In thinking about the new ultrasensitive troponin I tests under development (e.g. Singulex, Nanosphere) that might have diagnostic applications for routine screening or assessment of high-risk individuals, what initial clinical data/studies would be needed for you (physician) to send a patients sample to be processed in a CLIA laboratory. I appreciate that large prospective studies will eventually be required for adoption, but are there initial retrospective or comparative studies that would generate interest? I would appreciate any specifics in terms of sample type, inclusion/exclusion, specimen numbers, primary outcome measures etc. that would be important. Many thanks.
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