AmniSure ROM Test Overview

AmniSure ROM Test
  • What is the AmniSure ROM Test?
  • Clinical Validation
  • Guidelines & Clinical Practice Opinions

What is the AmniSure ROM Test?

The AmniSure ROM Test is an FDA-cleared diagnostic device (Rx only) that solves a long-standing problem in obstetric practice - diagnosis of Premature Rupture of Membranes (PROM). It is both more accurate and less invasive than the battery of methods currently used to diagnose the same condition.

Premature ROM (PROM) occurs in about one out of ten pregnant women and constitutes the major factor of pre-and post-natal complications. In the U.S., up to 30 % of pregnant women are checked for PROM during pregnancy.

If the rupture of the amniotic sac that results in the leakage of the fluid is not detected and treated in a timely and accurate manner (within 24 hours from the occurrence of the rupture), infection and other serious complications for the neonate and the mother may occur. Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy for prompt hospitalization and for timely and proper treatment.

The PAMG-1 immunoassay is ~99% accurate to aid in the diagnosis ROM, does not require a speculum examination, and can be used at any gestational age.

Clinical Validation

The PAMG-1 immunoassay is ~99% accurate to aid in diagnosing ROM, does not require a speculum examination, can be used at any gestational age and is considered superior to conventional clinical assessment (i.e. combined use of nitrazine, ferning, pooling and/or ultrasound) and comparable to indigo carmine amnioinfusion (Tables 1, 2).

Table 1: Performance of PAMG-1 Assay in Clinical Trials
Author Year SN(%) SP(%) PPV(%) NPV(%)
*Cousins7 2005 98.9 100 100 99.1
*Lee12 2007 98.7 87.5 98.1 91.3

*Used in package insert for the PAMG-1 test to calculate its performance metrics
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Table 2: Traditional Method Performance (via sterile speculum examination)
Traditional Method SN(%) SP(%) FNR(%) FPR(%)
Nitrazine/pH18-28 90.2 79.3 12.4 28.2
Ferning (non-laboring patient)(29) 51.4 70.8 40.6 11.8
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