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

Eleje, George Uchenna; Ezugwu, Euzebus Chinonye; Ogunyemi, Dotun; Eleje, Lydia İjeoma; Ikechebelu, Joseph Ifeanyichukwu; Igwegbe, AO; Okonkwo, J. E. N.; Ikpeze, Okechukwu C; Udigwe, Gerald Okanandu; Onah, HE; Nwosu, Betrand Obi; Ezeama, Chukwuemeka Okwudili; Ezenkwele, Eziamaka Pauline

doi:10.1111/jog.12475

Cited by 20 publications

(15 citation statements)

References 23 publications

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“…They also conclude that accuracy, sensitivity and specificity for the PAMG-1 test were 97.2%, 97.4% and 96.7%, higher than for standard clinical assessment (SCA) which were 83.7%, 87.9% and 70.5%, respectively (P < 0.001). In women without pooling, accuracy of the PAMG-1 test was 96.7%, while it was 40.0% with standard clinical assessment (SCA) [28]. These results are consistent with those reported by Cousins [18], Sosa and Abdelazim.…”

Section: Discussionsupporting

confidence: 89%

The Study of Vaginal Fluid Urea, Creatinine, B-HCG and Placental Alpha-1 Microglobulin in Diagnosis of Premature Rupture of Membranes

Borg¹,

Omar²,

Suliman³

2019

OJOG

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Purpose: To evaluate and compare the reliability, accuracy and the cost benefit ratio of vaginal washing fluid urea, creatinine, Beta Human Chorionic Gonadotropin (β-HCG) and placental alpha Microglobulin-1 (PAMG-1) for diagnosis of premature rupture of membranes (PROM). Material and Methods: A diagnostic study conducted on 70 patients. The patients were divided into three groups: Group A (n = 25): (Confirmed PROM group) patients who were either in labor or not in labor, Gestational age was from 24 weeks onwards and fulfilled the following criteria and/or two of these criteria with low AFI positive pooling, positive nitrazine paper test, positive fern test. Group B (n = 25): (Suspected PROM group) patients who fulfilled the following criteria: Patients with fluid leakage complaint with negative pooling and/or negative nitrazine paper test and/or negative fern test. Group C (n = 25): (Control group with no PROM) patients that were admitted to prenatal clinic for their regular prenatal control visit with 24 -42 weeks of gestational age without any complaint or complication and with negative pooling, negative nitrazine paper test and/or negative fern test. The vaginal washing fluid urea, creatinine, Beta-Human Chorionic Gonadotropin (β-HCG) and placental alpha Microglobulin-1 (PAMG-1) were determined for diagnosis of premature rupture of membranes (PROM). Results: PAMG-1 detection in cervico vaginal discharge was a very good test for diagnosis of PROM with high sensitivity, specificity, positive predictive value, negative predictive value, accuracy and P-value (96%, 100%, 100%, 95.84%, 97.78% and <0.0001 respectively). Urea and Creatinine is the second option in diagnosis of PROM with high sensitivity, and specificity after PAMG-1 with a privilege of low cost than PAMG-1. Furthermore they were more accurate than β-HCG. Conclusion: Detection of PAMG-1 in cervico vaginal discharge is promising How to cite this paper: Borg, H.M., Omar, M. and Suliman, G.A. (2019) The Study of Vaginal Fluid Urea, Creatinine, B-HCG and Placental Alpha-1 Microglobulin in Diagnosis of Premature Rupture of Membranes. Open Journal of Obstetrics and Gynecology, 9, 811-826.

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Section: Discussionsupporting

confidence: 89%

The Study of Vaginal Fluid Urea, Creatinine, B-HCG and Placental Alpha-1 Microglobulin in Diagnosis of Premature Rupture of Membranes

Borg¹,

Omar²,

Suliman³

2019

OJOG

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“…PAMG‐1 rapid immunoassay (the ‘New! Reduced‐time Kit’) was performed according to the manufacturer's instructions, as described in previous reports, by another investigator who was not aware of the Amnioquick duo+ result. Thus, the Amnioquick duo+ and PAMG‐1 rapid immunoassay test were collected and performed simultaneously but independently by two different investigators in a blinded fashion.…”

Section: Methodsmentioning

confidence: 99%

“…Previous studies have shown that the PAMG‐1 test has high diagnostic accuracy and cost–benefit, although the accuracy is not 100% . However, AFP alone is a useful marker for PROM although there is concern for the overlap in its concentrations between women with and without ROM .…”

Section: Introductionmentioning

confidence: 99%

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

Eleje

Ezugwu

Eke

et al. 2017

J of Obstet and Gynaecol

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“…Due to their procedural ease of use, these point of care tests can be performed rapidly at the patients’ bedside and provide essential information in understanding the initial clinical scenario of pregnant women with suspected ROM. This diagnostic approach may be very useful in low resource settings where rapid, point of care testing has been shown to be more accurate and cost-effective than a sterile speculum exam [31]. …”

Section: Discussionmentioning

confidence: 99%

Comparison of rapid immunoassays for rupture of fetal membranes

Igbinosa

Moore

Johnson

et al. 2017

BMC Pregnancy Childbirth

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BackgroundRupture of membranes (ROM) before the onset of uterine contractions, particularly in pregnancies less than 37 weeks gestational age, is a common diagnostic problem in obstetrical practice. Timely detection of ROM is vital to support gestational age-specific interventions to optimize perinatal outcomes and minimize the risk of serious complications such as preterm delivery, fetal distress and maternal/fetal infections. Rapid bedside immunoassay tests designed to detect amniotic fluid proteins in cervicovaginal fluids have emerged as valuable clinical tools to provide timely ROM diagnosis.MethodsIn this prospective observational study, two commercially-available immunoassay tests (ROM Plus®, AmniSure®) were evaluated concurrently in 111 pregnant women who presented with the chief complaint of ROM. Immunoassay results were compared to clinical parameters for determining ROM via comprehensive, retrospective clinical chart review. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy.ResultsOverall, diagnostic performance characteristics were robust and similar between ROM Plus® and AmniSure®, respectively: sensitivity (96.4 and 89.3%), specificity (98.8 and 100%), PPV (96.4 and 100%), NPV (98.8% and 96.5) and accuracy (98.2 and 97.3%). For term patients (≥37 weeks gestation), the sensitivities were 93.8 and 81.3% and specificities were 97.1 and 100% for ROM Plus® and AmniSure®, respectively. For preterm patients (<37 weeks gestation), both immunoassay tests provided exact concordance with clinical confirmation of ROM resulting in 100% diagnostic accuracy.ConclusionsBoth rapid immunoassay tests provided similarly excellent diagnostic accuracy for the rapid detection of ROM with only two discrepant results for ROM Plus® and three discrepant results for AmniSure® compared to clinical confirmation. The findings from this study recommend these tests for pregnant women presenting with suspected ROM to guide correct clinical management decisions to improve obstetrical and neonatal outcomes.Trial registrationClinicalTrials.gov, NCT02208011 (1 August 2014).

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

Abstract: 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.

Cited by 20 publications

References 23 publications

The Study of Vaginal Fluid Urea, Creatinine, B-HCG and Placental Alpha-1 Microglobulin in Diagnosis of Premature Rupture of Membranes

The Study of Vaginal Fluid Urea, Creatinine, B-HCG and Placental Alpha-1 Microglobulin in Diagnosis of Premature Rupture of Membranes

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

Comparison of rapid immunoassays for rupture of fetal membranes

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