LITERATURE UPDATE
databases identified studies published up to 1 November 2024, comparing the ARCHITECT HCV Ag assay to an HCV-RNA reference standard. Sensitivity, specificity, and likelihood ratios were pooled using a random-effects model within the MIDAS module of Stata software. Study quality was assessed using QUADAS-2. Heterogeneity was evaluated using the Q statistic, quantified using the I², and further explored through meta- regression. Ten studies (n=494 participants) met inclusion criteria. The Abbott ARCHITECT HCV Ag assay demonstrated high sensitivity (91%, 95% confidence interval [CI]: 76–97%) and specificity (99%, 95% CI: 99–100%). The positive likelihood ratio (PLR) was 81.20 (95% CI: 12.34–534.36), and the negative likelihood ratio (NLR) was 0.09 (95% CI: 0.03–0.27). The area under the summary receiver operating characteristic curve (AUC-SROC) was 99% (95% CI 98–100%). In regions with high HCV prevalence (≥ 10%), the test accurately confirmed active HCV infection in over 90% of cases. However, confirmatory testing remains necessary in low-prevalence settings (≤5%). The assay demonstrated an excellent ability to identify individuals without HCV infection, with a low false-negative rate (≤2%) regardless of HCV prevalence. Heterogeneity analysis revealed moderate to substantial variation in test performance (I² = 72.09% for sensitivity, 35.47% for PLR, and 78.33% for NLR). QUADAS-2 applicability concerns predicted heterogeneity, but differences were likely insignificant due to minimal variations and limited studies.
The Abbot ARCHITECT HCV Ag assay
exhibited promising accuracy in detecting active HCV infection among PLWHB. This test might help diagnose active HCV infection in high-prevalence scenarios (≥10%) but needs further confirmation in low-prevalence setings (≤5%).
We have reached single-visit testing, diagnosis, and treatment for hepatitis C infection, now what? Grebely J, Mathews S, Causer LM et al. Expert Rev Mol Diagn. 2024 Mar; 24 (3): 177–191. doi: 10.1080/14737159.2023.2292645.
Progress toward hepatitis C virus (HCV) elimination is impeded by low testing and treatment due to the current diagnostic pathway requiring multiple visits leading to loss to follow-up. Point-of-care testing (POCT) technologies capable of detecting current HCV infection in one hour are a game-changer. These tests enable diagnosis and treatment in a single visit, overcoming the barrier of multiple
visits that frequently leads to loss to follow-up. Combining point-of-care HCV antibody and RNA tests should improve cost-effectiveness, patient/provider acceptability, and testing efficiency. However, implementing HCV POCT programmes at scale requires multiple considerations. This commentary explores the need
for point-of-care HCV tests, diagnostic strategies to improve HCV testing, key considerations for implementing point- of-care HCV testing programmes, and remaining challenges for POCT (including operator training, quality management, connectivity and reporting systems, regulatory approval processes, and the need for more efficient tests). It is exciting that single-visit testing,
diagnosis, and treatment for HCV infection have been achieved. Innovations afforded through COVID-19 should facilitate the accelerated development of low-cost, rapid, and accurate tests to improve HCV testing. The next challenge will be to address barriers and facilitators for implementing POCT to deliver them at scale.
Diagnostic performance of dried blood spot hepatitis C virus core antigen testing for hepatitis C screening: A systematic review and meta-analysis Treviño-Nakoura A, Sepúlveda-Crespo D, Bellon JM et al. J Med Virol. 2024 Oct; 96 (10): e70018. doi: 10.1002/jmv.70018.
Dried blood spot (DBS) sampling is increasingly used for hepatitis C virus (HCV) screening. HCVcAg testing offers a faster and more streamlined approach to diagnosing HCV infection. Here, the authors conducted a systematic review and meta-analysis to assess the diagnostic performance of the Abbot ARCHITECT HCV Ag assay for screening active HCV infection using DBS samples. Eight studies (n=1229) were selected among all published studies available up to October 4, 2024, in different databases with a search strategy registered (PROSPERO: CRD42022363975). The gold standard method was the HCV PCR test. Data were analysed using the MIDAS module in STATA with a random effects model. Combined diagnostic accuracy measures were as follows: sensitivity 85%, specificity 100%, positive likelihood ratio (PLR) 233.1, negative likelihood ratio (NLR) 0.15, and summary receiver operating characteristic (SROC) 0.99. Likelihood ratios and Fagan’s nomogram suggested that the HCVcAg assay with DBS samples can confirm or rule out active HCV infection with over 92% accuracy in high- prevalence setings (≥5%). However, in low- prevalence setings (≤1%), a confirmatory
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test must be required for positive results. The ability of the test to identify people without HCV infection was high regardless of HCV prevalence, with an error rate of less than 3%. This meta-analysis is subject to
limitations, particularly due to the number of included studies and significant heterogeneity among them. HCV screening using the Abbot ARCHITECT HCV Ag assay with DBS samples showed excellent diagnostic performance, but its external validity may be limited when HCV prevalence is low (≤1%).
Identifying missed opportunities for hepatitis C virus antenatal testing and diagnosis in England Hibbert M, Simmons R, Sabin CA, Mandal S, Desai M. J Viral Hepat. 2024 Mar; 31 (3): 131–136. doi: 10.1111/jvh.13906.
New case-finding opportunities are needed to achieve hepatitis C virus (HCV) elimination in England by the year 2030. HCV antenatal testing is not offered universally in England but is recommended for women with risk factors for HCV (eg injecting drug use, being born in a high-prevalence country). The aim of this analysis was to investigate the missed opportunities for HCV antenatal testing among women who had given birth and were subsequently diagnosed with HCV at some time after childbirth. By linking data on live births
(2010–2020) to laboratory reports of HCV diagnoses (1995–2021), the authors identified all women who were diagnosed with HCV after the date of their first childbirth. This group was considered to potentially have experienced a missed opportunity for HCV antenatal testing; HCV-RNA testing and treatment outcomes were also obtained for these women.
Of the 32,295 women who gave birth
between 2010 and 2020 with a linked diagnosis of HCV (median age: 34 years, 72.1% UK-born), over half (n=17,123) were diagnosed after childbirth. In multivariable analyses, the odds of being diagnosed with HCV after childbirth were higher in those of Asian Bangladeshi, Black African or Chinese ethnicity and among those born in Africa. Over four- fifths (3510/4260) of those eligible for treatment were linked to treatment, 30.7% (747/2435) of whom had a liver scarring level of at least moderate and 9.4% (228/2435) had cirrhosis. Given the potential opportunity to
identify cases of HCV with targeted case-finding through antenatal services, universal opt-out testing should be considered in these settings.
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