pregnancies.

Accuracy and response time of dual biomarker model of insulin-like growth factor binding protein-1/ alpha fetoprotein (Amnioquick duo+) in comparison to placental alpha-microglobulin-1 test in diagnosis of premature rupture of membranes.

AIM: The aim of this study was to determine accuracy and response time of duo of insulin-like growth factor binding protein-1 (IGFBP-1)/alpha-fetoprotein (Amnioquick duo+) versus placental alpha-microglobulin-1 (PAMG-1) in diagnosing premature rupture of membranes (PROM). METHODS: A multicenter prospective study was conducted among women with features suggestive of PROM between 24 and 42 gestational weeks (GW). PROM was confirmed post-delivery based on presence of any two of these criteria: delivery within 48 h to 7 days, chorioamnionitis, membranes overtly ruptured at delivery, and adverse perinatal outcomes strongly correlated with prolonged PROM. Response time analysis was also done. Outcome measures included specificity, sensitivity, positive predictive value, negative predictive value, accuracy, and response time for both tests. RESULTS: Sensitivity, specificity, and accuracy for Amnioquick duo+ were 97.9%, 97.6%, and 97.9%, which were higher than the levels for PAMG-1, of 95.3%, 90.0%, and 95.7%, respectively (not significant). Accuracy of Amnioquick duo+ versus PAMG-1 in equivocal (pooling = negative) cases was (98.4% vs 96.8%) at ≥34 GW but each was 100.0% at <34 GW (not significant). Overall diagnostic concordance rate of Amnioquick duo+ and PAMG-1 was 97.0% and both have equal positive predictive value (99.5%). Response time analysis showed that the overall response time of PAMG-1 was 4.5% higher than that of Amnioquick duo+. CONCLUSION: This is the largest study to date to reveal that Amnioquick duo+ and PAMG-1 have a comparatively high diagnostic accuracy in identifying women with PROM, with a concordance rate of 97.0%. The diagnostic response time of Amnioquick duo+ appears shorter. In equivocal cases, accuracy of Amnioquick duo+ was equal to that of the PAMG-1.

Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings.

AIM: To determine accuracy and costs of placental α-microglobulin-1 (PAMG-1) test compared to standard clinical assessment (SCA) for diagnosing rupture of membranes (ROM). METHODS: A multicenter double-blind study of consecutive women with symptoms and signs of ROM in Nnamdi Azikiwe University Teaching Hospital, Nnewi and University of Nigeria Teaching Hospital, Enugu, both in south-east Nigeria using SCA for ROM and the PAMG-1 test was done. ROM was diagnosed if two out of three methods from SCA (pooling, positive nitrazine test or ferning) were present and confirmed post-delivery based on presence of any two of these clinical criteria: delivery in 48 h to 7 days, evidence of chorioamnionitis, membranes overtly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. A cost-analysis was also done. The outcome measures included sensitivity, specificity, accuracy and costs for the two tests. RESULTS: Accuracy, sensitivity and specificity for the PAMG-1 test were 97.2%, 97.4% and 96.7%, higher than for SCA which were 83.7%, 87.9% and 70.5%, respectively (P < 0.001). Accuracy of SCA was higher at less than 34 weeks than 34 weeks or more (88.3% vs 81.4%) while the PAMG-1 test performed equally at both gestational age categories (96.1% vs 97.7%). In women without pooling, accuracy of the PAMG-1 test was 96.7%, while it was 40.0% with SCA. Analysis showed that the overall cost of SCA was 45% higher than the PAMG-1 test. CONCLUSION: This study confirms that the PAMG-1 test has a consistently high diagnostic accuracy at all gestational ages and with equivocal cases of ROM. The PAMG-1 test appears less costly than SCA.

Comparative study on the adequacy of cervical smears using wooden Ayre's spatula, VS Papcone® sampling device.

This is a comparative study on the adequacy of cervical smears obtained using the Papcone® sampling device or wooden Ayre's spatula conducted from two tertiary health facilities -- Nnamdi Azikiwe University Teaching Hospital Nnewi and Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka, in Anambra State, Nigeria. Slides from smears obtained using both devices were read by a cytopathologist blinded for the study. The primary outcome was the proportion of smears with an adequate endocervical component. Significantly higher adequate cervical smears were obtained in 177/192 (92.2%) women using the Papcone® sampling device, compared to 152/192 (79.2%) using wooden Ayre's spatula (p < 0.001). Kappa analysis showed moderate inter-rater agreement between the two devices. We recommend the use of the Papcone device when it is available, as the adequacy of cervical smears obtained with the Papcone® was better than that obtained using wooden Ayre's spatula.