Analytical performances of simultaneous detection of HIV-1, HIV-2 and hepatitis C- specific antibodies and hepatitis B surface antigen (HBsAg) by multiplex immunochromatographic rapid test with serum samples: A cross-sectional study

Abstract

Background: The HIV/HCV/HBsAg Triplex consists in manually performed, visually interpreted, lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting in 15min human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (Ab) (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood.

Methods: A hospital-based cross-sectional study was conducted on a prospective panel of serum samples from adult inpatients included from routine analysis irrespectively of age and sex, including 250 sera positive for HIV-1-specific Ab, 250 for HCV-specific Ab, 250 for HBsAg and 250 sera negative for HIV- and HCV- Ab and HBsAg, and from 110 HIV-2-infected patients living in Ivory Coast, according to the results obtained by the reference chemiluminiscent microparticle immunoassay (CMIA) Abbott Architect i2000SR analyzer (Abbott Diagnostic, Chicago, IL, USA). Among HCV-seropositive sera, 187 were positive for HCV RNA (chronic infection), whereas 63 were negative (resolved infection), respectively. Serum samples were further tested blindly by HIV/HCV/HBsAg Triplex according to manufacturers' recommendations.

Results: HIV/HCV/HBsAg Triplex showed very high sensitivity and specificity, as well as excellent concordance with CMIA Abbott results, as shown in the Table. Lower sensitivity was observed only in individuals who had cleared their HCV infection (presence of HCV-specific Ab in absence of HCV RNA). The mean lower limit of HBsAg detection was 2.38±0.63 IU/ml. Erythrocytes-spiked serum samples gave similar results than serum samples.

Conclusions: Advantages of HIV/HCV/HBsAg Triplex for HIV-1, HIV-2, HCV and HBV include the requirement for less overall specimen volume, fewer finger-sticks if capillary whole blood is used, cost savings through lower cost per virus tested, improved patient flow with results for multiple viruses available at the same time, overall service delivery efficiencies with less time required per infected patient; and patient benefits from fewer visits and lower cost associated with each clinic attendance. The screening of chronic HIV, HCV and HBV by multiplex HIV-1/HIV-2/HCV/HBsAg Triplex may improve the "cascade of screening" and quite possibly linkage-to-care with reduced cost.

Keywords: Blood-specimen; HCV testing; HIV-1 testing; HIV-2 testing; Hepatitis B surface antigen detection; Immunochromatography; Multiplex; Predictive values; Rapid diagnostic test; Sensitivity; Specificity.