Feasibility of HIV point-of-care tests for resource-limited settings: challenges and solutions

Wendy Stevens, Natasha Gous, Nathan Ford, Lesley E Scott, Wendy Stevens, Natasha Gous, Nathan Ford, Lesley E Scott

Abstract

Improved access to anti-retroviral therapy increases the need for affordable monitoring using assays such as CD4 and/or viral load in resource-limited settings. Barriers to accessing treatment, high rates of loss to initiation and poor retention in care are prompting the need to find alternatives to conventional centralized laboratory testing in certain countries. Strong advocacy has led to a rapidly expanding repertoire of point-of-care tests for HIV. point-of-care testing is not without its challenges: poor regulatory control, lack of guidelines, absence of quality monitoring and lack of industry standards for connectivity, to name a few. The management of HIV increasingly requires a multidisciplinary testing approach involving hematology, chemistry, and tests associated with the management of non-communicable diseases, thus added expertise is needed. This is further complicated by additional human resource requirements and the need for continuous training, a sustainable supply chain, and reimbursement strategies. It is clear that to ensure appropriate national implementation either in a tiered laboratory model or a total decentralized model, clear country-specific assessments need to be conducted.

References

    1. UNAIDS: Global Report. UNAIDS Report on the global AIDS epidemic 2013. []
    1. UNAIDS: Global Report. UNAIDS Report on the global AIDS epidemic 2012. []
    1. World Health Organization: Scaling up antiretroviral therapy in resource limited settings. Guidelines for a public health approach 2002. []
    1. World Health Organization: Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach 2010. []
    1. World Health Organization: Consolidated guidelines on the use of anti-retrovirals for treating and preventing HIV infection: Recommendations for a public health approach 2013. []
    1. De Cock KM, El-Sadr WM. Perspective: When to start ART in Africa—an urgent research priority. N Engl J Med. 2013;368:886–889. doi: 10.1056/NEJMp1300458.
    1. Nkengasong JN. A shifting paradigm in strengthening laboratory health systems for global health: acting now, acting collectively, but acting differently. Am J Clin Pathol. 2010;134:359–360. doi: 10.1309/AJCPY5ASUEJYQ5RK.
    1. Clouse K, Pettifor AE, Maskew M, Bassett J, Van Rie A, Behets F, Gay C, Sanne I, Fox MP. Patient retention from HIV diagnosis through one year on antiretroviral therapy at a primary health care clinic in Johannesburg, South Africa. J Acquir Immune Defic Syndr. 2013;62:e39–e46. doi: 10.1097/QAI.0b013e318273ac48.
    1. Govender N, Chetty V, Roy M, Chiller TM, Oladoyinbo S, Maotoe T, Stevens WS, Pinini Z, Spencer D, Venter F, Jassat W, Cameron D, Meintjes G, Mbengashe T, Pillay Y. Phased implementation of screening for cryptococcal disease in South Africa. S Afr Med J. 2012;102:914–917. doi: 10.7196/samj.6228.
    1. Calmy A, Ford N, Hirschel B, Reynolds SJ, Lynen L, Goemaere E, Garcia de la Vega F, Perrin L, Rodriguez W. HIV viral load monitoring in resource-limited regions: optional or necessary? Clin Infect Dis. 2007;44:128–134. doi: 10.1086/510073.
    1. Rutherford GW, Anglemyer A, Easterbrook PJ, Horvath T, Vitoria M, Penazzato M, Doherty MC. Predicting treatment failure in adults and children on antiretroviral therapy: a systematic review of the performance characteristics of the 2010 WHO immunologic and clinical criteria for virologic failure. AIDS. 2014;2:S161–S169. doi: 10.1097/QAD.0000000000000236.
    1. World Health Organization/UNITAID: HIV/AIDS Diagnostics Technology Landscape 2014 4th Edition. []
    1. World Health Organization/UNITAID: HIV/AIDS: Diagnostic Technology landscape. Semi-annual update 2013. []
    1. Gale HB, Gitterman SR, Hoffman HJ, Gordin FM, Benator DA, Labriola AM, Kan VL. Is frequent CD4+ T-lymphocyte count monitoring necessary for persons with counts > =300 cells/uL and HIV-1 suppression? Clin Infect Dis. 2013;56:1340–1343. doi: 10.1093/cid/cit004.
    1. Mosen DM, Horberg M, Roblin D, Gullion CM, Meenan R, Leyden W, Hu W. Effect of once-daily FDC treatment era on initiation of cART. HIV AIDS (Auckl) 2010;2:19–26.
    1. World Health Organization: March 2014 Supplement to the 2013 Consolidated Guidelines on the use of Antiretroviral Drugs for Treating and Preventing HIV infection. []
    1. World Health Organization: Global Tuberculosis Report 2013. Country profiles. []
    1. Kost GJ. Point-of-care testing in intensive care, and planning and implementing point-of-care test systems. In: Tobin MA, editor. Principles and Practice of Intensive Care Monitoring. New York, NY: McGraw Hill; 1998. pp. 1267–1328.
    1. Zucker ML. Point of care testing guideline published by CLSI. Lab Medicine. 2010;41:499–500. doi: 10.1309/LM22RU1RCUXZPRXN.
    1. Kilgore ML, Steindel SJ, Smith JA. Cost analysis for decision support: the case of comparing centralized versus distributed methods for blood gas testing. J Healthc Manag. 1999;44:207–215.
    1. Kost GJ, Ehrmeyer SS, Chernow B, Winkelman JW, Zaloga GP, Dellinger RP, Shirey T. The laboratory-clinical interface: point-of-care testing. Chest. 1999;115:1140–1154. doi: 10.1378/chest.115.4.1140.
    1. Plebani M. Does POCT reduce the risk of error in laboratory testing? Clin Chim Acta. 2009;404:59–64. doi: 10.1016/j.cca.2009.03.014.
    1. Warsinke A. Point-of-care testing of proteins. Anal Bioanal Chem. 2009;393:1393–1405. doi: 10.1007/s00216-008-2572-0.
    1. Hammett-Stabler CA, Nichols JH. Point-of-care testing, a critical component of laboratory medicine. Clin Biochem. 2009;42:135. doi: 10.1016/j.clinbiochem.2008.09.097.
    1. Lewandrowski K. Point-of-care testing: an overview and a look to the future (circa 2009, United States) Clin Lab Med. 2009;29:421–432. doi: 10.1016/j.cll.2009.06.015.
    1. Girardin CM, Huot C, Gonthier M, Delvin E. Continuous glucose monitoring: a review of biochemical perspectives and clinical use in type 1 diabetes. Clin Biochem. 2009;42:136–142. doi: 10.1016/j.clinbiochem.2008.09.112.
    1. Sorger PK. Microfluidics closes in on point-of-care assays. Nat Biotechnol. 2008;26:1345–1346. doi: 10.1038/nbt1208-1345.
    1. Kricka LJ. Microchips, microarrays, biochips and nanochips: personal laboratories for the 21st century. Clin Chim Acta. 2001;307:219–223. doi: 10.1016/S0009-8981(01)00451-X.
    1. Alharbi KK, Al-Sheikh YA. Role and implications of nanodiagnostics in the changing trends of clinical diagnosis. Saudi J Biol Sci. 2014;21:109–117. doi: 10.1016/j.sjbs.2013.11.001.
    1. Syed MA. Advances in nanodiagnostic techniques for microbial agents. Biosens Bioelectron. 2014;51:391–400. doi: 10.1016/j.bios.2013.08.010.
    1. Jani IV, Peter T. How point-of-care testing could drive innovation in global health. New Engl J Med. 2013;368:2319–2324. doi: 10.1056/NEJMsb1214197.
    1. Grand View Research: Report 2014: Point of Care Diagnostics (POC) Market Analysis By Product (Blood Gas/Electrolytes, Infectious Diseases, Hospital Glucose Testing, Cardiac Markers, Hematology, Coagulation, Primary Care Systems, Decentralized Clinical Chemistry, Urinalysis, Drug Abuse Testing, Fertility, OTC and Rapid Diagnostic Tests) And Segment Forecasts To 2020. []
    1. WHO Department of HIV/AIDS,UNAIDS: The treatment 2.0 framework for action: catalysing the next phase of treatment, care and support. Accessed August 2014.
    1. WHO: Consolidated guidelines on the use of antiretroviral drugs for treatment and prevention of HIV infection.. Accessed August 2014.
    1. Fox MP, Shearer K, Maskew M, Macleod W, Majuba P, Macphail P, Sanne I. Treatment outcomes after 7 years of public-sector HIV treatment. AIDS. 2012;26:1823–1828. doi: 10.1097/QAD.0b013e328357058a.
    1. WHO: Global Health Strategy on HIV/AIDS: 2011-2015.. Accessed August 2014.
    1. Peeling RW, McNerney R. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings. Expert Rev Mol Diagn. 2014;14:525–534. doi: 10.1586/14737159.2014.915748.
    1. South African National Accreditation System: ISO Point-of-care testing (POCT) - requirements for quality and competence, in ISO 22870:2006200. []
    1. Scott L: An evaluation of the Liat assay (IQUUM). []
    1. Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, Quevedo JI, Lehe JD, Loquiha O, Vojnov L, Peter TF. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014;16:e1–e4. doi: 10.1097/QAI.0000000000000250.
    1. Lee H, Diagnostics for the Real World, Ltd . Presentation in 1st International Conference of the African Society for Laboratory Medicine: 2012 December 1-7; Cape Town, South Africa. Cape Town: ASLM; 2013. Point of care HIV molecular tests: Bridging the gap between laboratory and patient.
    1. Logan C, Givens M, Ives JT, Delaney M, Lochhead MJ, Schooley RT, Benson CA. Performance evaluation of the MBio Diagnostics point-of-care CD4 counter. J Immunol Methods. 2013;387:107–113. doi: 10.1016/j.jim.2012.10.002.
    1. Bornheimer S, Bui N, Le D, Wai H, Tran A, Goldberg E, Bouic P, Huang W, Sugarman J, Crowe M, Kumar V, Shook J, Tomas C, Yu J, Clark A, Broszeit E, Chen R, Bush-Donovan C. Poster presentation TUPE265 in 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention: 2013 June 30 - July 3, Kuala Lumpur. Kuala Lumpur: International AIDS Society; 2013. Development of the BD FACSPresto instrument, a new point-of-care system for CD4+ counting.
    1. Murtagh M: Viral load: Current technologies and the pipeline, including point-of-care assays. []
    1. Gandelman OA, Church VL, Moore CA, Kiddle G, Carne CA, Parmar S, Jalal H, Tisi LC, Murray JA. Novel bioluminescent quantitative detection of nucleic acid amplification in real-time. PLoS One. 2010;5:e14155. doi: 10.1371/journal.pone.0014155.
    1. Laurence C, Gialamas A, Yelland L, Bubner T, Ryan P, Willson K, Glastonbury B, Gill J, Shephard M, Beilby J. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics. Trials. 2008;9:50. doi: 10.1186/1745-6215-9-50.
    1. Shephard MD, Mazzachi BC, Watkinson L, Shephard AK, Laurence C, Gialamas A, Bubner T. Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices. Rural Remote Health. 2009;9:1189.
    1. Shephard MD. Influence of geography on the performance of quality control testing in the Australian Government's point of care testing in general practice trial. Clin Biochem. 2009;42:1325–1327. doi: 10.1016/j.clinbiochem.2009.05.008.
    1. South African National Department of Health, National Health Laboratory Service: Point-of-care testing: Position paper Forum Report to support National Strategic Plan for POCT for the management of HIV and TB in South Africa: An overview of the Point-Of Care Forum hosted by the National Department of Health. 2013. In preparation.
    1. Jani IV, Sitoe NE, Alfai ER, Chongo PL, Quevedo JI, Rocha BM, Lehe JD, Peter TF. Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet. 2011;378:1572–1579. doi: 10.1016/S0140-6736(11)61052-0.
    1. World Health Organization: Prequalification of diagnostics. []
    1. Benzaken AS, Bazzo ML, Galban E, Pinto IC, Nogueira CL, Golfetto L, Benzaken NS, Sollis KA, Mabey D, Peeling RW. External quality assurance with dried tube specimens (DTS) for point-of-care syphilis and HIV tests: experience in an indigenous populations screening programme in the Brazilian Amazon. Sex Transm Infect. 2014;90:14–18.
    1. Gous N, Cunningham B, Kana B, Stevens W, Scott LE. Performance monitoring of mycobacterium tuberculosis dried culture spots for use with the GeneXpert system within a national program in South Africa. J Clin Microbiol. 2013;51:4018–4021. doi: 10.1128/JCM.01715-13.
    1. Scott LE, Gous N, Cunningham BE, Kana BD, Perovic O, Erasmus L, Coetzee GJ, Koornhof H, Stevens W. Dried culture spots for Xpert MTB/RIF external quality assessment: results of a phase 1 pilot study in South Africa. J Clin Microbiol. 2011;49:4356–4360. doi: 10.1128/JCM.05167-11.
    1. Cepheid: Remote connectivity. In Presentation in 5th Annual GLI Conference: 2013 April 15-18; Annecy, France. []
    1. Kessler HH, Jungkind D, Stelzl E, Direnzo S, Vellimedu SK, Pierer K, Santner B, Marth E. Evaluation of AMPLILINK software for the COBAS AMPLICOR system. J Clin Microbiol. 1999;37:436–437.
    1. St John A, Merkle H. A connectivity standard for point-of-care testing. Med Device Technol. 2001;12:23–26.
    1. Stevens W: Viral load testing in Africa - 23 years later. []
    1. Faal M, Naidoo N, Glencross DK, Venter WD, Osih R. Providing immediate CD4 count results at HIV testing improves ART initiation. J Acquir Immune Defic Syndr. 2011;58:e54–e59. doi: 10.1097/QAI.0b013e3182303921.
    1. Manyazewal T, Paterniti AD, Redfield RR, Marinucci F. Role of secondary level laboratories in strengthening quality at primary health care facilities’ laboratories: an innovative approach to ensure accurate HIV, tuberculosis and malaria tests is resource-limited settings. Diagn Microbiol Infect Dis. 2013;75:55–59. doi: 10.1016/j.diagmicrobio.2012.09.020.
    1. World Health Organization: The Maputo declaration on strengthening of laboratory systems 2008. []

Source: PubMed

3
Subskrybuj