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ROM Plus® Rupture of Membranes Test

ROM Plus® Rupture of Membranes Test

Best in class sensitivity delivered conveniently and cost effectively.

ROM Plus® is unique in that it detects both Alpha-fetoprotein (AFP) and Insulin-like growth factor-binding protein 1 (IGFBP-1) using a monoclonal/polyclonal antibody approach–improving its sensitivity. Timely and accurate diagnosis of PROM allows for gestational age-specific interventions designed to minimize the potential risk of complications to both mother and baby.

Dual Protein Markers: IGFBP-1 & AFP

  • IGFBP-1 is detected early in first trimester and “plateaus” throughout the duration of the pregnancy
  • AFP is detected at the end of the 2nd trimester/beginning of the 3rd trimester (< 37 weeks) where full confidence is required in the accurate diagnosis
  • AmniSure and Actim PROM tests only employ one protein marker

Request a product demo or find out more

Product Enquiry

Polyclonal Antibodies

Recognizes multiple epitopes on any one antigen

Monoclonal Antibodies

Recognizes only one epitope on an antigen

Polyclonal & Monoclonal Antibody Approach:

  • Reduces the chance of false negatives
  • Provides a better “screening” method to detect the presence protein markers
  • Improves the opportunity for denatured protein detection
  • AmniSure and Actim PROM tests only employ a monoclonal antibody approach

Ease of Use:

  • 15 Second Sample Collection
  • 15 Second Mix Within Buffer Solution

Additionally, ROM Plus has:

  • Spill resistant vial to avoid accidental spilling of buffer solution and/or sample
  • Easy to use test cassette with built in timer

ROM Plus® FAQs

Are there gestational age limitations for using ROM Plus?

ROM Plus does not have any gestational age limits.

Do you have to use the timer in the cassette to run the test?

No. The timer that is built into the cassette is included for convenience and does not need to be used while running the test.

Does blood contamination affect the test result?

ROM Plus test kits have been tested up to 10% blood concentration. In other words, it will function properly with trace amounts of blood in the sample, however, significant amounts of bloody discharge may cause the test to malfunction. ROM Plus is not recommended for use in these situations and it should be determined what is causing the bleeding.

How often should external QC’s be run?

It is the company’s recommendation that external QC be completed every 30 days, or for every new lot number or shipmnt received, whichever comes first.

Is there a time limit for reading the test?

Yes. The ROM Plus test is an immunoassay test and as with all immunoassay tests the results will diminish over time. Do not read the test results after 30 minutes have passed

What is ROM Plus’ CLIA Classification?

ROM Plus test is not a waived test. It has been classified as Moderately Complex by CLIA (Clinical Laboratory Improvement Amendments).

What is sensitivity/specificity?

Sensitivity is the percentage probability that a positive test will occur in a patient who is really experiencing rupture of membranes, or the proportion of actual positives which are correctly identified as such. In a multi-site hospital study involving 285 patients, ROM Plus resulted in an overall sensitivity of 99% (see IFU for details). Specificity is the percentage probability that a negative test will occur in a patient who is not experiencing rupture of membranes, or the proportion of actual negatives which are correctly identified as such. Specificity also refers to the ability of the test to detect the correct result in the presence of interfering components that may be present in a sample matrix (i.e., blood, urine, semen, etc.). ROM Plus resulted in an overall specificity of 85%.

Will semen, urine or disinfectants interfere with test?

Tylenol, aspirin, Lever Soap, Noxema cream, Pert Shampoo, human semen, urine and blood were tested as possible interference’s and were shown to be negative. For additional information please see the ROM Plus IFU

ROM Plus® Videos

ROM Plus Video A - Test Procedure

ROM Plus Video B - Quality Control Procedure

ROM Plus® Reimbursement

CPT 84112 “Evaluation of cervicovaginal fluid for specific amniotic fluid protein(s) (eg, placental alpha microglobulin-1 [PAMG-1], placental protein 12 [PP12], alpha-fetoprotein), qualitative, each specimen”.

*The national limit is $87.74; however, reimbursement amount may vary by state.

Clinical lab services are paid under the Medicare Clinical Laboratory Fee Schedule. The National Limitation Amount (NLA) for CPT 84112 as determined by the Centers Medicare and Medicaid Services (CMS) for 2016 is $87.74.

**CI is in no way advertising or guaranteeing reimbursement. Work with your coding & billing department to determine what works for your facility.

ROM Plus® Testimonials

I’m a believer!

“The transition from AmniSure to ROM Plus was incredibly easy. I was anticipating push back from the staff but I had absolutely none. The staff felt that ROM Plus was a reliable test and even easier to run than their previous POC test. The ROM Plus representatives were organized, friendly and made the transition that much easier. Very rarely can you make a transition to a product that is easier to use and clinically reliable, all while saving the hospital thousands of dollars a year. I’m a believer!”

- Elizabeth Kissinger RN, MSN | Director of Women and Children’s Services

The collection process is easier on the patient

“I like the ROM Plus test kits because they have separate packaging for the collection vs the testing so there is no extra packaging that we  have to deal with. The collection process is easier on the patient and the stability of the specimen is great so we do not have to be in a rush to get the result out. The ease of testing is great for the techs. So far we have enjoyed performing the ROM Plus test.”

- Nicole Fisher MT(ASCP), MHA | Lab Clinical Facilitator

ROM Plus® Ordering Information

Product Description Quantity Part Number
ROM Plus (25) Test cassette w/test strip, built in timer, ID tracker, swab, vial with solution and convenient dropper cap 25/box ROM-5025
ROM ES Plus ROM Plus ES is unique in that it detects both AFP and PP12 using a monoclonal/polyclonal antibody approach–improving its sensitivity 25/box ROM-1025
Collection Kits 1 box of 25 collection kits include a swab, vial with solution and dropper cap 25/box ROM-6000
Lab Test Kits
Lab Collection Kit
1 box of 25 collection kits includes swab, vial with solution and cap
1 box of 25 cassettes with test strip and timer
25/box ROM-6025
ROM Plus Quality Control
Quality Control Kit
1 Positive control & 1 Negative control 5/box ROM-QC
Validation Kit 1 box of 25 cassettes with test strip, timer and ID.
3 boxes of ROM-QC (1 positive & 1 negative control)
1/box ROM-7025
P.O.C. Correlation Kit 1 box of 25 cassettes with test strip, timer and ID, swab and vial
1 each ROM-QC (1 positive & 1 negative control)
1/box ROM-7055
Lab Correlation Kit 1 box of 25 collection kits includes a swab, vial with solution and dropper cap
1 box of 25 cassettes 1 each ROM-QC (1 positive & 1 negative control)
1/box ROM-7065

Who We Are...

JB Medical Supplies delivers leading edge products & practices in labour, delivery and perinatal care. Our Partner agencies are Promed Technologies in New Zealand, and Fusion Healthcare in SA. WA and NT.

JB Medical Supplies
enquiries@clinicalinnovations.com.au
Phone No. (07) 3862 2000 Fax No. (07) 3862 2077
36 Matheson Street, Virginia, QLD 4017 AUSTRALIA