Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings & populations.

Autor: Cruz HM; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. h.medina@ioc.fiocruz.br., Scalioni Lde P; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. lescali@ioc.fiocruz.br., de Paula VS; Laboratory of Technological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. vdepaula@ioc.fiocruz.br., da Silva EF; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. elis-ferreira@ioc.fiocruz.br., do Ó KM; São Lucas Hospital, Petropolis, Rio de Janeiro, Brazil. kyciadoo@gmail.com., Milagres FA; Medicine Faculty, Federal University of Tocantins, Palmas, Brazil. flaviomilagres@uft.edu.br., Cruz MS; Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. marcelosantoscruz@ipub.ufrj.br., Bastos FI; Institute of Communication and Scientific Information & Technology for Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. francisco.inacio.bastos@hotmail.com., Pollo-Flores P; Antonio Pedro University Hospital, Federal Fluminense University, Rio de Janeiro, Brazil. priscilapollo96@gmail.com., Leal E; Federal University of Rio de Janeiro, Campus Macaé, Rio de Janeiro, Brazil. eroleal@gmail.com., Motta-Castro AR; Federal University of Mato Grosso do Sul and FIOCRUZ-MS, Campo Grande, MS, Brazil. arcm.castro@hotmail.com., Pilotto JH; Laboratory of AIDS and Molecular Immunology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. pilotto@ioc.fiocruz.br., Lewis-Ximenez LL; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. llewis@ioc.fiocruz.br., Lampe E; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. elampe@ioc.fiocruz.br., Villar LM; Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. liviafiocruz@gmail.com.; Present address: Viral Hepatitis Laboratory, Helio and Peggy Pereira Pavilion - Ground, Floor - Room B09, FIOCRUZ Av. Brazil, 4365 - Manguinhos, Rio de Janeiro, RJ, 210360-040, Brazil. liviafiocruz@gmail.com.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2015 Nov 30; Vol. 15, pp. 548. Date of Electronic Publication: 2015 Nov 30.
DOI: 10.1186/s12879-015-1249-5
Abstrakt: Background: 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. 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.
Methods: Three 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.
Results: For 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 %.
Conclusions: The 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.
Databáze: MEDLINE
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