Project Description
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 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
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
ROM-CS
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.
ROM Plus FAQ’s
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.
The lyophilized positive and negative controls can be stored in a dry place at room temperature until the expiration date. No refrigeration is required.
For additional information please see the ROM Plus IFU by clicking here.
For a copy of Clinical Innovations QC recommendation click here.
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
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
CONTACT YOUR LOCAL DISTRIBUTOR TO ORDER
| 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