title: Comparison of HIV-1 detection in plasma specimens and dried blood spots using the Roche COBAS Ampliscreen HIV-1 test in Kisumu, Kenya.
abstract: The World Health Organization recommends screening donor blood for HIV in centralized laboratories. This recommendation contributes to quality, but presents specimen transport challenges for resource-limited settings which may be relieved by using dried blood spots (DBS). In sub-Saharan Africa, most countries screen donor blood with serologic assays only. Interest in window period reduction has led blood services to consider adding HIV nucleic acid testing (NAT). The U.S. Food and Drug Administration (FDA) mandates that HIV-1 NAT blood screening assays have a 95% detection limit at or below 100 copies/ml and 5000 copies/ml for pooled and individual donations, respectively. The Roche COBAS Ampliscreen HIV-1 test, version 1.5, used for screening whole blood or components for transfusion, has not been tested with DBS. We compared COBAS Ampliscreen HIV-1 RNA detection limits in DBS and plasma. An AIDS Clinical Trials Group, Viral Quality Assurance laboratory HIV-1 standard with a known viral load was used to create paired plasma and DBS standard nine member dilution series. Each was tested in 24 replicates with the COBAS Ampliscreen. A probit analysis was conducted to calculate 95% detection limits for plasma and DBS, which were 23.8 copies/ml (95% CI 15.1-51.0) for plasma and 106.7 copies/ml (95% CI 73.8-207.9) for DBS. The COBAS Ampliscreen detection threshold with DBS suggests acceptability for individual donations, but optimization may be required for pooled specimens.
authors.affiliation: Centre for Biomedical Research and Technology, Kenya Medical Research Institute (KEMRI), Off Kisumu-Busia Road, P.O. Box 1578-40100, Kisumu, Kenya. jokonji@ke.cdc.gov
authors.forename: Jully A
authors.initials: JA
authors.lastname: Okonji
authors.forename: Sridhar V
authors.initials: SV
authors.lastname: Basavaraju
authors.forename: Jane
authors.initials: J
authors.lastname: Mwangi
authors.forename: Ray W
authors.initials: RW
authors.lastname: Shiraishi
authors.forename: Matthew
authors.initials: M
authors.lastname: Odera
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ouma
authors.forename: John P
authors.initials: JP
authors.lastname: Pitman
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Marum
authors.forename: Chin-Yih
authors.initials: CY
authors.lastname: Ou
authors.forename: Clement
authors.initials: C
authors.lastname: Zeh
mesh_terms: D017954:Africa South of the Sahara; D001769:Blood / Q000821:virology*; D003890:Desiccation; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007630:Kenya; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010949:Plasma / Q000821:virology*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic