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Evaluation of a worldwide EQA scheme for complex clonality analysis of clinical lymphoproliferative cases
Cleo Keppens1, Elke Boone2, Paula Gameiro3
1Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.
Insights
External quality assessment (EQA) participation significantly improves immunoglobulin (IG) and T-cell receptor (TR) gene rearrangement analysis in lymphoid malignancy diagnostics. Repeated EQA rounds reduce performance gaps between laboratories and sample types, emphasizing the need for ongoing education.
Area of Science:
- Molecular diagnostics
- Immunogenetics
- Oncology
Background:
- Clonality analysis of immunoglobulin (IG) and T-cell receptor (TR) gene rearrangements is crucial for diagnosing lymphoid malignancies.
- External quality assessment (EQA) programs are essential for identifying and rectifying laboratory performance issues.
Purpose of the Study:
- To evaluate the improvement in IG/TR analysis and interpretation by laboratories over five EQA rounds (2014-2018).
- To assess the impact of repeated EQA participation on laboratory performance and identify areas for improvement.
Main Methods:
- Participants analyzed five paper-based and five wet cases for IG and TR testing annually.
- Performance was evaluated based on the accuracy of molecular conclusions and routine protocol analysis.
- Statistical analysis compared performance between EuroClonality and non-EuroClonality labs, and across EQA rounds.
Main Results:
- High accuracy rates were observed: 94.9% for IG wet, 97.9% for IG paper, 96.8% for TR wet, and 93.2% for TR paper.
- Laboratory analysis scores significantly improved with increased EQA participation (p=0.001).
- EuroClonality laboratories demonstrated significantly higher overall performance (99% IG, 97% TR) compared to non-EuroClonality labs (95% IG, 93% TR).
Conclusions:
- Repeated EQA participation effectively reduces performance disparities among laboratories and across different sample types.
- The study highlights the need for continuous education through meetings and EQA schemes, particularly for interpreting complex oligoclonal cases.
Abstract:
Clonality analysis of immunoglobulin (IG) or T-cell receptor (TR) gene rearrangements is routine practice to assist diagnosis of lymphoid malignancies. Participation in external quality assessment (EQA) aids laboratories in identifying systematic shortcomings. The aim of this study was to evaluate laboratories' improvement in IG/TR analysis and interpretation during five EQA rounds between 2014 and 2018. Each year, participants received a total of five cases for IG and five cases for TR testing. Paper-based cases were included for analysis of the final molecular conclusion that should be interpreted based on the integration of the individual PCR results. Wet cases were distributed for analysis of their routine protocol as well as evaluation of the final molecular conclusion. In total, 94.9% (506/533) of wet tests and 97.9% (829/847) of paper tests were correctly analyzed for IG, and 96.8% (507/524) wet tests and 93.2% (765/821) paper tests were correctly analyzed for TR. Analysis scores significantly improved when laboratories participated to more EQA rounds (p=0.001). Overall performance was significantly lower (p=0.008) for non-EuroClonality laboratories (95% for IG and 93% for TR) compared to EuroClonality laboratories (99% for IG and 97% for TR). The difference was not related to the EQA scheme year, anatomic origin of the sample, or final clinical diagnosis. This evaluation showed that repeated EQA participation helps to reduce performance differences between laboratories (EuroClonality versus non-EuroClonality) and between sample types (paper versus wet). The difficulties in interpreting oligoclonal cases highlighted the need for continued education by meetings and EQA schemes.
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