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Value assignment of the reference material for human T-cell leukemia virus type 1 quantitative PCR in Japan.

Quantitative PCR (qPCR) of human T-cell leukemia virus type 1 (HTLV-1) provirus is used for HTLV-1 testing or for the risk assessment of HTLV-1-related diseases. In this study, we developed reference material for HTLV-1 qPCR. Freeze-dried TL-Om1 cells diluted with Jurkat cells were prepared and the proviral load (PVL) was value assigned as 2.71 copies/100 cells using digital PCR. Measurement by nine Japanese laboratories resulted in PVLs of the reference ranging from 1.08-3.49 copies/100 cells. The maximum difference among laboratories was 3.2-fold. Correcting measured reference PVLs to the assigned value should minimize these discrepancies.

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