Comparison of rapid immunoassays for rupture of fetal membranes

Irogue Igbinosa, Ferney A Moore 3rd, Cheri Johnson, Jon E Block, Irogue Igbinosa, Ferney A Moore 3rd, Cheri Johnson, Jon E Block

Abstract

Background: Rupture 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.

Methods: In 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.

Results: Overall, 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.

Conclusions: Both 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 registration: ClinicalTrials.gov, NCT02208011 (1 August 2014).

Keywords: Alpha-fetoprotein (AFP); Amnisure®; Insulin-like growth factor binding protein (IGFBP-1); Placental alpha microglobulin-1 (PAMG-1); Point of care immunoassay; Premature rupture of membranes; ROM plus®.

References

    1. Bulletins-Obstetrics ACoP ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007;109(4):1007–1019. doi: 10.1097/01.AOG.0000263888.69178.1f.
    1. Mercer BM, Goldenberg RL, Meis PJ, Moawad AH, Shellhaas C, Das A, Menard MK, Caritis SN, Thurnau GR, Dombrowski MP, et al. The preterm prediction study: prediction of preterm premature rupture of membranes through clinical findings and ancillary testing. The national institute of child health and human development maternal-fetal medicine units network. Am J Obstet Gynecol. 2000;183(3):738–745. doi: 10.1067/mob.2000.106766.
    1. Naeye RL, Peters EC. Causes and consequences of premature rupture of fetal membranes. Lancet. 1980;1(8161):192–194. doi: 10.1016/S0140-6736(80)90674-1.
    1. Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011;54(2):307–312. doi: 10.1097/GRF.0b013e318217d4d3.
    1. Ananth CV, Oyelese Y, Srinivas N, Yeo L, Vintzileos AM. Preterm premature rupture of membranes, intrauterine infection, and oligohydramnios: risk factors for placental abruption. Obstet Gynecol. 2004;104(1):71–77. doi: 10.1097/01.AOG.0000128172.71408.a0.
    1. Caughey AB, Robinson JN, Norwitz ER. Contemporary diagnosis and management of preterm premature rupture of membranes. Rev Obstet Gynecol. 2008;1(1):11–22.
    1. Di Renzo GC, Roura LC, Facchinetti F, Antsaklis A, Breborowicz G, Gratacos E, Husslein P, Lamont R, Mikhailov A, Montenegro N, et al. Guidelines for the management of spontaneous preterm labor: identification of spontaneous preterm labor, diagnosis of preterm premature rupture of membranes, and preventive tools for preterm birth. J Matern Fetal Neonatal Med. 2011;24(5):659–667. doi: 10.3109/14767058.2011.553694.
    1. Garite TJ. Management of premature rupture of membranes. Clin Perinatol. 2001;28(4):837–847. doi: 10.1016/S0095-5108(03)00081-2.
    1. de Haan HH, Offermans PM, Smits F, Schouten HJ, Peeters LL. Value of the fern test to confirm or reject the diagnosis of ruptured membranes is modest in nonlaboring women presenting with nonspecific vaginal fluid loss. Am J Perinatol. 1994;11(1):46–50. doi: 10.1055/s-2007-994535.
    1. El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010;32(6):561–569. doi: 10.1016/S1701-2163(16)34525-X.
    1. Friedman ML, McElin TW. Diagnosis of ruptured fetal membranes. Clinical study and review of the literature. Am J Obstet Gynecol. 1969;104(4):544–550. doi: 10.1016/S0002-9378(16)34244-2.
    1. Gorodeski IG, Haimovitz L, Bahari CM. Reevaluation of the pH, ferning and Nile blue sulphate staining methods in pregnant women with premature rupture of the fetal membranes. J Perinat Med. 1982;10(6):286–292. doi: 10.1515/jpme.1982.10.6.286.
    1. Reece EA, Chervenak FA, Moya FR, Hobbins JC. Amniotic fluid arborization: effect of blood, meconium, and pH alterations. Obstet Gynecol. 1984;64(2):248–250.
    1. Rosemond RL, Lombardi SJ, Boehm FH. Ferning of amniotic fluid contaminated with blood. Obstet Gynecol. 1990;75(3 Pt 1):338–340.
    1. Smith RP. A technic for the detection of rupture of the membranes. A review and preliminary report. Obstet Gynecol. 1976;48(2):172–176.
    1. Mariona FG, Cabero L. Are we ready for a new look at the diagnosis of premature rupture of membranes? J Matern Fetal Neonatal Med. 2012;25(4):403–407. doi: 10.3109/14767058.2011.581715.
    1. Doret M, Cartier R, Miribel J, Massardier J, Massoud M, Bordes A, Moret S, Gaucherand P. Premature preterm rupture of the membrane diagnosis in early pregnancy: PAMG-1 and IGFBP-1 detection in amniotic fluid with biochemical tests. Clin Biochem. 2013;46(18):1816–1819. doi: 10.1016/j.clinbiochem.2013.10.006.
    1. Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol. 2007;109(3):634–640. doi: 10.1097/01.AOG.0000252706.46734.0a.
    1. Palacio M, Kuhnert M, Berger R, Larios CL, Marcellin L. Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes: comparison of performance indexes. BMC Pregnancy Childbirth. 2014;14:183. doi: 10.1186/1471-2393-14-183.
    1. Rutanen EM, Bohn H, Seppala M. Radioimmunoassay of placental protein 12: levels in amniotic fluid, cord blood, and serum of healthy adults, pregnant women, and patients with trophoblastic disease. Am J Obstet Gynecol. 1982;144(4):460–463. doi: 10.1016/0002-9378(82)90254-X.
    1. Rutanen EM, Pekonen F, Karkkainen T. Measurement of insulin-like growth factor binding protein − 1 in cervical/vaginal secretions: comparison with the ROM-check membrane immunoassay in the diagnosis of ruptured fetal membranes. Clin Chim Acta. 1993;214(1):73–81. doi: 10.1016/0009-8981(93)90304-M.
    1. Thomasino T, Levi C, Draper M, Neubert AG. Diagnosing rupture of membranes using combination monoclonal/polyclonal immunologic protein detection. J Reprod Med. 2013;58(5–6):187–194.
    1. McQuivey RW, Block JE. ROM plus((R)): accurate point-of-care detection of ruptured fetal membranes. Med Devices (Auckl) 2016;9:69–74.
    1. Cousins LM, Smok DP, Lovett SM, Poeltler DM. AmniSure placental alpha microglobulin — 1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005;22(6):317–320. doi: 10.1055/s-2005-870896.
    1. Altman DG, Bland JM. Diagnostic tests. 1: Sensitivity and specificity. BMJ. 1994;308(6943):1552. doi: 10.1136/bmj.308.6943.1552.
    1. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003;138(1):W1–12. doi: 10.7326/0003-4819-138-1-200301070-00012-w1.
    1. Jahn UR, Van Aken H. Near-patient testing-point-of-care or point of costs and convenience? Br J Anaesth. 2003;90(4):425–427. doi: 10.1093/bja/aeg082.
    1. Price CP. Point of care testing. BMJ. 2001;322(7297):1285–1288. doi: 10.1136/bmj.322.7297.1285.
    1. Rogers LC, Scott L, Block JE. Accurate point-of-care detection of ruptured fetal membranes: improved diagnostic performance characteristics with a monoclonal/polyclonal immunoassay. Clin Med Insights Reprod Health. 2016;10:15–18.
    1. Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013;122(4):918–30.
    1. Eleje GU, Ezugwu EC, Ogunyemi D, Eleje LI, Ikechebelu JI, Igwegbe AO, Okonkwo JE, Ikpeze OC, Udigwe GO, Onah HE, et al. Accuracy and cost-analysis of placental alpha-microglobulin — 1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings. J Obstet Gynaecol Res. 2015;41(1):29–38. doi: 10.1111/jog.12475.

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