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Test Code LAB9516 Ruptured Fetal Membrane Test

Intended Use

The AmniSure ROM (Rupture Of [fetal] Membranes) test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The AmniSure ROM test detects PAMG-1 protein marker of the amniotic fluid in vaginal discharge. The test is for use by health care professionals to aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM.

Methodology

Immunochromatographic

Performing Laboratory

RCH-SPH

Specimen Requirements

  1. All materials needed for collection should be provided in the kit. 
  2. Collect specimen using a sterile polyester swab. Insert 2 inches to 3 inches into vagina. Wait 1 minute, then withdraw swab.
  3. Label container with patient’s name (first and last), date and time of collection, and type of specimen.
  4. Maintain sterility and forward promptly within 30 minutes of collection at ambient temperature only.


 Note:

  1. The presence of significant amounts of blood collected with the swab can lead to false positive results.
  2. AmniSure should not be used earlier than 6 hours after the removal of any solutions or medicines from the vagina.
  3. Bleeding, placenta previa, and performing digital exams prior to the sample collection may lead to inaccurate test results.
  4. In rare cases, if the sample is taken 12 hours or later after rupture, a false negative result may occur.

Specimen Stability

Forward Promptly. Testing should be performed as soon as possible after collection.

Day(s) Test Set Up

Monday through Sunday

Test Classification and CPT Coding

83518

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