Clinical Evaluation of the AmniSure ROM Test

Clinical Evaluation of the AmniSure ROM Test

To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.

The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.

Inclusion Criteria:

• Subjects must be pregnant.
• Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
• Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
• Subjects providing informed consent.

Exclusion Criteria:

• Subjects who have placenta previa.
• Subjects who have heavy vaginal bleeding.
• Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.