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External quality assessment for PML-RARα detection in acute promyelocytic leukemia: Findings and summary
Qisheng Wu1,2,3, Rui Zhang1,3, Yu Fu1,2,3
1National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, China.
Background:
The confirmation of clinical diagnosis, molecular remission, and sequential minimal residual disease monitoring required PML-RARα detection in acute promyelocytic leukemia (APL). The current status of PML-RARα detection in various laboratories remains unknown.
Methods:
In 2018, external quality assessment (EQA) for PML-RARα detection was carried out in China. Three EQA sample panels for PML-RARα isoform L/S/V were prepared by different mock leukocyte samples. The performances of PML-RARα detection, including admission screening, and qualitative and quantitative detection by real-time quantitative reverse transcription PCR (RT-qPCR), were assessed based on APL simulated clinical case.
Results:
The mock leukocyte samples met the requirements of a clinically qualified sample for PML-RARα EQA panel. Among the laboratories, 13/50 (26.0%) were "competent," 21/50 (42%) classified as "acceptable," and 16/50 (32.0%) classified as "improvable." One (1/50, 2.0%) laboratory reported one screening mistake. Twenty-six (26/50, 52.0%) laboratories reported 29 false-positive and 19 false-negative results. Twenty-three (23/50, 46.0%) laboratories reported 42 quantitative incorrect results.
Conclusion:
Significant differences were not found in PML-RARα detection performance among laboratories that used different extraction methods. The performances of qualitative and quantitative RT-qPCR detection were worse accurate for PML-RARα isoform V. Quantitative variation was higher for low-level samples. Further continuous external assessment and education are needed in the management of PML-RARα detection.
Insights
External quality assessment of PML-RARα detection in China revealed significant variability in laboratory performance. Continuous external assessment and education are crucial for improving acute promyelocytic leukemia diagnosis and monitoring.
Area of Science:
- Hematology
- Molecular Diagnostics
- Quality Assurance
Background:
- PML-RARα detection is essential for acute promyelocytic leukemia (APL) diagnosis, molecular remission confirmation, and minimal residual disease monitoring.
- The current status and performance of PML-RARα detection across various laboratories were largely unknown.
Purpose of the Study:
- To assess the performance of PML-RARα detection in Chinese laboratories through external quality assessment (EQA).
- To evaluate qualitative and quantitative detection methods, including real-time quantitative reverse transcription PCR (RT-qPCR).
Main Methods:
- An external quality assessment (EQA) program for PML-RARα detection was conducted in China in 2018.
- Three EQA sample panels with different PML-RARα isoforms (L/S/V) were prepared using mock leukocyte samples.
- Laboratory performance was assessed based on admission screening, qualitative, and quantitative RT-qPCR detection against simulated APL clinical cases.
Main Results:
- Out of 50 participating laboratories, only 26.0% were deemed 'competent,' while 42.0% were 'acceptable' and 32.0% 'improvable.'
- Significant errors were observed, including one screening mistake, 52.0% reporting false positives/negatives, and 46.0% reporting incorrect quantitative results.
- PML-RARα isoform V detection showed lower accuracy in both qualitative and quantitative assays, with higher variation in low-level samples.
Conclusions:
- Laboratory performance in PML-RARα detection varied significantly, indicating a need for improvement.
- No significant differences in detection performance were observed based on extraction methods used.
- Continuous external assessment and targeted education are recommended to enhance the management and accuracy of PML-RARα detection in APL.
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