Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Sepúlveda‐Crespo, Daniel; Treviño‐Nakoura, Ana; Bellón, José M.; Fernández‐Rodríguez, Amanda; Ryan, Pablo; Martı́nez, Isidoro; Jiménez-Sousa, María Ángeles; Resino, Salvador

doi:10.1002/rmv.2436

Cited by 4 publications

(2 citation statements)

References 113 publications

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“…Sensitivity (98.0%, CI: 95.4%-99.3%) and specificity (98.6% CI: 95.0%-99.8%) for HCVcAg in our study with a cut-off of ≥3 fmol/L, is consistent with other studies. 6 Another study from Pakistan, reported a lower sensitivity and specificity of 96.8% and 91.8% (95%, CI: 83%-97%) 7 at ≥3 fmol/L. While they reported the higher HCVcAg sensitivity at a threshold of ≥10 fmol/L (99.1%, CI: 95-100%).…”

Section: Discussionmentioning

confidence: 94%

Performance of HCV core antigen and PCR testing in a predominantly genotype 3 population

Naveed,

Khalid,

Janjua

et al. 2024

Journal of Viral Hepatitis

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Hepatitis C core antigen (HCVcAg) is becoming increasingly recognized as an alternative to molecular testing for the confirmation of chronic hepatitis C. However, there are limited data on the performance of this assay in a genotype 3 (GT3) predominant country like Pakistan. We conducted a study to evaluate the diagnostic performance of HCVcAg against the HCV polymerase chain reaction (PCR) molecular test. HCV antibody‐positive patients requiring confirmatory testing were recruited from August to October 2018 at the Pakistan Kidney and Liver Institute and Research Center (PKLI&RC), Lahore, Pakistan. Patients with previously known diagnoses or treatment histories were excluded. The Abbott HCV Ag assay was used for HCVcAg testing. Results ≥3.00 fmol/L were considered positive for HCVcAg. The Abbott RealTime HCV assay was used for PCR testing with a lower detection limit of ≥12 IU/mL. We computed the sensitivity, specificity and correlation of HCVcAg against HCV PCR. A total of 394 patients were recruited. The median age of the patients was 42 years. Most participants were females (51.5%, n = 203), 30.7% (n = 121) had HTN, 10.4% DM (n = 41) and 5% had APRI ≥2. The overall sensitivity was 98.0% and the specificity was 98.6%. The lowest detection limit of cAg was an HCV RNA value of 4657 IU/mL. The levels of cAg were highly correlated with those of HCV RNA by Spearman's rank correlation test (r = 0.935, p < .001). HCVcAg represents a suitable alternative with high sensitivity and specificity compared with HCV PCR in the GT3‐predominant population and can be incorporated into algorithms to improve linkage to care.

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Section: Discussionmentioning

confidence: 94%

Performance of HCV core antigen and PCR testing in a predominantly genotype 3 population

Naveed,

Khalid,

Janjua

et al. 2024

Journal of Viral Hepatitis

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“…HCVcAg correlates well with HCV RNA levels ≥10 000 IU/mL and, thus, can detect viremia in the vast majority of persons with active HCV infection. A recent metanalysis of 46 studies using HCVcAg reported the assay to have high specificity and sensitivity for active HCV infection but suboptimal positive predictive value in low prevalence settings [ 16 ]. Nonetheless, this test may be a valuable addition to the rapid diagnostic armamentarium, especially in high-prevalence settings where nucleic acid testing is less feasible or unavailable [ 15 ].…”

Section: Remaining Issues With Hcv Diagnostic Down-classificationmentioning

confidence: 99%

Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis

Terrault

2023

The Journal of Infectious Diseases

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In November 2021, the U.S. Food and Drug Administration (FDA) reclassified two types of hepatitis C diagnostic tests (HCV antibody and HCV nucleic acid) from Class III to Class II, providing a less burdensome pathway to market for diagnostic companies. This down-classification is anticipated to facilitate innovation in HCV diagnostics, particularly for new point-of-care viral detection assays, and ultimately support HCV elimination efforts by increasing the ease of screening as well as test-and-treat models of HCV care.

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Diagnostic performance of dried blood spot hepatitis C virus core antigen testing for hepatitis C screening: A systematic review and meta‐analysis

Treviño‐Nakoura,

Sepúlveda‐Crespo,

Bellon

et al. 2024

Journal of Medical Virology

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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. We conducted a systematic review and meta‐analysis to assess the diagnostic performance of the Abbott 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 analyzed 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 settings (≥5%). However, in low‐prevalence settings (≤1%), a confirmatory 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 Abbott ARCHITECT HCV Ag assay with DBS samples showed excellent diagnostic performance, but its external validity may be limited when HCV prevalence is low (≤1%).

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Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Cited by 4 publications

References 113 publications

Performance of HCV core antigen and PCR testing in a predominantly genotype 3 population

Performance of HCV core antigen and PCR testing in a predominantly genotype 3 population

Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis

Diagnostic performance of dried blood spot hepatitis C virus core antigen testing for hepatitis C screening: A systematic review and meta‐analysis

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