This guideline is applicable to medical laboratories that apply for accreditation or have been accredited when conducting performance verification experimental activities on molecular diagnostic-related detection procedures. It can also be used as a reference by medical laboratory assessors during on-site assessments. Molecular diagnostic technologies applicable to this guideline include: PCR, Sanger sequencing, second-generation gene sequencing (NGS), in situ hybridization, etc. Other test procedures/methods used in molecular diagnosis can be used as a reference. This document applies to validated testing procedures used in medical laboratories.