Test Overview
Test Methodology

ROM Plus - in-vitro qualitative immunochromatography

Test Usage

Performed at authorized locations by point of care operators. The ROM PLUS is used to detect the presence of amniotic fluid in the vaginal canal. High concentrations of AFP and PP12 are seen in Amniotic fluid, which contrasts the vaginal mucosa. Normal rupturing of the amniotic sac due to uterine contractions is a biological process that occurs just before child birth (ROM). Spontaneous rupturing without uterine contractions is referred to as premature rupture of membrane (PROM) If the amniotic sac ruptures before 37 weeks of pregnancy it is considered as preterm premature rupture of the membraned (PPROM). PROM and PPROM may cause the following sequelae; excessive hemorrhaging (placenta and uterus separation), blood clots, cord prolapse, infection, still birth and many other life threatening conditions that can affect both the infant and mother. Early and accurate detection of the PROM or PPROM increases the chances for the patient to have a positive outcome with fewer complications.

Reference Range *

Negative (indicating no premature rupture of membranes, PROM)

Note: Normal positive results are seen in patients who are at full term pregnancy and the rupturing of the amniotic sac is brought on by uterine contractions.

Test Limitations

•The ROM Plus is a qualitative assay and is reported as "Negative" and "Positive".
•Excessive vaginal bloody discharge may cause a false positive result

Test Details
Analytic Time

5 - 20 minutes

Soft Order Code
PPROM
MiChart Code
POC ROM Fetal Membrane Rupture
Laboratory
Point of Care
Section
Point of Care
Specimen Requirements
Collection Instructions

1. Remove all the contents from the ROM Plus foil pouch. Inside will be a test cassette with a timer, sterile vaginal swab and a vial containing buffered solution. The vaginal swab is sterile and should remain so until the actual collection of the patient sample. Only opening the swab's packaging half way leaving the wooden portion exposed will keep the swab tip sterile and also make accessible when ready to collect.
2. To collect, remove the vaginal swab by grabbing the wooden section. Without touching an other surface, insert the polyester tip of the swab 2- 3 inches in to the vagina. Allow the swab to remain in vagina for a minimum of 15 seconds before withdrawing.

Rejection Criteria
Test should not be utilized on patients diagnosed with the following diseases; neural-tube defect, hypothyroidism, autoimmune disorders, congenital heart defects, and cystic fibrosis.
Contraindications
Patient diagnosed with the following diseases may cause false positive results; neural-tube defect, hypothyroidism, autoimmune disorders, congenital heart defects, and cystic fibrosis.
Additional Information

For more test specific information, please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care.

Billing
CPT Code
84112
LOINC
1832-5
NY State Approved
No