External quality assessment of p210 BCR-ABL1 transcript quantification by RT-qPCR: Findings and recommendations

Area of Science:

• Molecular diagnostics
• Quality assurance in laboratory testing
• Hematologic malignancies

Background:

• External quality assessment (EQA) is vital for validating analytical testing of p210 BCR-ABL1 transcripts via RT-qPCR.
• The National Center for Clinical Laboratories initiated China's first EQA scheme for p210 BCR-ABL1 testing to identify and rectify existing challenges.

Purpose of the Study:

• To establish and evaluate the first national EQA scheme for p210 BCR-ABL1 transcript testing in China.
• To assess the reliability and identify performance gaps in p210 BCR-ABL1 detection across participating laboratories.

Main Methods:

• Utilized armored RNA technology to create p210 and common control gene (CG) armored RNAs.
• Prepared lyophilized p210 quality control (QC) sample panels using these armored RNAs for distribution.
• Evaluated the detection performance of 66 laboratories across China using the developed QC panels.

Main Results:

• High variability in raw p210 BCR-ABL1 results was observed, with coefficients of variation (CV%) ranging from 60.0% to 100.0%.
• Standardization using laboratory-specific conversion factors improved CV% in International Scale (IS) laboratories, but inconsistencies persisted.
• False-negative and false-positive results were detected, indicating significant room for improvement in assay performance.

Conclusions:

• The initial EQA scheme highlighted substantial problems in p210 BCR-ABL1 detection across Chinese laboratories.
• Addressing identified issues, such as assay variability and conversion factor accuracy, is essential.
• Improving p210 BCR-ABL1 detection performance will enhance laboratory diagnostic capabilities in China.