Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST? for sample collection
R.S. Diaz1, M. Zanoni1, C. Loveday2, M. Holodniy3, R.M. Lloyd Jr.4
1Federal University of Sao Paulo, Retrovirology Laboratory, Sao Paulo, Brazil, 2ICVC Charitable Trust HQ, Clinical Director, Buckinghamshire, United Kingdom, 3VA Palo Alto Healthcare System, AIDS Research Center, Palo Alto, United States, 4Research Think Tank, Inc., CEO, Buford, United States
Background: ViveST? (ST) is an inexpensive transportation system for HIV-1 virologic assays of dried plasma. Herein we describe the precision, and reproducibility of using ViveST? as a transportation method for shipping specimens and subsequent HIV-1 viral load (VL) testing.
Methods: Ten-fold dilutions from clinical plasma
samples with HIV VL > 5 log10/mL were created to generate samples
with values of 4 log10, 3 log10 and 2 log10 copies/mL.
Thirty singlicate samples at each dilution from ST were compared to frozen (F)
(180 samples). Ten samples in triplicate were compared F to ST (60 samples).
Finally, 299 samples with HIV VL < 50 copies/mL (99); 1.7 log10 to
3.99 log10 (100); and 4 log10 to 5.99 log10
(100) were applied to ST, dried via driDOC for 12 hours, stored at room
temperature for up to 4 days, and reconstituted using 1.175mL of buffer and
compared to F using the Siemens VERSANT® HIV-1 RNA 3.0 Assay (bDNA).
Significance was analyzed using Student t-test and Pearson correlation.
F vs. ST dried plasma intra-assay
mean variance among 3 dried replicates was < 0.15 log10 copies/mL
(P = NS). Compared to F plasma, there
was a mean reduction in VL of 0.3, 0.27, and 0.35 log10
copies/mL at the 4, 3, 2 log10 copy/mL samples respectively (all
comparisons, P < 0.01). 12/99 undetectable F VL were positive with ST,
whereas 5/100 F detectable VL were undetectable with ST (mean VL 2.1, 2.3 log10/mL
respectively). Overall correlation between F and ST was r =0.97.
Conclusions: Viral load results using SampleTanker were highly reproducible. Quantitation of HIV-1 viral load assays
using dried plasma yielded minimally lower values compared to frozen
plasma, and were within accepted assay variation for replicate
samples. Our comparative data suggests that
SampleTanker has promise for use in HIV clinical practice.
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