Performance of an antigen–antibody combined assay for hepatitis C virus testing without venipuncture

Larrat, Sylvie; Bourdon, Cécile; Baccard, Monique; Garnaud, Cécile; Mathieu, Sophie; Quésada, Jean-Louis; Signori-Schmück, Anne; Germi, Raphaële; Blanc, M.; Leclercq, Pascale; Hilleret, Marie‐Noëlle; Leroy, Vincent; Zarski, Jean–Pierre; Morand, Patrice

doi:10.1016/j.jcv.2012.07.016

Cited by 25 publications

(32 citation statements)

References 31 publications

(46 reference statements)

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“…Most studies used 50 μl to 100 μl of whole blood on filter paper to test for HCV-Ab. Six studies reported using capillary blood samples [ 26 , 55 , 57 , 58 , 63 , 66 ], while others either did not report on this or used venous blood. One study included children [ 68 ], however, age ranges or gender for patients were not always reported.…”

Section: Resultsmentioning

confidence: 99%

“…For HCV-Ab detection, eight of the included studies used case-control designs [ 27 , 43 , 64 , 66 – 69 , 71 ] and only two reported consecutive sampling [ 39 , 40 ]. Only three studies reported blinding of laboratory personnel to results of the reference test [ 27 , 57 , 66 ]. However, most of the other studies (as with HBsAg detection) used and reported a clear and consistent protocol for both reference and index test, so this was not judged as a major cause of bias.…”

Section: Resultsmentioning

confidence: 99%

“…Cut-offs varied widely and as no standardized cut-offs exist, investigators for many studies determined their own cut-off via ROC curves using the same set of samples. Nine of the included studies reported on cut-offs used for DBS [ 26 , 27 , 40 , 59 , 60 , 64 – 66 ]. Stratification by type of test or cut-off used was not possible as the number of strata would have been large and the results difficult to interpret.…”

Section: Resultsmentioning

confidence: 99%

“…In one study, three out of three previously negative samples exceeded cut-off values (i.e. would have been interpreted as positive) after storage for 3 days at room temperature [ 66 ]. Similarly, one of the included studies showed that after 6 days of storage at room temperature, the cut-off values were exceeded and previously negative samples became positive [ 63 ].…”

Section: Resultsmentioning

confidence: 99%

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Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses

et al. 2017

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BackgroundDried blood spots (DBS) are a convenient tool to enable diagnostic testing for viral diseases due to transport, handling and logistical advantages over conventional venous blood sampling. A better understanding of the performance of serological testing for hepatitis C (HCV) and hepatitis B virus (HBV) from DBS is important to enable more widespread use of this sampling approach in resource limited settings, and to inform the 2017 World Health Organization (WHO) guidance on testing for HBV/HCV.MethodsWe conducted two systematic reviews and meta-analyses on the diagnostic accuracy of HCV antibody (HCV-Ab) and HBV surface antigen (HBsAg) from DBS samples compared to venous blood samples. MEDLINE, EMBASE, Global Health and Cochrane library were searched for studies that assessed diagnostic accuracy with DBS and agreement between DBS and venous sampling. Heterogeneity of results was assessed and where possible a pooled analysis of sensitivity and specificity was performed using a bivariate analysis with maximum likelihood estimate and 95% confidence intervals (95%CI). We conducted a narrative review on the impact of varying storage conditions or limits of detection in subsets of samples. The QUADAS-2 tool was used to assess risk of bias.ResultsFor the diagnostic accuracy of HBsAg from DBS compared to venous blood, 19 studies were included in a quantitative meta-analysis, and 23 in a narrative review. Pooled sensitivity and specificity were 98% (95%CI:95%–99%) and 100% (95%CI:99–100%), respectively. For the diagnostic accuracy of HCV-Ab from DBS, 19 studies were included in a pooled quantitative meta-analysis, and 23 studies were included in a narrative review. Pooled estimates of sensitivity and specificity were 98% (CI95%:95–99) and 99% (CI95%:98–100), respectively. Overall quality of studies and heterogeneity were rated as moderate in both systematic reviews.ConclusionHCV-Ab and HBsAg testing using DBS compared to venous blood sampling was associated with excellent diagnostic accuracy. However, generalizability is limited as no uniform protocol was applied and most studies did not use fresh samples. Future studies on diagnostic accuracy should include an assessment of impact of environmental conditions common in low resource field settings. Manufacturers also need to formally validate their assays for DBS for use with their commercial assays.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses

et al. 2017

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“…Storage at -20 °C, however, resulted in the lowest variation of optical densities. Applying a fourth generation anti-HCV ELISA, i.e., Monolisa HCV-Ag-Ab-ULTRA, in the context of DBS testing, Larrat et al 40 observed a sharp decrease in analytical specificity after storing the DBS specimens for more than three days at RT. On the other hand, precise testing results were obtained with the same kit utilizing samples deposited for 60 days under various conditions (-20 °C, 2 -8 °C, and 22 -26 °C) by Brandao and co-workers 41 .…”

Section: Parametersmentioning

confidence: 99%

Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques

Grüner

Stambouli

Roß

2015

JoVE

116

110

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The idea of collecting blood on a paper card and subsequently using the dried blood spots (DBS) for diagnostic purposes originated a century ago. Since then, DBS testing for decades has remained predominantly focused on the diagnosis of infectious diseases especially in resourcelimited settings or the systematic screening of newborns for inherited metabolic disorders and only recently have a variety of new and innovative DBS applications begun to emerge. For many years, pre-analytical variables were only inappropriately considered in the field of DBS testing and even today, with the exception of newborn screening, the entire pre-analytical phase, which comprises the preparation and processing of DBS for their final analysis has not been standardized. Given this background, a comprehensive step-by-step protocol, which covers al the essential phases, is proposed, i.e., collection of blood; preparation of blood spots; drying of blood spots; storage and transportation of DBS; elution of DBS, and finally analyses of DBS eluates. The effectiveness of this protocol was first evaluated with 1,762 coupled serum/DBS pairs for detecting markers of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus infections on an automated analytical platform. In a second step, the protocol was utilized during a pilot study, which was conducted on active drug users in the German cities of Berlin and Essen.

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Laboratory‐based testing for hepatitis C infection using dried blood spot samples: A systematic review and meta‐analysis of diagnostic accuracy

Carty¹,

McCarthy

O’Neill

et al. 2021

Reviews in Medical Virology

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The use of dried blood spot (DBS) samples can facilitate the implementation of reflex testing by circumventing the need for centrifugation and freezing of venous blood samples. This systematic review assessed the accuracy of using DBS samples to diagnose chronic hepatitis C virus (HCV) infection. A comprehensive search was undertaken to identify articles published up to July 2020 evaluating the diagnostic accuracy of anti-HCV, HCV-RNA and HCV core antigen tests using DBS. Screening, data extraction, quality appraisal and Grading of Recommendations, Assessment, Development and Evaluations certainty of the evidence assessment were performed independently by two reviewers. Meta-analysis, meta-regression and sensitivity analyses were conducted. The evidence demonstrates that laboratorybased anti-HCV and HCV-RNA tests using DBS samples have high diagnostic accuracy. All comparisons were between DBS and venous samples. For the detection of anti-HCV, sensitivity was 95% (95% CI: 92%-97%) and specificity was 99% ([95% CI: 98%-99%]; n = 25; I 2 = 81%; moderate certainty). For the detection of HCV-RNA, the sensitivity was 95% (95% CI: 93%-97%) and specificity was 97% ([95% CI: 94%-98%]; n = 20; I 2 = 52%; moderate certainty). The sensitivity of HCV core antigen tests was 86% (95% CI: 79%-91%) and specificity was 98% ([95% CI: 94%-99%]; n = 5; I 2 = 37%; low certainty) compared with HCV-RNA (the gold standard for detecting chronic HCV). DBS samples could facilitate diagnosis of chronic HCV infection as the necessary sequential tests (anti-HCV and then HCV-RNA or HCV core antigen) can be undertaken using the same blood sample. This could reduce loss of patient follow-up and support international efforts towards HCV elimination in both high and low prevalence settings.

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Performance of an antigen–antibody combined assay for hepatitis C virus testing without venipuncture

Cited by 25 publications

References 31 publications

Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses

Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses

Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques

Laboratory‐based testing for hepatitis C infection using dried blood spot samples: A systematic review and meta‐analysis of diagnostic accuracy

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