Comparison between Amnisure Placental Alpha Microglobulin-1 Rapid Immunoassay and Standard Diagnostic Methods for Detection of Rupture of Membranes

Abstract

Objective. To determine the diagnostic accuracy of placental alpha microglobulin-1 assay and standard diagnostic methods for detecting rupture of membrane. Study Design. Prospective diagnostic study, between June 2011 to November 2011 at a tertiary centre. Initial evaluation included both the standard diagnostic methods for rupture of membranes and placental alpha microglobulin-1 immunoassay. The actual rupture of membranes was diagnosed on review of the medical records after delivery (absence of membrane or a positive pad chart). Main Outcome Measures. Placental alpha microglobulin-1 immunoassay and standard diagnostic methods for diagnosis of rupture of membrane. Results. A total of 211 patients were recruited. At initial presentation, 187 patients (88.6%) had ruptured membranes, while 24 patients (11.4%) had intact membranes. Placental alpha microglobulin-1 immunoassay confirmed rupture of membranes at initial presentation with a sensitivity of 95.7% (179 of 187), specificity of 100% (24 of 24), positive predictive value of 100% (179 of 179), and negative predictive value of 75.0% (24 of 32). By comparison, the conventional standard diagnostic methods had a sensitivity of 78.1% (146 of 187), specificity of 100% (24 of 24), positive predictive value of 100% (146 of 146), and negative predictive value of 36.9% (24 of 65) in diagnosing rupture of membrane. Conclusion. Placental alpha-microglobulin-1 immunoassay is a rapid and accurate method for confirming the diagnosis of rupture of membrane. It was superior to conventional standard diagnostic methods (pooling, nitrazine, and ferning), the nitrazine test alone or fern test alone.

Aspartate aminotransferase and free thyroid hormones in vaginal washing fluid as markers for preterm pre‐labor rupture of membranes

“…The authors believe that although placental a‐microglobulin‐1 rapid immunoassay has the highest sensitivity and specificity among all the diagnostic tools for PPROM, it can be replaced with washing fluid testing for biochemical markers in low‐resource settings. Moreover, a recent meta‐analysis could not recommend any of the other markers, namely vaginal pH, AFP and IGFBP‐1 .…”

The Importance of Tissue Doppler Imaging and M‐Mode Ultrasonography in Fetuses With Preterm Premature Rupture of Membranes

“…The diagnosis was confirmed by placental alpha microglobulin-1 test in amniotic fluid in vaginal discharge, which is the most sensitive and specific method. 12 Demographic and obstetric data of the patients were recorded. Those with positive diagnostic criteria were included in the study and were hospitalized.…”

“…If necessary, the Nitrazine test, a pH test, was completed. The diagnosis was confirmed by placental alpha microglobulin‐1 test in amniotic fluid in vaginal discharge, which is the most sensitive and specific method 12 . Demographic and obstetric data of the patients were recorded.…”

A high concentration of fetal fibronectin in cervical secretions increases the risk of intra-amniotic infection and inflammation in patients with preterm labor and intact membranes

“…Fetal fibronectin is considered a biochemical marker of membrane/decidual activation, as is the increased expression of insulin growth factor binding protein (IGFBP)-1 [39][40][41][42][43][44][45][46][47][48][49][50][51][52] or α−1 microglobulin (also measurable with a PMG test in cervical and vaginal fluid) [53][54][55][56][57][58][59][60][61][62][63][64][65][66][67]. Membrane/decidual activation can be induced by the physiologic events that lead to spontaneous labor and delivery, or by pathologic insults, such as infection or inflammation [1,2,[5][6][7][8].…”