Sign in →

Test Code ROM Rupture of Fetal Membrane, AmniSure

Useful For

The AmniSure ROM test is a rapid, non-instrumented, qualitative test for the detection of amniotic fluid in vaginal secretions of pregnant patients who report signs, symptoms or complaints suggestive of rupture of membranes. Rupture of membranes (pPROM) prior to 37 weeks’ gestation complicates up to 12% of all pregnancies.1 It uses the principle of immunochromatography to detect human PAMG-1 (placental a-1 microglobulin) protein present in amniotic fluid of pregnant women. Placental Microglobulin was selected as a marker of fetal membrane rupture due to its unique characteristics, i.e. its high level in the amniotic fluid, low level in blood, and extremely low background level in cervicovaginal secretions when the fetal membranes are intact.

Patient Preparation

The test does not require a speculum exam.

Collection Method

i. Open the AmniSure test kit and remove the contents
ii. Shake the solvent vial to make sure that all of the liquid in the vial settles to the bottom.
iii. Open the solvent vial and place it in a vertical position
iv. Insert the sterile polyester swab from the AmniSure test kit into the vagina for 2-3 inches. Withdraw the swab after one minute has elapsed
v. Place the polyester swab tip into the vial, break off excess part of swab and send specimen to the lab. (As soon as possible).
vi. Properly identify the solvent vial labeling the specimen with the patients name (Pathnet Label). Provide the date, time and Collector initials on the label.
 

Container

Plastic vial with solvent

Preferred Specimen

Plastic vial with solvent included in AmniSure ROM kit

Reference or Target Ranges

Negative

Critical Value

Positive

Reasons for Rejection

  • Significant presence of blood on the swab, the test can malfunction and is not recommended.
  • False negative results may occur when the sample is taken more than 12 hours after the fetal membrane rupture has occurred.

Specimen Stability

The sample must be tested within 30 minutes of collection, if specimen is stored at room temperature. If absolutely necessary, the sample may be held in the refrigerator (+4°C) by the lab for up to six (6) hours.

Performance Information

Days and Time Performed 24/7
Expected Turn Around Time Stat:  1 hour
Routine: 4 hours
Stat Availability Yes
Performing Bench UH Hematology
Methodology/Method Description AmniSure

CPT Codes

84112