Test Kit assists physicians in assessing fetal lung maturity.

Press Release Summary:



Used in hospitals and reference laboratories as screening test when premature labor is suspected, AmnioStat-FLM-PG is semi-quantitative, immunologic, card-agglutination test for detection of phosphatidylglycerol (PG) in amniotic fluid. With PG sensitivity at 0.5 µg/mL, kit can be used as early as 33 weeks of pregnancy. It features blue-colored agglutinations against white background, one storage temperature for entire kit, and extended shelf life of 12 months.



Original Press Release:



Irvine Scientific Launches AmnioStat-FLM®-PG the Innovative Next-Generation Fetal Lung Maturity Kit



SANTA ANA, Calif., Nov. 13 / - Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA, and the makers of AmnioStat-FLM®, announced today the launch of their next-generation fetal lung maturity test kit called AmnioStat-FLM-PG. After a one-year redesign process and receiving clearance from the U.S. Food and Drug Administration, this next-generation fetal lung maturity kit is now easier and more convenient to use.

The new design features of AmnioStat-FLM-PG include blue-colored agglutinations against a white background for faster reading, one storage temperature for the entire kit, no dry-ice for shipments, an extended shelf life to 12 months, and an attractive new package design. Used to assess fetal lung maturity in hospitals and reference laboratories, AmnioStat-FLM-PG can be used in doctors' offices as a fast screening test when premature labor is suspected.

Just like the first generation kit, this next-generation kit is a rapid, in-house, STAT test with results in 15 minutes. With PG sensitivity at 0.5ug/mL, this kit can be used as early as 33 weeks of pregnancy. AmnioStat-FLM-PG is a semi-quantitative, immunologic, card-agglutination test for the detection of phosphatidylglycerol (PG) in amniotic fluid. The detection of PG is more advantageous than other test methods because results are not affected by blood or meconium contamination and is more reliable for pregnancies associated with maternal complications such as diabetes mellitus.

When premature labor is suspected, the ability to assess fetal lung maturity is critical in avoiding Respiratory Distress Syndrome (RDS) upon delivery. If left undiagnosed, RDS can lead to neonate mortality. Once diagnosed, however, prenatal or postnatal therapy can decrease or prevent the occurrence of RDS. AmnioStat-FLM-PG is an innovative diagnostic test method that assists physicians in fetal lung maturity assessment.

"We are pleased to offer this next generation kit that will continue to impact prenatal healthcare and help physicians determine fetal lung maturity," stated Dr. Michael Kelly, President and CEO, at Irvine Scientific.

Irvine Scientific, which has provided Prenatal and Cytogenetics products to the healthcare community for over 25 years, is located in Santa Ana, California and is a subsidiary of Japan Energy Corporation.

For more information contact
Heather Mills
hmills@irvinesci.com
800-437-5706 x215.

Source: Irvine Scientific

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