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Reliable Sensitivity Delivered Conveniently and Cost Effectively
The ROM Plus® Rupture of Membranes Tests are unique in that they detect 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.
There are two tests available:
- ROM Plus® Rupture of Membranes Test
- ROM Plus® ES Rupture of Membrane Test (Not available in the US)
Select the different tabs to find out more.
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ROM PLUS® RUPTURE of MEMBRANES TEST
Reliable Sensitivity Delivered Conveniently and Cost Effectively
ROM Plus®Rupture of Membranes Test is unique in that it detects both Alpha-fetoprotein (AFP) and Insulin-like growth factor-binding protein 1 (IGFBP-1) usingamonoclonal/polyclonalantibody approach–improving itssensitivity.
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.
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ROM PLUS®ES RUPTURE of MEMBRANES TEST
Reliable Sensitivity Delivered Conveniently and Cost Effectively
ROM Plus® ES Rupture of Membranes Test, is a self-contained test kit that provides qualitative results for rupture of fetal membranes and is obtained at point-of-care sites. It comes with a simple test strip and results can be read within 5-10 minutes.
As with the ROM Plus Rupture of Membranes Test, 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.
*ROM Plus ES is currently not available in the US
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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 Rupture of Membranes Test has:
- Spill resistant vial to avoid accidental spilling of buffer solution and/or sample
- Easy to use test cassette with built in timer
Dual Protein Markers: IGFBP-1 & AFP
- IGFBP-1 is detected early infirst 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 PROMtests only employ one protein marker
What about blood?
ROM Plus Rupture of Membranes Test 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.
What Our Customers Are Saying
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
What Our Customers Are Saying
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 Products
| 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 |
ROM Plus ES Products*
| Product | Description | Quantity | Part Number |
| ROM Plus ES Kit | Test Kit W/Test Strip, Swab, Vial With Solution | 25/Box | ROM-1025 |
| ROM Plus ES QC | 1 Positive Control & 1 Negative Control. Each Box Contains 1 Activation Sleeve | 5/Box | ROM-QCS |
CONTACT YOUR LOCAL DISTRIBUTOR TO ORDER
U.S. Patent 10,338,065
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 Rupture of Membranes Test
LOINCapplies universal code names and identifiers tomedical terminologyrelated toelectronic 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
Product Literature White Papers Videos Ordering Reimbursement
What about correlation?
The 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. It test results for these samples fall within the manufacturers 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 CS is only available for the ROM Plus® Rupture of Membranes Test in the US.