PRO•Mcomplete™

When traditional tests are not enough to make an accurate diagnosis of PROM….

PRO•Mcomplete™ proposes an alternative tool to aid in the diagnosis of premature rupture of the fetal membranes by identification of IGFBP-1 (Insulin-like Growth Factor-Binding Protein-1) and AFP (Alpha-Feto Protein) from amniotic fluid in a vaginal swab sample.

Only test that measures both IGFBP-1 and AFP separately
Higher sensitivity with addition of AFP than IGFBP-1 alone
Results as quickly as 10 minutes
Non-invasive, no speculum required for easy specimen collection
Effective for all gestational ages
Can be used in the presence of blood, semen, urine and hygiene products
Available in single tests for Midwives, OB offices and remote triage locations
Easy QC with external positive and negative controls
Educational PowerPoint available for staff training to meet POC and hospital accreditation requirements Click here for documents

Test Procedure

Note: For detailed steps, please refer to Instructions For Use in Available Documents below

Utilizing PRO•Mcomplete™ will ensure a safe and happy outcome

A rapid and accurate diagnosis of PROM improves patient outcomes and reduces overall hospital costs.
The diagnosis of PROM is based primarily on traditional methods that have been utilized for over 60 years. Traditional methods include the patient’s clinical history and physical examination using a speculum. The diagnosis of membrane rupture is typically confirmed by the visualization of amniotic fluid passing from the cervical canal and pooling in the vagina; a basic pH test of vaginal fluid (Amniotest™); or arborization (ferning) of dried vaginal fluid, which is identified under microscopic evaluation.

Despite this, diagnosing PROM remains a common problem, as there is no single universally accepted method for confirming rupture of membranes.

PRO•Mcomplete™ is an ideal test when…..

Equivocal result – Pregnant patients present with conflicting history and physical examination findings; a history highly suspicious for ruptured membranes with a normal fern test but positive nitrazine test or positive nitrazine test and negative fern test
pH and fern tests are often inaccurate as they are affected by interfering substances, such as blood, semen, urine, bacterial vaginosis and vaginal mucus. PRO•Mcomplete™ can be used in the presence of blood and other interfering substances.
In cases in which the patient’s history suggests PROM, but physical examination findings fail to confirm the diagnosis
As a first-line screening tool in remote locations or locations without Obstetrics

Hospitals that utilize PRO•Mcomplete™ as another diagnostic tool benefit from…

Overall cost savings
Reduction in overnight patient admissions for observation
Reduction in unnecessary transfer of patients to hospitals with a higher level of care
Reduction in unnecessary medications that have possible side effects
Reduction in unnecessary labour inductions
Reduction in time consuming diagnosis for clinicians allowing them to focus their attention on others
Reduction in mother’s being held in Triage for lengthy periods of time or returning for ultrasounds
Reduction on impact to department’s budget with small test sizes available (1, 5 and 10 tests)
Reduction of mother’s anxiety with an accurate rapid diagnosis

Ordering Information

Item	Product Code	Name	Size
Test Kit	PL.950-1	PRO•Mcomplete™ Test Kit	1 test
	PL.950- 5		5 tests
	PL.950-10		10 tests
Positive Control	PL.953	PRO•Mcomplete™ External Positive Control	1 vial
Negative Control	N/A	*Open pouch and add 3 drops of Extraction Buffer to the cassette.