Cost-Effectiveness of the AmniSure ROM Test

cost of 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.

Table III: Costs of False Negative Diagnisis of PROM
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
11%-28% Antibiotics37 Maternal Chorioamnionitis 25% 16% 34% $5,892
Neonatal Infection 17% 10% 38% $6,466
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.

Costs of False Positive ROM


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