- Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK Obstet Gynecol. 2007 Mar;109(3):634-40.
This study was designed to detect the accuracy of the placental alpha microglobulin-1 (PAMG-1) (AmniSure Test) to diagnose premature rupture of the fetal membranes (PROM).
A prospective observational study was performed in consecutive patients with signs or symptoms of rupture of membranes at Seoul National University Hospital from March 2005 to February 2006. Initial evaluation included both standard clinical evaluation for rupture of membranes and placental alpha-microglobulin-1 immunoassay. Rupture of membranes was diagnosed if fluid was seen leaking from the cervical os or if two of the following three conditions were present: pooling of fluid, positive nitrazine test, or ferning. Rupture of membranes was diagnosed definitively on review of the medical records after delivery.
Of 184 patients (11-42 weeks of gestation), rupture of membranes was diagnosed at initial presentation in 76% (139 of 184) using conventional clinical assessment and 88% (161 of 184) using placental alpha-microglobulin-1 immunoassay. Follow-up confirmed that a total of 159 of 183 patients (87%) had rupture of membranes at their initial presentations. Using this longitudinal assessment as the clinical gold standard, placental alpha-microglobulin-1 immunoassay confirmed rupture of membranes at initial presentation with a sensitivity of 98.7% (157 of 159), specificity of 87.5% (21 of 24), positive predictive value of 98.1% (157 of 160), and negative predictive value of 91.3% (21 of 23). Placental alpha-microglobulin-1 immunoassay was better than both the conventional clinical assessment and the nitrazine test alone in confirming the diagnosis of rupture of membranes.
Measurement of placental alpha-microglobulin-1 in cervicovaginal secretions is superior to conventional clinical assessment in the diagnosis of rupture of membranes.
17329514 [PubMed - indexed for MEDLINE]
- Cousins LM, Smok DP, Lovett SM, Poeltler DM Am J Perinatol. 2005 Aug;22(6):317-20.
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.
16118720 [PubMed - indexed for MEDLINE]