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Clinical Innovations

747 West 4170 South

Murray, UT  84123

Phone: (888)268-6222

Fax:  (802)266-7373

Email:   mail@clinicalinnovations.com

  www.clinicalinnovations.com


COMPANY DESCRIPTION: 
Clinical Innovations develops, manufactures and markets state-of-the-art medical devices that improve healthcare outcomes for clinicians and their patients worldwide. With particular emphasis on healthcare solutions for women and their infants, Clinical Innovations employs high quality standards in every aspect of business to make advancements in technology and bring innovative ideas to life.

ROM Plus Fetal Membranes Rupture Test: 

ROM Plus Fetal Membranes Rupture Test is a rapid, qualitative test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. It utilizes a combination of monoclonal and polyclonal antibodies to detect alpha-fetoprotein (AFP) and placental protein 12 (PP12, or insulin growth factor binding protein-1) found in amniotic fluid. Testing for two protein markers using the monoclonal and polyclonal antibody combination increases

ROM Plus' sensitivity and improves diagnosis, particularly of PPROM. Housed in a convenient test cassette, ROM Plus quickly and accurately provides test results essential to optimizing perinatal outcomes.

Features:

  • Two Protein Markers:
    Testing for both AFP and PP12 improves diagnostic accuracy.

  • Lateral Flow Technology:
    Latest in lateral flow test strip technology makes performing the test and reading results easy.

  • On-Demand, Rapid Test:
    No need for a speculum. Using at prescription point-of-care sites produces immediate results.

  • Convenient Cassette:
    Cassette contains test strip, built-in timer and patient ID tracker for convenience, portability and quality control.

  • Spill-Resistant Vial/ Scored Swab:
    Preventing spills enables a clean test procedure and reduces need for re-sampling. Keeping the swab tip in the vial reduces mess.

Test Kit Requirements:
  • CLIA Classification:
    Moderately complex

  • Analytes performed on this device:
    Identifies presence of AFP (alphafetoprotein) and PP12 (placental protein 12, insulin growth factor binding protein)

  • CPT Code:
    In process

  • Test methodology:
    Rapid Immunoassay

  • Sample volume:
    Threshold 5ng/mL

  • Time to result:
    5-20 minutes

  • Units in which the test is reported:
    Quantitative: result

  • MSDS's associated with the use of this product:
    N/A

  • Instrument requirements:
    N/A

  • Software information requirements:
    N/A


Last updated: 06/22/2013 Questions or corrections: editor@pointofcare.net

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