Cost-Effectiveness of the AmniSure ROM Test
Cost of Making Diagnosis
In 40-47% of patients presenting with suspicion of ROM, obvious leakage from the cervix cannot be visualized and the diagnosis becomes difficult to confirm or rule out.20,27 Traditional methodologies, including nitrazine, ferning, pooling and ultrasound, alone or in combination with one another, have proven inaccurate in non-obvious cases.
Alone, the PAMG-1 immunoassay provides superior accuracy to combined clinical assessment in cases of non-obvious membrane rupture. Using one non-invasive, more accurate method is financially preferable to testing and re-testing a patient with a variety of more invasive and lengthy procedures.
Cost of Misdiagnosing ROM
In the absence of an accurate test to diagnose or rule out ROM, the patient is at a greater risk for not receiving the necessary interventions, including appropriate use of steroids. Failure to implement salutary measures can have both significant medical and financial implications for the payer, the mother and baby, as well as for the hospital and the obstetrician. Conversely, a false positive diagnosis can lead to unnecessary hospitalizations and induction of labor.
Currently, there are two main treatments used on patients diagnosed with PROM: antibiotics (to fight infection and prolong latency) and corticosteroids (to help mature the fetal lungs in preparation for birth). Both have a significant impact in reducing the incidence of various conditions that may result as a consequence of PROM. As show in Table III, reducing the incidence of the various conditions associated with PROM through an accurate and timely diagnosis allows for timely salutary interventions that ultimately reduce overall costs associated with these conditions.
|False Negative Rate of ROM Diagnosis of Traditional Methods 12, 16, 35, 36||Treatment||Condition||Incidence w/o Treatment||Incidence w/Treatment||Incidence Reduction of Condition w/Treatment||Average DRG Costs|
|Corticosterolds42||Fetal and Neonatal Death||19%||14%||23%||$1,793|
|Respiratory Distress Syndrome (RDS)||26%||17%||34%||$6,198|
|Intra-ventricular Hemorrhage (IVH)||11%||6%||44%||$3,479|
|Necrotizing Enterocolitis (NEC)||6%||3%||54%||$3,479|
|Systematic Infection within 48 hours||9%||5%||44%||$6,198|
|Cerebral Palsy (CP)||7%||4%||40%||$3,479|
There are two main pathways for managing the patient diagnosed with PROM: at more than 34 weeks of gestation, induction of delivery is recommended; and at less than 34 weeks of gestation, hospitalization and observation is indicated. Depending on the gestational age of the patient falsely diagnosed with PROM, one of these two pathways will be unnecessarily followed and lead to significant costs associated with each as described in Figure I.
- Peter R. L. Neil and Euan M. Wallace. Is Amnisure useful in the management of women with prelabour rupture of the membranes? ANZJOG 2010; 50:534-538.
- John W. C. Johnson, MD, Norman H. Daikoku, MD, Jennifer R. Niebyl, MD, Timothy R. B. Johnson, Jr, MD, Victor A. Khouzami, MD, Frank R. Witter, MD. Premature Rupture of the Membranes and Prolonged Latency. Obstet Gynecol 1981; 57: 547-556.
- James Alexander et al, Seminars in Perinatology, Vol 20, No 5, 1996: pp 369-374; Mercer et al, Am J Obstet Gynecol, 1999
- Society of Maternal Fetal Medicine, “High-Risk Pregnancy Care, Research, and Education for Over 35 Years” February 2010
- Martinez de Tejada B, Boulvain M, Dumps P, Bischof P, Meisser A, Irion O. Can we improve the diagnosis of rupture of membranes? The value of insulin-like growth factor binding protein-1. BJOG 2006;113:1096-1099
- Frank Chih-Kang Chen, M.D., and Joachim Wolfram Dudenhausen, M.D. Comparison of Two Rapid Strip Tests Based on IGFBP-1 and PAMG-1 for the Detection of Amniotic Fluid. Am J Perinatol 2008; 25:243-246.
- Cousins LM, Smok DP, Lovett SM, Poeltler DM. Amnisure placental a microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol 2005;22:317-320.
- Garite TJ. Management of premature rupture of membranes. Clin Perinatol. 2001;28:837-847.
- Berkowitz GS, Papiernik E. Epidemiology of preterm birth. Epidemiol Rev. 1993;15:414-418.
- Park JS, Norwitz ER. Technical Innovations in Clinical Obstetrics. Contemporary OB/GYN. 15 Sept. 2005; 50.
- AmniSure ROM (Rupture of [fetal] Membranes) Test. Directions for In Vitro Diagnostic Use. [Package Insert]. ASPI100-US002. AmniSure International LLC.
- Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental a-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol 2007;109:634-640.
- Grizzell et al. Wesley Medical Center | Data found in AmniSure ROM Test Package Insert (FDA Cleared). AmniSure International, LLC. 2011.
- Silva E, Martinez JC. Diagnosing ROM: a comparison of the gold standard, indigo carmine amnioinfusion, to the rapid immunoassay, the AmniSure ROM test. J Perinat Med 2009; 37(S1):956.
- Tagore S, Kwek K. Comparative analysis of insulin-like growth factor binding protein-1 (IGFBP-1), placental alpha microglobulin-1 (PAMG-1) and nitrazine test to diagnose premature rupture of membranes in pregnancy. J. Perinat. Med 2010; 38: 1-4.
- Birkenmaier A, Ries JJ Kuhle J, Burki N, Lapaire N, & Hosli I. Placental a-microglobulin-1 to detect uncertain rupture of membranes in a European cohort of pregnancies. Arch Gynecol Obstet, April 2011
- Albayrak M, Ozdemir I, Koc O, Ankarali H, & Oren O. Comparison of the diagnostic efficacy of the two rapid bedside immunoassays and combined clinical conventional diagnosis in prelabour rupture of membranes. European Journal of Obstetrics & Gynecology and Reproductive Biology, January 2011.
- Gaucherand P, Salle B, Sergeant P, Guibaud S, Brun J, Bizollon CA, et al. Comparative study of three vaginal markers of the premature rupture of membranes—insulin like growth factor binding protein 1, diamine-oxidase, pH. Acta Obstet Gynecol Scand 1997;76:536-40.
- Friedman ML, McElin TW. Diagnosis of ruptured fetal membranes. Clinical study and review of the literature. Am J Obstet Gynecol 1969;104:544-50.
- Gall SA, Spellacy WN. Cyologic diagnosis of ruptured membranes. Obstet Gynecol 1964;24:732-5.
- Kovacs D. Crystallization test for the diagnosis of ruptured membranes. Am J Obstet Gynecol 1962;83:1257.
- Ferron M, Bilodeau R. Amniotic fluid crystallization test for ruptured membranes. Can Med Assoc J 1963;89:1064-7.
- Erdemoglu E, Mungan T. Significance of detecting insulin-like growth factor binding protein-1 in cervicovaginal secretions: comparison with nitrazine test and amniotic fluid volume assessment. Acta Obstet Gynecol Scan 2004;83:622-6.
- Rochelson BL, Rodke G, White R, Bracero L, Baker DA. A rapid calorimetric AFP monoclonal antibody test for the diagnosis of preterm rupture of the membranes. Obstet Gynecol 1987;69:163-5.
- Hjertberg R, Belfrage P, Eneroth P. Latex agglutination test for alpha-fetoprotein in the diagnosis of premature rupture of the amniotic membranes (PROM). Acta Obstet Gynecol Scand 1987;66:437-9.
- Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S. Diagnosis of preterm rupture of the membranes using a newly developed AFP monoclonal antibody test kit. Eur J Obstet Gynecol Reprod Biol 1995;58:67-72.
- Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S. Diagnosis of premature rupture of the membranes in preterm patients, using an improved AFP kit: comparison with ROM-check and/or nitrazine test. Eur J Obstet Gynecol Reprod Biol 1996;69:77-82.
- Esim, E, Turan C, Unal O, Dansuk R, Cengizglu B. Diagnosis of premature rupture of membranes by identification of _-HCG in vaginal washing fluid. Eur J Obstet Gynecol Reprod Biol 2003;107:37-40.
- de Haan HH, Offermans PM, Smits F, et al. 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.
- Di Renzo GC, Cabero Roura L, Facchinetti F & the EAPM-Study Group on “Preterm Birth”. 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. The Journal of Maternal-Fetal & Neonatal Medicine 2011; 24(5): 659-667.
- Duff P & Lockwood, C. Diagnosis of Premature Rupture of Membranes. Up-to-Date, 2011.
- Sayres W. Chapter D: Preterm Labor & Premature Rupture of Membranes, AAFP-ALSO, June 2011
- Caughey AB, Robinson JN, Norwitz ER. Contemporary diagnosis and management of preterm premature rupture of membranes. Rev Obstet Gynecol 2008;1:11-22.
- 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;32:561-569.
- Jeurgens-Borst AJ, Bekkers RL, Sporken JM, van der Berg PP. 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.
- Eriksen NL, Parisi VM, Daoust S, Flamm B, Garite TJ, Cox SM. Fetal fibronectin: a method for detecting the presence of amniotic fluid. Obstet Gynecol. 1992 Sep;80(3 Pt 1):451-4.
- Kenyon S, Boulvain M, Neilson JP. Antibiotics for preterm rupture of membranes. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD001058.
- Roberts D, Dallies S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006 Jul 19;3:CD004454. (Updated 2010)
- Peter R. L. Neil and Euan M. Wallace. Is Amnisure useful in the management of women with prelabour rupture of the membranes? ANZJOG 2010;50:534-538.
- Admission Costs for False Labor, http://healthcarebluebook.com/. Accessed September 6 2010.
- Grant JM, Serle E, Mahmood T, Sarmandal P, Conway D. Management of prelabor rupture of the membranes in term primigravidae: Report of a randomized prospective trial. Br J obstet Gynecol 1992; 99: 557-562.
- Joffe GM, Jacques D, Bemis-Hayes R. Impact of the fetal fibronectin assay on admissions for preterm labor. American Journal of Obstetrics and Gynecology. 1999; 180:581-586.