ROM Plus® Rupture of Membrane Test Family of Products

ROM Plus® Rupture of Membrane Test Family of Products

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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 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

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.

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

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

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

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.

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