title: Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests.
abstract: The SAMBA HIV-1 Qual Whole Blood Test is a nucleic acid-based amplification assay for the qualitative detection of HIV-1 in whole blood of adults or infants. The test can be run on either the semi-automated SAMBA I system for clinical use or the fully automated, including readout, SAMBA II system for point-of-care use in resource-limited settings. We have assessed the performance characteristics of the SAMBA HIV-1 Qual Whole Blood Test on SAMBA I and SAMBA II. The limit of detection obtained for the two tests were 518IU/ml and 399copies/ml on SAMBA I and 457IU/ml and 433copies/ml on SAMBA II. Test specificity on both systems was 100% with a panel of 503 HIV-1 negative samples. Evaluation of test reproducibility showed 100% concordance with expected gold standard results as well as 100% agreement between operators, days, and runs as well as within runs on both SAMBA I and SAMBA II. Our results thus show that the SAMBA HIV-1 Qual Whole Blood Test performs equivalently on SAMBA I and SAMBA II, and also suggest that the test is suitable for implementation in medium-throughput clinical facilities (SAMBA I) or low-throughput point-of-care (POC) settings (SAMBA II) in resource-poor regions.
authors: Diagnostics Development Unit, Department of Haematology, University of Cambridge, Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK.
authors: Allyson V
authors: AV
authors: Ritchie
authors: Diagnostics Development Unit, Department of Haematology, University of Cambridge, Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK.
authors: Neha
authors: N
authors: Goel
authors: Diagnostics for the Real World EU Ltd., Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK.
authors: Hiroshi
authors: H
authors: Sembongi
authors: Diagnostics for the Real World Ltd., 840 Del Rey Avenue, Sunnyvale, CA 94085, USA.
authors: Jesse
authors: J
authors: Lehga
authors: Diagnostics for the Real World EU Ltd., Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK.
authors: Laura E
authors: LE
authors: Farleigh
authors: Diagnostics for the Real World Ltd., 840 Del Rey Avenue, Sunnyvale, CA 94085, USA.
authors: Daniel
authors: D
authors: Edemaga
authors: Diagnostics Development Unit, Department of Haematology, University of Cambridge, Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK; Diagnostics for the Real World Ltd., 840 Del Rey Avenue, Sunnyvale, CA 94085, USA.
authors: Craig A
authors: CA
authors: Wisniewski
authors: Diagnostics Development Unit, Department of Haematology, University of Cambridge, Science Village, Chesterford Research Park, Great Chesterford, CB10 1XL, UK; Diagnostics for the Real World Ltd., 840 Del Rey Avenue, Sunnyvale, CA 94085, USA. Electronic address: hl207@cam.ac.uk.
authors: Helen H
authors: HH
authors: Lee
mesh_terms: D000328:Adult; D042241:Early Diagnosis; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D007223:Infant; D057230:Limit of Detection; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014766:Viremia / Q000175:diagnosis / Q000821:virology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Diagnosis; Early infant diagnosis; HIV-1; Point-of-care