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Test Code AMNISURE AMNISURE

Department

Chemistry

Specimen Type

Amniotic Fluid

Method

Immunochromatography

Container

Obtain collection kit from Lab

Special Requirements

Sample must be collected with a plain sterile polyester tip swab obtaind from the lab and transported to the lab in the plastic transport sleeve. The sample must be in the lab in less than 30 minutes.

Ship Temperature

Room Temperature

Stability Refrigerated

N/A

Stability Room Temp

30 minutes

Stability Frozen

N/A

Days Test Set Up

Monday through Sunday

Clinical Information

The Amnisure ROM test is for the detection of human amniotic fluid PAMG-1 protein in vaginal discharge of pregnant women. The test should be used to evaluate patients with clinical signs/symptoms suggestive of fetal membrane rupture.

Test Use

For the detection of amniotic fluid suggestive of ROM.

Cautions

Specimen needs to be received by the laboratory in less than 30 minutes. Significant amounts of blood can cause the test to malfunction and is not recommended. The test is qualitative only. In rare cases when a sample is taken 12 hours or more after rupture, a false negative may occur due to obstruction of the rupture by the fetus or resealing of the amniotic sace. Placenta previa, and performing a digital exam prior to sample collection can lead to inaccurate results. 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 Amnisure has not been established in the presence of the following contaminants: meconium, anti-fungal creams or suppositories, K-Y jelly, Monistat, baby powder, Replens or baby oil.

Interpretation

Positive indicates the presence of PAMG-1 protein found in high concentrations in amniotic fluid, thus suggesting ROM.
Negative indicates the absence of PAMG-1 protein, and thus no ROM.