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Test Code Amnisure Amnisure

Important Note

These supplies can be obtained from the POCT Coordinator (in the Main Lab) at 75696.

Additional Codes

Cerner

NextGen
AmniSure Test

AmniSure Test

Useful For

The AmniSure® ROM Test detects the qualitative presence of PAMG-1 protein marker of amniotic fluid in vaginal secretions of pregnant women reporting signs, symptoms, or complaints suggestive of ROM. Timely and accurate diagnosis of the rupture of fetal membranes is crucial for preventing serious neonatal and maternal consequences.

Methodology

The AmniSure® ROM Test uses the principles of immunochromatography to detect human PAMG-1 (placental α1-microglobulin) protein present in amniotic fluid of pregnant women.  Placental microglobulin was selected as a marker of fetal membranes rupture due to its unique characteristics, i.e., its high level in the amniotic fluid, low level in blood and extremely low background level (50-220 picogram/ml) in cervico-vaginal discharge when the fetal membranes are intact. This test employs highly sensitive monoclonal antibodies that detects a minimum amount of the protein which is present after the rupture of the fetal membranes. To minimize false results, two monoclonal antibodies have been selected to set the sensitivity threshold at the optimal low level which allows the detection of extremely small quantities of amniotic fluid in vaginal discharge.

Patient Preparation

  • Patient’s vagina should be free from disinfectant solutions or medicines for 6 hours prior to specimen collection.
  • Digital exams should not be performed prior to specimen collection.

Collection Instructions

See Amnisure Collection Instructions and/ or Nursing Procedure- AmniSure® ROM Testing for Detection of Rupture of Membranes (ROM) in Pregnant Women for complete instructions.

Specimen collection process:

  • Shake the solvent vial well to make sure all liquid in the vial has dropped to the bottom of the vial.
  • Carefully insert the sterile polyester tip of the swab into the vagina no more than 2-3 inches or 5-7 cm deep.
  • Withdraw the swab from the vagina after one minute.
  • Immediately place the swab into the solvent vial and rinse by rotating for one minute.
  • Remove and discard the swab. Recap the vial.
  • Submit properly labeled vial to Lab for testing.

Specimen Requirements

Container

AmniSure® ROM Test Kit plastic vial with solvent (specimen is collected by nursing department using supplied sterile polyester applicator swab and solvent vial).

Stability

Inocculated vial is stable:

  • 4 hours at room temperature
  • 6 hours at 2-8⁰ C.

Rejection Criteria
  • Vial submitted with a swab in it
  • Bloody specimens
  • Improperly or mislabeled specimen
  • Vial submitted past stability limits.

Result Reporting and Reference Values

Reference Range
  • Negative Results: No evidence of amniotic fluid.
  • Positive Results:  Evidence of amniotic fluid detected

Critical Ranges

None

Reflex Testing

None

Limitations

  • Results should be used in conjunction with other clinical information.
  • Inaccurate results may be caused by:
    • Placenta previa.
    • Digital cervical exam prior to specimen collection.
    • Significant amounts of blood on the swab can cause test malfunction and is not recommended.
  • False Negative Sources:
    • In very rare cases when a sample is taken 12 hours or later after a rupture, a false negative result may occur due to obstruction of the rupture by fetus or resealing of the amniotic sac.
    • Interrupted leakage with minimal residual fluid.
  • Negative results alone may not rule out membrane rupture. False negative results can delay the diagnosis of rupture of membrane and can increase the risk of chorioamnionitis, oligohydramnios and fetal umbilical cord accident.
  • Test performance in patients without signs or symptoms of ROM is unknown.
  • Failure to detect membrane rupture does not assure the absence of membrane rupture.
  • Women may labor spontaneously despite a negative test result.
  • The performance of the AmniSure® test has not been established in the presence of the following contaminants: Meconium, anti-fungal creams or suppositories, K-Y Jelly, Monistat, baby powder (Starch and Talc), Replens, or baby oil.