Comparison of Hepatitis C Antibody Assays and Evaluation of Agreement Between Hepatitis C Antigen and PCR Results

Iqbal, Sahar; Baig, Samina; Naseem, Saima; Naeem, Syed Talha; Fatima, Ambreen; Khan, Saeed

doi:10.55519/jamc-03-9483

Cited by 3 publications

(1 citation statement)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A high correlation between HCV-Ag test and HCV PCR, such as the CAP/CTM test, has been described in the literature (12,21,23,25,26). Similar to Chang, et al (12) and, more recently, to Iqbal, et al (26), who found an excellent correlation (r=0.960 and r=0.950, respectively), our findings showed a strong positive association (r=0.890) between the two tests in all samples with quantifiable viral load, which suggests that the HCV-Ag test may be a good predictor for the identification of clinical cases of active hepatitis C infection.…”

Section: Discussionmentioning

confidence: 89%

HCV Core-antigen Assay as an Effective Alternative to HCV RNA Quantification in Patients With Hepatitis C

Vieira

Caldas

Carvalho

et al. 2023

In Vivo

View full text Add to dashboard Cite

Background/Aim: Hepatitis C virus (HCV) core antigen (Ag) test has been increasingly applied as an effective alternative to conventional molecular tests allowing rapid and affordable diagnosis, which is of paramount relevance to achieve global elimination of HCV infection. Materials and Methods: ARCHITECT ® HCV Ag test was evaluated in comparison with HCV RNA quantification test (CAP/CTM) to calculate its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and to determine their correlation level. Its performance, according to low and high viral load values and in different treatment stages [during treatment (T), at the end of the therapeutic protocol (EOT) and when sustained virological response (SVR) was evaluated]. Results: In total, 145 samples were included. Considering CAP/CTM, the sensitivity, specificity, PPV and NPV of the HCV-Ag test were 88.9%, 99.1%, 97.0% and 96.4%, respectively, and the correlation among tests was high (r=0.890), with only five discordant results. A decrease in sensitivity was found for low viral load values (<1,000 IU/ml), but the opposite was verified for high viral concentrations (≥1,000 IU/ml). A good agreement was verified for the T and EOT groups (k=0.789 and k=0.638) and an excellent agreement in the SVR group (k=1.000). Conclusion: HCV-Ag seems to be an effective alternative that can be routinely combined with other faster and more accessible tests (e.g., HCV antibody tests) for the identification of new HCV infections in suspected patients, eventually reserving the molecular techniques for samples with discordant results.

show abstract

Section: Discussionmentioning

confidence: 89%

HCV Core-antigen Assay as an Effective Alternative to HCV RNA Quantification in Patients With Hepatitis C

Vieira

Caldas

Carvalho

et al. 2023

In Vivo

View full text Add to dashboard Cite

show abstract

Diagnostic performance of hepatitis C virus core antigen testing for detecting hepatitis C in people living with hepatitis B: a systematic review and meta-analysis

Treviño-Nakoura,

Sepúlveda-Crespo,

Bellon

et al. 2024

Infect Dis Poverty

View full text Add to dashboard Cite

Background The current diagnostic strategy for hepatitis C virus (HCV) infection involves a two-step approach: antibody HCV screening followed by confirmatory nucleic acid testing. This study aimed to evaluate the diagnostic performance of the Abbott ARCHITECT HCV Ag assay in serum/plasma samples as a potential one-step alternative for diagnosing active HCV infection in people living with hepatitis B virus (PLWHB) through a systematic review and meta-analysis. Methods A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. This protocol was registered on PROSPERO (CRD42023402093). A comprehensive search of electronic 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. Results 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. Conclusions The Abbott 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 settings (≤ 5%). Graphical Abstract

show abstract

An Update on National Consensus Practice Guidelines for the Treatment of Hepatitis C & Literature Review in Epidemiology of Hepatitis C in Pakistan - 2022

Syed,

Umar,

Khaar

et al. 2024

JRMC

View full text Add to dashboard Cite

Hepatitis C is a global health problem affecting around 58 million people worldwide and killing almost 0.29 million in on one year [1]. The world has united to fight against this lethal disease in 2016 with a moto to eliminate hepatitis by 2030. To achieve this goal WHO’s World Health Assembly has set some targets and individual countries have developed their own strategies to achieve those targets [2]. Pakistan has the 2nd highest prevalence of hepatitis C in the world with 5.8% viremia positive patients [3]. Pakistan is amongst the few countries that have been assisted by the Center for Disease Control and Prevention(CDC) to prevent and control Hepatitis[4]. With the availability of Direct Acting Antivirals(DAAs), the whole paradigm of treatment of hepatitis C has changed not only globally but also in Pakistan. However, the patients in Pakistan are unable to gain access to the latest DAAs at the pace, as they are available globally. International guidelines are being updated on regular basis as per global evidence, recommending such combinations which are not readily available to many parts of the world. Hence there is a dire need to develop national guidelines, keeping in consideration the efficacy of the drugs as well as their availability, in the broader canvas of achieving the targets of eliminating Hepatitis set by WHO. In this context, our consensus guidelines are an effort to fill the gap created because of upgraded scientific evidence and possible combinations available in our part of the world. Furthermore, quite some good research and evidence has also been shared in the literature from Pakistan during last five years (2016-2021). Hence a literature review has also been carried out to update our own epidemiologic data, risk factors and treatment responses to Hepatitis C in Pakistan.

show abstract

Comparison of Hepatitis C Antibody Assays and Evaluation of Agreement Between Hepatitis C Antigen and PCR Results

Cited by 3 publications

References 23 publications

HCV Core-antigen Assay as an Effective Alternative to HCV RNA Quantification in Patients With Hepatitis C

HCV Core-antigen Assay as an Effective Alternative to HCV RNA Quantification in Patients With Hepatitis C

Diagnostic performance of hepatitis C virus core antigen testing for detecting hepatitis C in people living with hepatitis B: a systematic review and meta-analysis

An Update on National Consensus Practice Guidelines for the Treatment of Hepatitis C & Literature Review in Epidemiology of Hepatitis C in Pakistan - 2022

Contact Info

Product

Resources

About