Boehringer Mannheim-Diagnostics received FDAclearance to market a new assay based on the markertroponin T to help in the diagnosis of myocardialinfarction.
Troponin T is found inside cardiac muscle and releasedonly when cells are damaged. Antibodies in the assay linkto cardiac troponin T. The new bedside test is called theCardiac T Rapid Assay.
Boehringer Mannheim, of Indianapolis, expects to beginselling the product by the end of the year, primarily tohospitals for use in their emergency departments, saidLynda Koester, a marketing manager for the company.Boehringer Mannheim has marketed an ELISA version ofthe assay since June 1994.
"[The new assay] is going to help identify all patientswho are having AMIs [acute myocardial infarctions] sotheir physicians get a definitive diagnosis," Koester said."This will have a lot more access because there's nothingelse you need," such as instrumentation, reagents orcomplicated procedures.
A red control line appears in the self-contained,disposable unit to verify the test is working properly. Theappearance of a second red line indicates the presence ofcardiac troponin T.
The gold standard protein marker for AMI now is CK-MB, but that is not fully cardiac specific, Koester said.Troponin I, another protein, will be picked up but furtheralong in the process, when more damage has been done,she said.
"It appears troponin T is more sensitive in detectingdamage," Koester said. "You're not going to miss thosepatients who are having unstable angina or areexperiencing the start of irreversible damage." n
-- Jim Shrine
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