Cobas amplicor hcv test

Manufactured by Roche

Sourced in Canada

The COBAS AMPLICOR HCV Test is a qualitative in vitro diagnostic test used for the detection of hepatitis C virus (HCV) RNA in human serum or plasma specimens. The test utilizes polymerase chain reaction (PCR) technology to amplify and detect HCV genetic material.

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Lab products found in correlation

Axsym 3, by Abbott (2 mentions) Realtime hcv, by Abbott (1 mentions) Inno lia hcv score, by Fujirebio (1 mentions) Architect anti hcv, by Abbott (1 mentions) Multichannel autoanalyzer, by Hitachi (1 mentions) Versant hcv rna 3, by Bayer (1 mentions)

Spelling variants of this product

Cobas Amplicor (64 citations) Cobas Amplicor HCV Monitor Test (6 citations) COBAS Amplicor HCV Monitor test v.2.0 (6 citations) COBAS AMPLICOR HCV MONITOR v2.0 Test (4 citations) COBAS AMPLICOR HCV Test v2.0 (3 citations) COBAS AMPLICOR HCV MONITOR Test version 2.0 (2 citations)

7 protocols using cobas amplicor hcv test

Cohort Study of Liver Fibrosis in HCV

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For our study, HCV RNA-negative participants or those who had significant fibrosis (APRI≥1.5), end-stage liver disease or chronic Hepatitis B at study entry were excluded, as were individuals on HCV treatment. HCV RNA was measured using qualitative tests (COBAS AMPLICOR HCV Test, version 2.0, Roche Diagnostics, Hoffmann-La Roche Ltd, Laval, Canada, lower limit of detection <50 IU ml-¹) and was available at most visits. Presence of Hepatitis B surface antigen was used to determine Hepatitis B chronicity.
As immune and genetic markers were not measured during regular CCC visits, we used a case cohort study design as an economical way to gather this information. From an eligible study sample of n = 679 (Fig 1), a random subsample or “subcohort” was selected from the population at entry, to provide comparison observations for each event of significant liver fibrosis, occurring during study follow-up. Because the subcohort was a representation of the full cohort, it also contained a few incident cases.

Moqueet N., Kanagaratham C., Gill M.J., Hull M., Walmsley S., Radzioch D., Saeed S., Platt R.W, & Klein M.B. (2017). A prognostic model for development of significant liver fibrosis in HIV-hepatitis C co-infection. PLoS ONE, 12(5), e0176282.

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Hepatitis C Antibody and RNA Detection

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The anti-HCV antibody was detected using a third-generation, commercially available enzyme-linked immunosorbent assay kit (AxSYM 3.0; Abbott Laboratories, Chicago, IL). The presence of serum HCV RNA was evaluated using a standardized automated quantitative reverse-transcription polymerase chain reaction (COBAS AMPLICOR HCV Test, version 2.0; Roche, Branchburg, NJ; detection limit: 50 IU/mL) before 2011 or a real-time polymerase chain reaction assay (RealTime HCV; Abbott Molecular, Des Plaines IL; detection limit: 12 IU/mL) after 2011.^{39 (link)}

Yu M.L., Yeh M.L., Tsai P.C., Huang C.I., Huang J.F., Huang C.F., Hsieh M.H., Liang P.C., Lin Y.H., Hsieh M.Y., Lin W.Y., Hou N.J., Lin Z.Y., Chen S.C., Dai C.Y., Chuang W.L, & Chang W.Y. (2015). Huge Gap Between Clinical Efficacy and Community Effectiveness in the Treatment of Chronic Hepatitis C: A Nationwide Survey in Taiwan. Medicine, 94(13), e690.

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Viral Hepatitis Seroprevalence Assessment

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Sera from the patients were tested for IgM antibody against HAV (anti-HAV IgM) and for total antibodies against HAV (anti-HAV [total]) by enzyme-linked immunosorbentassay (ELISA) (HAM(N)-EIA and HAT-EIA, respectively; Denkaseiken, Tokyo, Japan). HBsAg was assessed by ELISA (IMxHBsAg Assay System; Abbott Japan, Tokyo, Japan); antibodies to HBsAg (anti-HBs) and antibodies to HBV core (anti-HBc [total]) was by passive hemagglutination with commercial assay kits (Mycell II anti-HBs and Mycell anti-HBc, respectively; Institute of Immunology Co. Ltd, Tokyo, Japan). Anti-HCV antibodies were assayed by the hemagglutination method (Abbott HCV-PHA; Abbott Japan). The presence of antibodies to HDV-IgM antibodies was determined by ELISA. Due to resource constraints, no other serological test or viral quantification was available. Serum HCV RNA was measured by a COBAS Amplicor HCV Test (Roche Diagnostics, Branchburg, NJ, USA) (<600 IU/mL).

Baatarkhuu O., Lee H.W., George J., Munkh-Orshikh D., Enkhtuvshin B., Ariunaa S., Eslam M., Ahn S.H., Han K.H, & Kim D.Y. (2017). Acute hepatitis A, B and C but not D is still prevalent in Mongolia: a time trend analysis. Clinical and Molecular Hepatology, 23(2), 147-153.

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Spontaneous Hepatitis C Clearance Study

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For the spontaneous clearance study, we included individuals who had never been treated for HCV and who had at least two HCV RNA tests available (n = 538). Visits after HCV treatment initiation were censored. A spontaneous clearance case was defined as an individual who was HCV-RNA negative on two consecutive PCR tests, at least six months apart (Figure 3a). HCV RNA levels were measured at most visits (COBAS AMPLICOR HCV Test, version 2.0, Roche Diagnostics, Hoffmann-La Roche Ltd., Laval, QC, Canada, lower limit of detection < 50 IU·mL⁻¹).
To compare the genotype distribution of the three IFNL3 SNPs of interest between Canadian whites and Aboriginals, self-reported ethnicity was used. Participants self-identified as being of Caucasian, black, other (Asian or Hispanic Latino), or Aboriginal (First Nations, Metis, or Inuit) ethnicity. In the CCC, 15.6% reported some Aboriginal ancestry (n = 181), but analysis was restricted to those who did not report any other ancestry (n = 140). These results were compared to those from 620 genotyped Canadian-born whites (Figure 3b).

Moqueet N., Infante-Rivard C., Platt R.W., Young J., Cooper C., Hull M., Walmsley S, & Klein M.B. (2015). Favourable IFNL3 Genotypes Are Associated with Spontaneous Clearance and Are Differentially Distributed in Aboriginals in Canadian HIV-Hepatitis C Co-Infected Individuals. International Journal of Molecular Sciences, 16(3), 6496-6512.

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HCV Seroprevalence Surveillance in D-County

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Serum samples from 557 of 613 (91%) newly notified HCV-positive cases in D-county were collected between 2002 and 2009. All HCV confirmatory tests were performed at Capio Diagnostics (Eskilstuna, D-county); detection of antibodies with ARCHITECT Anti-HCV (Abbott, Chicago, USA) and INNO-LIA HCV Score (Fujirebio, Tokyo, Japan). RNA qualitative tests were performed using COBAS AMPLICOR HCV Test (Roche, Pleasanton, California). Demographic information was retrieved from SmiNet. All serum samples were coded with lab nr-ID and could only be associated with an identifiable individual by authorized staff at Public Health of Sweden working with hepatitis C case notifications in SmiNet. This study did not modify the existing diagnosis or the therapeutic strategy.

Ederth J., Jern C., Norder H., Magnius L., Alm E., Rognsvåg B.K., Sundin C.G., Brytting M., Esbjörnsson J, & Mild M. (2016). Molecular characterization of HCV in a Swedish county over 8 years (2002–2009) reveals distinct transmission patterns. Infection Ecology & Epidemiology, 6, 10.3402/iee.v6.30670.

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Comprehensive Metabolic Profiling in HCV

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Serum HBsAg and anti-HCV were detected using an enzyme-linked immunosorbent assay kit (AxSYM 3.0; Abbott Laboratories, Chicago, IL). Before initiation of the study, general demographic characteristics and serum biochemical parameters were analyzed using commercial tests. These included aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, and platelet count. Biochemical tests and complete blood counts were measured using a standard autoanalyzer, including serum fasting glucose level. Patients were also checked for serum total cholesterol, triglycerides (TG), and high-density lipoprotein cholesterol (HDLC) levels. Also, lipid profiles were measured (in mg/dL) by a multichannel autoanalyzer (Hitachi, Inc, Tokyo, Japan) using standardized enzymatic procedures.
CHC was defined as detectable serum HCV RNA (checked by COBAS AMPLICOR HCV test [detection limit 50 IU/mL] version 2.0; Roche, Branchburg, NJ). Quantitative serum HCV RNA levels were measured using the branched DNA assay (Versant HCV RNA 3.0, Bayer, Tarrytown, NJ; quantification limit 615 IU/mL). HCV genotypes 1a, 1b, 2a, 2b, and 3a were determined by the method described by Okamoto et al. For calculating body mass index (BMI), we used the following formula: BMI (kg / m 2 ) = weightkg / height (m 2 ) .

Gantumur G., Batsaikhan B., Huang C.I., Yeh M.L., Huang C.F., Lin Y.H., Lin T.C., Liang P.C., Liu T.W., Lee J.J., Lin Y.C., Lin I.L., Huang J.F., Chuang W.L., Yu M.L., Tu H.P, & Dai C.Y. (2021). The association between hepatitis C virus infection and renal function. Journal of the Chinese Medical Association : JCMA, 84(8).

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HCV and HIV/HCV Cohort Study

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HIV/HCV patients (n=17) attending Outpatient Clinics at Royal Perth Hospital (Western Australia) were monitored for a median (range) interval of 597 (186-766) weeks after starting ART (triple therapy with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor). Some patients had participated in previous studies [6, 8] . Initial diagnoses were based on serology and confirmed by COBAS AMPLICOR HCV Test (Roche Diagnostics). Four patients also received anti-HCV therapy during the follow-up period. We included seventeen HCV mono-infected patients attending Royal Perth Hospital, matched for sex and HCV genotype to co-infected patients. HCV mono-infected patients were negative for hepatitis B surface antigens and antibodies to HIV, and had not been treated with IFNα/ribavirin. Seventeen healthy individuals with no reported exposure to HCV or HIV were included as controls. All subjects gave their informed consent and the study was approved by the Human Ethics Committee of Royal Perth Hospital.

Lee S., Laiman A., French M.A., Flexman J., Watson M.W, & Price P. (2017). The dynamics of HCV-specific antibody responses in HIV/HCV patients on long-term antiretroviral therapy. Clinical immunology (Orlando, Fla.), 179.

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