Reliability and Validity of Proposed Risk Stratification Methods for Laboratory Developed Tests

Educational Objectives:

• Prior to legislative advancement or rule-making, future LDT risk stratification proposals should be tested in application exercises to obtain information on reliability, validity, risk stratification distributions, clarity, and ease of use. Results of such exercises will provide valuable feedback on regulatory burden.
• Reliability of a LDT risk stratification method can be evaluated by inter-rater agreement.
• Some proposals may be valid for some LDTs, while other LDTs may not be risk-stratified correctly with the currently proposed risk stratification methods.
• Estimating disease incidence may cause confusion in accurately classifying LDTs.
• Consensus meetings may help resolve confusion in classifying LDTs.
• Lack of specific criteria for each risk category, non-simple wording and lack of algorithms decrease the reliability of LDT risk stratification proposals.