Actim® PROM Competitive Comparison
Point-of-Care Test Options to Diagnose Premature Ruptured Fetal Membranes (PROM)
FDA 510(k) Clearance
K123986
K030849
K110605
Moderately Complex
Moderately Complex
Moderately Complex
20 Years
Approx. 10 Years
Approx. 3 Years
Protein Marker Type
Insulin-like Growth Factor Binding Protein-1
Placental Alpha Microglobulin-1
Placental Protein 12 and Alpha-fetoprotein
Protein Abbreviation
IGFBP-1
PAMG-1
PP 12 & AFP
Vaginal Swab Collection
10-15 Seconds
1 Minute
15 Seconds
Extraction Solution Time
CLIA Classification
Clinical History
Test Protocol
10-15 Seconds
1 Minute
15 Seconds
Total Maximum Test Time
Required in Non-Obvious
PROM Diagnosis
(To Administer & Interpret)
≤ 5 Minutes
≤ 10 Minutes
≤ 20 Minutes
Gestational Age
> 29 Weeks
No Gestational Age
No Gestational Age
No
No
No
Speculum Required?
Tested to work in the
presence of:
Actim PROM has been tested to perform
in the presence of:
AmniSure has been tested to perform
in the presence of:
ROM Plus has been tested to perform
in the presence of:
• Whole Blood
• Urine
• Semen
• Personal Lubricant
• Baby Oil
• Baby Powder
• Feminine Deodorant Suppositories
• RepHresh Vaginal Gel
• Feminine Deodorant Film
• Pevaryl (Econatzol Nitras)
• Gyno-Trosyd (Tioconazol)
• Flagyl (Metronidazolel)
• Canesten (Clotrimazol)
• Candida Albicans
• Gardnerella Vagnalis
• Neisseria Gonorrhea
• Chlamydia Trachomatis
• HSV-1
• HSV-2
• Insignificant Blood Admixtures*
• Vaginal Infections
• Urine
• Semen
• Alpha-2-Microglobulin
• Human Chorionic Gonadotropin
• Trophoblastic Beta-1-Glycoprotein
• Human Placental Lactogen
• Alpha Fetoprotein
• Human Serum Albumin
• Some IGFBP Proteins
• Blood*
• Urine
• Semen
• Tylenol
• Pert Shampoo
• Noxzema Skin Moisturizer
• Lever Bath Soap
Test Administration
Constraints
Actim PROM does not have any time restrictions
related to when the test can be administered
Why choose Actim PROM?
• Multiple clinical studies have proven Actim
PROM’s accuracy in the presence of blood
while the clinical studies of the other two
point-of-care PROM tests excluded patients
with active vaginal bleeding from most of
their study protocols.
• Actim PROM has a 20 year clinical history
and has been used to diagnose over
5,000,000 women
*ROM Plus Control Tests were spiked with
peripheral blood. Patients with active vaginal
bleeding were excluded from clinical studies.
*AmniSure Control Tests were spiked with
peripheral blood. Patients with active vaginal
bleeding were excluded from clinical studies.
AmniSure should not be used earlier than 6
hours after the removal of any disinfectant
solutions or medicines from the vagina.
ROM Plus does not have any time restrictions
related to when the test can be administered.
• Patients with active vaginal bleeding were
excluded from most study protocols.
• ROM Plus cannot be used as a sole method
to determine PROM:
• AmniSure’s 99% accuracy claim is based on
one study (Cousins et al. 2005) while Actim
PROM relies on a variety of clinical data
representative of real-life presentation in
both known and unknown patient groups.
arning Statement on Test: The test may
W
report positive results in patients with intact
membranes and therefore decisions to induce
labor should not be based solely on the ROM
Plus test results.
• Patients with active vaginal bleeding were
excluded from most study protocols.
• Actim PROM is the fastest POC test available,
with accurate results within 5 minutes
CPT Code
84112
Resources:
510(k) Clearance Letters: K123986, K030849, K110605
AmniSure Product Insert/Instructions for Use
ROM Plus Product Insert/Instructions for Use
84112
84112
82574 Rev. 2/15
Specimen Extraction Solution
Dipstick
VaginalSwab
Vaginal bleeding
occurs in up to
20%
of all suspected
PROM patients
Actim PROM –
used to diagnose over
5,000,000
WOMEN
for PROM
Up To 20% of PROM Patients Exhibit Vaginal Bleeding1
Other point-of-care PROM tests are only indicated for use with trace vaginal bleeding while
Actim PROM has been proven to perform regardless of the amount of vaginal bleeding.
With up to 20% of women presenting with vaginal bleeding at the time of PROM diagnosis,
you need a reliable test for all patients. The Actim PROM advantages are clear:
• Multiple clinical studies have proven Actim PROM’s accuracy in the presence of blood
5
• 20 years of proven results outside the U.S. with more than 5,000,000 PROM tests performed
• Fastest POC test available, with accurate results within 5 minutes
MINUTES
Actim PROM is the fastest
point-of-care
test available2
Now Available in the United States!
1 Palacio et al.: Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes:
comparison of performance indexes. BMC Pregnancy and Childbirth 2014 14:183
2 Actim PROM, AmniSure and ROM Plus Instructions for Use documentation