title: Sensitivity and specificity of dried blood spots for HIV-1 viral load quantification: A laboratory assessment of 3 commercial assays.
abstract: The use of dried blood spots (DBS) instead of plasma as a specimen type for HIV-1 viral load (VL) testing facilitates the decentralization of specimen collection and can increase access to VL testing in resource-limited settings. The performance of DBS for VL testing is lower, however, when compared to the gold standard sample type plasma. In this diagnostic accuracy study, we evaluated 3 VL assays with DBS.Participants were recruited between August 2012 and April 2015. Both plasma and DBS specimens were prepared and tested for HIV-1 VL with the Roche CAP/CTM HIV-1 test v2.0, the Abbott RealTime HIV-1, and the bioMérieux NucliSENS EasyQ HIV-1 v2.0. Sensitivity and specificity to detect treatment failure at a threshold of 1000 cps/mL with DBS were determined.A total of 272 HIV-positive patients and 51 HIV-negative people were recruited in the study. The mean difference or bias between plasma and DBS VL was <0.5 log cps/mL with all 3 assays but >25% of the specimens differed by >0.5 log cps/mL.All 3 assays had comparable sensitivities around 80% and specificities around 90%. Upward misclassification rates were around 10%, but downward misclassification rates ranged from 20.3% to 23.6%. Differences in between assays were not statistically significant (P > 0.1).The 3 VL assays evaluated had suboptimal performance with DBS but still performed better than immunological or clinical monitoring. Even after the introduction of the much-anticipated point-of-care VL devices, it is expected that DBS will remain important as a complementary option for supporting access to VL monitoring, particularly in rural, resource-limited settings. Manufacturers should accelerate efforts to develop more reliable, sensitive and specific methods to test VL on DBS specimens.
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland Department of HIV and Global Hepatitis Programme, World Health Organization, Geneva, Switzerland.
authors.forename: Pieter
authors.initials: P
authors.lastname: Pannus
authors.forename: Maarten
authors.initials: M
authors.lastname: Claus
authors.forename: Maria Mercedes Perez
authors.initials: MMP
authors.lastname: Gonzalez
authors.forename: Nathan
authors.initials: N
authors.lastname: Ford
authors.forename: Katrien
authors.initials: K
authors.lastname: Fransen
mesh_terms: D001769:Blood / Q000821:virology*; D015497:HIV-1; D006801:Humans; D025202:Molecular Diagnostic Techniques; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D019562:Viral Load
chemical_list: D011933:Reagent Kits, Diagnostic