Rupture of Membranes by AmniSure

Abbrev Code:AMNI   
Order Code:LAB3000Order Name:Rupture of Membranes by AmniSure
Synonyms:ROM; AMNI
Methodology:Immunochromatographic assay
CPT Codes: 84112 x1
Turnaround Time:Performed and reported 24 hours/day;
Special Instructions:Requires special collection kit.

Collection Instructions

Specimen:Cervicovaginal secretions
Container:Amnisure Collection kit
Collection Instructions:

Requires AmniSure Collection Kit that includes Dacron swab, liquid vial and test strip.

1.        Insert Dacron swab 2 to 3 inches into the vagina.

2.        Allow swab to remain in vagina for one minute then withdraw.

3.        Place swab tip into liquid vial and rotate for one minute. Remove and discard swab.

4.        Place the white end of the test strip with arrow pointing downward into the liquid vial. If two lines are clearly visible, remove test strip at 5 minutes. Remove test strip after 10 minutes, regardless of the number of lines present.

5.        Interpretation: One line indicates a negative test and no fetal membrane rupture, two lines indicate a positive test for fetal membrane rupture, no lines indicate an invalid test that must be recollected.



Patient Preparation:Specimen should be obtained prior to digital cervical examination.
Causes for Rejection:Swab contaminated with lubricants, soaps, creams or disinfectants. Do not use visibly bloody specimens because of potential false positives.

Processing and Shipping

Specimen Processing:Do not process.
Shipping Instructions:Send refrigerated or room temperature; do not freeze or exceed 25 C.
Test Performed at or Referral Lab Chemistry  (Grand Itasca)


Reference Range:Negative indicates no rupture of fetal membranes.
Limitations:Interrupted leakage with minimal residual fluid or samples taken 12 hours or later after rupture may lead to false negative results. AmniSure should not be used earlier than 6 hours after the removal of any disinfectant solutions or medications from the vagina. Placenta previa, performing digital exams and contaminants such as KY Jelly, anti-fungal creams, baby powder, etc. may lead to inaccurate results. When there is a significant presence of blood on the swab, the test can malfunction and is not recommended. In cases of only trace amounts of blood on the swab, the test still functions properly.
Use:Detection of amniotic fluid in vaginal secretions of pregnant women.

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