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AmniSure International LLC
30 JFK Street, 4th Floor
Cambridge, MA 02138
(617) 234-4441 (tel)
(617) 661-5617 (fax)

Administration:
administration@amnisure.com

www.amnisure.com

CORPORATE DESCRIPTION: 

AmniSure International LLC is a Massachusetts based company that develops, manufactures, and markets diagnostic and therapeutic products based on research and development in the field of cellular biotechnology. AmniSure International’s current focus is on diagnostic products that utilize monoclonal antibodies against specific proteins associated with particular diseases. AmniSure International LLC’s proprietary scientific platform allows maximizing the peak-to-background (PTB) concentration ratio in diagnostic products. The high PTB index means that the diagnostic device is capable of detecting very small quantities of the substance indicative of the disease. This in turn has an immediate implication on the early and accurate detection of a dangerous medical condition and the opportunity to treat it in a timely manner. AmniSure International’s flagship product, AmniSure® is a rapid in-vitro diagnostic test that detects rupture of fetal membranes (ROM), a major cause of pregnancy complications. AmniSure International LLC manufactures and markets AmniSure® through its own sales force and a network of worldwide distributors.

PRODUCT DESCRIPTION:

AmniSure® is a new diagnostic device that solves a long-standing problem in obstetric practice - diagnosis of ruptured fetal membranes (ROM).  ROM occurs in about one out of ten women and constitutes the major factor of pre-and post-natal complications.  In the U.S., at least 30% of pregnant women are checked for ROM during pregnancy.  If the rupture of the amniotic sac that results in the leakage of the fluid is not detected and treated in a timely and accurate manner (within 24 hours from the occurrence of the rupture), infection and other serious complications for the neonate and the mother may occur. 

Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy for prompt hospitalization and for timely and proper treatment.

Features:

  • FDA Approved
  • Specific, simple, convenient and reliable test, which allows rapid and accurate detection of fetal membranes rupture
  • Detects tiny amounts of amniotic fluid in vaginal secretions
  • No need for speculum examination, additional reagents or equipment
  • Results can be evaluated visually

Reliable aid for physicians, the test can also be performed by nurses and midwives

Test Kit Requirements:

Test kit name AmniSure™ ROM (Rupture Of [fetal] Membranes) Test
CLIA Classification Moderately Complex
Analytes performed on this device Amniotic fluid and/or Placental Alpha Microglobulin-1 (PAMG-1, commercial positive QC analyte)
CPT Code  N/A
Test methodology Rapid immunoassay
Sample volume Test sensitivity cutoff is 5 ng of amniotic fluid per 1 ml of vaginal secretions
Time to result ~ 5 minutes
Units in which the test is reported Qualitative: + or - result
MSDS's associated N/A
Instrument requirements N/A
Software information requirements N/A

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Last updated:  01/11/2007 • Questions or corrections:  Webmaster
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