Point-of-care diagnostics, a major opportunity for change in traditional diagnostic approaches: Potential and limitations

Expert Review of Molecular Diagnostics

Volumn 14, Issue 8, 2014, Pages 979-998

  McPartlin, Daniel A ^a   O'Kennedy, Richard J ^a  

^a DUBLIN CITY UNIVERSITY   (Ireland)

Author keywords

acute myocardial infarction; antibody; biosensor; cardiovascular disease; HIV; mHealth; POC; prostate cancer; TB

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CARBONATE DEHYDRATASE III; D DIMER; FATTY ACID BINDING PROTEIN; GAMMA INTERFERON INDUCIBLE PROTEIN 10; ISCHEMIA MODIFIED ALBUMIN; MONOCYTE CHEMOTACTIC PROTEIN 2; PROSTATE SPECIFIC ANTIGEN; TROPONIN I; TROPONIN T;

ACUTE HEART INFARCTION; BIOSENSOR; CANCER TEST; CARDIOVASCULAR DISEASE; CHEMILUMINESCENCE ANALYZER; CHEMILUMINESCENCE IMMUNOASSAY KIT; CONDUCTOMETRIC BIOSENSOR; ENZYME LINKED IMMUNOSPOT ASSAY; FLOW CYTOMETER; HIV TEST; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOASSAY; IMMUNOASSAY ANALYZER; IMPEDIMETRIC BIOSENSOR; LATERAL FLOW IMMUNOASSAY; MICROPARTICLE ENZYME IMMUNOASSAY; NUCLEIC ACID AMPLIFICATION; NUCLEIC ACID ANALYSIS; PIEZOELECTRIC BIOSENSOR; POINT OF CARE TESTING; PROSTATE CANCER; REVIEW; TUBERCULOSIS; CARDIOVASCULAR DISEASES; DEVICES; DIAGNOSTIC PROCEDURE; GENETIC PROCEDURES; HIV INFECTIONS; HOSPITAL INFORMATION SYSTEM; HUMAN; NEOPLASMS; PROCEDURES; STANDARDS;

BIOSENSING TECHNIQUES; CARDIOVASCULAR DISEASES; DIAGNOSTIC TECHNIQUES AND PROCEDURES; HIV INFECTIONS; HUMANS; NEOPLASMS; POINT-OF-CARE SYSTEMS; TUBERCULOSIS;

EID: 84911862025     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2014.960516     Document Type: Review

References (158)

1. Mabey D, Peeling R, Ustianowski A, Perkins M. Diagnostics for the developing world. Nat Rev Microbiol 2004;2(3):231-40
2. Jahn U, Van Aken H. Near-patient testing-point-of-care or point of costs and convenience? Br J Anaesth 2003;90(4):425-7
3. Chan CPY, Mak WC, Cheung KY, et al. Evidence-based point-of-care diagnostics: current status and emerging technologies. Annu Rev Anal Chem (Palo Alto Calif) 2013;6:191-211
4. Pai NP, Pai M. Point-of-care diagnostics for HIV and tuberculosis: landscape, pipeline, and unmet needs. Discov Med 2012;68: 35-45
5. Lee WG, Kim Y, Chung BG, et al. Nano/Microfluidics for diagnosis of infectious diseases in developing countries. Adv Drug Deliv Rev 2010;62(4-5):449-57
6. Healy DA, Hayes CJ, Leonard P, et al. Biosensor developments: application to prostate-specific antigen detection. Trends Biotechnol 2007;25(3):125-31
7. Bunde R, Jarvi E, Rosentreter J. Piezoelectric quartz crystal biosensors. Talanta 1998;46(6):1223-36
8. Byrne B, Stack E, Gilmartin N, O'Kennedy R. Antibody-based sensors: principles, problems and potential for detection of pathogens and associated toxins. Sensors (Basel) 2009;9(6):4407-45
9. Wang C, Sun Z, Ma L, Su M. Simultaneous detection of multiple biomarkers with over three orders of concentration difference using phase change nanoparticles. Anal Chem 2011;83(6): 2215-19
10. Fan X, White IM, Shopova SI, et al. Sensitive optical biosensors for unlabeled targets: a review. Anal Chim Acta 2008; 620(2):8-26
11. Borisov SM, Wolfbeis OS. Optical biosensors. Chem Rev 2008;108(2):423-61
12. Prodromidis MI. Impedimetric immunosensors-A review. Electrochim Acta 2010;55(14):4227-33
13. Soldatkin OO, Peshkova VM, Saiapina OY, et al. Development of conductometric biosensor array for simultaneous determination of maltose, lactose, sucrose and glucose. Talanta 2013;115:200-7
14. Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno) assay: its strengths, weaknesses, opportunities and threats. a literature survey. Anal Bioanal Chem 2009;393(2):569-82
15. Ngom B, Guo Y, Wang X, Bi D. Development and application of lateral flow test strip technology for detection of infectious agents and chemical contaminants: a review. Anal Bioanal Chem 2010;397(3):1113-35
16. World Health Organization-Cardiovascular diseases (CVDs). Available from: www.who.int/mediacentre/factsheets/fs317/en/
17. Murphy SL, Xu J, Kochanek KD. Deaths: final data for 2010. Natl Vital Stat Rep 2013;61(4):1-117
18. McDonnell B, Hearty S, Leonard P, O'Kennedy R. Cardiac biomarkers and the case for point-of-care testing. Clin Biochem 2009;42(7-8):549-61
19. Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med 2005;352(16):1685-95
20. Suprun EV, Shilovskaya AL, Lisitsa AV, et al. Electrochemical immunosensor based on metal nanoparticles for cardiac myoglobin detection in human blood plasma. Electroanalysis 2011;23(5):1051-7
21. Boersma E, Mercada N, Poldermans D, et al. Acute myocardial infarction. Lancet 2003;361(9360):847-58
22. Xu Q, Chan CPY, Cao X, et al. Cardiac multi-marker strategy for effective diagnosis of acute myocardial infarction. Clin Chim Acta 2010;411(21-22):1781-7
23. Mion MM, Novello E, Altinier S, et al. Analytical and clinical performance of a fully automated cardiac multi-markers strategy based on protein biochip microarray technology. Clin Biochem 2007;40(16-17): 1245-51
24. Peacock F, Morris DL, Anwaruddin S, et al. Acute ischemic heart disease-Meta-analysis of ischemia-modified albumin to rule out acute coronary syndromes in the emergency department. Am Heart J 2006;152(2): 253-62
25. Than M, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet 2011; 377(9771):1077-84
26. Stengaard C, Sorensen JT, Ladefoged SA, et al. Quantitative point-of-care troponin T measurement for diagnosis and prognosis in patients with a suspected acute myocardial infarction. Am J Cardiol 2013;112(9): 1361-6
27. Lippi G, Mattiuzzi C, Cervellin G. Critical review and meta-analysis on the combination of heart-type fatty acid binding protein (H-FABP) and troponin for early diagnosis of acute myocardial infarction. Clin Biochem 2013;46(1-2):26-30
28. Slot MHEB, Reitsma JB, Rutten FH, et al. Heart-type fatty acid-binding protein in the early diagnosis of acute myocardial infarction: a systematic review and meta-analysis. Heart 2010;96(24):1957-63
29. Abadie JM, Blassingame CL, Bankson DD. Albumin cobalt binding assay to rule out acute coronary syndrome. Ann Clin Lab Sci 2005;35(1):66-72
30. Patil SM, Banker MP, Padalkar RK, et al. The clinical assessment of ischaemia modified albumin and troponin I in the early diagnosis of the acute coronary syndrome. J Clin Diagn Res 2013;7(5): 804-8
31. Gaze DC. Biomarkers of cardiac disease (Chapter 6). In: Gaze D, editor. Ischemia heart disease. InTech; Croatia: 2013;p.13. doi; 10.5772/55250
32. Tomonaga Y, Gutzwiller F, Luescher TF, et al. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial. Bmc Fam Pract 2011;12:12
33. Straface AL, Myers JH, Kirchick HJ, Blick KE. A rapid point-of-care cardiac marker testing strategy facilitates the rapid diagnosis and management of chest pain patients in the emergency department. Am J Clin Pathol 2008;129(5):788-95
34. Food and Drug Administration-Biosite brand Triage Cardiac Panel. Available from: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman MedicalProducts/ucm150579.htm
35. Keller T, Zeller T, Peetz D, et al. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med 2009; 361(9):868-77
36. Dekker MS, Mosterd A, van't Hof AWJ, Hoes AW. Novel biochemical markers in suspected acute coronary syndrome: systematic review and critical appraisal. Heart 2010;96(13):1001-10
37. Eggers KM, Oldgren J, Nordenskjold A, Lindahl B. Diagnostic value of serial measurement of cardiac markers in patients with chest pain: limited value of adding myoglobin to troponin I for exclusion of myocardial infarction. Am Heart J 2004; 148(4):574-81
38. Geersing GJ, Janssen KJM, Oudega R, et al. Excluding venous thromboembolism using point of care D-dimer tests in outpatients: a diagnostic meta-analysis. Br Med J 2009;339:b2990
39. Health Quality Ontario. Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Ont Health Technol Assess Ser 2009;9(12):1-114
40. Ten Cate-Hoek AJ, Prins MH. Management studies using a combination of D-dimer test result and clinical probability to rule out venous thromboembolism: a systematic review. J Thromb Haemost 2005;3(11):2465-70
41. Bingisser R, Cairns CB, Christ M, et al. Measurement of natriuretic peptides at the point of care in the emergency and ambulatory setting: current status and future perspectives. Am Heart J 2013;166(4): 614-21
42. Dahler Eriksen BS, Lassen JF, Petersen PH, et al. Evaluation of a near-patient test for C-reactive protein used in daily routine in primary healthcare by use of difference plots. Clin Chem 1997;43(11):2064-75
43. Cals JWL, Butler CC, Hopstaken RM, et al. Effect of point of care testing for C reactive protein and training in communication skills on antibiotic use in lower respiratory tract infections: cluster randomised trial. Br Med J 2009;338:b1374
44. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61(2):69-90
45. Nelson W, De Marzo A, DeWeese T. The molecular pathogenesis of prostate cancer: Implications for prostate cancer prevention. Urology 2001;57(4A):39-45
46. American Cancer Society-What are the key statistics about prostate cancer? Available from: www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics
47. Epstein JI. Precursor lesions to prostatic adenocarcinoma. Virchows Arch 2009; 454(1):1-16
48. Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of US Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis 2011;14(2): 177-83
49. Jayasekera J, Onukwugha E, Bikov K, et al. The economic burden of skeletal-related events among elderly men with metastatic prostate cancer. Pharmacoeconomics 2014; 32(2):173-91
50. Thompson I, Pauler D, Goodman P, et al. Prevalence of prostate cancer among men with a prostate-specific antigen level <= 4.0 ng per milliliter. N Engl J Med 2004; 350(22): 2239-46
51. Oh SW, Kim YM, Kim HJ, et al. Point-of-care fluorescence immunoassay for prostate specific antigen. Clin Chim Acta 2009;406(1-2):18-22
52. Mikolajczyk S, Song Y, Wong J, et al. Are multiple markers the future of prostate cancer diagnostics? Clin Biochem 2004; 37(7):519-28
53. Rhodes D, Sanda M, Otte A, et al. Multiplex biomarker approach for determining risk of prostate-specific antigen-defined recurrence of prostate cancer. J Natl Cancer Inst 2003;95(9):661-8
54. Gilgunn S, Conroy PJ, Saldova R, et al. Aberrant PSA glycosylation-a sweet predictor of prostate cancer. Nat Rev Urol 2013;10(2):99-107
55. Ilic D, O'Connor D, Green S, Wilt TJ. Screening for prostate cancer: an updated Cochrane systematic review. BJU Int 2011; 107(6):882-91
56. Catalona WJ, Partin AW, Sanda MG, et al. A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. J Urol 2011;185(5):1650-5
57. Guazzoni G, Nava L, Lazzeri M, et al. Prostate-specific antigen (PSA) Isoform p2PSA significantly improves the prediction of prostate cancer at initial extended prostate biopsies in patients with total PSA between 2.0 and 10 ng/ml: results of a prospective study in a clinical setting. Eur Urol 2011;60(2):214-22
58. Lazzeri M, Haese A, Abrate A, et al. Clinical performance of serum prostate-specific antigen isoform [-2] proPSA (p2PSA) and its derivatives, % p2PSA and the prostate health index (PHI), in men with a family history of prostate cancer: results from a multicentre European study, the PROMEtheuS project. BJU Int 2013;112(3):313-21
59. Hessels D, Gunnewiek JMTK, van Oort I, et al. DD3(PCA3)-based molecular urine analysis for the diagnosis of prostate cancer. Eur Urol 2003;44(1):8-15
60. Sartori DA, Chan DW. Biomarkers in prostate cancer: what's new? Curr Opin Oncol 2014;26(3):259-64
61. Rajabi H, Ahmad R, Jin C, et al. MUC1-C oncoprotein confers androgen-independent growth of human prostate cancer cells. Prostate 2012;72(15):1659-68
62. Stenman UH, Leinonen J, Alfthan H, et al. A complex between prostate-specific antigen and alpha-1-antichymotrypsin is the major form of prostate-specific antigen in serum of patients with prostatic-cancer-assay of the complex improves clinical sensitivity for cancer. Cancer Res 1991;51(1):222-6
63. Progensa® PCA3 Assay. Available from: www.gen-probe.com/pdfs/pi/502083-EN-RevB.pdf
64. Rodon N, Trias I, Verdu M, et al. Diagnostic and predictive value of urine PCA3 gene expression for the clinical management of patients with altered prostatic specific antigen. Actas Urol Esp 2014;38(3):150-5
65. Vlaeminck-Guillem V, Ruffion A, Andre J, et al. Urinary prostate cancer 3 test: toward the age of reason? Urology 2010;75(2): 447-53
66. UniCel® DxI 800 Immunoassay System. Available from: www.beckmancoulter.com/wsrportal/wsr/diagnostics/clinical-products/immunoassay/unicel-dxl-800/index.htm#2/10//0/25/1/0/asc/2/91500///0/1//0/
67. Zheng G, Patolsky F, Cui Y, et al. Multiplexed electrical detection of cancer markers with nanowire sensor arrays. Nat Biotechnol 2005;23(10):1294-301
68. Wan Y, Deng W, Su Y, et al. Carbon nanotube-based ultrasensitive multiplexing electrochemical immunosensor for cancer biomarkers. Biosens Bioelectron 2011;30(1): 93-9
69. Chin CD, Laksanasopin T, Cheung YK, et al. Microfluidics-based diagnostics of infectious diseases in the developing world. Nat Med 2011;17(8):1015-U138
70. McArthur J, Brew B, Nath A. Neurological complications of HIV infection. Lancet Neurol 2005;4(9):543-55
71. Global Report UNAIDS: Report on the Global AIDS epidemic 2013. Available from: www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/gr2013/unaids-global-report- 2013-en.pdf
72. Anonymous Improving blood safety worldwide. Lancet 2007;370(9585):361-1
73. Kanekar A. Biomarkers predicting progression of human immunodeficiency virus-related disease. J Clin Med Res 2010; 2(2):55-61
74. Patel P, Mackellar D, Simmons P, et al. Detecting acute human immunodeficiency virus infection using 3 different screening immunoassays and nucleic acid amplification testing for human immunodeficiency virus RNA, 2006-2008. Arch Intern Med 2010;170(1):66-74
75. Cohen MS, Gay CL, Busch MP, Hecht FM. The detection of acute HIV infection. J Infect Dis 2010;202:S270-7
76. Patel P, Bennett B, Sullivan T, et al. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol 2012;54(1):42-7
77. Wang S, Xu F, Demirci U. Advances in developing HIV-1 viral load assays for resource-limited settings. Biotechnol Adv 2010;28(6):770-81
78. Whiteaker JR, Zhao L, Zhang HY, et al. Antibody-based enrichment of peptides for mass-spectrometry-based quantification on magnetic beads of serum biomarkers. Anal Biochem 2007;362(1):44-54
79. World Health Organization Website-HIV/AIDS-summary of new recommendations. Available from: www.who.int/hiv/pub/guidelines/arv2013/intro/rag/en/index2.html
80. Moon S, Gurkan UA, Blander J, et al. Enumeration of CD4(+) T-cells using a portable microchip count platform in Tanzanian HIV-infected patients. PLoS One 2011;6(7):e21409
81. Glynn MT, Kinahan DJ, Ducrée J. Rapid, low-cost and instrument-free CD4+ cell counting for HIV diagnostics in resource-poor settings. Lab Chip 2014; 14(15):2844-51
82. Branson BM, Stekler JD. Detection of acute HIV infection: we can't close the window. J Infect Dis 2012;205(4):521-4
83. Manlutac ALM, Giesick JS, McVay PA. Identification of early HIV infections using the fourth generation Abbott ARCHITECT HIV Ag/Ab Combo chemiluminescent microparticle immunoassay (CIA) in San Diego County. J Clin Virol 2013;58:E44-7
84. Rosenberg NE, Kamanga G, Phiri S, et al. Detection of acute HIV infection: a field evaluation of the determine (R) HIV-1/2 Ag/Ab combo test. J Infect Dis 2012; 205(4):528-34
85. Alere DetermineTM HIV-1/2 Ag/Ab Combo. Available from: www.alere.com/us/en/product-details/determine-1-2-ag-ab-combo-us.html
86. Brauer M, De Villiers JC, Mayaphi SH. Evaluation of the Determine (TM) fourth generation HIV rapid assay. J Virol Methods 2013;189(1):180-3
87. Kilembe W, Keeling M, Karita E, et al. Failure of a novel, rapid antigen and antibody combination test to detect antigen-positive HIV infection in African Adults with early HIV infection. PLoS One 2012;7(6):e37154
88. Pavie J, Rachline A, Loze B, et al. Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting. PLoS One 2010;5(7):e11581
89. Conway DP, Holt M, McNulty A, et al. Multi-centre evaluation of the determine HIV combo assay when used for point of care testing in a high risk clinic-based population. PLoS one 2014;9(4):e94062
90. Byrne H, Conroy PJ, Whisstock JC, O'Kennedy RJ. A tale of two specificities: bispecific antibodies for therapeutic and diagnostic applications. Trends Biotechnol 2013;31(11):621-32
91. Dormans J, Burger M, Aguilar D, et al. Correlation of virulence, lung pathology, bacterial load and delayed type hypersensitivity responses after infection with different Mycobacterium tuberculosis genotypes in a BALB/c mouse model. Clin Exp Immunol 2004;137(3):460-8
92. Lin P, Pawar S, Myers A, et al. Early events in Mycobacterium tuberculosis infection in cynomolgus macaques. Infect Immun 2006; 74(7):3790-803
93. Wallis RS, Pai M, Menzies D, et al. Tuberculosis 4 Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. Lancet 2010; 375(9729):1920-37
94. WHO. Diagnostics evaluation series 2-laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis. WHO; Geneva, Switzerland: 2008
95. Ferrara G, Losi M, D'Amico R, et al. Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study. Lancet 2006;367(9519): 1328-34
96. Luetkemeyer AF, Charlebois ED, Flores LL, et al. Comparison of an interferon-gamma release assay with tuberculin skin testing in HIV-infected individuals. Am J Respir Crit Care Med 2007;175(7):737-42
97. Kobashi Y, Mouri K, Yagi S, et al. Usefulness of the QuantiFERON TB-2G test for the differential diagnosis of pulmonary tuberculosis. Intern Med 2008; 47(4):237-43
98. Ruhwald M, Bjerregaard-Andersen M, Rabna P, et al. IP-10, MCP-1, MCP-2, MCP-3, and IL-1RA hold promise as biomarkers for infection with M. tuberculosis in a whole blood based T-cell assay. BMC Res Notes 2009;2:19-19
99. Ruhwald M, Bodmer T, Maier C, et al. Evaluating the potential of IP-10 and MCP-2 as biomarkers for the diagnosis of tuberculosis. Eur Respir J 2008;32(6): 1607-15
100. Frahm M, Goswami ND, Owzar K, et al. Discriminating between latent and active tuberculosis with multiple biomarker responses. Tuberculosis (Edinb) 2011;91(3): 250-6
101. Whittaker E, Gordon A, Kampmann B. Is IP-10 a better biomarker for active and latent tuberculosis in children than IFN gamma? PLoS One 2008;3(12):e3901
102. Bielekova B, Komori M, Xu Q, et al. Cerebrospinal fluid IL-12p40, CXCL13 and IL-8 as a combinatorial biomarker of active intrathecal inflammation. PLoS One 2012; 7(11):e48370
103. Kim YW, Bae SM, Lim H, et al. Development of multiplexed bead-based immunoassays for the detection of early stage ovarian cancer using a combination of serum biomarkers. PLoS One 2012;7(9): e44960
104. Liu C, Liu A, Halabi S. A min-max combination of biomarkers to improve diagnostic accuracy. Stat Med 2011;30(16): 2005-14
105. Glannelli G, Fransvea E, Trerotoli P, et al. Clinical validation of combined serological biomarkers for improved hepatocellular carcinoma diagnosis in 961 patients. Clin Chim Acta 2007;383(1-2):147-52
106. Makawita S, Dimitromanolakis A, Soosaipillai A, et al. Validation of four candidate pancreatic cancer serological biomarkers that improve the performance of CA19.9. BMC Cancer 2013;13:404
107. Wang F, Hou H, Xu L, et al. Mycobacterium tuberculosis-specific TNF-alpha is a potential biomarker for the rapid diagnosis of active tuberculosis disease in Chinese population. PLoS One 2013;8(11): e79431
108. Haddow LJ, Dibben O, Moosa MS, et al. Circulating inflammatory biomarkers can predict and characterize tuberculosis-associated immune reconstitution inflammatory syndrome. AIDS 2011;25(9):1163-74
109. Shekhawat SD, Jain RK, Gaherwar HM, et al. Heat shock proteins: possible biomarkers in pulmonary and extrapulmonary tuberculosis. Hum Immunol 2014;75(2):151-8
110. Breslauer DN, Maamari RN, Switz NA, et al. Mobile phone based clinical microscopy for global health applications. PLoS One 2009;4(7):e6320
111. Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis 2007;196:S15-27
112. Lane ND, Miluzzo E, Lu H, et al. A survey of mobile phone sensing. IEEE Commun Mag 2010;48(9):140-50
113. Linder E, Grote A, Varjo S, et al. On-chip imaging of schistosoma haematobium eggs in urine for diagnosis by computer vision. Plos Negl Trop Dis 2013;7(12):e2547
114. Tseng D, Mudanyali O, Oztoprak C, et al. Lensfree microscopy on a cellphone. Lab Chip 2010;10(14):1787-92
115. Lillehoj PB, Huang M, Truong N, Ho C. Rapid electrochemical detection on a mobile phone. Lab Chip 2013;13(15):2950-5
116. Veigas B, Jacob JM, Costa MN, et al. Gold on paper-paper platform for Au-nanoprobe TB detection. Lab Chip 2012;12(22): 4802-8
117. Khandoker AH, Black J Palaniswami M. Smartphone-based low cost oximeter photoplethysmography. 2010 International Conference on Electrical and Computer Engineering (ICECE); 18-20 Dec 2010; Dhaka, Bangladesh p. 634-7
118. Karlen W, Dumont G, Petersen C, et al. Human-centered phone oximeter interface design for the operating room pulse oximeter interfaced to a mobile device for anesthesia monitoring in the developing world. HEALTHINF 2011-Proceedings of the International Conference on Health Informatics; 26-29 January 2011; Rome, Italy
119. Shinar J, Shinar R. Organic light-emitting devices (OLEDs) and OLED-based chemical and biological sensors: an overview. J Phys DAppl Phys 2008; 41(13):133001
120. Mancuso M, Jiang L, Cesarman E, Erickson D. Multiplexed colorimetric detection of Kaposi's sarcoma associated herpesvirus and Bartonella DNA using gold and silver nanoparticles. Nanoscale 2013; 5(4):1678-86
121. Soo P, Horng Y, Chang K, et al. A simple gold nanoparticle probes assay for identification of Mycobacterium tuberculosis and Mycobacterium tuberculosis complex from clinical specimens. Mol Cell Probes 2009;23(5):240-6
122. Li C, Vandenberg K, Prabhulkar S, et al. Paper based point-of-care testing disc for multiplex whole cell bacteria analysis. Biosens Bioelectron 2011;26(11):4342-8
123. Fu E, Liang T, Houghtaling J, et al. Enhanced sensitivity of lateral flow tests using a two-dimensional paper network format. Anal Chem 2011;83(20):7941-6
124. 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
125. Glynn M, Kirby D, Chung D, et al. Centrifugo-magnetophoretic purification of CD4+ cells from whole blood toward future HIVAIDS point-of-care applications. J Lab Autom 2013;19(3):285-96
126. Shafiee H, Jahangir M, Inci F, et al. Acute on-chip HIV detection through label-free electrical sensing of viral nano-lysate. Small 2013;9(15):2553-63
127. Chen Z, Abrams WR, Geva E, et al. Development of a generic microfluidic device for simultaneous detection of antibodies and nucleic acids in oral fluids. Biomed Res Int 2013;2013:543294
128. Shekalaghe S, Cancino M, Mavere C, et al. Clinical performance of an automated reader in interpreting malaria rapid diagnostic tests in Tanzania. Malar J 2013;12:141
129. Bock JL, Singer AJ, Thode HC Jr. Comparison of emergency department patient classification by point-of-care and central laboratory methods for cardiac troponin I. Am J Clin Pathol 2008;130(1): 132-5
130. Venge P, Ohberg C, Flodin M, Lindahl B. Early and late outcome prediction of death in the emergency room setting by point-of-care and laboratory assays of cardiac troponin I. Am Heart J 2010; 160(5):835-41
131. Capoluongo E, Zambon CF, Basso D, et al. PCA3 score of 20 could improve prostate cancer detection: results obtained on 734 Italian individuals. Clin Chim Acta 2014;429:46-50
132. Pepe P, Fraggetta F, Galia A, et al. PCA3 score and prostate cancer diagnosis at repeated saturation biopsy. which cut-off: 20 or 35? Int Braz J Urol 2012;38(4): 489-95
133. Ochiai A, Okihara K, Kamoi K, et al. Clinical utility of the prostate cancer gene 3 (PCA3) urine assay in Japanese men undergoing prostate biopsy. BJU Int 2013; 111(6):928-33
134. Adam A, Engelbrecht MJ, Bornman MS, et al. The role of the PCA3 assay in predicting prostate biopsy outcome in a South African setting. BJU Int 2011; 108(11):1728-33
135. Fossati N, Lazzeri M, Haese A, et al. Clinical performance of serum isoform [-2] proPSA (p2PSA) and its derivatives, namely %p2PSA and PHI (Prostate Health Index) in men younger than 60 years of age: results from a multicentre European study. BJU Int 2014;doi; 10.1111/bju.12718. [Epub ahead of print]
136. Guazzoni G, Lazzeri M, Nava L, et al. Preoperative prostate-specific antigen isoform p2PSA and its derivatives, % p2PSA and prostate health index, predict pathologic outcomes in patients undergoing radical prostatectomy for prostate cancer. Eur Urol 2012;61(3):455-66
137. Lazzeri M, Haese A, de la Taille A, et al. Serum Isoform [-2]proPSA derivatives significantly improve prediction of prostate cancer at initial biopsy in a total PSA range of 2-10 ng/ml: a multicentric European study. Eur Urol 2013;63(6):986-94
138. Agnihotri S, Mittal RD, Ahmad S, Mandhani A. Free to total serum prostate specific antigen ratio in symptomatic men does not help in differentiating benign from malignant disease of the prostate. Indian J Urol 2014;30(1):28-32
139. Lee R, Localio AR, Armstrong K, Free PSA Study Grp. A meta-analysis of the performance characteristics of the free prostate-specific antigen test. Urology 2006; 67(4):762-8
140. Yoneyama T, Ohyama C, Hatakeyama S, et al. Measurement of aberrant glycosylation of prostate specific antigen can improve specificity in early detection of prostate cancer. Biochem Biophys Res Commun 2014;448(4):390-6
141. Zhang Z, Yang J, Zhang C, et al. The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. Acad Radiol 2014;21(5): 578-89
142. Herbert S, Edwards S, Carrick G, et al. Evaluation of PIMA point-of-care CD4 testing in a large UK HIV service. Sex Transm Infect 2012;88(6):413-17
143. Jani IV, Sitoe NE, Alfai ER, et al. 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(9802):1572-9
144. Galiwango RM, Lubyayi L, Musoke R, et al. Field evaluation of PIMA point-of-care CD4 testing in Rakai, Uganda. PLoS One 2014;9(3):e88928
145. Mtapuri-Zinyowera S, Chideme M, Mangwanya D. Evaluation of the PIMA point-of-care CD4 analyzer in VCT clinics in Zimbabwe. J Acquir Immune Defic Syndr 2010;55(1):1-7
146. Bergman J, Gratrix J, Plitt S, et al. Feasibility and field performance of a simultaneous syphilis and HIV point-of-care test based screening strategy in at risk populations in Edmonton, Canada. AIDS Res Treat 2013;2013:819593-3
147. INSTI HIV-1/HIV-2 Antibody Test. Available from: www.biolytical.com/insti-doc/CEInsert.pdf
148. Lee BE, Plitt S, Fenton J, et al. Rapid HIV tests in acute care settings in an area of low HIV prevalence in Canada. J Virol Methods 2011;172(1-2):66-71
149. Parpia ZA, Elghanian R, Nabatiyan A, et al. p24 antigen rapid test for diagnosis of acute pediatric HIV infection. J Acquir Immune Defic Syndr 2010;55(4):413-19
150. Kfutwah A, Lemée V, Ngono HV, et al. Field evaluation of the Abbott ARCHITECT HIV Ag/Ab Combo immunoassay. J Clin Virol 2013; 58(Suppl 1):e70-5
151. Tao CM, Cho Y, Ng KP, et al. Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia. J Clin Virol 2013; 58(1):221-6
152. Mercier-Delarue S, Vray M, Plantier JC, et al. Higher specificity of nucleic acid sequence-based amplification isothermal technology than of real-time PCR for quantification of HIV-1 RNA on dried blood spots. J Clin Microbiol 2014;52(1): 52-6
153. Chang K, Lu W, Wang J, et al. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J Infect 2012;64(6): 580-8
154. Menzies D, Pai M, Comstock G. Metaanalysis: new tests for the diagnosis of latent tuberculosis infection: areas of uncertainty and recommendations for research. Ann Intern Med 2007;146(5):340-54
155. Sollai S, Galli L, de Martino M, Chiappini E. Systematic review and meta-analysis on the utility of Interferon-gamma release assays for the diagnosis of Mycobacterium tuberculosis infection in children: a 2013 update. BMC Infect Dis 2014;14:S6
156. 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
157. Anderson BL, Welch RJ, Litwin CM. Assessment of three commercially available serologic assays for detection of antibodies to mycobacterium tuberculosis and identification of active tuberculosis. Clin Vaccine Immunol 2008;15(11):1644-9
158. Blick KE. Economic and Operational benefits of a rapid, Point-of-care cTnI-only protocol for triaging patients with chest pain in the emergency department. Available from: www.abbottpointofcare.com/EducationCenter/~/media/Files/PDFS/Home/iLearn-Center/Case-Studies/030753-Oklahoma-Univ-Troponin-Paper.ashx