Traditional Methods

ROM Plus® Rupture of Membranes Test provides reliable sensitivity1, delivered conveniently and cost effectively.

HIGH SENSITIVITY AT ALL GESTATIONAL AGES

Insert swab 5-7 cm and collect sample for 15

seconds.

QUICK AND EASY

Control LineTest Line

Control LineTest Line

2-3 in

>>

5-7cm

Control LineTest Line

Control LineTest Line

2-3 in

>>

5-7cm

Control LineTest Line

Control LineTest Line

2-3 in

>>

5-7cm

Control LineTest Line

Control LineTest Line

2-3 in

>>

5-7cm

1. Collect Sample 2. Place Swab & Mix 3. Insert Test Strip 3. Remove & Interpret

Place swab into vial and mix in buffer solution for

15 seconds.

Place ROM Plus ES strip into the vial with the

arrows down.

Remove strip if two lines are visible or after 10

minutes.

See Package Insert for Full Instructions, Warnings, Precautions & Contraindications

F E R N I N G 5

S P E C I F I C I T YS E N S I T I V I T Y

N I T R A Z I N E 5 9 0 - 9 7 % 1 6 - 7 0 %

5 1 - 9 8 % 7 0 - 8 8 %

P O O L I N G S u b j e c t i v e S u b j e c t i v e

E S P L I N , 2 0 1 9 9 3 2 4 9 1 . 7 % 9 7 %

R O M P l u s I F U 9 0 . 7 %9 9 . 5 %2 8 5

R O G E R S , 2 0 1 6 4

I G B I N O S A , 2 0 1 7 3

S P E C I F I C I T YS E N S I T I V I T YP A T I E N T S

T H O M A S I N O , 2 0 1 3 2 9 0 . 7 %9 9 . 5 %2 8 5

1 1 1 9 6 . 4 % 9 8 . 8 %

S E N A N A Y A K E , 2 0 1 3 1 9 5 9 8 . 9 % N / A

7 5 1 0 0 % 9 4 . 8 %

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PRODUCT SUPPORT

Ordering Information

THE SCIENCE BEHIND THE TEST

1. Senanayake HM. Actim™ PROM, AmniSure®, and ROM+plus®: Rupture of membrane kits tested on amniotic fluid from women at C-section: a comparative study. Sri Lanka Journal of Obstetrics and Gynaecology. 2013; 116-121. 2. Thomasino T, Levi C, Draper M, Neubert AG. Diagnosing rupture of membranes using combination monoclonal/polyclonal immunologic protein detection. J Reprod Med. 2013;58(5–6):187–194. 3. Igbinosa, Irogue & A. Moore, Ferney & Johnson, Cheri & Block, Jon. (2017). Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy and Childbirth. 17. . 10.1186/s12884-017-1311-y. 4. Rogers LC, Scott L, Block JE. Accurate point-of-care detection of ruptured fetal membranes: improved diagnostic performance characteristics with a monoclonal/polyclonal immunoassay. Clin Med Insights Reprod Health. 2016;10:15–8. 5. Caughey, et al. Rev Obstet Gynecol 2008; 1:11-22. de Haan et al., Am J Perinatol 1994; 11:46-506. Wathen et. al 19937. Rose, N. C., MD, & Mennuti, M. T., MD. Gynecology & Obstetrics (Vol. 3).8. McQuivey RW, Block JE. ROM Plus: accurate point-of-care detection of ruptured fetal membranes. Med Devices (Auckl) 2016;9:69–74.9. Esplin, et. al. Prospective evaluation of the efficacy of immunoassays in the diagnosis of rupture of the membranes. J Matern Fetal Neonatal Med. 2019 Jan 13:1-7. doi: 10.1080/14767058.2018.1555809. [Epub ahead of print]

forMOM. forBABY. forLIFE.™

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Ask for additional details.

Potential savings compared to similar immunoassay tests.

MONEY BACK

GUARANTEE

Product Description Box Quantity

Test Kits- Kit w/test strip, swab, vial with solution

Product Code

ROM-1025 25/box

Quality Control- 1 Positive control & 1 Negative control ROM-QCS 5/box

Increased sensitivity in all gestational ages by detecting AFP as well as IGFBP-1.2

Increase the likelihood of detecting proteins and help avoid false negatives by using both monoclonal and

polyclonal antibodies.8

Monoclonal Antibody(One receptor site)

Polyclonal Antibodies(Multiple receptor sites)

TWO PROTEINSProtein Levels in Amniotic Fluid

TWO ANTIBODIES

30,000

20,000

10,000

1,000

10 20 30 40Gestation (weeks)

AFP μg/ml7 IGFBP-1 μg/ml6

100,000

10,000

1,000

100

10

ROM Plus uses a unique monoclonal and polyclonal antibody approach while looking for two protiens, AFP (alpha-fetoprotein) and IGFBP-1 (insulin growth factor binding protein-1),

to improve overall test sensitivity.