Effectiveness was evaluated based on the rate of EOT response and sustained virologic response (SVR12), defined as undetectability of HCV RNA in blood 12 weeks after treatment termination. SVR was presented either as intent-to-treat (ITT) analysis or after exclusion of patients lost to follow up as a modified ITT (mITT). HCV RNA detection level was <18 IU/mL, but varied across study centers depending on the assay used (<15 IU/mL in 88.0% of patients). Plasma HCV RNA concentrations were measured using quantitative polymerase chain reaction assays: COBAS TaqMan HCV v2.0 (Roche Molecular Diagnostics, Pleasanton, CA, USA), COBAS AmpliPrep HCV (Roche Molecular Diagnostics, Pleasanton, CA, USA) and the m2000 Real-Time System (Abbott Molecular, Des Plaines, IL, USA). Safety outcomes, such as adverse events and laboratory abnormalities, were followed during the treatment and 12-week follow-up period. Safety data analysis also included the possible effect of DAA on the function of a transplanted kidney (measured by the creatinine concentration and eGFR, as well as proteinuria), assessment of the risk of acute rejection of the transplanted kidney and interaction with immunosuppressive medications.
Cobas taqman hcv v2
Manufactured by Roche
Sourced in United States
The COBAS TaqMan HCV v2.0 is a laboratory diagnostic instrument designed for the quantitative detection of hepatitis C virus (HCV) RNA in human serum or plasma samples. The device utilizes real-time PCR technology to provide accurate and precise measurements of HCV viral load.
Automatically generated - may contain errors
Lab products found in correlation
M2000 realtime system, by Abbott (2 mentions)
Cobas ampliprep, by Roche (1 mentions)
Vitros eci immunodiagnostic system, by Ortho Clinical Diagnostics (1 mentions)
Realtime hcv, by Abbott (1 mentions)
Realtime hcv genotype 2, by Abbott (1 mentions)
Versant hcv genotype 2.0 assay, by Siemens (1 mentions)
6 protocols using cobas taqman hcv v2
1
HCV RNA Elimination Post-Transplant
2
Tracking Hepatitis C Infection Patterns
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Clinical laboratory results were extracted from the database of Quest Diagnostics, a large clinical laboratory test provider throughout the U.S. Deidentified person-level data from HCV antibody immunoassay testing and RNA diagnostic tests ordered January 1, 2018–August 8, 2020, were included. Patient age and sex were included in the analysis, when available. Data extracted from Quest Diagnostics were determined not to be individually identifiable.
All specimens with positive antibody test results reflex to HCV RNA quantitative testing, used to diagnose current infection. HCV qualitative immunoglobulin G antibody testing was performed using the U.S. Food and Drug Administration–cleared, automated VITROS ECi Immunodiagnostic System (Ortho Clinical Diagnostics). The Food and Drug Administration–cleared HCV RNA test methods included the COBAS AmpliPrep/COBAS TaqMan HCV v2.0 (Quantitative) method and COBAS HCV Quantitative nucleic acid test for use on the COBAS 6800/6880 systems (both from Roche Diagnostics).
All specimens with positive antibody test results reflex to HCV RNA quantitative testing, used to diagnose current infection. HCV qualitative immunoglobulin G antibody testing was performed using the U.S. Food and Drug Administration–cleared, automated VITROS ECi Immunodiagnostic System (Ortho Clinical Diagnostics). The Food and Drug Administration–cleared HCV RNA test methods included the COBAS AmpliPrep/COBAS TaqMan HCV v2.0 (Quantitative) method and COBAS HCV Quantitative nucleic acid test for use on the COBAS 6800/6880 systems (both from Roche Diagnostics).
3
HCV RNA and Genotype Testing Protocol
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The serum HCV RNA at baseline, treatment W4, W8, W12, and W24 were determined by standardized automated real-time PCR assays (Roche Cobas Taqman HCV v2.0 Roche Diagnostics GmbH, Mannheim, Germany) with a detection limit of 15 IU/mL; or RealTime HCV (Abbott Molecular, Des Plaines IL, USA) with a detection limit of 12 IU/ml).[15 (link)]
HCV genotype was determined by a reverse hybridization assay (Versant HCV Genotype 2.0 assay, Siemens Healthcare Diagnostics, Illinois) or a real-time PCR assay (Abbott RealTime HCV Genotype II; Abbott Molecular, Des Plaines IL, USA).[16 (link)] The sustained virological response (SVR) was defined as seronegativity of HCV RNA throughout 24 weeks of post-treatment follow-up period.
HCV genotype was determined by a reverse hybridization assay (Versant HCV Genotype 2.0 assay, Siemens Healthcare Diagnostics, Illinois) or a real-time PCR assay (Abbott RealTime HCV Genotype II; Abbott Molecular, Des Plaines IL, USA).[16 (link)] The sustained virological response (SVR) was defined as seronegativity of HCV RNA throughout 24 weeks of post-treatment follow-up period.
4
Measuring Sustained Virologic Response in HCV
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The efficacy endpoint of the study was SVR. It was defined as undetectable HCV RNA at least 12 wk after completion of treatment. Patients with detectable HCV RNA at this time point were identified as virologic non-responders, whereas those with no HCV RNA assessment 12 wk after the end of treatment were considered lost to follow-up. Depending on local practices at the testing site, the concentration of HCV RNA was measured using COBAS TaqMan HCV v2.0 (Roche Molecular Diagnostics, Pleasanton, CA, United States), COBAS AmpliPrep HCV (Roche Molecular Diagnostics, Pleasanton, CA, United States), the m2000 Real-Time System (Abbott Molecular, Des Plaines, IL, United States), or the Xpert HCV Viral Load real-time assay (Cepheid, Sunnyvale, California, United States).
5
HCV Diagnosis and Staging Protocol
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Patients who tested anti-HCV positive with the OraQuick HCV test underwent a serological confirmation test for HCV antibodies in venous blood by a gold-standard immunoassay (COBAS Elecsys® Anti-HCV-II electrochemiluminescence immunoassay Roche diagnostics, Mannheim, Germany). Those with a confirmed positive test were offered appropriate care that included determination of viral genotype (Versant® HCV Genotype LiPA 2.0, Siemens Healthcare Diagnostics, Berkeley, USA), HCV-RNA levels (real-time PCR-based assay Cobas® TaqMan HCV v2.0, Roche Diagnostics, Sant Cugat, Spain) and liver fibrosis stage (elastography and/or liver biopsy), as well as indication for antiviral therapy.
6
Rapid Anti-HCV Antibody Detection
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After completion of the questionnaire, a rapid cassette test was administered to determine the presence of anti-HCV antibodies. Testing was performed in the whole blood using rapid anti-HCV kits, detecting antibodies generated against the proteins encoded by all HCV genotypes’ most conserved parts of Core, NS3, NS4, and NS5 regions in the HCV genome, which demonstrate sensitivity of 100% and specificity of 100% according to manufacturer (Türklab, Izmir, Turkey). Each individual with a positive serological test result had blood drawn for HCV RNA molecular assays. The HCV RNA levels were obtained by quantitative PCR assays: COBAS TaqMan HCV v2.0 (Roche Molecular Diagnostics, Pleasanton, CA, USA-detection level < 15 IU/mL). Those with a viral load were referred to a specialist outpatient clinic for further diagnostics and antiviral treatment.
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