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Perspective

Challenges of development and implementation of point of care pharmacogenetic testing

Pages 949-960 | Received 10 May 2016, Accepted 08 Jul 2016, Published online: 22 Jul 2016

References

  • Rajan A, Glorikian H. Point-of-care diagnostics: market trends and growth drivers. Expert Opin Med Diagn. 2009;3(1):1–4.
  • Huckle D. The impact of new trends in POCTs for companion diagnostics, non-invasive testing and molecular diagnostics. Expert Rev Mol Diagn. 2015;15(6):815–827.
  • Nelson MR, Johnson T, Warren L, et al. The genetics of drug efficacy: opportunities and challenges. Nat Rev Genet. 2016;17(4):197–206.
  • Polillo M, Galimberti S, Barate C, et al. Pharmacogenetics of BCR/ABL inhibitors in chronic myeloid leukemia. Int J Mol Sci. 2015;16(9):22811–22829.
  • FDA. Table of Pharmacogenomic Biomarkers in Drug Labels; 2014 [cited 2015 May 14]. Available from: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
  • Hillebrenner E, Litwack E, Bradley P, et al. FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care. J Clin Pharmacol. 2015;55(7):728–730.
  • Levy KD, Pratt VM, Skaar TC, et al. FDA’s draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing. J Clin Pharmacol. 2015;55(7):725–727.
  • O’Donnell PH, Bush A, Spitz J, et al. The 1200 patients project: creating a new medical model system for clinical implementation of pharmacogenomics. Clin Pharmacol Ther. 2012;92(4):446–449.
  • O’Donnell PH, Danahey K, Jacobs M, et al. Adoption of a clinical pharmacogenomics implementation program during outpatient care–initial results of the University of Chicago “1,200 Patients Project”. Am J Med Genet C Semin Med Genet. 2014;166C(1):68–75.
  • Hoffman JM, Haidar CE, Wilkinson MR, et al. PG4KDS: A model for the clinical implementation of pre-emptive pharmacogenetics. Am J Med Genet C. 2014;166(1):45–55.
  • Pulley JM, Denny JC, Peterson JF, et al. Operational implementation of prospective genotyping for personalized medicine: the design of the Vanderbilt PREDICT project. Clin Pharmacol Ther. 2012;92(1):87–95.
  • Johnson JA, Elsey AR, Clare-Salzler MJ, et al. Institutional profile: University of Florida and Shands Hospital Personalized Medicine Program: clinical implementation of pharmacogenetics. Pharmacogenomics. 2013;14(7):723–726.
  • Leeder JS. Meaningful use and clinical utility of preemptive pharmacogenetic testing: (re)view from a CYP2D6 poor metabolizer. Clin Pharmacol Ther. 2015;97(2):119–121.
  • Scott SA. Clinical pharmacogenomics: opportunities and challenges at point of care. Clin Pharmacol Ther. 2013;93(1):33–35.
  • Janssens AC, Deverka PA. Useless until proven effective: the clinical utility of preemptive pharmacogenetic testing. Clin Pharmacol Ther. 2014;96(6):652–654.
  • Price C, St John ALK, editors. Point-of-care testing. Needs, opportunities, and innovation. Washington (DC): AACC Press; 2010.
  • Ritzi-Lehnert M. Development of chip-compatible sample preparation for diagnosis of infectious diseases. Expert Rev Mol Diagn. 2012;12(2):189–206.
  • Choi JR, Tang R, Wang S, et al. Paper-based sample-to-answer molecular diagnostic platform for point-of-care diagnostics. Biosens Bioelectron. 2015;74:427–439.
  • Jafari M, Pirouzi A, Anoosheh S, et al. Rapid and simultaneous detection of vitamin D receptor gene polymorphisms by a single ARMS-PCR assay. Mol Diagn Ther. 2014;18(1):97–103.
  • Minarik M, Kopeckova M, Gassman M, et al. Rapid testing of clopidogrel resistance by genotyping of CYP2C19 and CYP2C9 polymorphisms using denaturing on-chip capillary electrophoresis. Electrophoresis. 2012;33(8):1306–1310.
  • Saracini C, Vestrini A, Galora S, et al. Pharmacogenetics of clopidogrel: comparison between a standard and a rapid genetic testing. Genet Test Mol Biomarkers. 2012;16(6):500–503.
  • Sharafi H, Pouryasin A, Alavian SM, et al. Development and validation of a simple, rapid and inexpensive PCR-RFLP method for genotyping of common IL28B polymorphisms: a useful pharmacogenetic tool for prediction of hepatitis C treatment response. Hepat Mon. 2012;12(3):190–195.
  • Spohn G, Geisen C, Luxembourg B, et al. Validation of a rapid and inexpensive allele-specific amplification (ASA)-PCR genotyping assay for vitamin K antagonist pharmacogenomics. Mol Diagn Ther. 2011;15(1):13–19.
  • Borras E, Jurado I, Hernan I, et al. Clinical pharmacogenomic testing of KRAS, BRAF and EGFR mutations by high resolution melting analysis and ultra-deep pyrosequencing. BMC Cancer. 2011;11:406.
  • Carpi FM, Xu J, Vincenzetti S, et al. Rapid allele-specific PCR method for CDA 79A>C (K27Q) genotyping: a useful pharmacogenetic tool and world-wide polymorphism distribution. Clin Chim Acta. 2011;412(23–24):2237–2240.
  • Ahmed MU, Saaem I, Wu PC, et al. Personalized diagnostics and biosensors: a review of the biology and technology needed for personalized medicine. Crit Rev Biotechnol. 2014;34(2):180–196.
  • Knez K, Spasic D, Janssen KP, et al. Emerging technologies for hybridization based single nucleotide polymorphism detection. Analyst. 2014;139(2):353–370.
  • Song Y, Huang YY, Liu X, et al. Point-of-care technologies for molecular diagnostics using a drop of blood. Trends Biotechnol. 2014;32(3):132–139.
  • Dutse SW, Yusof NA. Microfluidics-based lab-on-chip systems in DNA-based biosensing: an overview. Sensors (Basel). 2011;11(6):5754–5768.
  • Su W, Gao X, Jiang L, et al. Microfluidic platform towards point-of-care diagnostics in infectious diseases. J Chromatogr A. 2015;1377:13–26.
  • Rodriguez NM, Wong WS, Liu L, et al. A fully integrated paperfluidic molecular diagnostic chip for the extraction, amplification, and detection of nucleic acids from clinical samples. Lab Chip. 2016;16(4):753–763.
  • Rohrman BA, Richards-Kortum RR. A paper and plastic device for performing recombinase polymerase amplification of HIV DNA. Lab Chip. 2012;12(17):3082–3088.
  • Linnes JC, Fan A, Rodriguez NM, et al. Paper-based molecular diagnostic for. RSC Adv. 2014;4(80):42245–42251.
  • Rodriguez NM, Linnes JC, Fan A, et al. Paper-based RNA extraction, in situ isothermal amplification, and lateral flow detection for low-cost, rapid diagnosis of influenza A (H1N1) from clinical specimens. Anal Chem. 2015;87(15):7872–7879.
  • Sharma A, Jaiswal S, Shukla M, et al. Dried blood spots: concepts, present status, and future perspectives in bioanalysis. Drug Test Anal. 2014;6(5):399–414.
  • Stangegaard M, Borsting C, Ferrero-Miliani L, et al. Evaluation of four automated protocols for extraction of DNA from FTA cards. J Lab Autom. 2013;18(5):404–410.
  • Zhang L, Zhang Y, Wang C, et al. Integrated microcapillary for sample-to-answer nucleic acid pretreatment, amplification, and detection. Anal Chem. 2014;86(20):10461–10466.
  • Choi JR, Hu J, Tang R, et al. An integrated paper-based sample-to-answer biosensor for nucleic acid testing at the point of care. Lab Chip. 2016;16(3):611–621.
  • Kwon L, Long KD, Wan Y, et al. Medical diagnostics with mobile devices: comparison of intrinsic and extrinsic sensing. Biotechnol Adv. 2016;34(3):291–304.
  • Azzazy HM, Elbehery AH. Clinical laboratory data: acquire, analyze, communicate, liberate. Clin Chim Acta. 2015;438:186–194.
  • Yu H, Tan Y, Cunningham BT. Smartphone fluorescence spectroscopy. Anal Chem. 2014;86(17):8805–8813.
  • Petryayeva E, Algar WR. Single-step bioassays in serum and whole blood with a smartphone, quantum dots and paper-in-PDMS chips. Analyst. 2015;140(12):4037–4045.
  • Zhang L, Yang W, Yang Y, et al. Smartphone-based point-of-care testing of salivary alpha-amylase for personal psychological measurement. Analyst. 2015;140(21):7399–7406.
  • Hu J, Cui X, Gong Y, et al. Portable microfluidic and smartphone-based devices for monitoring of cardiovascular diseases at the point of care. Biotechnol Adv. 2016;34(3):305–320.
  • Liao SC, Peng J, Mauk MG, et al. Smart cup: a minimally-instrumented, smartphone-based point-of-care molecular diagnostic device. Sens Actuators B Chem. 2016;229:232–238.
  • Stedtfeld RD, Tourlousse DM, Seyrig G, et al. Gene-Z: a device for point of care genetic testing using a smartphone. Lab Chip. 2012;12(8):1454–1462.
  • Stedtfeld RD, Liu YC, Stedtfeld TM, et al. Static self-directed sample dispensing into a series of reaction wells on a microfluidic card for parallel genetic detection of microbial pathogens. Biomed Microdevices. 2015;17(5):89. doi:10.1007/s10544-015-9994-1
  • Carrio A, Sampedro C, Sanchez-Lopez JL, et al. Automated low-cost smartphone-based lateral flow saliva test reader for drugs-of-abuse detection. Sensors (Basel). 2015;15(11):29569–29593.
  • Wang SM, Hu SY, Chen W, et al. Feasibility and accuracy evaluation of three human papillomavirus assays for FTA card-based sampling: a pilot study in cervical cancer screening. BMC Cancer. 2015;15:848.
  • Craw P, Balachandran W. Isothermal nucleic acid amplification technologies for point-of-care diagnostics: a critical review. Lab Chip. 2012;12(14):2469–2486.
  • Ahmad F, Hashsham SA. Miniaturized nucleic acid amplification systems for rapid and point-of-care diagnostics: a review. Anal Chim Acta. 2012;733:1–15.
  • Brunklaus S, Hansen-Hagge TE, Erwes J, et al. Fast nucleic acid amplification for integration in point-of-care applications. Electrophoresis. 2012;33(21):3222–3228.
  • Chang CM, Chang WH, Wang CH, et al. Nucleic acid amplification using microfluidic systems. Lab Chip. 2013;13(7):1225–1242.
  • Wang JH, Wang CH, Lee GB. Sample pretreatment and nucleic acid-based detection for fast diagnosis utilizing microfluidic systems. Ann Biomed Eng. 2012;40(6):1367–1383.
  • De Paz HD, Brotons P, Munoz-Almagro C. Molecular isothermal techniques for combating infectious diseases: towards low-cost point-of-care diagnostics. Expert Rev Mol Diagn. 2014;14(7):827–843.
  • Xu Y, Liu Y, Wu Y, et al. Fluorescent probe-based lateral flow assay for multiplex nucleic acid detection. Anal Chem. 2014;86(12):5611–5614.
  • Litos IK, Ioannou PC, Christopoulos TK, et al. Quadruple-allele dipstick test for simultaneous visual genotyping of A896G (Asp299Gly) and C1196T (Thr399Ile) polymorphisms in the toll-like receptor-4 gene. Clinica Chimica Acta. 2011;412(21–22):1968–1972.
  • Liu F, Liu H, Liao Y, et al. Multiplex detection and genotyping of pathogenic bacteria on paper-based biosensor with a novel universal primer mediated asymmetric PCR. Biosens Bioelectron. 2015;74:778–785.
  • Li J, Macdonald J. Multiplexed lateral flow biosensors: technological advances for radically improving point-of-care diagnoses. Biosens Bioelectron. 2016;83:177–192.
  • Cate DM, Adkins JA, Mettakoonpitak J, et al. Recent developments in paper-based microfluidic devices. Anal Chem. 2015;87(1):19–41.
  • Hartman MR, Ruiz RC, Hamada S, et al. Point-of-care nucleic acid detection using nanotechnology. Nanoscale. 2013;5(21):10141–10154.
  • Muangsuwan W, Ruangsuj P, Chaichanachaicharn P, et al. A novel nucleic lateral flow assay for screening of PHA-producing haloarchaea. J Microbiol Methods. 2015;116:8–14.
  • Rosser A, Rollinson D, Forrest M, et al. Isothermal recombinase polymerase amplification (RPA) of Schistosoma haematobium DNA and oligochromatographic lateral flow detection. Parasit Vectors. 2015;8:446.
  • Terao Y, Takeshita K, Nishiyama Y, et al. Promising nucleic acid lateral flow assay plus PCR for Shiga toxin-producing Escherichia coli. J Food Prot. 2015;78(8):1560–1568.
  • Hu J, Wang L, Li F, et al. Oligonucleotide-linked gold nanoparticle aggregates for enhanced sensitivity in lateral flow assays. Lab Chip. 2013;13(22):4352–4357.
  • ISO 22870. Point-of-Care Testing (POCT) - Requirements for Quality and Competence; 2006. Available from: https://www.iso.org/obp/ui/#iso:std:iso:22870:ed-1:v1:en
  • Nichols JH, Christenson RH, Clarke W, et al. Executive summary. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guideline: evidence-based practice for point-of-care testing. Clin Chim Acta. 2007;379(1–2):14-28; discussion 29-30.
  • Holt H, Freedman DB. Internal quality control in point-of-care testing: where’s the evidence? Ann Clin Biochem. 2016;53(Pt 2):233–239.
  • Gill JP, Shephard MD. The conduct of quality control and quality assurance testing for PoCT outside the laboratory. Clin Biochem Rev. 2010;31(3):85–88.
  • Lewandrowski K. Point-of-care testing: an overview and a look to the future (circa 2009, United States). Clin Lab Med. 2009;29(3):421–432.
  • 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):1405–1414.
  • Huddy JR, Ni MZ, Barlow J, et al. Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption. BMJ Open. 2016;6(3):e009959.
  • Vu CL, Chan J, Todaro M, et al. Point-of-care molecular diagnostic devices: an overview. Pharmacogenomics. 2015;16(12):1399–1409.
  • Hess GP, Fonseca E, Scott R, et al. Pharmacogenomic and pharmacogenetic-guided therapy as a tool in precision medicine: current state and factors impacting acceptance by stakeholders. Genet Res (Camb). 2015;97:e13.
  • Roberts JD, Wells GA, Le May MR, et al. Point-of-care genetic testing for personalisation of antiplatelet treatment (RAPID GENE): a prospective, randomised, proof-of-concept trial. Lancet. 2012;379(9827):1705–1711.
  • So DY, Wells GA, McPherson R, et al. A prospective randomized evaluation of a pharmacogenomic approach to antiplatelet therapy among patients with ST-elevation myocardial infarction: the RAPID STEMI study. Pharmacogenomics J. 2016;16(1):71–78.
  • Jacobs LG. Warfarin pharmacology, clinical management, and evaluation of hemorrhagic risk for the elderly. Clin Geriatr Med. 2006;22(1):17-32, vii-viii.
  • Budnitz DS, Lovegrove MC, Shehab N, et al. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002–2012.
  • Higashi MK, Veenstra DL, Kondo LM, et al. Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. Jama. 2002;287(13):1690–1698.
  • Rieder MJ, Reiner AP, Gage BF, et al. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N Engl J Med. 2005;352(22):2285–2293.
  • Lee MT, Klein TE. Pharmacogenetics of warfarin: challenges and opportunities. J Hum Genet. 2013;58(6):334–338.
  • Goulding R, Dawes D, Price M, et al. Genotype-guided drug prescribing: a systematic review and meta-analysis of randomized control trials. Br J Clin Pharmacol. 2015;80(4):868–877.
  • Zhuang B, Han J, Xiang G, et al. A fully integrated and automated microsystem for rapid pharmacogenetic typing of multiple warfarin-related single-nucleotide polymorphisms. Lab Chip. 2016;16(1):86–95.
  • Perera MA, Cavallari LH, Limdi NA, et al. Genetic variants associated with warfarin dose in African-American individuals: a genome-wide association study. Lancet. 2013;382(9894):790–796.
  • Scott SA, Jaremko M, Lubitz SA, et al. CYP2C9*8 is prevalent among African-Americans: implications for pharmacogenetic dosing. Pharmacogenomics. 2009;10(8):1243–1255.
  • Cavallari LH, Perera MA. The future of warfarin pharmacogenetics in under-represented minority groups. Future Cardiol. 2012;8(4):563–576.
  • Kimmel SE, French B, Kasner SE, et al. A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med. 2013;369(24):2283–2293.
  • Drozda K, Wong S, Patel SR, et al. Poor warfarin dose prediction with pharmacogenetic algorithms that exclude genotypes important for African Americans. Pharmacogenet Genomics. 2015;25(2):73–81.
  • Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: part II. Clin Pharmacokinet. 2009;48(12):761–804.
  • Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: part I. Clin Pharmacokinet. 2009;48(11):689–723.
  • Centers for Medicare and Medicaid Services. Division of laboratory services. CLIA UPDATE – January 2016; 2016. Available from: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/factype.pdf
  • Angulo B, Lopez-Rios F, Gonzalez D. A new generation of companion diagnostics: cobas BRAF, KRAS and EGFR mutation detection tests. Expert Rev Mol Diagn. 2014;14(5):517–524.
  • Spartan Bio. SpartanRX; [cited 2016 May 5]. Available from: http://www.spartanbio.com/products/spartan-rx/overview/
  • Quinn AD, Dixon D, Meenan BJ. Barriers to hospital-based clinical adoption of point-of-care testing (POCT): A systematic narrative review. Crit Rev Clin Lab Sci. 2016;53(1):1–12.
  • De Denus S, Letarte N, Hurlimann T, et al. An evaluation of pharmacists’ expectations towards pharmacogenomics. Pharmacogenomics. 2013;14(2):165–175.
  • Elewa H, Alkhiyami D, Alsahan D, et al. A survey on the awareness and attitude of pharmacists and doctors towards the application of pharmacogenomics and its challenges in Qatar. J Eval Clin Pract. 2015;21(4):703–709.
  • McCullough KB, Formea CM, Berg KD, et al. Assessment of the pharmacogenomics educational needs of pharmacists. Am J Pharm Educ. 2011;75(3):51.
  • O’Brien TJ, LeLacheur S, Ward C, et al. Impact of a personal CYP2D6 testing workshop on physician assistant student attitudes toward pharmacogenetics. Pharmacogenomics. 2016;17(4):341–352.
  • Bell GC, Crews KR, Wilkinson MR, et al. Development and use of active clinical decision support for preemptive pharmacogenomics. J Am Med Inform Assoc. 2014;21(e1):e93–99.
  • Vitek CRR, Nicholson WT, Schultz C, et al. Evaluation of the use of clinical decision support and online resources for pharmacogenomics education. Pharmacogenomics. 2015;16(14):1595–1603.
  • Formea CM, Nicholson WT, McCullough KB, et al. Development and evaluation of a pharmacogenomics educational program for pharmacists. Am J Pharm Educ. 2013;77(1):10.
  • Lee KC, Hudmon KS, Ma JD, et al. Evaluation of a shared pharmacogenomics curriculum for pharmacy students. Pharmacogenomics. 2015;16(4):315–322.
  • Rao US, Mayhew SL, Rao PS. Strategies for implementation of an effective pharmacogenomics program in pharmacy education. Pharmacogenomics. 2015;16(8):905–911.
  • Howerton D, Anderson N, Bosse D, et al. Good laboratory practices for waived testing sites: survey findings from testing sites holding a certificate of waiver under the clinical laboratory improvement amendments of 1988 and recommendations for promoting quality testing. MMWR Recomm Rep. 2005;54(RR–13):1-25; quiz CE21-24.
  • Aslan B, Stemp J, Yip P, et al. Method precision and frequent causes of errors observed in point-of-care glucose testing: a proficiency testing program perspective. Am J Clin Pathol. 2014;142(6):857–863.
  • Kavsak PA, Zielinski N, Li D, et al. Challenges of implementing point-of-care testing (POCT) glucose meters in a pediatric acute care setting. Clin Biochem. 2004;37(9):811–817.
  • Meier FA, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med. 2005;129(10):1262–1267.
  • O’Kane MJ, McManus P, McGowan N, et al. Quality error rates in point-of-care testing. Clin Chem. 2011;57(9):1267–1271.
  • Shephard MD, Mazzachi BC, Watkinson L, et al. 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(3):1189.
  • Accreditation Council for Pharmacy Education. Accreditation standards and guidelines: professional program in pharmacy leading to the doctor of pharmacy degree. Chicago (IL): Accreditation Council for Pharmacy Education; 2011.
  • Gous NM, Scott LE, Potgieter J, et al. Implementation and operational research: implementation of multiple point-of-care testing in 2 HIV antiretroviral treatment clinics in South Africa. J Acquir Immune Defic Syndr. 2016;71(2):e34–43.
  • Fargher EA, Tricker K, Newman W, et al. Current use of pharmacogenetic testing: a national survey of thiopurine methyltransferase testing prior to azathioprine prescription. J Clin Pharm Ther. 2007;32(2):187–195.
  • Higgs J, Gambhir N, Ramsden SC, et al. Pharmacogenetic testing in the United Kingdom genetics and immunogenetics laboratories. Genet Test Mol Biomarkers. 2010;14(1):121–125.
  • Johnson JA. Pharmacogenetics in clinical practice: how far have we come and where are we going? Pharmacogenomics. 2013;14(7):835–843.
  • Ikediobi ON, Shin J, Nussbaum RL, et al. Addressing the challenges of the clinical application of pharmacogenetic testing. Clin Pharmacol Ther. 2009;86(1):28–31.
  • Sharp L, Farrance I, Greaves RF. The application of glucose point of care testing in three metropolitan hospitals. Pathology. 2016;48(1):51–59.
  • Mirzazadeh M, Morovat A, James T, et al. Point-of-care testing of electrolytes and calcium using blood gas analysers: it is time we trusted the results. Emerg Med J. 2016;33(3):181–186.
  • Peter JG, Zijenah LS, Chanda D, et al. Effect on mortality of point-of-care, urine-based lipoarabinomannan testing to guide tuberculosis treatment initiation in HIV-positive hospital inpatients: a pragmatic, parallel-group, multicountry, open-label, randomised controlled trial. Lancet. 2016;387(10024):1187–1197.
  • Natoli L, Guy RJ, Shephard M, et al. I do feel like a scientist at times: a qualitative study of the acceptability of molecular point-of-care testing for chlamydia and gonorrhoea to primary care professionals in a remote high STI burden setting. PLoS One. 2015;10(12):e0145993.
  • Crocker JB, Lee-Lewandrowski E, Lewandrowski N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640–646.
  • Adams AJ, Klepser ME, Klepser D. An update on community pharmacies as CLIA-waived facilities. Res Social Adm Pharm. 2016;12(4):666–667.
  • Midwest Pharmacy Workforce Research Consortium National Pharmacist Workforce Survey; 2014 [cited 2016 May 5]. Available from: http://www.aacp.org/resources/research/pharmacyworkforcecenter/Documents/FinalReportOfTheNationalPharmacistWorkforceStudy2014.pdf
  • Darin KM, Klepser ME, Klepser DE, et al. Pharmacist-provided rapid HIV testing in two community pharmacies. J Am Pharm Assoc. 2015;55(1):81–88.
  • Weber NC, Klepser ME, Akers JM, et al. Use of CLIA-waived point-of-care tests for infectious diseases in community pharmacies in the United States. Expert Rev Mol Diagn. 2016;16(2):253–264.
  • Haggerty L, Tran D. Cholesterol point-of-care testing for community pharmacies: a review of the current literature. J Pharm Pract. 2016 Apr 26. pii: 0897190016645023. [Epub ahead of print].
  • Challen L, Agbahiwe S, Cantieri T, et al. Impact of point-of-care implementation in pharmacist-run anticoagulation clinics within a community-owned health system: a two-year retrospective analysis. Hosp Pharm. 2015;50(9):783–788.
  • Geerts AF, De Koning FH, De Vooght KM, et al. Feasibility of point-of-care creatinine testing in community pharmacy to monitor drug therapy in ambulatory elderly patients. J Clin Pharm Ther. 2013;38(5):416–422.
  • Doucette WR, McDonough RP, Mormann MM, et al. Three-year financial analysis of pharmacy services at an independent community pharmacy. J Am Pharm Assoc (2003). 2012;52(2):181–187.
  • Gubbins PO, Klepser ME, Dering-Anderson AM, et al. Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc (2003). 2014;54(2):163–171.
  • Kim JY, Lewandrowski K. Point-of-care testing informatics. Clin Lab Med. 2009;29(3):449–461.
  • Cook CB, Moghissi E, Joshi R, et al. Inpatient point-of-care bedside glucose testing: preliminary data on use of connectivity informatics to measure hospital glycemic control. Diabetes Technol Ther. 2007;9(6):493–500.
  • Dyer K, Nichols JH, Taylor M, et al. Development of a universal connectivity and data management system. Crit Care Nurs Q. 2001;24(1):25–38; quiz 22 p following 75.
  • Flore KM, Fiers T, Delanghe JR. Critical evaluation of connectivity-based point of care testing systems of glucose in a hospital environment. Clin Chem Lab Med. 2008;46(12):1763–1768.
  • Cvitkovic M. Point-of-care testing. conception, regulations, and usage. Crit Care Nurs Q. 2011;34(2):116–127.
  • Clinical and Laboratory Standards Institute (CLSI). Point-of-care connectivity; approved standard. Wayne (PA): Clinical and Laboratory Standards Institute; 2006.
  • Stahl JE, McGowan H, DiResta E, et al. Systems engineering and point of care testing: report from the NIBIB POCT/systems engineering workshop. Point Care. 2015;14(1):12–24.
  • Peeling RW. Diagnostics in a digital age: an opportunity to strengthen health systems and improve health outcomes. Int Health. 2015;7(6):384–389.

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