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AmniSure
24 School Street, 6th Floor

Boston, MA 02108

T: 617-234-4441

F: 617-227-2489

E: info@amnisure.com

CORPORATE DESCRIPTION:

AmniSure® International LLC was formed in 2005 to manufacture, market and distribute the AmniSure® ROM Test worldwide. The Company’s objective is to establish AmniSure® as a Gold-Standard test - a staple test for every pregnancy. AmniSure® LLC works to achieve that objective through in-house sales capabilities and by working with an extensive 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 Cleared

  • 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

  • Simple procedure - No need for speculum examination, additional reagents or equipment and the result can be evaluated visually

  • One short incubation - Produces quick results - within minutes

  • Monoclonal antibodies - New generation device employing immunochromatographic method

  • One Test - In trials, AmniSure® correlated with the clinical diagnosis obtained through the combined usage of three routinely used tests (Nitrazine, Ferning, and Pooling)

Test Strip Before Use
Positive Result : Fetal membrane rupture is detected
Negative Result : No fetal membrane rupture

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  84112
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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