This is a systematic review and meta-analysis of 10 studies on the diagnostic accuracy of TRBC1-based flow cytometry (TRBC1-FC) for detecting T-cell clonality in patients with mature T-cell neoplasms. The authors synthesized pooled performance metrics, finding a sensitivity of 97.6% (95% CI, 95.1-99.4%) and a specificity of 90.7% (95% CI, 76.0-99.3%). The positive likelihood ratio was 10.9 (95% CI, 4.1-28.9), the negative likelihood ratio was 0.053 (95% CI, 0.025-0.12), and the diagnostic odds ratio was 339 (95% CI, 64-1,788). The area under the curve was 0.974.
The authors acknowledge substantial between-study heterogeneity (I²=83.3%), which mainly affected specificity and the diagnostic odds ratio. They also noted significant small-study effects (p<0.001) and that excluding one influential study markedly reduced heterogeneity. Variability in specificity, positive likelihood ratio, and diagnostic odds ratio advises caution for rule-in use.
The review concludes that TRBC1-FC demonstrates high sensitivity and a low negative likelihood ratio, supporting its potential role as a rule-out test. However, the authors emphasize that standardized protocols and cost-effectiveness analyses are needed before broad clinical adoption. The practice relevance is restrained, noting the need for further validation.
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INTRODUCTION: Accurate assessment of T-cell clonality is key for diagnosing mature T-cell neoplasms. TRBC1-based flow cytometry provides a rapid, robust, and cost-efficient approach. This systematic review and meta-analysis assessed the diagnostic accuracy of TRBC1 flow cytometry (TRBC1-FC) for detecting T-cell clonality in mature T-cell neoplasms.
CONTENT: We systematically searched Scopus, PubMed (MEDLINE), and Google Scholar for articles on TRBC1-FC diagnostic accuracy published up to July 1, 2025. Pooled sensitivity and specificity were estimated, between-study heterogeneity was evaluated and small-study effects were examined.
SUMMARY: This meta-analysis included 10 studies. The pooled sensitivity was 97.6 % (95 % CI, 95.1-99.4 %) and specificity 90.7 % (95 % CI, 76.0-99.3 %). The pooled LR+ was 10.9 (95 % CI, 4.1-28.9), LR-was 0.053 (95 % CI, 0.025-0.12), and DOR 339 (95 % CI, 64-1,788). The HSROC curve demonstrated an AUC of 0.974 (partial AUC=0.970), confirming excellent global discriminatory capacity. Between-study heterogeneity was substantial (I=83.3 %), mainly affecting specificity and DOR, while sensitivity remained highly consistent. No evidence of a threshold effect was found. Deeks' test showed significant small-study effects (p<0.001), and sensitivity analyses identified one influential study whose exclusion markedly reduced heterogeneity. These results confirm the high diagnostic performance and robustness of TRBC1-FC for T-cell clonality assessment.
OUTLOOK: TRBC1-FC demonstrates high sensitivity and low LR-, supporting its role as a rule-out test. Variability in specificity, LR+ and DOR, mainly due to small-study effects, advises caution for rule-in use. Standardized protocols and cost-effectiveness analyses are needed before broad clinical adoption.