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•Mcompletecan 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

ItemProduct CodeNameSize
Test KitPL.950-1PRO•Mcomplete™ Test Kit 1 test
PL.950- 55 tests
PL.950-1010 tests
Positive ControlPL.953PRO•Mcomplete™ External Positive Control1 vial
Negative ControlN/A*Open pouch and add 3 drops of Extraction Buffer to the cassette.

Available Documents