Establishment of the First National Standard for Nucleic Acid Amplification Technology Assay for HCV Rna

Mizusawa, Saeko; Okada, Yoshiaki; Horiuchi, Yoshinobu; Tanaka, Takeshi; Sato, Koei; Kaneko, Kaichi; Sasaki, Yuko; Tanaka, Toshiaki; Tomono, Tsugikazu; Tomomizu, Takeo; Hayami, Shouichi; Hijikata, Makoto; Hirako, Ichiro; Mayumi, Makoto; Mikami, Kōichi; Mishiro, Shunji; Miyamoto, Seiji; Muta, Kengo; Komuro, Kaoru; Yamaguchi, Teruhide; Weimer, Thomas; Gierman, Todd

doi:10.3925/jjtc1958.51.515

J. j. t. m

2005

DOI: 10.3925/jjtc1958.51.515

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Establishment of the First National Standard for Nucleic Acid Amplification Technology Assay for HCV Rna

Saeko Mizusawa¹,

Yoshiaki Okada²,

Yoshinobu Horiuchi³

et al.

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Viral Safety of Biologicals: Evaluation of Hepatitis C Virus (HCV) Nucleic Acid Amplification Test (NAT) Assay and Development of Concentration Method of HCV for Sensitive Detection by NAT

Uchida

Yamaguchi²

2010

YAKUGAKU ZASSHI

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The most important issue for the safety of biological products and blood products derived from human sources is how to prevent transmission of infectious agents. The hepatitis C virus (HCV) is a major public health problem due to its high prevalence. HCV is mainly transmitted by exposure to blood and highly infectious during the early window period with extremely low viral loads. Therefore it is important to develop more sensitive detection methods for HCV. In the case of blood products, both serological test and nucleic acid ampliˆcation test (NAT) are required to detect HCV. Since NAT is highly sensitive, establishment of a new standard is required for validation of NAT assay. NAT guideline and establishment of the standard for HCV RNA and HCV genotype panel is introduced in this review. On the other hand, to enhance the sensitivity of virus detection by NAT, a novel viral concentration method using polyethyleneimine (PEI)-conjugated magnetic beads (PEI beads) was developed. PEI beads concentration method is applicable to a wide range of viruses including HCV. Studies using the national standard for HCV RNA, HCV genotype panel and seroconversion panel, suggest that virus concentration method using PEI-beads is useful for improvement of the sensitivity of HCV detection by NAT and applicable to donor screening for HCV.

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Viral Safety of Biologicals: Evaluation of Hepatitis C Virus (HCV) Nucleic Acid Amplification Test (NAT) Assay and Development of Concentration Method of HCV for Sensitive Detection by NAT

Uchida

Yamaguchi²

2010

YAKUGAKU ZASSHI

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REEVALUATION OF THE JAPANESE NATIONAL STANDARDS FOR VIRAL NUCLEIC ACID AMPLIFICATION TESTS (NATs) TO ENSURE SAFETY OF HUMAN BLOOD PRODUCTS

Matsuoka

Mizusawa

Ochiai

et al. 2018

JJTC

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Establishment of the First National Standard for Nucleic Acid Amplification Technology Assay for HCV Rna

Cited by 2 publications

References 0 publications

Viral Safety of Biologicals: Evaluation of Hepatitis C Virus (HCV) Nucleic Acid Amplification Test (NAT) Assay and Development of Concentration Method of HCV for Sensitive Detection by NAT

Viral Safety of Biologicals: Evaluation of Hepatitis C Virus (HCV) Nucleic Acid Amplification Test (NAT) Assay and Development of Concentration Method of HCV for Sensitive Detection by NAT

REEVALUATION OF THE JAPANESE NATIONAL STANDARDS FOR VIRAL NUCLEIC ACID AMPLIFICATION TESTS (NATs) TO ENSURE SAFETY OF HUMAN BLOOD PRODUCTS

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