Anti-JOVI.1 antibody to detect clonal T cell populations: implementation into a diagnostic flow cytometry laboratory and correlation with clinical findings

Abstract

The development of a high through-put flow cytometric assay for the identification of clonal T cells has proved challenging. We assessed the surface expression of a specific T Cell Receptor β-chain constant region using conjugated anti-JOV1.1 monoclonal antibodies to identify clonal T cell populations in a large diagnostic flow cytometry laboratory within a quaternary referral hospital. 37 cases were analysed. We identified 15 cases of clonal JOVI.1 expression, 7 of which had a consensus diagnosis of T-cell lymphoproliferative disease (TLPD). The remaining 22 cases had polyclonal JOVI.1 expression, none of which had a consensus diagnosis of TLPD, resulting in a sensitivity of 100% and specificity of 73%. When clonal NK-T cells were excluded, specificity further improves to 97%. These results provide real-world data and support the widespread adoption of this assay into diagnostic use.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics approval was obtained from Western Sydney Local Health District Research Office on 09/02/2022. The committee granted a waiver for the usual requirement of consent for the use of re-identifiable information by New South Wales (NSW) agencies, in line with the State Privacy Commissioner's Guidelines for Research and the Health Records and Information Privacy Act 2022 (NSW).

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Data Availability

All data produced in the present work are contained in the manuscript.

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