2015-10-24-世界卫生组织-WHO_BS_2015.2270_Collaborative_Study_to_establish_the_1st_WHO_IS_for_BKV_DNA_for_nucleic_acid_amplification_technique_NAT_-based_assays_57页_3mb

WHO International Standard for BKV DNA Detection

Summary

This collaborative study aimed to establish the first WHO International Standard for BKV DNA for nucleic acid amplification technique (NAT)-based assays. Two candidate materials, 14/202 and 14/202, were evaluated. Results from 33 laboratories across 15 countries indicated that candidate 14/202 was most suitable, with a potency of 7.0 log IU/mL after reconstitution in 1 mL of nuclease-free water.

Key Findings

• Assay Standardization: BKV NAT detection assays vary widely between laboratories due to lack of international standards.
• Proper Standard: The candidate standard (NIBSC code 14/202) ensures consistent potency measurements for calibrating kits and reference materials.
• Clinical Relevance: Standardized detection is crucial for monitoring BKV reactivation in immunocompromised patients to prevent nephropathy and other complications.

Recommendation

• Establish 14/202 as the first WHO International Standard for BKV DNA, with a potency of 7.0 log IU/mL, intended for use by manufacturers and laboratories to improve assay accuracy and comparison of viral loads.