AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes

 

 Buy Article Permissions and Reprints

ABSTRACT

The purpose of this study was to compare the AmniSure rapid immunoassay with standard methods for diagnosing rupture of fetal membranes. Patients presenting with signs/symptoms of membrane rupture between 15 and 42 weeks of gestation were invited to participate. Standard/control methods were performed to establish a diagnosis and compare it with AmniSure results. AmniSure performance metrics and their 95% confidence intervals were calculated. A total of 203 patients agreed to participate. Discrepancies between the control method and AmniSure were noted in seven cases. In these cases, true positives and negatives were determined by retesting with the control method and AmniSure and by noting sonographic evidence of low amniotic fluid. In the final analysis, the AmniSure diagnostic test demonstrated a sensitivity of 98.9%, specificity of 100%, positive predictive value of 100%, and a negative predictive value of 99.1%. AmniSure is highly accurate in diagnosing fetal membrane rupture.

REFERENCES

• 1 Alexander J M, Cox S M. Clinical course of premature rupture of the membranes.  Semin Perinatol. 1996;  20 369-374
  PubMedGoogle Scholar
• 2 Philipson E H, Hoffman D S, Hansen G O, Ingardia C J. Preterm premature rupture of membranes: experience with latent periods in excess of seven days.  Am J Perinatol. 1994;  11 416-419
  PubMedGoogle Scholar
• 3 Mercer B M, Goldenberg R L, Meis P J 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;  183 738-745
  CrossrefPubMedGoogle Scholar
• 4 French J I, McGregor J A. The pathobiology of premature rupture of membranes.  Semin Perinatol. 1996;  20 344-368
  CrossrefPubMedGoogle Scholar
• 5 Furman B, Shoham-Vardi I, Bashiri A, Erez O, Mazor M. Clinical significance and outcome of preterm prelabor rupture of membranes: population-based study.  Eur J Obstet Gynecol Reprod Biol. 2000;  92 209-216
  CrossrefPubMedGoogle Scholar
• 6 Lockwood C J, Wein R, Chien D, Ghidini A, Alvarez M, Berkowitz R L. Fetal membrane rupture is associated with the presence of insulin-like growth factor-binding protein-1 in vaginal secretions.  Am J Obstet Gynecol. 1994;  171 146-150
  PubMedGoogle Scholar
• 7 Gorodeski I G, Haimovitz L, Bahari C M. 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;  10 286-292
  PubMedGoogle Scholar
• 8 Friedman M L, McElin T W. Diagnosis of ruptured fetal membranes.  Am J Obstet Gynecol. 1969;  104 544-550
  PubMedGoogle Scholar
• 9 Lodeiro J G, Hsieh K A, Byers J H, Feinstein S J. The fingerprint, a false-positive fern test.  Obstet Gynecol. 1989;  73 873-874
  PubMedGoogle Scholar
• 10 McGregor J A, Johnson S. “Fig-Leaf” ferning and positive nitrazine testing: semen as a cause of misdiagnosis of premature rupture of membranes (letter to the editor).  Am J Obstet Gynecol. 1985;  151 1142-1143
  PubMedGoogle Scholar
• 11 Reece E A, Chervenak F A, Moya F R, Hobbins J C. Amniotic fluid arborization: effect of blood, meconium, and pH alterations.  Obstet Gynecol. 1984;  64 248-250
  PubMedGoogle Scholar
• 12 Rosemond R L, Lombardi S J, Boehm F H. Ferning of amniotic fluid contaminated with blood.  Obstet Gynecol. 1990;  75 338-340
  PubMedGoogle Scholar
• 13 Smith R P. A technique for the detection of rupture of the membranes: a review and preliminary report.  Obstet Gynecol. 1976;  48 172-176
  PubMedGoogle Scholar
• 14 de Haan H H, Offermans P M, Smits F, Schouten H J, Peeters L L. Value of the fern test to confirm or reject the diagnosis of ruptured membranes in modest in nonlaboring women presenting with nonspecific vaginal fluid loss.  Am J Perinatol. 1994;  11 46-50
  PubMedGoogle Scholar
• 15 Gaucherand P, Salle B, Sergeant P et al.. Comparative study of three vaginal markers of the premature rupture of membranes. Insulin like growth factor binding protein, 1 diamine-oxidase, and PH.  Acta Obstet Gynecol Scand. 1997;  76 536-540
  CrossrefPubMedGoogle Scholar
• 16 Koninckx P R, Trappeniers H, van Assche F A. Prolactin concentration in vaginalfluid: a new method for diagnosing ruptured membranes.  Br J Obstet Gynaecol. 1981;  88 607-610
  PubMedGoogle Scholar
• 17 Rochelson B L, Richardson D A, Macri J N. Rapid assay: possible application in the diagnosis of premature rupture of the membranes.  Obstet Gynecol. 1983;  62 414-418
  PubMedGoogle Scholar
• 18 Lockwood C J, Senyei A E, Dische M R et al.. Fetal fibronectin in cervical and vaginal secretions defines a patient population at high risk for preterm delivery.  N Engl J Med. 1991;  325 669-674
  CrossrefPubMedGoogle Scholar
• 19 Jeurgens-Borst A J, Bekkers R L, Sporken J M, van der Berg P P. Use of insulin like growth factor binding protein-1 in the diagnosis of ruptured fetal membranes.  Eur J Obstet Gynecol Reprod Biol. 2002;  102 11-14
  CrossrefPubMedGoogle Scholar
• 20 Petrunin D D, Griaznova I M, Petrunina IuA, Tatarinov IuS. [Immunochemical identification of organ specific human placental alpha-globulin and its concentration in amniotic fluid].  Akush Ginekol (Mosk). 1977;  1 62-64
  PubMedGoogle Scholar
• 21 Boltovskaia M N, Zaraiskii E I, Fuks B B et al.. [Histochemical and clinical-diagnostic study of placental alpha 1-microglobulin using monoclonal antibodies].  Biull Eksp Biol Med. 1991;  112 397-400
  PubMedGoogle Scholar

Larry CousinsM.D. 

Sharp Mary Birch Hospital for Women

3003 Health Center Drive, San Diego, CA 92123