Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST for sample collection

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Abstract

Background

Utilization of dried plasma for HIV-1 viral load testing would significantly decrease sample shipping costs.

Objectives

To describe the precision and reproducibility of ViveST® (ST) as a transportation method for shipping specimens for HIV-1 viral load (VL) testing.

Study design

Thirty clinical plasma samples were used to generate replicate samples with HIV VL values of 4 log10, 3 log10 and 2 log10 copies/mL for reproducibility testing and an additional 299 samples with HIV VL <50 copies/mL (99); 1.7 log10 to 3.99 log10 (100); and 4 log10 to 5.99 log10/mL (100) were used to compare ViveST to frozen plasma samples using the VERSANT® HIV-1 RNA 3.0 Assay. Results were compared using Student t-test, Pearson correlation and Bland–Altman analyses.

Results

Mean intra-assay variance among frozen and dried plasma triplicates was 0.15 log10 and 0.09 log10 copies/mL respectively (n = 10, P = NS). Compared to frozen plasma, there was a mean reduction of 0.3 log10, 0.27 log10, and 0.35 log10 copies/mL at the 4 log10, 3 log10, and 2 log10 copy/mL samples respectively (n = 30, all comparisons, P < 0.01). Overall correlation between 299 frozen and ViveST samples was r = 0.97, where 12 of 99 undetectable frozen VL were positive with ST, and 12 of 200 frozen detectable VL were undetectable with ViveST (mean VL 2.1, 1.9 log10 copies/mL respectively).

Conclusions

HIV-1 viral load results using ViveST were reproducible, correlated well with frozen plasma, though yielding minimally lower values. Our data suggest that dried plasma for HIV-1 VL testing using ViveST has promise for use in HIV clinical practice.

Section snippets

Background

Plasma HIV-1 viral load (VL) testing is commonly used to monitor HIV-1 infected patients receiving antiretroviral (ARV) therapy, to assess clinical disease progression, or to detect acute HIV infection in some clinical circumstances.1 Guidelines for HIV-1 viral load testing in developing countries have been established to confirm treatment failure as well.2 Several commercial VL assay platforms are currently available and various government-approved assays require blood plasma separation and

Objectives

To describe the precision and reproducibility of using ViveST® as a transportation method for dried specimens for subsequent HIV-1 viral load (VL) testing in Brazil.

Study design

All samples were obtained from HIV-1 infected patients in Brazil and the study was approved by the ethics committee at the Universidade Federal de Sao Paulo, Sao Paulo, Brazil.

Results

Ten samples analyzed in triplicate demonstrated a mean intra-assay variance among replicates of 0.15 log10 and 0.09 log10 copies/mL for fresh and ViveST® dried plasma respectively (P = NS). Thirty samples each at 4 log10, 3 log10, and 2 log10 copies/mL were then compared. There was a mean reduction in viral load of 0.3 log10, 0.27 log10, and 0.35 log10 copies/mL at the 4, 3, and 2 log10 copy/mL samples respectively (all comparisons, P < 0.01). There was no significant difference between reductions

Discussion

We have demonstrated that bDNA HIV-1 viral load results from dried plasma eluted from ViveST® are generally comparable to that of fresh plasma. Although only bDNA was used in this study, we have previously shown that other available HIV-1 assay platforms including Amplicor, NucliSens and M2000 HIV-1 viral load assay perform well using ViveST.8, 10 The results with bDNA reported here are consistent and modestly improved from our previous results using this assay, which indicated that HIV-1 viral

Conflict of interest

Michelle Zanoni, Ricardo S. Diaz, Rodrigo Cortes, M. Cecilia Sucupira, Cintia Vilhena, Denise Ferreira, Lilian A. Inocencio, and Mark Holodniy have no conflict of interest.Clive Loveday and R.M. Lloyd Jr. are paid consultants of ViveBio.

References (21)

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