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Research ArticleResearch and Reports

Automation and Molecular Diagnostics: a New Era in Clinical Microbiology

Jason V. Evans
American Society for Clinical Laboratory Science October 2019, 32 (4) 156-165; DOI: https://doi.org/10.29074/ascls.2019001883
Jason V. Evans
West Virginia University
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    Table 1.

    FDA-approved (nonpanel) molecular tests per organism/organism group


    Organism
    Number
    of Tests*

    Organism
    Number
    of Tests*
    Adenovirus3Influenza and respiratory viruses50
    Bacillus anthracis1Leishmania spp.1
    Bordetella spp.5Mycobacterium tuberculosis8
    Candida spp.6Mycobacterium spp.9
    Clostridium difficile17Mycoplasma genitalium1
    Coxiella burnetii1Mycoplasma pneumoniae2
    Chlamydia trachomatis/Neisseria gonorrhoeae47Nonvariola orthopoxvirus1
    Cytomegalovirus5Norovirus1
    Dengue virus1Plasmodium spp.1
    Enterococcus spp.6Rickettsia spp.1
    Enterovirus1Staphylococci19
    Escherichia coli/Klebsiella pneumoniae/Pseudomonas aeruginosa1Streptococci21
    Francisella tularensis1Shiga toxin1
    Herpes simplex virus18Trichomonas vaginalis7
    Hepatitis virus14Variola1
    Human metapneumovirus3Yersinia pestis1
    Human papillomavirus7

    *Modified from www.fda.gov nucleic-acid–based tests.

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    American Society for Clinical Laboratory Science: 32 (4)
    American Society for Clinical Laboratory Science
    Vol. 32, Issue 4
    1 Oct 2019
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    Automation and Molecular Diagnostics: a New Era in Clinical Microbiology
    Jason V. Evans
    American Society for Clinical Laboratory Science Oct 2019, 32 (4) 156-165; DOI: 10.29074/ascls.2019001883

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    Jason V. Evans
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    • Article
      • LEARNING OBJECTIVES
      • ABSTRACT
      • INTRODUCTION
      • SINGLE-TARGET MOLECULAR DIAGNOSTICS
      • POINT-OF-CARE MOLECULAR DIAGNOSTICS
      • SYNDROMIC PANELS
      • NEXT-GENERATION SEQUENCING
      • TOTAL LABORATORY AUTOMATION
      • DISCUSSION
      • References
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    Keywords

    • BCID - blood culture identification
    • BD - Becton Dickinson
    • CLIA - Clinical Laboratory Improvement Amendments
    • CNS - central nervous system
    • FDA - Food and Drug Administration
    • FDA-ARGOS - Food and Drug Administration Database for Regulatory-Grade Microbial Sequences
    • GI - gastrointestinal
    • MALDI-TOF - matrix-assisted laser desorption/ionization time-of-flight
    • NGS - next-generation sequencing
    • PCR - polymerase chain reaction
    • POC - point-of-care
    • STI - sexually-transmitted infection
    • TLA - total laboratory automation
    • WASP - Walk-Away Specimen Processor
    • molecular diagnostics
    • syndromic panels
    • next-generation sequencing
    • total laboratory automation

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