Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions

Author(s):  
Evelyn Stelzl ◽  
Hannah M. Appel ◽  
Rochak Mehta ◽  
Ed G. Marins ◽  
Jörg Berg ◽  
...  

Abstract Background: Determination of the hepatitis C virus (HCV) genotype and discrimination between HCV subtypes 1a and 1b is still mandatory prior to anti-HCV treatment initiation. The aim of this study was to evaluate the performance of the recently introduced cobas Methods: The cobas Results: When accuracy was tested, panel members containing HCV subtypes 1a, 1b, and 3a were identified as expected; however, the new assay failed to identify low titer panel members containing HCV subtype 5a correctly. Of 183 clinical samples, 160 gave concordant results. For seven samples, an indeterminate result was reported with the cobas Conclusions: The cobas

2016 ◽  
Vol 55 (2) ◽  
pp. 504-509 ◽  
Author(s):  
Leonardo Nieto-Aponte ◽  
Josep Quer ◽  
Alicia Ruiz-Ripa ◽  
David Tabernero ◽  
Carolina Gonzalez ◽  
...  

ABSTRACTThe unequivocal identification of hepatitis C virus (HCV) subtypes 1a/1b and genotypes 2 to 6 is required for optimizing the effectiveness of interferon-free, direct-acting antiviral therapies. We compared the performance of a new real-time HCV genotyping assay used on the Cobas 4800 system (C4800) with that of high-resolution HCV subtyping (HRCS). In total, 502 samples were used, including 184 samples from chronic HCV patients (from routine laboratory activity during April 2016), 5 stored samples with double HCV genotype infections for testing the limitations of the method, and 313 samples from a screening protocol implemented in our hospital (from May to August 2016) based on the new method to further determine its genotyping accuracy. A total of 282 samples, including 171 from April 2016 (the 13 remaining had too low of a viral load for HRCS), 5 selected with double infections, and 106 from screening, were analyzed by both methods, and 220 were analyzed only by the C4800. The C4800 correctly subtyped 125 of 126 1a/1b samples, and the 1 remaining sample was reported as genotype 1. The C4800 correctly genotyped 38 of 45 non-1a/1b samples (classified by HRCS), and it reported the remaining 7 samples as indeterminate. One hundred two of 106 non-1a/1b genotype samples that were identified using the C4800 for screening were confirmed by HRCS. In the 4 remaining samples, 3 were correctly reported as genotype 1 (without defining the subtype) and 1 was reported as indeterminate. None of the samples were misgenotyped. Four of 7 samples with double HCV infections were correctly genotyped by the C4800. Excluding the 5 selected double-infected samples, the C4800 showed 95.7% concordant results for genotyping HCVs 2 to 6 and 1a/1b subtyping, and 99.2% concordance for subtyping 1a/1b single infections in clinical samples. To improve laboratory workflow, we propose using the C4800 as a first-line test for HCV genotyping and 1a/1b classification, followed by transferring non-1a/1b samples to a center where HRCS is available, if further characterization is needed.


2021 ◽  
Vol 7 (1) ◽  
pp. 955-959
Author(s):  
Abu Sufian ◽  
Ashish Kumar Majumder ◽  
M Abu Taher ◽  
Md Abul Khaleque ◽  
Sharif Akhteruzzaman ◽  
...  

Determination of hepatitis C virus (HCV) genotype and viral load are two significant prognostic and assessment markers of treatment decisions. The study aimed to determine the predominant HCV types or subtypes and any association with the viral load in Bangladeshi chronic HCV infected patients. A total of 359 anti-HCV positive patients underwent investigation to estimate viral load and determination of genotype and subtype using real-time reverse transcriptase polymerase chain reaction (real-time RT-PCR). Among 306 detectable viral loads containing individuals, 278 (90.85%) genotyped successfully, and 28 (9.15%) had unknown genotypes. Among typable genotypes, 1a accounted for 14 (5.03%), 1b for 14 (5.03%), 3 for 247 (88.85%), 4 for 2 (0.72%) and genotype 6 for 1 (0.36%). Based on pre-treatment viral load levels, study subjects classified into three categories such as low (<50000 IU/mL), intermediate (50000-500000 IU/mL), and high (>500000 IU/mL). The majority of HCV other types (1a, 1b, 4, 6) infected patients (96.4%) had intermediate to high viral load compared to those infected with genotype 3 (77.7%) and unclassified types (55.0%) (χ2 =15.41; p = 0.004). HCV type 3 was prevalent (68.4%) in the above 40 years of group compared to less than 40 years group (31.6%). HCV genotype 3 was the predominant genotype circulating in Bangladesh. Pre-treatment viral load demonstrated significant difference among individuals having HCV other types and type 3. However, sequencing the HCV genome analysis would determine the exact types and subtypes among all possible HCV strains available in Bangladesh. Bioresearch Commu. 7(1): 955-959, 2021 (January)


2017 ◽  
Vol 239 ◽  
pp. 1-8 ◽  
Author(s):  
Wasun Chantratita ◽  
Keum-Soo Song ◽  
Choi GunHo ◽  
Viroj Pongthanapisith ◽  
Nipa Thongbaiphet ◽  
...  

2019 ◽  
Vol 70 (1) ◽  
pp. e500
Author(s):  
Chen-Hua Liu ◽  
Tung-Hung Su ◽  
Chun-Jen Liu ◽  
Chun-Ming Hong ◽  
Hung-Chih Yang ◽  
...  

2011 ◽  
Vol 42 (6) ◽  
pp. 333-337
Author(s):  
Karina del Carmen Trujillo-Murillo ◽  
Diana Cristina Pérez-Ibave ◽  
Clara Patricia Ríos-Ibarra ◽  
Eda Guadalupe Ramirez-Valles ◽  
Ana Rosa Rincón-Sánchez ◽  
...  

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Tanyaporn Wansom ◽  
Oluwaseun Falade-Nwulia ◽  
Catherine G. Sutcliffe ◽  
Shruti H. Mehta ◽  
Richard D. Moore ◽  
...  

Abstract Background Hepatitis C is a major cause of mortality among human immunodeficiency virus (HIV)-infected patients, yet hepatitis C virus (HCV) treatment uptake has historically been low. Although the removal of interferon removes a major barrier to HCV treatment uptake, oral therapies alone may not fully eliminate barriers in this population. Methods Within the Johns Hopkins Hospital HIV cohort, a nested case-control study was conducted to identify cases, defined as patients initiating HCV treatment between January 1996 and 2013, and controls, which were selected using incidence density sampling (3:1 ratio). Controls were matched to cases on date of enrollment. Conditional logistic regression was used to evaluate factors associated with HCV treatment initiation. Results Among 208 treated cases and 624 untreated controls, the presence of advanced fibrosis (odds ratio [OR], 2.23; 95% confidence interval [CI], 1.26–3.95), recent active drug use (OR, 0.36; 95% CI, 0.19–0.69), and non-black race (OR, 2.01; 95% CI, 1.26–3.20) were independently associated with initiation of HCV therapy. An increasing proportion of missed visits was also independently associated with lower odds of HCV treatment (25%–49% missed visits [OR, 0.49; 95% CI, 0.27–0.91] and ≥50% missed visits [OR, 0.24; 95% CI, 0.12–0.48]). Conclusions Interferon-free treatments may not be sufficient to fully overcome barriers to HCV care in HIV-infected patients. Interventions to increase engagement in care for HIV and substance use are needed to expand HCV treatment uptake.


2006 ◽  
Vol 36 ◽  
pp. S104
Author(s):  
V. González ◽  
E. Martró ◽  
A. Buckton ◽  
V. Saludes ◽  
R. Planas ◽  
...  

2015 ◽  
Vol 54 (2) ◽  
pp. 296-299 ◽  
Author(s):  
Camelia Mokhtari ◽  
Anne Ebel ◽  
Birgit Reinhardt ◽  
Sandra Merlin ◽  
Stéphanie Proust ◽  
...  

Hepatitis C virus (HCV) genotyping continues to be relevant for therapeutic strategies. Some samples are reported as genotype 1 (gt 1) without subtype by the Abbott RealTime HCV Genotype II (GT II) test. To characterize such samples further, the Abbott HCV GenotypePlusRUO (Plus) assay, which targets the core region for gt 1a, gt 1b, and gt 6 detection, was evaluated as a reflex test in reference to NS5B or 5′-untranslated region (UTR)/core region sequencing. Of 3,626 routine samples, results of gt 1 without subtype were received for 171 samples (4.7%), accounting for 11.5% of gt 1 specimens. The Plus assay and sequencing were applied to 98 of those samples. NS5B or 5′-UTR/core region sequencing was successful for 91/98 specimens (92.9%). Plus assay and sequencing results were concordant for 87.9% of specimens (80/91 samples). Sequencing confirmed Plus assay results for 82.6%, 85.7%, 100%, and 89.3% of gt 1a, gt 1b, gt 6, and non-gt 1a/1b/6 results, respectively. Notably, 12 gt 6 samples that had been identified previously as gt 1 without subtype were assigned correctly here; for 25/28 samples reported as “not detected” by the Plus assay, sequencing identified the samples as gt 1 with subtypes other than 1a/1b. The genetic variability of HCV continues to present challenges for the current genotyping platforms regardless of the applied methodology. Samples identified by the GT II assay as gt 1 without subtype can be further resolved and reliably characterized by the new Plus assay.


Sign in / Sign up

Export Citation Format

Share Document