Development of reference material with assigned value for human T-cell leukemia virus type 1 quantitative PCR in Japan

Madoka Kuramitsu; Kazu Okuma; Makoto Nakashima; Tomoo Sato; Daisuke Sasaki; Hiroo Hasegawa; Kazumi Umeki; Ryuji Kubota; Keiko Sasada; Rieko Sobata; Chieko Matsumoto; Noriaki Kaneko; Kenta Tezuka; Sahoko Matsuoka; Atae Utsunomiya; Ki-Ryang Koh; Masao Ogata; Kenji Ishitsuka; Mai Taki; Kisato Nosaka; Kaoru Uchimaru; Masako Iwanaga; Yasuko Sagara; Yoshihisa Yamano; Akihiko Okayama; Kiyonori Miura; Masahiro Satake; Shigeru Saito; Toshiki Watanabe; Isao Hamaguchi

doi:10.1111/1348-0421.12644

Development of reference material with assigned value for human T-cell leukemia virus type 1 quantitative PCR in Japan

Microbiol Immunol. 2018 Oct;62(10):673-676. doi: 10.1111/1348-0421.12644.

Authors

Madoka Kuramitsu¹, Kazu Okuma¹, Makoto Nakashima², Tomoo Sato³, Daisuke Sasaki⁴, Hiroo Hasegawa⁴, Kazumi Umeki⁵, Ryuji Kubota⁶, Keiko Sasada⁷, Rieko Sobata⁸, Chieko Matsumoto⁸, Noriaki Kaneko⁹, Kenta Tezuka¹, Sahoko Matsuoka¹, Atae Utsunomiya¹⁰, Ki-Ryang Koh¹¹, Masao Ogata¹², Kenji Ishitsuka¹³, Mai Taki¹⁴, Kisato Nosaka¹⁵, Kaoru Uchimaru^{2

16}, Masako Iwanaga¹⁷, Yasuko Sagara¹⁸, Yoshihisa Yamano³, Akihiko Okayama⁵, Kiyonori Miura¹⁹, Masahiro Satake⁸, Shigeru Saito²⁰, Toshiki Watanabe^{2

21}, Isao Hamaguchi¹

Affiliations

¹ Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan.
² Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Tokyo, Japan.
³ Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki, Japan.
⁴ Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
⁵ Department of Rheumatology, Infectious Diseases and Laboratory Medicine, University of Miyazaki, Miyazaki, Japan.
⁶ Division of Molecular Pathology, Center for Chronic Viral Diseases, Kagoshima University, Kagoshima, Japan.
⁷ Department of Laboratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.
⁸ Central Blood Institute, Blood Service Headquarters, Japanese Red Cross Society, Tokyo, Japan.
⁹ Department of Infection and Immunology, SRL Inc., Tokyo, Japan.
¹⁰ Department of Hematology, Imamura General Hospital, Kagoshima, Japan.
¹¹ Department of Hematology, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.
¹² Department of Hematology, Oita University Hospital, Oita, Japan.
¹³ Division of Hematology and Immunology, Center for Chronic Viral Diseases, Kagoshima University, Kagoshima, Japan.
¹⁴ Rakuwakai Kyoto Medical Examination Center, Kyoto, Japan.
¹⁵ Department of Hematology, Kumamoto University of Medicine, Kumamoto, Japan.
¹⁶ Department of Hematology and Oncology, Research Hospital, Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
¹⁷ Department of Frontier Life Science, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
¹⁸ Japanese Red Cross Kyushu Block Blood Center, Fukuoka, Japan.
¹⁹ Department of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
²⁰ Department of Obstetrics and Gynecology, University of Toyama, Toyama, Japan.
²¹ Department of Advanced Medical Innovation, Graduate School of Medicine, St. Marianna University, Kawasaki, Japan.

PMID: 30125970
DOI: 10.1111/1348-0421.12644

Abstract

Quantitative PCR (qPCR) of human T-cell leukemia virus type 1 (HTLV-1) provirus is used for HTLV-1 testing and for assessment of risk of HTLV-1-related diseases. In this study, a reference material was developed for standardizing HTLV-1 qPCR. Freeze-dried TL-Om1 cells diluted with Jurkat cells were prepared and an assigned value for proviral load (PVL) of 2.71 copies/100 cells was determined by digital PCR. Nine Japanese laboratories using their own methods evaluated the PVLs of this reference material as 1.08-3.49 copies/100 cells. The maximum difference between laboratories was 3.2-fold. Correcting measured PVLs by using a formula incorporating the assigned value of this reference material should minimize such discrepancies.

Keywords: human T-cell leukemia virus type 1; proviral load; quantitative PCR; standard.

MeSH terms

Cell Line, Tumor
DNA, Viral / analysis*
DNA, Viral / genetics
Disaccharides / genetics
HTLV-I Infections / genetics
HTLV-I Infections / virology
Human T-lymphotropic virus 1 / genetics*
Humans
Japan
Jurkat Cells
Leukemia, T-Cell / virology*
Proviruses / genetics
Real-Time Polymerase Chain Reaction / methods*
Real-Time Polymerase Chain Reaction / standards*
Reference Standards
Viral Load / genetics

Substances

DNA, Viral
Disaccharides
N-acetylgalactosaminyl-1-3-galactose

Abstract

MeSH terms

Substances

Grants and funding