Instrumentation Laboratory Launches Hemostasis Testing System

A specialty-test analyzer offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform, can now be performed in as little as 25 minutes, with no special training required.

Hemostasis is the arrest of bleeding, whether by normal vasoconstriction (the vessel walls closing temporarily), by an abnormal obstruction (such as a plaque), or by coagulation or surgical means (such as ligation).

Called the ACL AcuStar, the hemostasis analyzer incorporates chemiluminescence technology, an accurate and sensitive method for routine immunoassay testing. All of the reagents necessary for testing are packaged in a ready-to-use cartridge, greatly simplifying operations.

Instrumentation Laboratory (IL; Bedford, MA, USA) received U.S. Food and Drug Administration (FDA; Rockville, MA, USA) clearance 510(k) for the ACL AcuStar hemostasis testing system. This clearance allows IL to market the ACL testing system, which will commence in Europe.

In conjunction with the ACL AcuStar system, the new HemosIL AcuStar D-Dimer assay also received FDA clearance, as an aid in the diagnosis of venous thromboembolism. It offers high analytic sensitivity and a broad working range, providing more accurate test results than conventional reagents.

"This assay marks the beginning of a very robust line of ACL AcuStar reagents we look forward to introducing over the next several months," said Giovanni Russi, director of marketing, hemostasis reagents at IL. "The ACL AcuStar assays will be a perfect complement to our existing comprehensive line of automated tests, which together, will provide healthcare providers with an integrated diagnostic assessment, enhancing the quality of patient care."

Following the HemosIL AcuStar D-Dimer assay, the IL anticipates introducing a panel of assays for the diagnosis of antiphospholipid syndrome, and other tests for complex disease states, all aimed at enhancing accuracy and efficiency in hemostasis testing.

Instrumentation Laboratory is a developer, manufacturer, and distributor of in vitro diagnostic instruments, related reagents, and controls for use in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems, and information management systems.

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