Smit P.W., Sollis K.A., Fiscus S., Ford N., Vitoria M., Essajee S., Barnett D., Cheng B., Crowe S.M., Denny T., Landay A., Stevens W., Habiyambere V., Perriens J.H., Peeling R.W.
Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC, United States; Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; HIV, Medicine and Science, Clinton Health Access Initiative, New York, NY, United States; Department of Haematology, UK NEQAS for Leucocyte Immunophenotyping, Sheffield, United Kingdom; Department of Technology and Innovation, Pangaea Global AIDS Foundation, San Fransisco, CA, United States; Centre for Biomedical Research, Burnet Institute, Melbourne, VIC, Australia; Department of Medicine, Duke Human Vaccine Institute, Center for HIV/AIDS Vaccine Immunology, Durham, NC, United States; Department of Immunology- Microbiology, Rush University Medical Center, Chicago, IL, United States; Department of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg, South Africa
Smit, P.W., Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom; Sollis, K.A., Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom; Fiscus, S., Department of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC, United States; Ford, N., Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; Vitoria, M., Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; Essajee, S., HIV, Medicine and Science, Clinton Health Access Initiative, New York, NY, United States; Barnett, D., Department of Haematology, UK NEQAS for Leucocyte Immunophenotyping, Sheffield, United Kingdom; Cheng, B., Department of Technology and Innovation, Pangaea Global AIDS Foundation, San Fransisco, CA, United States; Crowe, S.M., Centre for Biomedical Research, Burnet Institute, Melbourne, VIC, Australia; Denny, T., Department of Medicine, Duke Human Vaccine Institute, Center for HIV/AIDS Vaccine Immunology, Durham, NC, United States; Landay, A., Department of Immunology- Microbiology, Rush University Medical Center, Chicago, IL, United States; Stevens, W., Department of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg, South Africa; Habiyambere, V., Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; Perriens, J.H., Department of HIV/AIDS, World Health Organization, Geneva, Switzerland; Peeling, R.W., Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom
Background: Dried blood spots (DBS) have been used as alternative specimens to plasma to increase access to HIV viral load (VL) monitoring and early infant diagnosis (EID) in remote settings. We systematically reviewed evidence on the performance of DBS compared to plasma for VL monitoring and EID. Methods and Findings: Thirteen peer reviewed HIV VL publications and five HIV EID papers were included. Depending on the technology and the viral load distribution in the study population, the percentage of DBS samples that are within 0.5 log of VL in plasma ranged from 52-100%. Because the input sample volume is much smaller in a blood spot, there is a risk of false negatives with DBS. Sensitivity of DBS VL was found to be 78-100% compared to plasma at VL below 1000 copies/ml, but this increased to 100% at a threshold of 5000 copies/ml. Unlike a plasma VL test which measures only cell free HIV RNA, a DBS VL also measures proviral DNA as well as cell-associated RNA, potentially leading to false positive results when using DBS. The systematic review showed that specificity was close to 100% at DBS VL above 5000 copies/ml, and this threshold would be the most reliable for predicting true virologic failure using DBS. For early infant diagnosis, DBS has a sensitivity of 100% compared to fresh whole blood or plasma in all studies. Conclusions: Although limited data are available for EID, DBS offer a highly sensitive and specific sampling strategy to make viral load monitoring and early infant diagnosis more accessible in remote settings. A standardized approach for sampling, storing, and processing DBS samples would be essential to allow successful implementation. Trial Registration: PROSPERO Registration #: CRD42013003621. © 2014 Smit et al.