External quality assessment for PML-RAR? detection in acute promyelocytic leukemia: Findings and summary.

ABSTRACT:

Background

The confirmation of clinical diagnosis, molecular remission, and sequential minimal residual disease monitoring required PML-RAR? detection in acute promyelocytic leukemia (APL). The current status of PML-RAR? detection in various laboratories remains unknown.

Methods

In 2018, external quality assessment (EQA) for PML-RAR? detection was carried out in China. Three EQA sample panels for PML-RAR? isoform L/S/V were prepared by different mock leukocyte samples. The performances of PML-RAR? 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-RAR? 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-RAR? detection performance among laboratories that used different extraction methods. The performances of qualitative and quantitative RT-qPCR detection were worse accurate for PML-RAR? isoform V. Quantitative variation was higher for low-level samples. Further continuous external assessment and education are needed in the management of PML-RAR? detection.

SUBMITTER: Wu Q 

PROVIDER: S-EPMC6642306 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature