Testing Claimed Minimal Detectable Concentrations of in Vitro Medical Diagnostic Devices
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چکیده
منابع مشابه
Testing claimed minimal detectable concentrations of in vitro medical diagnostic devices.
Manufacturers and users of medical diagnostic devices are provided a statistical decision tool for investigating a claimed minimal detectable concentration (MDC). The MDC is defined by setting two respective probabilities: that the blank sample being analyzed is determined to have analyte and that the device fails to determine a low concentration of analyte at the MDC. The statistical procedure...
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متن کاملThe Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report
BACKGROUND In vitro diagnostic (IVD) investigations are indispensable for routine patient management. Appropriate testing allows early-stage interventions, reducing late-stage healthcare expenditure (HCE). AIM To investigate HCE on IVDs in two developed markets and to assess the perceived value of IVDs on clinical decision-making. Physician-perceived HCE on IVD was evaluated, as well as desir...
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In the Competing Interests statement, the inclusion of Carmen Binder as a Roche employee is incorrect. The publisher apologizes for the error. The correct Competing Interests statement is as follows: U-PR, HHS and CGMM are employees of F. Hoffmann-La Roche Ltd. None of the other authors have any competing interests to declare. This does not alter our adherence to PLOS ONE policies on sharing da...
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ژورنال
عنوان ژورنال: Clinical Chemistry
سال: 2000
ISSN: 0009-9147,1530-8561
DOI: 10.1093/clinchem/46.10.1669