ROM Plus ES Rupture of Membranes Test 2017-01-11T23:27:05+00:00

Project Description

This product is not cleared for sale in the U.S

Best in class sensitivity delivered conveniently and cost effectively.

ROM Plus ES is unique in that it detects both AFP and PP12 using a monoclonal/polyclonal antibody approach–improving its sensitivity.

Timely and accurate diagnosis of premature rupture of membrane (PROM) allows for gestational age-specific interventions designed to minimize the potential risk of complications to both mother and baby.

Dual Protein Markers: Placental Protein-12 & Alpha-fetal Protein

  • PP12 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
  • Other rupture of membrane (ROM) tests only employ one protein marker

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 protein markers
  • Improves the opportunity for denatured protein detection
  • Other ROM tests only employ a monoclonal antibody approach

Ease of Use:

Additionally, ROM Plus ES has:

  • Spill resistant vial to avoid accidental spilling of buffer solution and/or sample

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

ROM Plus ES FAQ’s

Click here to download the F.A.Q

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 ES resulted in an overall sensitivity of 99.5% (see IFU for details).
ROM Plus ES test kits have been tested up to 10% blood concentration. In other words, it will function properly with trace amounts of blood in the sample, however, significant amounts of bloody discharge may cause the test to malfunction. ROM Plus ES is not recommended for use in these situations and it should be determined what is causing the bleeding.
If only a control line (C) is visible, the test result is negative (no PP12 and/or AFP were detected). If both the control line (C) and test line (AF) are visible, the test result is positive (PP12 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 ES should be stored in a dry place at 4° to 24°C (40° to 75°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 ES within six (6) hours after opening foil pouch. Use ROM Plus ES 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.

Tylenol, aspirin, Lever Soap, Noxema 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 ES IFU by clicking here.

ROM Plus ES does not have any gestational age limits.

Product Literature

Clinical Studies

 Senanayake

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.

Ordering Information

CONTACT YOUR LOCAL DISTRIBUTOR TO ORDER

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