Development and validation of the HCV-MOSAIC risk score to assist testing for acute hepatitis C virus (HCV) infection in HIV-infected men who have sex with men (MSM) (original) (raw)
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Journal of Virology & Microbiology, 2013
Testing for the presence of antibody to hepatitis C virus (anti-HCV) is recommended for initially identifying persons with HCV infection. According to the CDC guidelines it is appropriate to use a signal-to-cutoff value (S/CO) to limit the number of samples that needs supplemental testing. Moreover, the use of quantitative PCR assays for HCV RNA testing is fundamental for the assessment of chronic hepatitis C. The purpose of this study is to determine a specific value for a serological test for anti-HCV with a Positive Predictive Value (PPV) of 95% on positive HCV Immunoblot, and also determine a cutoff value for performing a clinically relevant HCV PCR. Were observed 415 individuals identified de novo as anti-HCV reactive, between 2009 and 2011. We estimate that a S/CO of 6.0 has a PPV of 99.83% being positive Immunoblot assay and that 99.49% of the samples with a S/CO ≤6.0 will have no detectable virus on PCR. Based on these results we propose a new algorithm for evaluation persons identified de novo as anti-HCV reactive: Immunoblot assay needs to be performed only for samples with a S/CO ≤6.0 and HCV PCR will be performed for persons with a S/CO >6.0. Using these criteria it would be possible to save € 9,000/year with acceptable clinical accuracy. This algorithm does not apply to rare cases of suspected acute HCV infection or suspicion of HCV infection in immunocompromised patients; for these cases we maintain the current approach of NAT testing for laboratory diagnosis of HCV infection.
Journal of Clinical Virology, 2015
Highlights The two methods used to test HCV viral load using DBS generated comparable results Heating and shaking incubation was comparable to incubation at room temperature High correlation observed between results from plasma and either DBS methods Offset between DBS and plasma results can be fixed with a correction factor Summary (Word limit 200; current word count: 197) This study evaluated the use of dried blood spot (DBS) for HCV viral load quantification using the COBAS ® AmpliPrep/COBAS ® Taqman ® HCV Quantitative Test v2.0 (CAP/CTM HCV v2), and compared two different procedures for preparation of DBS samples with a Specimen Pre-Extraction (SPEX) reagent (either heated [SPEX with SH] for 10 minutes at 56°C on a thermomixer, or incubated for 1 hour at room temperature [SPEX at RT]) against the standard plasma input. Whole blood specimens from 48 patients with chronic HCV infection and Whatman ® 903 Protein Saver Cards were used to prepare 35 µL DBS. An aliquot of plasma was spun and frozen from each draw. Mean DBS viral load results were compared to the corresponding results from plasma. Correlation between DBS to plasma was linear for both SPEX with SH (R 2 = 0.96) and SPEX at RT (R 2 = 0.97) procedures, with a constant negative offset of approximately 2.0 log10 IU/mL between whole blood DBS without any adjustments and plasma results. After volume corrections, the mean offset to plasma decreased to-0.39 and-0.36 for the two procedures, respectively. The study demonstrated the use of DBS for HCV viral load correlates well with plasma with a constant offset.
Journal of clinical microbiology, 2008
In this study, we evaluate a cross-sectional testing strategy that identifies individuals with acute HCV infection and we estimate HCV incidence. Anti-HCV-negative persons from four populations with various risks, i.e., blood donors, Veterans Administration (VA) patients, young injection drug users (IDU), and older IDU, were screened for HCV RNA by minipool or individual sample nucleic acid testing (NAT). The number of detected viremic seronegative infections was combined with the duration of the preseroconversion NAT-positive window period (derived from analysis of frequent serial samples from plasma donors followed from NAT detection to seroconversion) to estimate annual HCV incidence rates. Projected incidence rates were compared to observed incidence rates. Projected HCV incidence rates per 100 person-years were 0.0042 (95% confidence interval [95% CI], 0.0025 to 0.007) for blood donors, 0.86 (95% CI, 0.02 to 0.71) for VA patients, 39.8 (95% CI, 25.9 to 53.7) for young IDU, and 53.7 (95% CI, 23.4 to 108.8) for older IDU. Projected rates were most similar to observed incidence rates for young IDU (33.4; 95% CI, 28.0 to 39.9). This study demonstrates the value of applying a cross-sectional screening strategy to detect acute HCV infections and to estimate HCV incidence.
Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions
Journal of Clinical Virology, 2008
Background: An improved test version of the Abbott ARCHITECT anti-hepatitis C virus (HCV) test became available at the end of 2005. Study design: We compared the new test version with the Ortho Vitros anti-HCV test by evaluating 2034 serum samples in parallel on both systems under routine laboratory conditions. Discordant samples were tested in the Inno-LIA HCV Score assay as well as in the RIBA HCV 3.0. Results: Of the 2034 samples 140 (6.9%) yielded positive and 1856 (91.2%) negative results in both assays. We observed discordant results in 38 samples (1.9%). All discrepant samples showed a low S/CO ratio of 1.0-6.9 (mean 2.8) in the Ortho assay and of 1.3-3.0 (mean 1.96) in the ARCHITECT assay. As expected, most of them could not be confirmed by immunoblot testing. Comparison of the results of the two immunoblots (Inno-LIA and RIBA) revealed a great variability in test results. Conclusions: This study represents the first comparative evaluation of the modified version of the Abbott ARCHITECT anti-HCV assay in comparison with the Ortho Vitros anti-HCV test. Under routine laboratory testing, we observed good overall concordance between the two assays and no evidence that one assay shows more false-reactive or negative results than the other.
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2017
Beckman Coulter has developed the VERIS HCV Assay for use on the new fully automated DxN VERIS Molecular Diagnostic System(¥) for HCV viral load monitoring. Evaluate the clinical performance of the new quantitative VERIS HCV Assay. Comparison was performed on 279 plasma specimens from HCV infected patients tested with the VERIS HCV Assay and COBAS(®) Ampliprep/COBAS(®) Taqman(®) HCV Test and 369 specimens tested with the VERIS HCV Assay and RealTime HCV Assay. Patient monitoring sample results from four time points were also compared. The average bias between the VERIS HCV Assay and the COBAS(®) Ampliprep/COBAS(®) Taqman(®) HCV Test was 0.04 log10IU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 log10IU/mL. Bias, however, was not consistent across the measuring range. Analysis at the lower end of quantification levels 50, 100, and 1000IU/mL showed a predicted bias for VERIS HCV Assay versus COBAS(®) Ampliprep/COBAS(®) Taqman(®) HCV Test betwee...
Pakistan Journal of Medical Sciences
Background and Objective: Blood transfusion is an essential and life-saving medical intervention. Despite multiple preventive measures transfusion-transmitted hepatitis C virus (HCV) infection continues to be a major healthcare issue in Pakistan. This study was conducted at National Institute of Blood Diseases & Bone Marrow Transplantation to evaluate the frequency of active HCV infection with or without co-infection in blood donors and also to determine comparative efficacy of Multisure HCV antibody assay (MHAA); a new serological device. Methods: A total of 14652 blood donors visiting National Institute of Blood Diseases & Bone Marrow Transplantation (NIBD) Blood Bank from January 2013 to July 2014 were enrolled and screened for a range of blood borne infections such as HBV, HCV, HIV, malaria and syphilis. The HCV was screened simultaneously by Abbot Architect anti-HCV assay (CLIA) and MHAA. The active HCV infection was confirmed by nucleic acid testing (NAT) in reactive donors. Later; for determination of comparative efficacy of MHAA; all NAT positive samples were further tested using Monolisa TM , HCV blot 3.0, Anti-HCV plus V2 and Anti-HCV-MPBIO-EIA. Results: The HCV reactive sera were observed in 1.563% (226) donors. The NAT confirmed active HCV infection in 138 donors. Overall 27.84% of HCV positive donors exhibited coinfection either with HBV (2.57%), syphilis (22.78%). Triple infection was not observed in any donor. The efficacy of MHAA is comparable to all the serological tests with a sensitivity of about 96.89%. Conclusion: Active HCV infection was present in 0.94% donors. With a sensitivity of 96.89% (95% CI: 95.66-98.12) the multi-parametric device MHAA can effectively detect HCV infection in donors. Thus, it can be used in limited health care settings for HCV screening.
Analytical evaluation of HCV core antigen and interest for HCV screening in haemodialysis patients
Journal of Clinical Virology, 2010
Background: It is important to diagnose a hepatitis C virus infection in the acute phase in order to reduce the incidence of this infection in high-risk populations like haemodialysis patients. But detection systems for serum HCV antibodies are insensitive in the acute phase because of the long serological window. Previous studies showed that the HCV core antigen (HCV Ag) may be an alternative to HCV RNA in this context. Objectives: To evaluate the performances of the new Abbott ARCHITECT ® HCV Ag test and its usefulness in screening for HCV infections in haemodialysis patients. Study design: The serum HCV Ag titre was compared to the HCV RNA viral load in 98 samples from HCVinfected patients to determine the correlation between the two markers and the influence of genotype. We screened 2752 patients from 37 French haemodialysis units who tested negative for HCV antibodies using the HCV Ag and RNA assays. Results: The HCV Ag titre was correlated with the HCV RNA (Spearman test coefficient 0.9041, p < 0.0001) and all genotypes and subtypes were detected. The HCV Ag and HCV RNA results agreed well for haemodialysis patients. Diagnostic specificity of HCV Ag was high (99.2%) considering HCV RNA as the reference. The two seronegative patients (of 2752) who were HCV RNA positive were also HCV Ag positive. Conclusions: The ARCHITECT ® HCV Ag test is a reliable, highly specific assay for screening acute HCV infections in haemodialysis units. It is a robust alternative to HCV RNA testing.