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Updated: Jul 6, 2026
Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques
Published on: March 13, 2015
Diagnostic performance of dried blood spot hepatitis C virus core antigen testing for hepatitis C screening: A
Ana Treviño-Nakoura1,2, Daniel Sepúlveda-Crespo3,4, José M Bellon4,5
1Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain.
Insights
Dried blood spot (DBS) testing for hepatitis C virus core antigen (HCVcAg) shows high accuracy for screening active infections. While effective in high-prevalence areas, confirmatory testing is advised for low-prevalence settings.
Area of Science:
- Infectious Diseases
- Hepatology
- Diagnostic Accuracy Studies
Background:
- Dried blood spot (DBS) sampling offers a minimally invasive method for hepatitis C virus (HCV) screening.
- Hepatitis C virus core antigen (HCVcAg) testing presents a rapid diagnostic approach for active HCV infection.
Approach:
- A systematic review and meta-analysis evaluated the diagnostic performance of the Abbott ARCHITECT HCV Ag assay using DBS samples.
- Eight studies (n=1229) were synthesized, comparing HCVcAg testing against HCV PCR as the gold standard.
- Data were analyzed using a random-effects model, calculating key diagnostic accuracy measures.
Key Points:
- The Abbott ARCHITECT HCV Ag assay demonstrated high diagnostic accuracy with a sensitivity of 85% and specificity of 100% for DBS samples.
- Likelihood ratios indicate strong performance in confirming or ruling out active HCV infection in high-prevalence settings (≥5%).
- In low-prevalence settings (≤1%), a confirmatory test is recommended for positive results due to potential external validity limitations.
Conclusions:
- HCV screening using the Abbott ARCHITECT HCV Ag assay with DBS samples exhibits excellent diagnostic performance.
- The assay effectively identifies individuals without HCV infection across various prevalence levels.
- While promising, the external validity of this method may be constrained in populations with very low HCV prevalence.
Abstract:
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%).
