Abstract
BackgroundRapid tests (RTs) might have several advantages over standard laboratory procedures, increasing access to diagnosis, especially among vulnerable populations and/or those living in remote areas. The aim of this study was to evaluate the performance of RTs for the detection of hepatitis B virus surface antigen (HBsAg) in samples from different populations/settings.MethodsThree RTs for HBsAg detection (Vikia® HBsAg, HBsAg Teste Rápido®, and Imuno-Rápido HBsAg®) and different biological specimens (serum, whole blood, and saliva) were evaluated. Analyses comprised a reference panel and samples from field studies targeting suspected cases of hepatitis B virus (HBV) (G I), individuals living in deprived areas (G II), and highly vulnerable individuals (G III). Enzyme immunoassay (EIA) was defined as the gold standard in this study. Reproducibility, repeatability, and cross-reactivity with other infectious agents such as dengue, immunodeficiency (HIV), and hepatitis C (HCV) viruses and T. pallidum were determined.ResultsFor the reference panel, the sensitivity and specificity of all HBsAg RTs were higher than 93.00 %. G I presented the highest kappa values for all rapid assays using sera samples. When using serum, the sensitivity values were higher than 93.40 for G I, 60.00 % for G II and 66.77 % for G III, and the specificity values were higher than 99.50 for GI, 97.20 for G II and 99.10 % for G III for all tests. For whole blood samples & the Vikia® HBsAg assay, the best performance was achieved for GIII (k = 79.75 %). For saliva samples, the Imuno-Rápido HBsAg® assay showed the highest concordance values with EIA for G I (40.68 %) and G II (32.20 %). The reproducibility and repeatability of all RTs for serum and saliva were excellent, and the concordance between HBsAg EIAs and RTs using samples reactive with other infectious agents varied from 70.10 % to 100.00 %.ConclusionsThe overall performance of RTs for HBsAg in serum was high/moderately high for all groups, thereby promoting increased access to HBV diagnosis among vulnerable populations as well as samples from individuals in emergency settings or remote areas. Rapid tests for HBsAg using whole blood could be used in prevalence studies, though these assays should not be used for saliva samples.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-015-1249-5) contains supplementary material, which is available to authorized users.
Highlights
Rapid tests (RTs) might have several advantages over standard laboratory procedures, increasing access to diagnosis, especially among vulnerable populations and/or those living in remote areas
Rapid tests for hepatitis B virus surface antigen (HBsAg) using whole blood could be used in prevalence studies, though these assays should not be used for saliva samples
HBsAg rapid test performance using reference panels The reference panel was composed of 393 individuals, 103 of which were HBsAg reactive, whereas 290 samples did not show HBsAg according to Enzyme immunoassay (EIA)
Summary
Rapid tests (RTs) might have several advantages over standard laboratory procedures, increasing access to diagnosis, especially among vulnerable populations and/or those living in remote areas. Standard HBV diagnosis consists of the use of enzyme immunoassays (EIAs) and electrochemiluminescence (ECLIA) with serum or plasma samples [2] These assays have limitations that may compromise their routine use in low- and middle-income countries: they require trained personnel as well as the availability of all necessary infrastructures. Rapid tests (RTs) may have several advantages over standard procedures because they are easy to perform and can provide conclusive results within a few minutes. These tests may be performed on a case-by-case basis and do not require laboratory infrastructure. Only minimal training is required to perform RTs [3,4,5]
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