Quantification of hepatitis C virus by TaqMan PCR: Comparison with HCV amplicor monitor assay

Kawai, Sadaaki; Yokosuka, Osamu; Kanda, Tatsuo; Imazeki, Fumio; Maru, Yoshiaki; Saisho, Hiromitsu

doi:10.1002/(sici)1096-9071(199906)58:2<121::aid-jmv4>3.0.co;2-4

Cited by 44 publications

(37 citation statements)

References 27 publications

(41 reference statements)

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“…Quantitative HCV RNA was determined by TaqMan PCR 19 ; viral load was available in only 5 patients pretreatment and ranged from 5.4 ϫ 10 6 to 3.9 ϫ 10 7 copies/mL.…”

Section: Hcv Genotype and Viral Loadmentioning

confidence: 99%

Treatment of progressive hepatitis C recurrence after liver transplantation with combination interferon plus ribavirin

Rabkin²,

et al. 2001

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Hepatitis C virus (HCV) recurrence after orthotopic liver transplantation (OLT) is common, although the majority of cases are mild. A subset of transplant recipients develops progressive allograft injury, including cirrhosis and allograft failure. Minimal data are available on the safety and efficacy of antiviral treatment in this group of patients. The aim of this study is to review our experience in the treatment of moderate to severe HCV recurrence with combination interferon-␣2b and ribavirin (IFN/RIB). Between October 1993 and October 1999, a total of 197 patients underwent OLT for HCV-related liver failure. This study describes 12 transplant recipients with moderate to severe recurrence treated with IFN/RIB. All patients met at least 1 of the following inclusion criteria: (1) moderate to severe inflammation (grade III to IV) on allograft biopsy, (2) bridging fibrosis on allograft biopsy, or (3) severe cholestasis attributable solely to HCV recurrence. Two patients had undergone re-OLT for allograft cirrhosis secondary to HCV recurrence and now had evidence of progressive HCV in their second allografts. Appropriate dose reductions of both IFN and RIB, as well as initiation of granulocyte colony-stimulating factor (G-CSF), for marked leukopenia were recorded. IFN/RIB therapy was started 60 to 647 days post-OLT, and duration of therapy ranged from 39 to 515 days. Seven patients were administered G-CSF to successfully treat leukopenia. Six of the 12 patients (50%) became HCV RNA negative by polymerase chain reaction. One of these 6 patients (no. 1) was HCV RNA negative at 6 months but chose to discontinue therapy because of intolerable side effects, experienced a relapse, and was HCV RNA positive at 12 months. Two of the remaining 5 patients were HCV RNA negative at 2 and 9 months off therapy. For the entire group, there was a statistically significant decrease in serum biochemical indices assessed at initiation of therapy and 1, 3, and 6 months into therapy. Most patients required dose reductions of both IFN and RIB.

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“…Quantitative HCV RNA was determined by TaqMan PCR 19 ; viral load was available in only 5 patients pretreatment and ranged from 5.4 ϫ 10 6 to 3.9 ϫ 10 7 copies/mL.…”

Section: Hcv Genotype and Viral Loadmentioning

confidence: 99%

Treatment of progressive hepatitis C recurrence after liver transplantation with combination interferon plus ribavirin

Rabkin²,

et al. 2001

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“…A number of homogeneous TaqMan reverse transcription-PCR assays for detection and quantitation of HCV RNA have been described (12,13,19,21,29). These tests are very sensitive, have broad dynamic ranges, and provide precise quantitation of viral load.…”

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confidence: 99%

Performance Characteristics of a Quantitative TaqMan Hepatitis C Virus RNA Analyte-Specific Reagent

et al. 2004

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We determined the dynamic range, reproducibility, accuracy, genotype bias, and sensitivity of the TaqMan hepatitis C virus (HCV) analyte-specific reagent (ASR). Serum samples were processed using the MagNA Pure LC instrument and run on the COBAS TaqMan Both qualitative and quantitative hepatitis C virus (HCV) RNA tests are used in diagnosis and management of patients with hepatitis C, because no single commercially available test combines high analytical sensitivity with a broad dynamic range. Qualitative nucleic acid amplification tests for detection of HCV RNA in serum are used to confirm the diagnosis of hepatitis C, distinguish active from resolved infection, assess virological response to therapy, and screen blood donors (3,18,23). Quantitative tests are used in evaluation of patients being considered for therapy and to assess early response to therapy. A pretreatment viral load of less than 800,000 IU/ml is one of several predictors of a sustained virological response (20,24). Viral load testing has also been used in early assessment of treatment response. Patients who fail to achieve at least a 2-log 10 decline in viral load after 12 weeks of treatment have little chance of a sustained response and can be spared the cost and toxicity of a complete treatment course (9, 17). However, viral load does not predict the progression of hepatitis C and is not associated with the severity of liver disease.A variety of tests for detection and quantitation of HCV RNA based on different nucleic acid amplification technologies are commercially available. The qualitative AMPLICOR HCV and quantitative AMPLICOR HCV MONITOR version 2.0 tests (Roche Diagnostics Corporation, Indianapolis, Ind.) are based on conventional reverse transcription-PCR in a heterogeneous format (17). The VERSANT HCV RNA qualitative and VERSANT HCV RNA 3.0 quantitative assays (Bayer Healthcare, Tarrytown, N.Y.) are based on transcription-mediated amplification and branched DNA signal amplification, respectively (10, 15).These tests also differ in their lower limits of detection and dynamic ranges. The qualitative AMPLICOR and VERSANT tests have lower limits of detection of 50 and 5 IU/ml, respectively. Although the lower limits of detection for the quantitative AMPLICOR and VERSANT tests are both approximately 600 IU/ml, the dynamic ranges differ by approximately 1 log 10 and are 3.1 and 4.1 log 10 , respectively. Because of the differences in sensitivity between the qualitative and quantitative assays, many clinical laboratories use a quantitative test to determine viral load and a sensitive qualitative test for diagnosis and test-of-cure. A single test with sensitivity similar to the qualitative tests that accurately quantitates high viral loads would be beneficial for clinical laboratories.A number of homogeneous TaqMan reverse transcription-PCR assays for detection and quantitation of HCV RNA have been described (12,13,19,21,29). These tests are very sensitive, have broad dynamic ranges, and provide precise quantitation of viral load. These tes...

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“…Quantitation of HCV RNA is used to predict and monitor the efficacy of antiviral therapy (5,6). In recent years, a variety of commercial and noncommercial test systems have been developed for this purpose, including competitive reverse transcription (RT)-PCR, noncompetitive RT-PCR, branched-DNA signal amplification, and real-time PCR (3,4,10,12,18). Each of these methods was calibrated with proprietary standards and exhibits its own sensitivity, specificity, and dynamic range.…”

mentioning

confidence: 99%

External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

Schirm¹,

Loon

Valentine-Thon³

et al. 2002

J Clin Microbiol

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Quantification of hepatitis C virus by TaqMan PCR: Comparison with HCV amplicor monitor assay

Cited by 44 publications

References 27 publications

Treatment of progressive hepatitis C recurrence after liver transplantation with combination interferon plus ribavirin

Treatment of progressive hepatitis C recurrence after liver transplantation with combination interferon plus ribavirin

Performance Characteristics of a Quantitative TaqMan Hepatitis C Virus RNA Analyte-Specific Reagent

External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

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