High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan

Mine, Hideko; Emura, Hiroyuki; Miyamoto, Masaki; Tomono, Tsugikazu; Minegishi, Kiyoshi; Murokawa, Hiroyuki; Yamanaka, Retsuji; Yoshikawa, Akira; Nishioka, Kusuya

doi:10.1016/s0166-0934(03)00215-5

Cited by 96 publications

(105 citation statements)

References 10 publications

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“…For HIV infection, the assays have been used for HIV-2 (7), HIV-1 group O (16), and HIV-1 DNA proviral load (10,12,44). Moreover, plasma HIV-1 RNA has been assessed by real-time PCR for multiplex nucleic acid amplification testing in blood donations (25,26,40) and for HAART monitoring in HIV-1-seropositive patients (15,30).…”

mentioning

confidence: 99%

Transfer and Evaluation of an Automated, Low-Cost Real-Time Reverse Transcription-PCR Test for Diagnosis and Monitoring of Human Immunodeficiency Virus Type 1 Infection in a West African Resource-Limited Setting

Raffi¹,

Ekouévi

Chaix³

et al. 2005

J Clin Microbiol

219

169

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mentioning

confidence: 99%

Transfer and Evaluation of an Automated, Low-Cost Real-Time Reverse Transcription-PCR Test for Diagnosis and Monitoring of Human Immunodeficiency Virus Type 1 Infection in a West African Resource-Limited Setting

Raffi¹,

Ekouévi

Chaix³

et al. 2005

J Clin Microbiol

219

169

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“…In general, the rate of repetitions for inadequacy (0.80%) or false-reactivity (0.16%) is similar to commercial NAT systems currently approved by regulatory agencies and in use worldwide. In Japan, using a Roche multiplex real-time PCR system, 0.17% of false-positive results were observed and 1.99% of the pools demanded repetition of the process due to internal control failure 24 . In Europe the combination of NucliSens extraction (Organon Teknika, Boxtel, Netherlands) and AmpliScreen (Roche Diagnostic Systems, Branchburg, NJ, USA) is adopted in some countries like the Netherlands.…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge, this kind of pooling is not adopted on primary screening in any center elsewhere. The USA has been using single pools of 16-24 samples 34 while Japan 24 and Germany 30 adopted pools of 48-96 donations.…”

Section: Introductionmentioning

confidence: 99%

Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

Wendel

Levi

Takaoka³

et al. 2007

Rev. Inst. Med. trop. S. Paulo

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SUMMARYAn "in-house" RT-PCR method was developed that allows the simultaneous detection of the RNA of the Hepatitis C Virus (HCV) and an artificial RNA employed as an external control. Samples were analyzed in pools of 6-12 donations, each donation included in two pools, one horizontal and one vertical, permitting the immediate identification of a reactive donation, obviating the need for pool dismembering. The whole process took 6-8 hours per day and results were issued in parallel to serology. The method was shown to detect all six HCV genotypes and a sensitivity of 500 IU/mL was achieved (95% hit rate). Until July 2005, 139,678 donations were tested and 315 (0.23%) were found reactive for HCV-RNA. Except for five false-positives, all 310 presented the corresponding antibody as well, so the yield of NAT-only donations was zero, presenting a specificity of 99.83%. Detection of a window period donation, in the population studied, will probably demand testing of a larger number of donations. International experience is showing a rate of 1:200,000 -1:500,000 of isolated HCV-RNA reactive donations.

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“…Twenty (20.4%) and 42 (42.9%) out of 98 whole semen samples were found to be positive for PCV and PPV using conventional multiplex and semi-nested PCR respectively [14] . Multiplex method for HBV/HCV/HIV-1 has been used for screening 6 805 010 units of serologically negative donation and 112 HBV DNA-positives, 25 HCV RNA positives and 4 HIV-1 RNA positives were screened out and prevented transfusion of the positive blood [15,16] . The sensitivity of our multiplex normalized PCR method was 78.6%, 75% and 83.3% for the detection of HBVDNA, HCVRNA, and super-infection of HBV and HCV respectively.…”

Section: Discussionmentioning

confidence: 99%

Simultaneous detection of HBV and HCV by multiplex PCR normalization

Wang

Huard

Han

2004

WJG

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AIM:To design and establish a method of multiplex PCR normalization for simultaneously detecting HBV and HCV. METHODS:Two pairs of primers with a 20 bp joint sequence were used to amplify the target genes of HBV and HCV by two rounds of amplification. After the two rounds of amplification all the products had the joint sequence. Then the joint sequence was used as primers to finish the last amplification. Finally multiplex PCR was normalized to a single PCR system to eliminate multiplex factor interference. Four kinds of nucleic acid extraction methods were compared and screened. A multiplex PCR normalization method was established and optimized by orthogonal design of 6 key factors. Then twenty serum samples were detected to evaluate the validity and authenticity of this method. RESULTS:The sensitivity, specificity, diagnostic index and efficiency were 83.3%, 70%, 153.3% and 72.2%, respectively for both HBsAg and anti-HCV positive patients, and were 78.6%, 80%, 258.6% and 79.2%, respectively for HBsAg positive patients, and were 75%, 90%, 165% and 83.3%, respectively for anti-HCV positive patients. CONCLUSION:The multiplex PCR normalization method shows a broad prospect in simultaneous amplification of multiple genes of different sources. It is practical, correct and authentic, and can be used to prevent and control HBV and HCV.Wang N, Gao XQ, Han JX. Simultaneous detection of HBV and HCV by multiplex PCR normalization.

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High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan

Cited by 96 publications

References 10 publications

Transfer and Evaluation of an Automated, Low-Cost Real-Time Reverse Transcription-PCR Test for Diagnosis and Monitoring of Human Immunodeficiency Virus Type 1 Infection in a West African Resource-Limited Setting

Transfer and Evaluation of an Automated, Low-Cost Real-Time Reverse Transcription-PCR Test for Diagnosis and Monitoring of Human Immunodeficiency Virus Type 1 Infection in a West African Resource-Limited Setting

Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

Simultaneous detection of HBV and HCV by multiplex PCR normalization

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