Emerging technologies in point-of-care molecular diagnostics for resource-limited settings

References

• Harrington M, Morgan S, Syed J. 2009 Report on tuberculosis. research funding trends, 2005-2008. 2nd edition. TAG; NY, USA: 2010
   Google Scholar
• Petti CA, Polage CR, Quinn TC, et al. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 2006;42(3):377-82
   PubMed Web of Science ®Google Scholar
• Berkelman R, Cassell G, Specter S, et al. The “Achilles heel” of global efforts to combat infectious diseases. Clin Infect Dis 2006;42(10):1503-4
   PubMed Web of Science ®Google Scholar
• Peeling RW, Mabey D. Point-of-care tests for diagnosing infections in the developing world. Clin Microbiol Infect 2010;16(8):1062-9
   Google Scholar
• Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep 2006;8(2):125-31
   PubMedGoogle Scholar
• Franco-Paredes C, Tellez I, del Rio C. Rapid HIV testing: a review of the literature and implications for the clinician. Curr HIV/AIDS Rep 2006;3(4):169-75
   Google Scholar
• Bell D, Peeling RW. Pacific/TDR WH-ROftW. Evaluation of rapid diagnostic tests: malaria. Nat Rev Microbiol 2006;4(9 Suppl):S34-8
   Google Scholar
• Murray CK, Gasser RA Jr, Magill AJ, Miller RS. Update on rapid diagnostic testing for malaria. Clin Microbiol Rev 2008;21(1):97-110
   PubMed Web of Science ®Google Scholar
• Steingart KR, Flores LL, Dendukuri N, et al. Commercial serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: an updated systematic review and meta-analysis. PLoS Med 2011;8(8):e1001062
   PubMed Web of Science ®Google Scholar
• Yager P, Domingo GJ, Gerdes J. Point-of-care diagnostics for global health. Annu Rev Biomed Eng 2008;10:107-44
   PubMed Web of Science ®Google Scholar
• Schito M, Peter TF, Cavanaugh S, et al. Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis. J Infect Dis 2012;205(Suppl 2):S169-80
   PubMed Web of Science ®Google Scholar
• Bissonnette L, Bergeron MG. Diagnosing infections – current and anticipated technologies for point-of-care diagnostics and home-based testing. Clin Microbiol Infect 2010;16(8):1044-53
   Google Scholar
• Dheda K, Ruhwald M, Theron G, et al. Point-of-care diagnosis of tuberculosis: past, present and future. Respirology 2013;18(2):217-32
   PubMed Web of Science ®Google Scholar
• Niemz A, Ferguson TM, Boyle DS. Point-of-care nucleic acid testing for infectious diseases. Trends Biotechnol 2011;29(5):240-50
   PubMed Web of Science ®Google Scholar
• UNITAID. Tuberculosis diagnostics technology and market landscape. UNITAID; Geneva, Switzerland: 2013
   Google Scholar
• UNITAID. HIV/AIDS diagnostic technology landscape. UNITAID; Geneva, Switzerland: 2013
   Google Scholar
• Abubakar I, Zignol M, Falzon D, et al. Drug-resistant tuberculosis: time for visionary political leadership. Lancet Infect Dis 2013;13(6):529-39
   PubMed Web of Science ®Google Scholar
• Joint United Nations Programme on HIV/AIDS (UNAIDS). Treatment 2015. UNAIDS; Geneva, Switzerland: 2013
   Google Scholar
• Kabue MM, Buck WC, Wanless SR, et al. Mortality and clinical outcomes in HIV-infected children on antiretroviral therapy in Malawi, Lesotho, and Swaziland. Pediatrics 2012;130(3):e591-9
   PubMed Web of Science ®Google Scholar
• Aledort JE, Ronald A, Le Blancq SM, et al. Reducing the burden of HIV/AIDS in infants: the contribution of improved diagnostics. Nature 2006;444(Suppl 1):19-28
   Google Scholar
• HIV/AIDS diagnostics technology landscape – semi-annual update. UNITAID. Available from: www.unitaid.eu/images/UNITAID_2013_Semi-annual_Update_HIV_Diagnostics_Technology_Landscape.pdf [Last accessed November 2013]
   Google Scholar
• Corbett EL, Marston B, Churchyard GJ, De Cock KM. Tuberculosis in sub-Saharan Africa: opportunities, challenges, and change in the era of antiretroviral treatment. Lancet 2006;367(9514):926-37
   PubMed Web of Science ®Google Scholar
• McNerney R, Maeurer M, Abubakar I, et al. Tuberculosis diagnostics and biomarkers: needs, challenges, recent advances, and opportunities. J Infect Dis 2012;205(Suppl 2):S147-58
   Google Scholar
• World Health Organisation. Global Tuberculosis Report 201. WHO; Geneva, Switzerland: 2013
   Google Scholar
• Keeler E, Perkins MD, Small P, et al. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature 2006;444(Suppl 1):49-57
   Google Scholar
• World Health Organisation. Strategic and technical advisory group for tuberculosis report of 10th meeting. WHO; Geneva, Switzerland; 2010
   Google Scholar
• Boehme CC, Nicol MP, Nabeta P, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 2011;377(9776):1495-505
   PubMed Web of Science ®Google Scholar
• Theron G, Zijenah L, Chanda D, et al. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet 2014;383(9915):424-35
   PubMed Web of Science ®Google Scholar
• Zumla A, Abubakar I, Raviglione M, et al. Drug-resistant tuberculosis – current dilemmas, unanswered questions, challenges, and priority needs. J Infect Dis 2012;205(Suppl 2):S228-40
   PubMed Web of Science ®Google Scholar
• WHO. Available from: http://apps.who.int/gho/data/view.main.CMNRWORLD-CH9?lang=en [Last accessed 9 January 2014]
   Google Scholar
• Lim YW, Steinhoff M, Girosi F, et al. Reducing the global burden of acute lower respiratory infections in children: the contribution of new diagnostics. Nature 2006;444(Suppl 1):9-18
   Google Scholar
• Kashinkunti MD, Gundikeri SK, Dhananjaya M. Acute undifferentiated febrile illness-clinical spectrum and outcome from a tertiary care teaching hospital of north Karnataka. Indian J Biol Med Res 2013;4(2):3399-402
   Google Scholar
• Reyburn H, Mbakilwa H, Mwangi R, et al. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 2007;334(7590):403
   PubMed Web of Science ®Google Scholar
• Gething PW, Kirui VC, Alegana VA, et al. Estimating the number of paediatric fevers associated with malaria infection presenting to Africa’s public health sector in 2007. PLoS Med 2010;7(7):e1000301
   Google Scholar
• Aledort JE, Ronald A, Rafael ME, et al. Reducing the burden of sexually transmitted infections in resource-limited settings: the role of improved diagnostics. Nature 2006;444(Suppl 1):59-72
   Google Scholar
• Peeling RW, Ronald A. Diagnostic challenges of sexually transmitted infections in resource-limited settings. Future Microbiol 2009;4(10):1271-82
   Google Scholar
• Tucker JD, Bien CH, Peeling RW. Point-of-care testing for sexually transmitted infections: recent advances and implications for disease control. Curr Opin Infect Dis 2013;26(1):73-9
   PubMed Web of Science ®Google Scholar
• Brent AJ, Ahmed I, Ndiritu M, et al. Incidence of clinically significant bacteraemia in children who present to hospital in Kenya: community-based observational study. Lancet 2006;367(9509):482-8
   PubMed Web of Science ®Google Scholar
• Berkley JA, Lowe BS, Mwangi I, et al. Bacteremia among children admitted to a rural hospital in Kenya. N Engl J Med 2005;352(1):39-47
   PubMed Web of Science ®Google Scholar
• Zhou XN, Xu J, Chen HG, et al. Tools to support policy decisions related to treatment strategies and surveillance of Schistosomiasis japonica towards elimination. PLoS Negl Trop Dis 2011;5(12):e1408
   Google Scholar
• Solomon AW, Engels D, Bailey RL, et al. A diagnostics platform for the integrated mapping, monitoring, and surveillance of neglected tropical diseases: rationale and target product profiles. PLoS Negl Trop Dis 2012;6(7):e1746
   Google Scholar
• Grigorenko E, Fisher C, Patel S, et al. Multiplex screening for blood-borne viral, bacterial, and protozoan parasites using an OpenArray platform. J Mol Diagn 2014;16(1):136-44
   Google Scholar
• Cunningham J, Hasker E, Das P, et al. A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis. Clin Infect Dis 2012;55(10):1312-19
   PubMed Web of Science ®Google Scholar
• Chappuis F, Sundar S, Hailu A, et al. Visceral leishmaniasis: what are the needs for diagnosis, treatment and control? Nat Rev Microbiol 2007;5(11):873-82
   PubMed Web of Science ®Google Scholar
• Cota GF, de Sousa MR, Demarqui FN, Rabello A. The diagnostic accuracy of serologic and molecular methods for detecting visceral leishmaniasis in HIV infected patients: meta-analysis. PLoS Negl Trop Dis 2012;6(5):e1665
   Google Scholar
• malERA Consultative Group on Diagnoses, Diagnostics. A research agenda for malaria eradication: diagnoses and diagnostics. PLoS Med 2011;8(1):e1000396
   Google Scholar
• Bejon P, Mwangi I, Ngetsa C, et al. Invasive Gram-negative bacilli are frequently resistant to standard antibiotics for children admitted to hospital in Kilifi, Kenya. J Antimicrob Chemother 2005;56(1):232-5
   Google Scholar
• Gordon MA, Graham SM, Walsh AL, et al. Epidemics of invasive Salmonella enterica serovar enteritidis and S. enterica Serovar typhimurium infection associated with multidrug resistance among adults and children in Malawi. Clin Infect Dis 2008;46(7):963-9
   PubMed Web of Science ®Google Scholar
• Blomberg B, Manji KP, Urassa WK, et al. Antimicrobial resistance predicts death in Tanzanian children with bloodstream infections: a prospective cohort study. BMC Infect Dis 2007;7:43
   PubMed Web of Science ®Google Scholar
• Castan P, de Pablo A, Fernandez-Romero N, et al. Point-of-Care System for Detection of Mycobacterium tuberculosis and Rifampin Resistance in Sputum Samples. J Clin Microbiol 2014;52(2):502-7
   PubMed Web of Science ®Google Scholar
• Huletsky A, Lebel P, Picard FJ, et al. Identification of methicillin-resistant Staphylococcus aureus carriage in less than 1 hour during a hospital surveillance program. Clin Infect Dis 2005;40(7):976-81
   PubMed Web of Science ®Google Scholar
• Bergval I, Sengstake S, Brankova N, et al. Combined species identification, genotyping, and drug resistance detection of Mycobacterium tuberculosis cultures by MLPA on a bead-based array. PLoS One 2012;7(8):e43240
   Google Scholar
• Urdea M, Penny LA, Olmsted SS, et al. Requirements for high impact diagnostics in the developing world. Nature 2006;444(Suppl 1):73-9
   PubMedGoogle Scholar
• Denkinger CM, Nicolau I, Ramsay A, et al. Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics? Eur Respir J 2013;42(2):544-7
   PubMed Web of Science ®Google Scholar
• Curtis KA, Rudolph DL, Nejad I, et al. Isothermal amplification using a chemical heating device for point-of-care detection of HIV-1. PLoS One 2012;7(2):e31432
   PubMed Web of Science ®Google Scholar
• LaBarre P, Hawkins KR, Gerlach J, et al. A simple, inexpensive device for nucleic acid amplification without electricity-toward instrument-free molecular diagnostics in low-resource settings. PLoS One 2011;6(5):e19738
   PubMed Web of Science ®Google Scholar
• Abd El Wahed A, El-Deeb A, El-Tholoth M, et al. A portable reverse transcription recombinase polymerase amplification assay for rapid detection of foot-and-mouth disease virus. PLoS One 2013;8(8):e71642
   PubMed Web of Science ®Google Scholar
• Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med 2011;135(11):1405-14
   PubMed Web of Science ®Google Scholar
• Basu S, Chatterjee S, Bandyopadhyay A, Sarkar K. Potential application of superparamagnetic nanoparticles for extraction of bacterial genomic DNA from contaminated food and environmental samples. J Sci Food Agric 2013;93(4):788-93
   Google Scholar
• Chung HJ, Castro CM, Im H, et al. A magneto-DNA nanoparticle system for rapid detection and phenotyping of bacteria. Nat Nanotechnol 2013;8(5):369-75
   PubMed Web of Science ®Google Scholar
• Lee H, Sun E, Ham D, Weissleder R. Chip-NMR biosensor for detection and molecular analysis of cells. Nat Med 2008;14(8):869-74
   PubMed Web of Science ®Google Scholar
• Tan E, Wong J, Nguyen D, et al. Isothermal DNA amplification coupled with DNA nanosphere-based colorimetric detection. Anal Chem 2005;77(24):7984-92
   PubMed Web of Science ®Google Scholar
• Baptista PV, Koziol-Montewka M, Paluch-Oles J, et al. Gold-nanoparticle-probe-based assay for rapid and direct detection of Mycobacterium tuberculosis DNA in clinical samples. Clin Chem 2006;52(7):1433-4
   PubMed Web of Science ®Google Scholar
• Neely LA, Audeh M, Phung NA, et al. T2 magnetic resonance enables nanoparticle-mediated rapid detection of candidemia in whole blood. Sci Transl Med 2013;5(182):182ra154
   Web of Science ®Google Scholar
• Hahm J. Lieber. Direct ultrasensitive electrical detection of DNA and DNA sequence variations using nanowire nanosensors. Nano Lett 2003;4(1):51054
   Google Scholar
• Lutz S, Weber P, Focke M, et al. Microfluidic lab-on-a-foil for nucleic acid analysis based on isothermal recombinase polymerase amplification (RPA). Lab Chip 2010;10(7):887-93
   PubMed Web of Science ®Google Scholar
• Mauk MG, Liu C-C, Corstjens PLAM, Bau HH. Streamlining POC microfluidic molecular diagnostics. IVD Technology 2011;17(6):22-8
   Google Scholar
• Rozand C. Paper-based analytical devices for point-of-care infectious disease testing. Eur J Clin Microbiol Infect Dis 2014;33(2):147-56
   PubMed Web of Science ®Google Scholar
• Chen D, Mauk M, Qiu X, et al. An integrated, self-contained microfluidic cassette for isolation, amplification, and detection of nucleic acids. Biomed Microdevices 2010;12(4):705-19
   Google Scholar
• Chen Z, Mauk MG, Wang J, et al. A microfluidic system for saliva-based detection of infectious diseases. Ann N Y Acad Sci 2007;1098:429-36
   PubMedGoogle Scholar
• Klostranec JM, Xiang Q, Farcas GA, et al. Convergence of quantum dot barcodes with microfluidics and signal processing for multiplexed high-throughput infectious disease diagnostics. Nano Lett 2007;7(9):2812-18
   PubMed Web of Science ®Google Scholar
• Palamountain KM, Baker J, Cowan EP, et al. Perspectives on introduction and implementation of new point-of-care diagnostic tests. J Infect Dis 2012;205(Suppl 2):S181-90
   PubMed Web of Science ®Google Scholar
• McNerney R, Daley P. Towards a point-of-care test for active tuberculosis: obstacles and opportunities. Nat Rev Microbiol 2011;9(3):204-13
   PubMed Web of Science ®Google Scholar
• Peeling R, McNerney R. Increasing access to diagnostics through technology transfer and local production. WHO; Geneva, Switzerland: 2011
   Google Scholar
• McNerney R, Sollis K, Peeling RW. Improving access to new diagnostics through harmonised regulation: priorities for action. Afr J Lab Med 2014. 3(1): p. 7
   Google Scholar
• The International Diagnostics Centre. Available from: www.idc-dx.org/resources?tid_1[]=26&keys= [Last accessed 12 January 2014]
   Google Scholar
• IMDRF. Available from: www.imdrf.org/workitems/wi-mdsap.asp [Last accessed 13 January 2014]
   Google Scholar
• AHWP. Available from: www.ahwp.info/ [Last accessed 12 January 2014]
   Google Scholar
• PAHWP. Available from: www.pahwp.org/ [Last accessed 12 January 2014]
   Google Scholar
• ALADDiV. Available from: http://en.aladdiv.org.br/ [Last accessed 28 March 2014]
   Google Scholar
• WHO. Tuberculosis. Available from: http://who.int/tb/laboratory/mtbrifrollout/en/ [Last accessed 13 January 2014]
   Google Scholar