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ROM Plus®: accurate point-of-care detection of

ruptured fetal membranes
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Medical Devices: Evidence and Research
9 May 2016
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Ross W McQuivey 1 Abstract: Accurate and timely diagnosis of rupture of fetal membranes is imperative to inform
Jon E Block 2 and guide gestational age-specific interventions to optimize perinatal outcomes and reduce
the risk of serious complications, including preterm delivery and infections. The ROM Plus is
1
Clinical Affairs, Clinical Innovations,
Salt Lake City, UT, 2Independent a rapid, point-of-care, qualitative immunochromatographic diagnostic test that uses a unique
For personal use only.

Clinical Consultant, San Francisco, monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic
CA, USA
fluid at high concentrations: alpha-fetoprotein and insulin-like growth factor binding protein-1.
Clinical study results have uniformly demonstrated high diagnostic accuracy and performance
characteristics with this point-of-care test that exceeds conventional clinical testing with external
laboratory evaluation. The description, indications for use, procedural steps, and laboratory and
clinical characterization of this assay are presented in this article.
Keywords: ROM Plus®, premature rupture of membranes, point-of-care immunoassay,
insulin-like growth factor binding protein-1, IGFBP-1, placental protein 12, PP12, alpha-
fetoprotein, AFP

Introduction
Over the past several decades, point-of-care diagnostic testing has revolutionized the
medical management of patients with emergent conditions in the acute care setting.1,2
Rapid provision of results can facilitate sounder clinical decision making, improved
patient adherence, and greater patient satisfaction, all of which lead to better clinical
outcomes. In fact, an international survey of primary care physicians identified a strong
clinical need and desire for a variety of point-of-care tests to inform more accurate
medical management decisions in a more timely fashion.3
There has been a concerted effort to develop and commercialize rapid, point-
of-care immunoassay tests for rupture of fetal membranes that accurately detect
proteins found in high concentrations in amniotic fluid but at extremely low back-
ground concentrations in cervicovaginal secretions.4 The first generation of these
tests employed a monoclonal antibody approach focusing on insulin-like growth
factor binding protein-1 (IGFBP-1, also known as placental protein 12) and placen-
tal alpha microglobulin-1.5–10 Enthusiasm about this point-of-care approach and to
more accurately diagnose rupture of membranes has led to the recent development
Correspondence: Jon E Block
of a combined monoclonal/polyclonal antibody immunoassay to detect two different
2210 Jackson Street, Suite 401, proteins found in amniotic fluid at high concentrations.11 The description, indications
San Francisco, CA 94115, USA
Tel +1 415 775 7947
for use, procedural steps, and laboratory and clinical characterization of this assay
Email [email protected] are presented herein.

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Device description concentration late in the second/early third trimesters.20–25

The ROM Plus® (ROM Plus, Clinical Innovations, Salt Lake This increases the chance that the proteins will be detected,
City, UT, USA) is a rapid, point-of-care, qualitative immuno- especially in the preterm patient, when an accurate diagnosis
chromatographic test (Figure 1). This diagnostic device uses of ruptured fetal membranes is most crucial.
a unique monoclonal/polyclonal antibody approach to detect In addition to using a unique monoclonal/polyclonal
two different proteins found in amniotic fluid at high con- antibody approach, ROM Plus provides several features
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centrations. ROM Plus detects alpha-fetoprotein (AFP) and designed to improve the ease of use. Unlike the first genera-
IGFBP-1. The combination of IGFBP-1 and AFP was chosen tion point-of-care immunoassays, the test strip is housed in
not only because of its robust historical literature support as a convenient cassette that is placed flat on the bench top
ideal protein markers for amniotic fluid but also the unique reducing the risk of inadvertent sample spills. It also contains
characteristics of each protein. IGFBP-1 is synthesized by a built-in, dye-infused timer that is activated with a finger.
the decidua of the placenta and reaches a very high concen- The control samples are housed in a glass ampoule within
tration level in the amniotic fluid early in the first trimester a plastic vial with a dropper top; they do not require freez-
and remains at that level until delivery.12–19 However, AFP, ing or special handling. To activate the control, one simply
synthesized by the fetal liver and yolk sac, reaches its peak breaks the glass ampoule within the vial, which releases the
lyophilized protein and allows it to mix with the buffer solu-
tion. The plastic vial with dropper top is then used to dispense
the sample into the well of the ROM Plus cassette.
For personal use only.

Indications for use

The ROM Plus fetal membrane rupture test is a rapid,
qualitative immunochromatographic test for the in vitro
detection of amniotic fluid in vaginal secretions of pregnant
women with signs and symptoms of rupture of membranes.
The test detects AFP and IGFBP-1 from amniotic fluid in
vaginal secretion. The test is for prescription use by health
care professionals to aid in the detection of rupture of mem-
branes in pregnant women in conjunction with other signs
and symptoms.

Procedural details
ROM Plus is a self-contained test kit that provides qualitative
results for rupture of fetal membranes and can be performed
at point-of-care sites. A speculum is not needed to obtain
ROM Plus results. The test is noninvasive, with only a simple
vaginal swab sample required.
Figure 2 illustrates the procedural details of the ROM
Plus when used as a point-of-care test. Briefly, a fluid sample
is collected by placing a swab 5–7 cm into the vagina for
15 seconds. The swab is then mixed into a vial containing
400 µL of buffer solution, and the diluted sample is applied
to the sample pad of the test strip via the sample well on the
cassette. A built-in timer is then activated and visualized as a
convenient feature to indicate the time of the test. The liquid
moves chromatographically and unidirectionally toward the
absorbent pad.
During migration, the sample reacts with the mono/
Figure 1 ROM Plus® fetal membrane rupture test.
Abbreviations: C, control; AF, amniotic fluid. polyclonal antibodies on the test strip membrane. These

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For personal use only.

Figure 2 ROM Plus® point-of-care procedural steps.

Notes: (A) The sterile swab is removed from its package to collect a sample from the surface of the vagina being careful not to touch anything prior to its insertion. The
swab is inserted into the vagina 5–7 cm deep and then withdrawn after a minimum of 15 seconds. (B) The swab tip is placed in the vial and mixed with the buffer solution.
After breaking off the swab tip at the scored mark, the tip is left in the vial. For point-of-care applications, the drop dispenser lid is employed and the tip is allowed to remain
in the buffer solution for a minimum of 15 seconds. (C) 4–6 drops of the sample/buffer solution are added to the sample well of the ROM Plus cassette and the timer is
started. The results can be visualized in 5–20 minutes. (D) If the control line is visible (C), the test result is negative. If both the control (C) and the test line (AF) are visible,
the result is positive. If no lines are visible, or just the test line (AF) is visible, the test result is invalid and should be repeated.
Abbreviation: AF, amniotic fluid.

antibodies are immunoreactive to the proteins, IGFBP-1 and Reproducibility was tested on different days at six
AFP, which are markers of amniotic fluid. As the ­membrane levels of amniotic fluid spiked into a negative control. The
absorbs the liquid sample, a control line will appear, indi- assay was run on three lots of ROM Plus to determine the
cating an adequate sample was applied and the device is visual positive results. Two low positives, two moderate
functioning properly. positives, and two high positives were run on three lots of
If the sample contains IGFBP-1 and/or AFP, it binds to the ROM Plus on four different days. No difference in activity
antibody of the test line, causing it to appear and indicating a was observed.
positive test result. If the sample does not contain IGFBP-1 To determine interference and cross-reactivity of the
and/or AFP, only the control line will be visible, indicating assay, Tylenol, aspirin, and three different bath products were
a negative result. spiked into the low positive control at a final concentration of
0.1% without visual loss of activity. The same bath products
Preclinical laboratory development were spiked into the negative control and shown to be nega-
The ROM Plus assay has been validated for the parameters tive. In addition, human semen, urine, and blood were spiked
of linearity, limit of detection, accuracy/reproducibility, into the low positive at a 10% final concentration without
sensitivity, specificity, and cross-reactivity. The “high dose loss of activity. Human semen, urine, and blood were also
hook” effect was determined to estimate ROM Plus’s upper spiked into the negative control and shown to be negative. The
detection range. Concentrations of IGFBP-1 were tested IGFBP-1 assay does not cross-react with IGFBP-2, -3, or -4
up to 400,000 ng/mL and AFP up to 200,000 ng/mL with on Western blot results. Finally, ROM Plus has been shown
positive visual results for 100% of ROM Plus tests sampled. to be negative when tested with specimens that were positive
The lowest limit of detection is 5 ng/mL for IGFBP-1 and for bacterial vaginosis and common sexually transmitted
150 ng/mL for AFP. diseases. All samples were tested at a pH .4.5.

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An external, independent evaluation of the ROM Plus was as ­measured in the same patient. Vaginal secretions were
conducted at Thomas Jefferson Medical Center to investigate evaluated using the conventional fern test as well as the ROM
the analytical and operational characteristics of the assay. The Plus in 75 pregnant patients who presented with complaints
sensitivity for detection and stability of controls, dilution fac- of rupture of membranes. Both tests were compared to an
tor of swab samples, and titer of near-term amniotic fluid and analytical confirmation of ruptured membranes using three
biological fluids commonly found in the vagina other than external laboratory tests. Diagnostic performance character-
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amniotic fluid were examined. The ROM Plus ­demonstrated istics uniformly favored ROM Plus compared to the fern test:
excellent analytical performance and user-friendly features. sensitivity (100% vs 77.8%), specificity (94.8% vs 79.3%),
Specifically, the mass-carrying capacity of the swab for a positive predictive value (75% vs 36.8%), negative predictive
7 g/dL albumin solution was, on average, 79±13 µL, given a value (100% vs 95.8%), and accuracy (95.5% vs 79.1%).
diluent volume of 380 µL, indicating an average minimum
dilution for samples of 18%. The positive control (stated Discussion
concentrations; AFP =600 ng/mL, IGFBP-1 =20 ng/mL) was Spontaneous rupture of membranes can occur at any gesta-
positive to 1:30 dilution, consistent with ROM Plus stated tional age and presents a particularly serious clinical problem
analytical sensitivity (AFP =150 ng/mL, IGFBP-1=5 ng/mL) if it occurs prior to 37 weeks gestation where it is respon-
after accounting for dilution. Also, the control (at a 1:8 titer) sible for 20%–40% of preterm births.27–29 Thus, accurate
remained positive after 10 days of ­storage, either refrigerated and timely diagnosis of membrane rupture is imperative to
or frozen. Amniotic fluid collected from near-term patients inform and guide gestational age-specific interventions to
For personal use only.

was positive to a titer of 1:3,000, while urine from near-term optimize perinatal outcomes and reduce the risk of serious
pregnant patients was negative. complications, including preterm delivery and infections such
as chorioamnionitis and neonatal sepsis.14,30,31 An incorrect
Clinical diagnostic performance diagnosis of membrane rupture (ie, false positive test) can
characteristics also have serious clinical ramifications, such as the initiation
Thomasino et  al11 conducted a multicenter, prospective of unnecessary obstetrical interventions that may include
observational study to compare the accuracy of the ROM hospitalization, administration of medications, and even
Plus with that of current conventional clinical assessment iatrogenic premature delivery.32
for the diagnosis of ruptured fetal membranes. Standard When rupture of membranes is suspected, the diagnosis
clinical assessment included a speculum examination for is conventionally made using the sterile speculum examina-
amniotic fluid pooling, ferning, and environmental pH change tion to identify leakage or pooling of amniotic fluid, coupled
using nitrazine. ­Rupture of membranes was diagnosed if with microscopic evaluation of the collected specimen for
fluid was seen leaking from the cervical os, or if two of evidence of ferning/crystallization and pH testing of the
the three conditions were present: pooling of fluid, positive fluid with nitrazine test paper.31,33,34 While this approach has
­nitrazine test, or ferning. Membrane rupture was confirmed remained the standard of care for decades, the results can be
on review of medical records following delivery. In 285 equivocal, especially when more than an hour has elapsed
patients (15–42 weeks gestation), the false positive rate for since ROM.35 Additionally, the sterile speculum exam is both
the ROM Plus was 9%, false negative rate 0.5%, sensitivity subjective and labor intensive and has been shown to have
99%, and specificity 91%, with positive and negative predic- inadequate diagnostic performance characteristics for the
tive values of 85% and 99%, respectively. In comparison, accurate detection of ruptured membranes.31,36–39
the sensiti­vity of conventional clinical evaluation was 85%, The high level of diagnostic accuracy achieved with the
specificity 98%, with positive and negative predictive values ROM Plus is particularly important in cases of equivocal
of 99% and 77%. Ferning’s sensitivity was 99%, specificity membrane rupture, as nearly one-quarter of all patients
72%, with positive and negative predictive values of 80% ultimately diagnosed with ruptured membranes do not pres-
and 99%. Finally, nitrazine ­testing had a sensitivity of 93%, ent with overt clinical evidence of ruptured membranes on
specificity of 83%, and positive and negative predictive values initial presentation.34
of 90% and 88%. The high sensitivity consistently achieved with the ROM
Rogers et al26 at a single clinical center, compared the Plus test in clinical studies is due, in large part, to the unique
diagnostic performance characteristics between two meth- monoclonal/polyclonal antibody approach where the poly-
ods used for the detection of rupture of fetal membranes clonal antibodies combine with multiple (8–12) amino acid

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 Dovepress ROM Plus®: point-of-care detection of ruptured fetal membranes

peptides contained in the 259 full-length IGFBP-1 protein 9. Rutanen EM, Bohn H, Seppala M. Radioimmunoassay of placental
protein 12: levels in amniotic fluid, cord blood, and serum of healthy
chain, while the monoclonal tests combine with a single adults, pregnant women, and patients with trophoblastic disease. Am J
epitope site. This may provide an advantage over other Obstet Gynecol. 1982;144(4):460–463.
­currently available rapid immunoassay tests that rely on a 10. Rutanen EM, Pekonen F, Karkkainen T. Measurement of insulin-like
growth factor binding protein-1 in cervical/vaginal secretions: compari-
single monoclonal antibody. Future comparative assessments son with the ROM-check membrane immunoassay in the diagnosis of
of different immunoassays will be necessary to elucidate ruptured fetal membranes. Clin Chim Acta. 1993;214(1):73–81.
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11. Thomasino T, Levi C, Draper M, Neubert AG. Diagnosing rupture of

any diagnostic and/or procedural advantages across various membranes using combination monoclonal/polyclonal immunologic
commercially-available tests. protein detection. J Reprod Med. 2013;58(5–6):187–194.
In conclusion, this unique monoclonal/polyclonal immuno­ 12. Albayrak M, Ozdemir I, Koc O, Ankarali H, Ozen O. Comparison of the
diagnostic efficacy of the two rapid bedside immunoassays and com-
assay can be performed easily and rapidly at the patients’ bined clinical conventional diagnosis in prelabour rupture of ­membranes.
bedside by a variety of caregivers without the need for a Eur J Obstet Gynecol Reprod Biol. 2011;158(2):179–182.
13. Darj E, Lyrenas S. Insulin-like growth factor binding protein-1,
speculum examination. a quick way to detect amniotic fluid. Acta Obstet Gynecol Scand.
1998;77(3):295–297.
Acknowledgment 14. Di Renzo GC, Roura LC, Facchinetti F, et al. Guidelines for the manage­
ment of spontaneous preterm labor: identification of spontaneous
RWM is an employee of, and JEB is an independent advisor preterm labor, diagnosis of preterm premature rupture of membranes,
to Clinical Innovations (Salt Lake City, UT). and preventive tools for preterm birth. J Matern Fetal Neonatal Med.
2011;24(5):659–667.
15. Guibourdenche J, Luton D, Andre E, Noel M, Porquet D. Rapid detection
Author contributions of insulin-like growth factor-binding protein-1 and foetal fibronectin in
For personal use only.

All authors contributed to the conception, execution, and cervico-vaginal secretions to diagnose premature membrane rupture.
Ann Clin Biochem. 1999;36(Pt 3):388–390.
drafting of the manuscript, and provided critical revision 16. Kubota T, Takeuchi H. Evaluation of insulin-like growth factor binding
of the manuscript for intellectual content. All authors read protein-1 as a diagnostic tool for rupture of the membranes. J Obstet
and provided final approval of the version to be published. Gynaecol Res. 1998;24(6):411–417.
17. Lockwood CJ, Wein R, Chien D, Ghidini A, Alvarez M, Berkowitz RL.
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work in ensuring that questions related to the accuracy and growth factor-binding protein-1 in vaginal secretions. Am J Obstet
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Disclosure 19. Rutanen EM, Karkkainen TH, Lehtovirta J, Uotila JT, Hinkula MK,
The authors report no conflicts of interest in this work. Hartikainen AL. Evaluation of a rapid strip test for insulin-like growth
factor binding protein-1 in the diagnosis of ruptured fetal membranes.
Clin Chim Acta. 1996;253(1–2):91–101.
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