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Comparative Study
. 2017 Jun:91:84-89.
doi: 10.1016/j.jcv.2017.03.011. Epub 2017 Mar 20.

Evaluation of dried blood spot protocols with the Bio-Rad GS HIV Combo Ag/Ab EIA and Geenius™ HIV 1/2 Supplemental Assay

Wei Luo  1 , Geoff Davis  2 , LiXia Li  1 , M Kathleen Shriver  2 , Joanne Mei  1 , Linda M Styer  3 , Monica M Parker  3 , Amanda Smith  1 , Gabriela Paz-Bailey  1 , Steve Ethridge  1 , Laura Wesolowski  1 , S Michele Owen  1 , Silvina Masciotra  4
Affiliations
Comparative Study

Evaluation of dried blood spot protocols with the Bio-Rad GS HIV Combo Ag/Ab EIA and Geenius™ HIV 1/2 Supplemental Assay

Wei Luo et al. J Clin Virol. 2017 Jun.

Abstract

Objective: FDA-approved antigen/antibody combo and HIV-1/2 differentiation supplemental tests do not have claims for dried blood spot (DBS) use. We compared two DBS-modified protocols, the Bio-Rad GS HIV Combo Ag/Ab (BRC) EIA and Geenius™ HIV-1/2 (Geenius) Supplemental Assay, to plasma protocols and evaluated them in the CDC/APHL HIV diagnostic algorithm.

Methods: BRC-DBS p24 analytical sensitivity was calculated from serial dilutions of p24. DBS specimens included 11 HIV-1 seroconverters, 151 HIV-1-positive individuals, including 20 on antiretroviral therapy, 31 HIV-2-positive and one HIV-1/HIV-2-positive individuals. BRC-reactive specimens were tested with Geenius using the same DBS eluate. Matched plasma specimens were tested with BRC, an IgG/IgM immunoassay and Geenius. DBS and plasma results were compared using the McNemar's test. A DBS-algorithm applied to 348 DBS from high-risk individuals who participated in surveillance was compared to HIV status based on local testing algorithms.

Results: BRC-DBS detects p24 at a concentration 18 times higher than in plasma. In seroconverters, BRC-DBS detected more infections than the IgG/IgM immunoassay in plasma (p=0.0133), but fewer infections than BRC-plasma (p=0.0133). In addition, the BRC/Geenius-plasma algorithm identified more HIV-1 infections than the BRC/Geenius-DBS algorithm (p=0.0455). The DBS protocols correctly identified HIV status for established HIV-1 infections, including those on therapy, HIV-2 infections, and surveillance specimens.

Conclusions: The DBS protocols exhibited promising performance and allowed rapid supplemental testing. Although the DBS algorithm missed some early infections, it showed similar results when applied to specimens from a high-risk population. Implementation of a DBS algorithm would benefit testing programs without capacity for venipuncture.

Keywords: DBS testing; HIV diagnostics; Surveillance.

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Conflict of interest statement

Competing interests

M. Kathleen Shriver and Geoff Davis are employees of Bio-Rad Laboratories. The other authors have no conflicts of interest to declare.

Figures

Fig. 1.
Fig. 1.
p24 analytical sensitivity of the Bio-Rad Combo investigational DBS protocol. [Table: see text]
See this image and copyright information in PMC

References

    1. Branson BM, Mermin J, Establishing the diagnosis of HIV infection: new tests and a new algorithm for the United States, J. Clin. Virol 52 (Suppl. 1) (2011) S3–S4. - PubMed
    1. Centers for Disease Control and Prevention and Association of Public Health Laboratories, Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations, 2014.
    1. Masciotra S, et al. , Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections, J. Clin. Virol 52 (Suppl. 1) (2011) S17–S22. - PubMed
    1. Monleau M, et al. , Effect of storage conditions of dried plasma and blood spots on HIV-1 RNA quantification and PCR amplification for drug resistance genotyping, J. Antimicrob. Chemother 65 (8) (2010) 1562–1566. - PubMed
    1. Monleau M, et al. , Field evaluation of dried blood spots for routine HIV-1 viral load and drug resistance monitoring in patients receiving antiretroviral therapy in Africa and Asia, J. Clin. Microbiol 52 (2) (2014) 578–586. - PMC - PubMed

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