Simple amplification-based assay: a nucleic acid-based point-of-care platform for HIV-1 testing

J Infect Dis. 2010 Apr 15;201 Suppl 1:S65-72. doi: 10.1086/650385.

Abstract

Background: A new nucleic acid-based assay (simple amplification-based assay [SAMBA]) for rapid visual detection of human immunodeficiency virus-type 1 (HIV-1) by dipstick is described. The assay was designed to be simple, stable, robust, self-contained, and capable of detecting a broad spectrum of HIV-1 subtypes and recombinant forms.

Methods: The performance of the SAMBA HIV-1 test (amplification and detection chemistry) was evaluated using the World Health Organization HIV-1 RNA Genotype Reference Panel, with clinical samples representing various viral subtypes and recombinant forms common in sub-Saharan Africa. Sixty-nine randomly selected and blinded clinical samples that had undergone HIV-1 genotypic resistance analyses in a large London teaching hospital were also tested. These samples included 14 different viral subtypes or recombinant forms with viral loads of 78-9.5 x 10(6) copies/mL.

Results: The sensitivity and viral subtype coverage of the SAMBA HIV-1 test were either comparable to or better than those of the commercially available nucleic acid-based HIV-1 diagnostic tests.

Conclusions: The unique characteristics and competitive performance of the SAMBA HIV-1 test render it suitable for point-of-care and near-patient testing in both developed and developing countries.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa South of the Sahara
  • HIV Infections / diagnosis*
  • Humans
  • Molecular Diagnostic Techniques / methods*
  • Nucleic Acid Amplification Techniques / methods*
  • Point-of-Care Systems*
  • Sensitivity and Specificity