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Activity Number:
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329
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #310300 |
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Title:
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Diagnostic and Analytical Accuracies of Qualitative Multiplex Tests
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Author(s):
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Marina Kondratovich*+
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Companies:
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Food and Drug Administration
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Address:
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CDRH, HFZ550 1350 Piccard Dr, Rockville, MD, 20850,
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Keywords:
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Diagnostic Device ; Multiplex Test ; Analytical Accuracy ; Limit of Detection ; Diagnostic Accuracy ; Sensitivity and Specificity
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Abstract:
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With increased frequency, medical tests are being designed as measuring devices of multiple (at least 2) measurands tested simultaneously in a single patient sample (multiplex tests). Multiplex tests generate multiple outputs on a single patient sample. We consider multiplex assays with a qualitative output for each measurand. When test reactions for multiple measurands occur simultaneously, analytical performance will depend on potentially complex interactions. Issues related to analytical performance of multiplex assays as analytical accuracy (measures of agreement of how well a multiplex assay detects presence or absence of each measurand separately and combination of measurands), limits of detections, and precision are considered. We present also issues related to reporting diagnostic accuracy (measures of agreement of outcomes of multiplex assay with clinical target condition).
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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