Cobas taqman hcv test 2

Manufactured by Roche

Sourced in United States, Japan

The COBAS TaqMan HCV Test 2.0 is a real-time PCR in vitro diagnostic test for the quantitative detection of hepatitis C virus (HCV) RNA in human serum or plasma. The test uses the COBAS TaqMan Analyzer system to perform automated sample preparation, amplification, and detection of HCV RNA.

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Fibroscan, by Echosens (1 mentions) Asunaprevir, by Bristol-Myers Squibb (1 mentions)

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Cobas TaqMan (73 citations) COBAS TaqMan HCV test (45 citations) Cobas TaqMan HCV Test version 2.0 (11 citations) COBAS TaqMan HCV Test (TaqMan HCV; (5 citations) COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, version 2.0 (2 citations) Cobas AmpliPrep/Cobas TaqMan HCV test version 2.0 (2 citations) COBAS TaqMan HCV quantitative test, version 2.0 (2 citations)

4 protocols using cobas taqman hcv test 2

Sofosbuvir and Velpatasvir for HCV

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Patients received one tablet of EPUCLUSA^® per os once daily (400 mg SOF and 100 mg VEL; Gilead Sciences, Foster City, CA, USA) for 12 weeks. Physical, hematological, and biochemical examinations were performed at treatment initiation, and every 4 weeks during the treatment and follow-up periods.
AEs including laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events v.5.0, as presented by the National Cancer Institute Cancer Therapy Evaluation Program [22 ].
Serum HCV RNA levels were measured using a real-time polymerase chain reaction (PCR)-based method (COBAS TaqMan HCV Test 2.0; Roche Molecular Systems, Pleasanton, CA, USA). The lower limit of quantification was 1.2 log IU/mL. HCV genotype was determined using PCR with genotype-specific primers for amplifying the core gene sequence [23 (link)].

Atsukawa M., Tsubota A., Kondo C., Toyoda H., Nakamuta M., Takaguchi K., Watanabe T., Hiraoka A., Uojima H., Ishikawa T., Iwasa M., Tada T., Nozaki A., Chuma M., Fukunishi S., Asai A., Asano T., Ogawa C., Abe H., Hotta N., Shima T., Iio E., Mikami S., Tachi Y., Fujioka S., Okubo H., Shimada N., Tani J., Hidaka I., Moriya A., Tsuji K., Akahane T., Yamashita N., Okubo T., Arai T., Morita K., Kawata K., Tanaka Y., Okanoue T., Maeda S., Kumada T, & Iwakiri K. (2020). Real-World Clinical Application of 12-Week Sofosbuvir/Velpatasvir Treatment for Decompensated Cirrhotic Patients with Genotype 1 and 2: A Prospective, Multicenter Study. Infectious Diseases and Therapy, 9(4), 851-866.

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Comprehensive Evaluation of Chronic Hepatitis C

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Each patient’s detailed medical history was recorded. Clinical examinations were performed on all patients. Baseline laboratory values were collected in all patients within 3 mo before starting treatment. The following data were recorded at the time of enrollment: Age, gender, fibrosis stage, history of treatment, anti-HCV antibody (ELISCAN HCV; RFCL Limited, Dehradun, India), genotype (Abbott Molecular Inc., Des Plaines, IL, United States), and any comorbidities, such as diabetes, HBV co-infection, hypertension and fatty liver disease. The baseline clinical chemistry results are shown in Table 2. HCV RNA was analyzed using COBAS TaqMan HCV Test 2.0 (Roche Diagnostics Corporation, Indianapolis, IN, United States). FibroScan transabdominal ultrasound and abdominal computerized tomography were also performed on the patients. Liver stiffness value > 12.5 kPa (FibroScan^®, Echosens, France), clinical manifestations such as esophageal varices and ascites or distinct sonographic signs of portal hypertension indicated cirrhosis.
This study was approved by the Institutional Review Board of Xi’an Jiaotong University.

Yang Y., Wu F.P., Wang W.J., Shi J.J., Li Y.P., Zhang X, & Dang S.S. (2019). Real life efficacy and safety of direct-acting antiviral therapy for treatment of patients infected with hepatitis C virus genotypes 1, 2 and 3 in northwest China. World Journal of Gastroenterology, 25(44), 6551-6560.

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HCV RNA Quantification and SVR Analysis

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Serum HCV RNA levels were measured using a real-time PCR method with the lower quantification limit of 1.2 log IU/mL (COBAS TaqMan HCV Test 2.0; Roche Diagnostics, Tokyo Japan). SVR was defined as undetectable HCV RNA at 24weeks post-treatment. Relapse was defined as undetectable HCV RNA at the end of treatment but detectable viremia during the follow-up period. Non-virological response was defined as persistent viremia throughout the treatment. Viral breakthrough was defined as undetectable HCV RNA after treatment but reappearance of HCV RNA during the treatment, or as an increase in the HCV RNA level of ≥1.0 log IU/mL from the lowest value during treatment period. Variants at L31 and Y93 in the NS5A region of HCV genome were detected using the direct sequencing method. The amino acid sequences of L31 and Y93 were defined as wild type.

Kato K., Shimada N., Atsukawa M., Abe H., Itokawa N., Matsumoto Y., Agata R, & Tsubota A. (2019). Single nucleotide polymorphisms associated with elevated alanine aminotransferase in patients receiving asunaprevir plus daclatasvir combination therapy for chronic hepatitis C. PLoS ONE, 14(7), e0219022.

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Chronic Hepatitis C Treatment Outcomes

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Patients diagnosed with chronic hepatitis C and receiving a combination of asunaprevir (ASV) (Bristol-Myers Squibb, New York, NY, USA) and daclatasvir (DCV) (Bristol-Myers Squibb) for 24 weeks were included in the present study. Patients with decompensated liver cirrhosis and infected with hepatitis B or human immunodeficiency virus were excluded. Patients received an oral dose of 100 mg ASV twice daily and 60 mg DCV once daily for 24 weeks. During this period, basic liver function indexes, such as ALT and the amount of HCV RNA, were monitored. Serum HCV RNA levels were measured using a real-time PCR method with the lower quantification limit of 1.2 log IU/mL (COBAS TaqMan HCV Test 2.0; Roche Diagnostics, Tokyo, Japan). A sustained virologic response (SVR) was defined as undetectable HCV RNA at 24 weeks post-treatment. The human leukocyte antigen (HLA) typing of patients was performed using peripheral blood mononuclear cells (PBMCs) and the PCR–reverse-sequence-specific oligonucleotide method. HLA-A24-positive patients were included in the present study. All patients provided written informed consent to participate, and the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the regional Ethics Committee (Medical Ethics Committee of Kanazawa University, No. 1639).

Li S., Mizukoshi E., Kawaguchi K., Miura M., Nishino M., Shimakami T., Arai K., Yamashita T., Sakai Y., Yamashita T., Honda M, & Kaneko S. (2022). Alterations in Hepatocellular Carcinoma-Specific Immune Responses Following Hepatitis C Virus Elimination by Direct-Acting Antivirals. International Journal of Molecular Sciences, 23(19), 11623.

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