Molecular Diagnostics and the Changing Face of Point-of-Care

In vitro diagnostics (IVDs) are undergoing an evolution that is being driven by nucleic acid–based molecular detection technologies, from fully automated, multistep miniaturized platforms that integrate sample prep, detection, and signal amplification into single-step cassettes processed on handheld or portable instrumentation (1, 2), to novel real-time detection chemistries that are platform-agnostic and allow high target multiplexing (3). With simplified laboratory requirements, portable equipment and wireless links to remote health care services, these sophisticated technology platforms have the potential to revolutionize patient testing, putting actionable information rapidly into the hands of the treating clinician during the patient encounter, regardless of where the interaction occurs.

[1]  K. Lewandrowski,et al.  Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. , 2011, Archives of pathology & laboratory medicine.

[2]  Á. Holguín,et al.  Performance of OraQuick Advance Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1+ subjects carrying different HIV-1 subtypes and recombinant variants. , 2009, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[3]  W. MacLeod,et al.  Scaling up Xpert MTB/RIF technology: the costs of laboratory- vs. clinic-based roll-out in South Africa , 2012, Tropical medicine & international health : TM & IH.

[4]  A. R. Fernandes,et al.  AuNPs for identification of molecular signatures of resistance , 2014, Front. Microbiol..

[5]  Jamie Burn Company profile: QuantuMDx group limited. , 2013, Pharmacogenomics.

[6]  L. Scott,et al.  Multicenter Feasibility Study To Assess External Quality Assessment Panels for Xpert MTB/RIF Assay in South Africa , 2014, Journal of Clinical Microbiology.

[7]  N. E. Babady,et al.  The FilmArray® respiratory panel: an automated, broadly multiplexed molecular test for the rapid and accurate detection of respiratory pathogens , 2013, Expert review of molecular diagnostics.

[8]  K. Sin,et al.  Evidence-based point-of-care diagnostics: current status and emerging technologies. , 2013, Annual review of analytical chemistry.

[9]  C. Toro,et al.  Point-of-Care System for Detection of Mycobacterium tuberculosis and Rifampin Resistance in Sputum Samples , 2013, Journal of Clinical Microbiology.

[10]  M. Klepser,et al.  Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. , 2014, Journal of the American Pharmacists Association : JAPhA.

[11]  Rosanna W. Peeling,et al.  Point-of-care testing for sexually transmitted infections: recent advances and implications for disease control , 2013, Current opinion in infectious diseases.

[12]  B. Branson,et al.  Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies , 2006, AIDS.

[13]  S. Bossmann,et al.  Point-of-care routine rapid screening: the future of cancer diagnosis? , 2013, Expert review of molecular diagnostics.

[14]  Yi Lu,et al.  Molecular diagnostic and drug delivery agents based on aptamer-nanomaterial conjugates. , 2010, Advanced drug delivery reviews.

[15]  Jens Ducrée Special Issue: Microfluidic Lab-on-a-Chip Platforms for High-Performance Diagnostics , 2012, Diagnostics.

[16]  F. S. Collins Faces of the Genome , 2011, Science.

[17]  D. Boyle,et al.  Nucleic acid testing for tuberculosis at the point-of-care in high-burden countries , 2012, Expert review of molecular diagnostics.

[18]  L. Peirson,et al.  Screening for cervical cancer: a systematic review and meta-analysis , 2013, Systematic Reviews.

[19]  P. Baptista,et al.  Gold nanoprobes for multi loci assessment of multi-drug resistant tuberculosis. , 2014, Tuberculosis.

[20]  Yi-Wei Tang,et al.  Past, present and future molecular diagnosis and characterization of human immunodeficiency virus infections , 2012, Emerging Microbes & Infections.

[21]  M. Pai,et al.  Point-of-care diagnostics for HIV and tuberculosis: landscape, pipeline, and unmet needs. , 2012, Discovery medicine.

[22]  Morten Ruhwald,et al.  Point‐of‐care diagnosis of tuberculosis: Past, present and future , 2013, Respirology.

[23]  Alimuddin Zumla,et al.  Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test. , 2013, The Lancet. Infectious diseases.

[24]  R. Walensky,et al.  HIV Self-testing and the Missing Linkage , 2011, PLoS medicine.

[25]  R. Sahli,et al.  Comparison of Seegene Anyplex II HPV28 with the PGMY-CHUV Assay for Human Papillomavirus Genotyping , 2013, Journal of Clinical Microbiology.

[26]  G. Whitesides,et al.  Measuring markers of liver function using a micropatterned paper device designed for blood from a fingerstick. , 2012, Analytical chemistry.

[27]  N. Engel,et al.  Point-of-Care Testing for Infectious Diseases: Diversity, Complexity, and Barriers in Low- And Middle-Income Countries , 2012, PLoS medicine.

[28]  M. Joloba,et al.  Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis , 2013, BMC Infectious Diseases.

[29]  Carlton A. Evans,et al.  GeneXpert—A Game-Changer for Tuberculosis Control? , 2011, PLoS medicine.

[30]  R. Bashir,et al.  Nanopore sensors for nucleic acid analysis. , 2011, Nature nanotechnology.

[31]  S. Pelton,et al.  Seroreversion in human immunodeficiency virus‐exposed but uninfected infants , 1995, The Pediatric infectious disease journal.

[32]  T. Notomi,et al.  Loop-mediated isothermal amplification of DNA. , 2000, Nucleic acids research.

[33]  J. Beilby,et al.  The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial , 2010, BMC health services research.

[34]  Luke P. Lee,et al.  Correction: A Handheld Point-of-Care Genomic Diagnostic System , 2013, PLoS ONE.

[35]  Chih-Ming Ho,et al.  When Medicine Meets Engineering—Paradigm Shifts in Diagnostics and Therapeutics , 2013, Diagnostics.

[36]  Wei Han,et al.  Point-of-care nucleic acid detection using nanotechnology. , 2013, Nanoscale.

[37]  Eduardo Gotuzzo,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 , 2011, The Lancet.

[38]  B. Munoz,et al.  Field Evaluation of the Cepheid GeneXpert Chlamydia trachomatis Assay for Detection of Infection in a Trachoma Endemic Community in Tanzania , 2013, PLoS neglected tropical diseases.

[39]  Dan Luo,et al.  Multiplexed detection of pathogen DNA with DNA-based fluorescence nanobarcodes , 2005, Nature Biotechnology.

[40]  J. Mouatcho,et al.  Malaria rapid diagnostic tests: challenges and prospects. , 2013, Journal of medical microbiology.

[41]  F. Hecht,et al.  Performance of Rapid Point-of-Care and Laboratory Tests for Acute and Established HIV Infection in San Francisco , 2013, PloS one.

[42]  Samuel K Sia,et al.  Commercialization of microfluidic point-of-care diagnostic devices. , 2012, Lab on a chip.

[43]  D. Klarkowski,et al.  Causes of false-positive HIV rapid diagnostic test results , 2014, Expert review of anti-infective therapy.

[44]  R. Peeling,et al.  Rapid tests for sexually transmitted infections (STIs): the way forward , 2006, Sexually Transmitted Infections.

[45]  Kevin T Collopy,et al.  What's the point of point-of-care testing? Understanding the potential of this evolving capability. , 2014, EMS world.

[46]  Aydogan Ozcan,et al.  Integrated rapid-diagnostic-test reader platform on a cellphone. , 2012, Lab on a chip.

[47]  Ruth McNerney,et al.  Rapid Detection of Mycobacterium tuberculosis by Recombinase Polymerase Amplification , 2014, PloS one.

[48]  Jorge I. Quevedo,et al.  Evaluating Operational Specifications of Point-of-Care Diagnostic Tests: A Standardized Scorecard , 2012, PloS one.

[49]  Tassaneewan Laksanasopin,et al.  Mobile device for disease diagnosis and data tracking in resource-limited settings. , 2013, Clinical chemistry.

[50]  C. Gaydos,et al.  Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae , 2013, Journal of Clinical Microbiology.

[51]  K. J. Johansen Taber,et al.  The promise and challenges of next-generation genome sequencing for clinical care. , 2014, JAMA internal medicine.

[52]  S. Makombe,et al.  Determinants and Consequences of Failure of Linkage to Antiretroviral Therapy at Primary Care Level in Blantyre, Malawi: A Prospective Cohort Study , 2012, PloS one.

[53]  Yong Wang,et al.  Nanopore-based detection of circulating microRNAs in lung cancer patients , 2011, Nature nanotechnology.

[54]  R. Peeling,et al.  A guide for diagnostic evaluations , 2006, Nature Reviews Microbiology.

[55]  S. Ramachandran,et al.  A low cost point-of-care viscous sample preparation device for molecular diagnosis in the developing world; an example of microfluidic origami. , 2012, Lab on a chip.

[56]  F. V. van Tiel,et al.  Alarmingly poor performance in Chlamydia trachomatis point-of-care testing , 2010, Sexually Transmitted Infections.

[57]  J. Justman,et al.  Poor Performance of the Determine HIV-1/2 Ag/Ab Combo Fourth-Generation Rapid Test for Detection of Acute Infections in a National Household Survey in Swaziland , 2014, Journal of Clinical Microbiology.

[58]  V. Dravid,et al.  Hybrid nanostructures for diagnostics and therapeutics. , 2011, Advanced drug delivery reviews.

[59]  M. Gatton,et al.  Malaria rapid diagnostic test performance : results of WHO product testing of malaria RDTs : round 5 (2013) , 2018 .

[60]  Ruth McNerney,et al.  Emerging technologies in point-of-care molecular diagnostics for resource-limited settings , 2014, Expert review of molecular diagnostics.

[61]  Russell Weiner,et al.  Navigating the Rapids: The Development of Regulated Next-Generation Sequencing-Based Clinical Trial Assays and Companion Diagnostics , 2014, Front. Oncol..

[62]  Carol A. Holland,et al.  Point-of-care molecular diagnostic systems--past, present and future. , 2005, Current opinion in microbiology.

[63]  B. Hamainza,et al.  Community Health Workers Use Malaria Rapid Diagnostic Tests (RDTs) Safely and Accurately: Results of a Longitudinal Study in Zambia , 2012, The American journal of tropical medicine and hygiene.

[64]  A StJohn,et al.  Economic Evidence and Point-of-Care Testing. , 2013 .

[65]  P. Craw,et al.  Isothermal nucleic acid amplification technologies for point-of-care diagnostics: a critical review. , 2012, Lab on a chip.