Point-of-care testing and molecular diagnostics: miniaturization required.

Turnaround time for molecular diagnostic tests is critical in detecting infectious agents, in determining a patient's ability to metabolize a drug or drug class, and in detecting minimal residual disease. These applications would benefit from the development of a point-of-care device for nucleic acid extraction, amplification, and detection. The ideal device would have a low cost per test, use a disposable unit use device for all steps in the assay, be portable, and provide a result that requires no interpretation. The creation of such a device requires miniaturization of current technologies and the use of microfluidics, microarrays, and small-diameter capillary tubes to reduce reagent volumes and simplify heat conduction by convection during nucleic acid amplification. This ideal device may be available in 3 to 5 years and will revolutionize and expand the global availability of molecular diagnostic assays.

[1]  Luke P. Lee,et al.  Innovations in optical microfluidic technologies for point-of-care diagnostics. , 2008, Lab on a chip.

[2]  Axel Scherer,et al.  Microfluidic vias enable nested bioarrays and autoregulatory devices in Newtonian fluids , 2006, Proceedings of the National Academy of Sciences.

[3]  M. Hermans,et al.  Single nucleotide polymorphism profiling assay to confirm the identity of human tissues. , 2007, The Journal of molecular diagnostics : JMD.

[4]  V. Bain.  Effect of HCV viral dynamics on treatment design: lessons learned from HIV. , 2001 .

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

[6]  D. Lim,et al.  Current and Developing Technologies for Monitoring Agents of Bioterrorism and Biowarfare , 2005, Clinical Microbiology Reviews.

[7]  Jianli Dong,et al.  Emerging Pathogens: Challenges and Successes of Molecular Diagnostics , 2008, The Journal of Molecular Diagnostics.

[8]  T. F. Smith,et al.  Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing , 2006, Clinical Microbiology Reviews.

[9]  Jerome P Ferrance,et al.  A low-cost, low-power consumption, miniature laser-induced fluorescence system for DNA detection on a microfluidic device. , 2007, Clinics in laboratory medicine.

[10]  Guo-Ping Zhao.  SARS molecular epidemiology: a Chinese fairy tale of controlling an emerging zoonotic disease in the genomics era , 2007, Philosophical Transactions of the Royal Society B: Biological Sciences.

[11]  D. Calfee,et al.  Use of Active Surveillance Cultures to Detect Asymptomatic Colonization With Carbapenem-Resistant Klebsiella pneumoniae in Intensive Care Unit Patients , 2008, Infection Control & Hospital Epidemiology.

[12]  M. Gottschalk,et al.  Spread of Streptococcus suis Sequence Type 7, China , 2008, Emerging infectious diseases.

[13]  Kate E. Jones,et al.  Global trends in emerging infectious diseases , 2008, Nature.

[14]  Point-of-Care Testing: 3 New Developments Needed for Future Growth , 2008 .

[15]  M. Ieven.  Currently used nucleic acid amplification tests for the detection of viruses and atypicals in acute respiratory infections , 2007, Journal of Clinical Virology.

[16]  Vincent Linder,et al.  Microfluidics at the crossroad with point-of-care diagnostics. , 2007, The Analyst.

[17]  Adam Zemla,et al.  Comparative Genomics Tools Applied to Bioterrorism Defence , 2003, Briefings Bioinform..

[18]  J. Ellis,et al.  Reverse transcriptase-polymerase chain reaction on Quickvue Influenza Test Strips , 2009 .

[19]  R Weber,et al.  HIV viral load response to antiretroviral therapy according to the baseline CD4 cell count and viral load. , 2001, JAMA.

[20]  Yusheng Zhu,et al.  Estimation of warfarin maintenance dose based on VKORC1 (-1639 G>A) and CYP2C9 genotypes. , 2007, Clinical chemistry.

[21]  J. Dujardin,et al.  Molecular Diagnosis of Leishmaniasis: Current Status and Future Applications , 2006, Journal of Clinical Microbiology.

[22]  Victor M Ugaz,et al.  A buoyancy-driven compact thermocycler for rapid PCR. , 2007, Clinics in laboratory medicine.

[23]  C. Auewarakul,et al.  Two-round allele specific-polymerase chain reaction: a simple and highly sensitive method for JAK2V617F mutation detection. , 2009, Clinica chimica acta; international journal of clinical chemistry.

[24]  Nathan D. Wolfe,et al.  Origins of major human infectious diseases , 2007, Nature.