Performance attributes of the LCx® HCV RNA quantitative assay

Leckie, Gregor; Schneider, George J.; Abravaya, Klara; Hoenle, Robert; Johanson, Julie; Lampinen, John; Ofsaiof, Reuben; Rundle, Lisa; Shah, Shruti; Frank, Andrea M.; Toolsie, Dan; Vijesurier, Roy; Wang, Hong; Robinson, John

doi:10.1016/j.jviromet.2003.10.001

Cited by 16 publications

(13 citation statements)

References 32 publications

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“…These assays are reportedly more sensitive than previous assays, have a wider dynamic range of quantification than CAM, and are "specific," "accurate," "precise," and "reproducible" (3,7,13,15,22,23).…”

Section: Discussionmentioning

confidence: 99%

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

et al. 2009

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Two commercial real-time PCR assays are currently available for sensitive hepatitis C virus (HCV) RNA quantification: the Abbott RealTime HCV assay (ART) and Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM). We assessed whether the two real-time PCR assays were more effective than Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM) for prediction of the sustained virological response (SVR) to pegylated interferon (PEG-IFN) plus ribavirin (RBV) in chronic hepatitis C. Sixty patients chronically infected with HCV genotype 1b (37 males and 23 females, 53 ؎ 12 years of age) were treated with PEG-IFN␣2b plus RBV for 48 weeks. Stored specimens at nine time points for each patient (at baseline, on treatment, and 24 weeks after treatment) were tested by the two real-time PCR assays and CAM. Twenty-six (43.3%) patients reached SVR. The positive predictive values (PPVs) for SVR of undetectable HCV RNA at week 12 by CAM, ART, and CAP/CTM were 74.3%, 88.0%, and 95.2%, respectively. An undetectable HCV RNA level by CAM, ART, and CAP/CTM correctly predicted SVR at week 4 in 100%, 100%, and 100% of patients, at weeks 5 to 8 in 91.7%, 100%, and 100% of patients, at weeks 9 to 12 in 55.6%, 75%, and 87.5% of patients, and at weeks 13 to 24 in 0%, 26.7%, and 40% of patients, respectively. Of 16 patients who relapsed after treatment, HCV RNA was detectable in 2 patients at the end of treatment by CAP/CTM but undetectable by ART and CAM. HCV RNA tests using ART and CAP/CTM are considered to be more effective at predicting SVR than CAM, and the PPV for SVR was slightly higher in CAP/CTM than in ART.The quantification of hepatitis C virus (HCV) RNA is essential for the management of chronic hepatitis C therapy based on the combination of pegylated interferon (PEG-IFN) and ribavirin (RBV). Based on pivotal trials in large multicenter studies, positive and negative predictions of sustained virological response (SVR) using viral load kinetics have been established and are now used for recommendations on antiviral therapy management by the American and European international consensus conferences (6, 9, 17). Initially, the effectiveness of antiviral therapy had been controlled by HCV RNA tests using end-point PCR assays sensitive to a level of 50 to 100 IU/ml, according to the Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM; Roche Molecular Systems, Inc., Pleasanton, CA). Recently, two novel commercial real-time PCR assays became available for highly sensitive HCV RNA quantification: the Abbott RealTime HCV assay (ART; Abbott Molecular, Inc., Des Plaines, IL) and the Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM; Roche Molecular Systems, Inc., Pleasanton, CA). The reported sensitivity of these real-time PCR assays is higher than that of CAM, they are reportedly not prone to carryover contamination, and they have a consistently wider dynamic range of quantification, which makes them particularly useful for quantifying the full range of viral genome levels observed in treated and untreated patients. Real-time PCR is rapidly r...

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Section: Discussionmentioning

confidence: 99%

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

et al. 2009

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“…When unavailable from the vendor, the genotype was determined via sequence analysis of the NS5 region [Muerhoff et al, 2002]. The HCV RNA titers were determined with the Abbott's LCx HCV RNA Quantitative assay as described previously [Leckie et al, 2004;Bertuzis et al, 2005].…”

Section: Hcv Seroconversion Panelsmentioning

confidence: 99%

A chemiluminescent, magnetic particle-based immunoassay for the detection of hepatitis C virus core antigen in human serum or plasma

et al. 2006

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Hepatitis C virus (HCV) exposure in blood donors is determined serologically by the detection of anti-HCV antibodies in serum or plasma. However, a "window" period of 30-70 days after exposure exists where specific antibodies to HCV antigens are not detected. The use of nucleic acid testing for the detection of HCV RNA or antigen testing for the detection of HCV core protein have resulted in dramatic reductions in the pre-seroconversion window period. In this study, an automated HCV core antigen detection test was developed. This magnetic microparticle-based assay utilizes anti-HCV core monoclonal antibody to capture antigen present in human serum or plasma. Captured antigen is then detected using an anti-HCV core monoclonal antibody conjugated with a chemiluminescent compound. The specificity of this assay was established at 99% upon testing a population of normal volunteer blood donors. Sensitivity was determined by testing 16 commercially available HCV seroconversion panels representing genotypes 1a, 1b, 2b, and 3a. In each panel tested, HCV core antigen was detected prior to anti-HCV antibody, resulting in a reduction of the window period by greater than 23 days on average, and greater than 34 days on panels initially NAT negative. In addition, HCV core antigen was detected in >97% of HCV RNA positive/antibody negative specimens, exhibiting sensitivity nearly equivalent to nucleic acid testing in the pre-seroconversion window period for the panels examined.

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“…Amplification, amplicon dilution, detection, and quantitation were automatically performed by the COBAS Amplicor analyzer [21]. The dynamic range of CAM is 500 to approximately 5,100,000 IU/ml with a specificity of almost 100%, independent of the HCV genotype [22][23][24]. To compare serum HCV RNA levels determined by ART with those determined by CAM, we transformed the levels determined by CAM (IU/ml) into logarithmic levels (log IU/ml).…”

Section: Determination Of Hcv Rna Levelmentioning

confidence: 99%

Abbott RealTime PCR assay is useful for evaluating virological response to antiviral treatment for chronic hepatitis C

Ikezaki¹,

Furusyo²,

Ihara³

et al. 2011

Journal of Infection and Chemotherapy

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Performance attributes of the LCx® HCV RNA quantitative assay

Cited by 16 publications

References 32 publications

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

A chemiluminescent, magnetic particle-based immunoassay for the detection of hepatitis C virus core antigen in human serum or plasma

Abbott RealTime PCR assay is useful for evaluating virological response to antiviral treatment for chronic hepatitis C

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