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Table 1 Evaluation Criteria for Sources of Clinical Assay Performance Data

From: Considerations in the development of circulating tumor cell technology for clinical use

Qualitative Rankings of Data Sources and Study Designs
Most Reliable Collaborative studies that use large panels of well characterized samples; summary data from well-designed external proficiency testing schemes; inter-laboratory comparison programs
Reliable Other data from proficiency testing schemes, well-designed peer-reviewed studies, and expert panel-reviewed FDA summaries
Less Reliable Less well designed peer-reviewed studies
Least Reliable Unpublished and/or non-peer reviewed research; clinical laboratory, or manufacturer data; studies on performance of the same basic methodology, but used to test for a different target
Criteria for Assessing the Internal Validity of the Studies Used to Obtain Data
• Adequate descriptions of the assay platform and test procedures, including the reproducibility of test results, quality control measures, and comparison to a “gold standard” reference assay.
• Samples representative of the study population, blinded testing and interpretation.
• Data analysis including point estimates of sensitivity and specificity with 95% confidence intervals, and sample size/power calculations.
• Studies graded as convincing, adequate, or inadequate based on their ability to provide confident estimates of analytic sensitivity and specificity using intended sample types from representative populations.