Recommendations for the Verification of Quantitative Molecular Hemato-Oncology Tests

Abstract

Quantitative molecular genetic tests are increasingly used for the detection and quantification of target molecules or genetic alterations. When introducing a new assay into clinical laboratories, it is necessary to verify the manufacturers’ claimed performance characteristics within individual laboratories. Appropriate assay verification procedures are essential to ensure the quality of test results in clinical laboratories. This study aimed to provide recommendations for the verification of quantitative molecular genetic testing focused on the hemato-oncology field in clinical genetic laboratories. Based on a literature review, we provide recommendations for the performance verification of quantitative molecular hemato-oncology tests. The performance characteristic elements that comprise the verification procedures are presented and exemplified. These recommendations can assist individual clinical laboratories in verifying quantitative molecular diagnostic assays.