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ROM Plus® Rupture of Membrane Test Family of Products

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    • ROM Plus Cassette, Vial and Swab
    ROM Plus Rupture of Membranes Test
    ROM Plus Cassette, Vial and Swab
    ROM Plus Rupture of Membranes Test

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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.

    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

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

    Diagnosing Rupture of Membranes Using Combination Monoclonoal/Polyclonal Immunologic Protein Detection

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

    An abstract of the study was presented at ACOG’s 59th Annual Clinic Meeting in May 2011 at the conference in Washington, DC.

    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

    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

    Product Literature Publications 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.

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