Project Description

ROM Plus Rupture of Membranes Test

ROM Plus Rupture of Membranes Test – Reliable 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

New ROM Plus Animation

Monoclonal Antibodies

Recognizes only one epitope on an antigen
Polyclonal Antibody-01

Polyclonal Antibodies

Recognizes multiple epitopes on any one antigen

Polyclonal & Monoclonal Antibody Approach:

  • Reduces the chance of false negatives
  • Provides a better “screening” method to detect the presence of 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
Bloody ROM Test Sample in Tube

What about blood?

ROM Plus has been shown to be effective in the presence of blood at a 10% concentration, as reflected in the ROM Plus Instructions for Use. 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.

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

Upward Trend Graph Under Magnifying Glass Image


ROM Plus Correlation Samples Kit

What about correlation?

The Clinical Innovations ROM CS is a commercially available quality control material with known values,

When implementing a new system, such as ROM Plus, the facility must verify the accuracy of the new system. This is best done by comparison to truth, but if truth is not available, the ROM-CS can be used.

From the CLIA Certification of Performance Specifications Brochure #2:

“The laboratory needs to compare the accuracy of the test results it obtains when using a test system with the manufacturer’s accuracy claims. This can be done by testing commercially available calibrators/calibration and quality control materials with known values, proficiency testing materials that have established values, and previously tested patient specimens with established values. If test results for these samples fall within the manufacturer’s stated acceptable limits, accuracy is verified.”

The ROM CS kit comes with:

  • 20 blinded samples
  • Sealed known results
  • ROM CS correlation log
  • Instructions for use

The ROM CS samples are either positive or negative. CLIA regulations only require a positive or a negative sample and do not require low/high positives.

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 99.5% (see IFU for details).

ROM Plus has been shown to be effective in the presence of blood at a 10% concentration, as reflected in the ROM Plus Instructions for Use. 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.

ROM Plus test is not a waived test. It has been classified as Moderately Complex by CLIA (Clinical Laboratory Improvement Amendments).
If only a control line (C) is visible, the test result is negative (no IGFBP-1 and/or AFP were detected). If both the control line (C) and test line (AF) are visible, the test result is positive (IGFBP-1 and/or AFP was detected). If no lines are visible, or just the test line (AF) is visible, the test result is invalid and should be repeated. Darkness of the stripes may vary. The test is valid even if the stripes are faint. Do not interpret test results based on darkness of the stripes.
ROM Plus should be stored in a dry place at 4° to 37°C (40° to 99°F). DO NOT FREEZE. When stored in the foil pouch at the recommended temperature, the test is stable until the expiration date. Use ROM Plus within six (6) hours after opening foil pouch. Use ROM Plus within six (6) hours of collecting the vaginal swab sample and placing it into the buffer vial.

The lyophilized positive and negative controls can be stored in a dry place at room temperature until the expiration date. No refrigeration is required.

No. The timer that is built into the cassette is included for convenience and does not need to be used while running the test.
KY Gel, Surgilube, Tylenol, aspirin, Lever Soap, Noxzema 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 by clicking here.

Yes. Please see the Reimbursement Information section below for additional information.
It is the company’s recommendation that external QC be completed for each new lot number or shipment of test material or if there is suspicion of improper storage and as required by regulatory or accrediting agencies.

For a copy of Clinical Innovations QC recommendation click here.

ROM Plus does not have any gestational age limits.

Clinical Studies


Accurate Point-of-Care Detection of Ruptured Fetal Membranes: Improved Diagnostic Performance Characteristics with a Monoclonal/Polyclonal Immunoassay


ROM Plus®: accurate point-of-care detection of ruptured fetal membranes


Actim™PROM, AmniSure®, and ROM Plus®: Rupture of membrane kits tested on amniotic fluid from women at C-section: a comparative study


Analytical and operational evaluation of the ROM-Plus test for rupture of fetal membranes


Comparison of rapid immunoassays for rupture of fetal membranes

ROM Plus Videos

ROM Plus Quality Control Instructional Video

Reimbursement Information

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 $98.11; 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 2018 is $98.11.

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

LOINC codes for ROM Plus

LOINC applies universal code names and identifiers to medical terminology related to electronic health records. The purpose is to assist in the electronic exchange and gathering of clinical results (such as laboratory tests, clinical observations, outcomes management and research). Suitability of LOINC Document Ontology as a reference terminology for clinical document types: A case report of a research-oriented EHR

ROM Plus has two LOINC codes, one for each protein.

IGFBP = 69945-4

AFP = 19171-8

Ordering Information


Product Description Quantity Part Number
P.O.C Kits Complete Test Kit Test cassette w/test strip, built-in timer, ID tracker,
swab, vial with solution and convenient dropper cap
25/box ROM-5025
Collection Kits
Collection Kit
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
Quality Control
Quality Control Kit
1 Positive control & 1 Negative control 5/box ROM-QC
Correlation Samples
Correlation Sample Kit
20 known blinded, frozen samples 1/box ROM-CS

U.S. Patent 10,338,065