Simple amplification-based assay: a nucleic acid-based point-of-care platform for HIV-1 testing.
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.
Lee
Helen H
HH
Diagnostics Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom. hl207@cam.ac.uk
Dineva
Magda A
MA
Chua
Yii Leng
YL
Ritchie
Allyson V
AV
Ushiro-Lumb
Ines
I
Wisniewski
Craig A
CA
D017954:Africa South of the Sahara; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity