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Volumn 55, Issue 8, 2017, Pages 2502-2520

Validation and implementation of clinical laboratory improvements act-compliant whole-genome sequencing in the public health microbiology laboratory

Author keywords

Bacteria; Bioinformatics pipeline; CLIA; Laboratory developed test; Performance specifications; Public health; Quality management; Validation; WGS; Whole genome sequencing

Indexed keywords

ARTICLE; BACTERIAL GENOME; BACTERIUM ISOLATE; CLINICAL LABORATORY; CONTROLLED STUDY; ENTEROBACTERIACEAE; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; LAW; LIMIT OF DETECTION; MEASUREMENT ACCURACY; MEASUREMENT REPEATABILITY; MULTILOCUS SEQUENCE TYPING; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PHYLOGENY; PRIORITY JOURNAL; PUBLIC HEALTH MICROBIOLOGY LABORATORY; QUALITY CONTROL; REPRODUCIBILITY; SINGLE NUCLEOTIDE POLYMORPHISM; VALIDATION STUDY; WHOLE GENOME SEQUENCING; BACTERIAL INFECTION; HUMAN; MICROBIOLOGICAL EXAMINATION; MOLECULAR DIAGNOSIS; MOLECULAR EPIDEMIOLOGY; PROCEDURES; SENSITIVITY AND SPECIFICITY;

EID: 85026266069     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.00361-17     Document Type: Article
Times cited : (73)

References (59)
  • 1
    • 84865231395 scopus 로고    scopus 로고
    • Transforming clinical microbiology with bacterial genome sequencing
    • Didelot X, Bowden R, Wilson DJ, Peto TEA, Crook DW. 2012. Transforming clinical microbiology with bacterial genome sequencing. Nat Rev Genet 13:601-612. https://doi.org/10.1038/nrg3226.
    • (2012) Nat Rev Genet , vol.13 , pp. 601-612
    • Didelot, X.1    Bowden, R.2    Wilson, D.J.3    Peto, T.E.A.4    Crook, D.W.5
  • 6
    • 84903782426 scopus 로고    scopus 로고
    • Bacterial whole-genome sequencing revisited: Portable, scalable, and standardized analysis for typing and detection of virulence and antibiotic resistance genes
    • Leopold SR, Goering RV, Witten A, Harmsen D, Mellmann A. 2014. Bacterial whole-genome sequencing revisited: portable, scalable, and standardized analysis for typing and detection of virulence and antibiotic resistance genes. J Clin Microbiol 52:2365-2370. https://doi.org/10 .1128/JCM.00262-14.
    • (2014) J Clin Microbiol , vol.52 , pp. 2365-2370
    • Leopold, S.R.1    Goering, R.V.2    Witten, A.3    Harmsen, D.4    Mellmann, A.5
  • 7
    • 84968903135 scopus 로고    scopus 로고
    • Coming of age: Ten years of next-generation sequencing technologies
    • Goodwin S, McPherson JD, McCombie WR. 2016. Coming of age: ten years of next-generation sequencing technologies. Nat Rev Genet 17: 333-351. https://doi.org/10.1038/nrg.2016.49.
    • (2016) Nat Rev Genet , vol.17 , pp. 333-351
    • Goodwin, S.1    McPherson, J.D.2    McCombie, W.R.3
  • 8
    • 84874469388 scopus 로고    scopus 로고
    • Whole genome sequencing versus traditional genotyping for investigation of a Mycobacterium tuberculosis outbreak: A longitudinal molecular epidemiological study
    • Roetzer A, Diel R, Kohl TA, Rückert C, Nübel U, Blom J, Wirth T, Jaenicke S, Schuback S, Rüsch-Gerdes S. 2013. Whole genome sequencing versus traditional genotyping for investigation of a Mycobacterium tuberculosis outbreak: a longitudinal molecular epidemiological study. PLoS Med 10:e1001387. https://doi.org/10.1371/journal.pmed.1001387.
    • (2013) PLoS Med , vol.10 , pp. e1001387
    • Roetzer, A.1    Diel, R.2    Kohl, T.A.3    Rückert, C.4    Nübel, U.5    Blom, J.6    Wirth, T.7    Jaenicke, S.8    Schuback, S.9    Rüsch-Gerdes, S.10
  • 12
    • 84927910898 scopus 로고    scopus 로고
    • Diagnostic metagenomics: Potential applications to bacterial, viral and parasitic infections
    • Pallen MJ. 2014. Diagnostic metagenomics: potential applications to bacterial, viral and parasitic infections. Parasitology 141:1856-1862. https://doi.org/10.1017/S0031182014000134.
    • (2014) Parasitology , vol.141 , pp. 1856-1862
    • Pallen, M.J.1
  • 13
    • 84959329062 scopus 로고    scopus 로고
    • The human microbiome during bacterial vaginosis
    • Onderdonk AB, Delaney ML, Fichorova RN. 2016. The human microbiome during bacterial vaginosis. Clin Microbiol Rev 29:223-238. https:// doi.org/10.1128/CMR.00075-15.
    • (2016) Clin Microbiol Rev , vol.29 , pp. 223-238
    • Onderdonk, A.B.1    Delaney, M.L.2    Fichorova, R.N.3
  • 15
    • 84904012195 scopus 로고    scopus 로고
    • Microbiome data distinguish patients with Clostridium difficile infection and non-C. Difficile-associated diarrhea from healthy controls
    • Schubert AM, Rogers MAM, Ring C, Mogle J, Petrosino JP, Young VB, Aronoff DM, Schloss PD. 2014. Microbiome data distinguish patients with Clostridium difficile infection and non-C. difficile-associated diarrhea from healthy controls. mBio 5:e01021-14. https://doi.org/10.1128/mBio .01021-14.
    • (2014) MBio , vol.5 , pp. e01021-e01114
    • Schubert, A.M.1    Rogers, M.A.M.2    Ring, C.3    Mogle, J.4    Petrosino, J.P.5    Young, V.B.6    Aronoff, D.M.7    Schloss, P.D.8
  • 17
    • 84891529869 scopus 로고    scopus 로고
    • Rapid whole genome sequencing for the detection and characterization of microorganisms directly from clinical samples
    • Hasman H, Saputra D, Sicheritz-Ponten T, Lund O, Svendsen CA, Frimodt-Møller N, Aarestrup FM. 2014. Rapid whole genome sequencing for the detection and characterization of microorganisms directly from clinical samples. J Clin Microbiol 52:139-146. https://doi.org/10.1128/JCM .02452-13.
    • (2014) J Clin Microbiol , vol.52 , pp. 139-146
    • Hasman, H.1    Saputra, D.2    Sicheritz-Ponten, T.3    Lund, O.4    Svendsen, C.A.5    Frimodt-Møller, N.6    Aarestrup, F.M.7
  • 19
    • 84989941155 scopus 로고    scopus 로고
    • Standardization and quality management in next-generation sequencing
    • Endrullat C, Glökler J, Franke P, Frohme M. 2016. Standardization and quality management in next-generation sequencing. Appl Transl Genom 10:2-9. https://doi.org/10.1016/j.atg.2016.06.001.
    • (2016) Appl Transl Genom , vol.10 , pp. 2-9
    • Endrullat, C.1    Glökler, J.2    Franke, P.3    Frohme, M.4
  • 20
    • 84905858372 scopus 로고    scopus 로고
    • Next-generation sequencing: A change of paradigm in molecular diagnostic validation
    • Salto-Tellez M, Gonzalez de Castro D. 2014. Next-generation sequencing: a change of paradigm in molecular diagnostic validation. J Pathol 234:5-10. https://doi.org/10.1002/path.4365.
    • (2014) J Pathol , vol.234 , pp. 5-10
    • Salto-Tellez, M.1    De Castro, D.G.2
  • 21
    • 84952836879 scopus 로고    scopus 로고
    • Making the leap from research laboratory to clinic: Challenges and opportunities for next-generation sequencing in infectious disease diagnostics
    • Goldberg B, Sichtig H, Geyer C, Ledeboer N, Weinstock GM. 2015. Making the leap from research laboratory to clinic: challenges and opportunities for next-generation sequencing in infectious disease diagnostics. mBio 6:e01888-15. https://doi.org/10.1128/mBio.01888-15.
    • (2015) MBio , vol.6 , pp. e01888-e01915
    • Goldberg, B.1    Sichtig, H.2    Geyer, C.3    Ledeboer, N.4    Weinstock, G.M.5
  • 22
    • 84964694300 scopus 로고    scopus 로고
    • Whole genome sequencing in clinical and public health microbiology
    • Kwong JC, McCallum N, Sintchenko V, Howden BP. 2015. Whole genome sequencing in clinical and public health microbiology. Pathology 47: 199-210. https://doi.org/10.1097/PAT.0000000000000235.
    • (2015) Pathology , vol.47 , pp. 199-210
    • Kwong, J.C.1    McCallum, N.2    Sintchenko, V.3    Howden, B.P.4
  • 23
    • 84952777752 scopus 로고    scopus 로고
    • Moving pathogen genomics out of the lab and into the clinic: What will it take?
    • Luheshi LM, Raza S, Peacock SJ. 2015. Moving pathogen genomics out of the lab and into the clinic: what will it take?. Genome Med 7:132. https://doi.org/10.1186/s13073-015-0254-z.
    • (2015) Genome Med , vol.7 , pp. 132
    • Luheshi, L.M.1    Raza, S.2    Peacock, S.J.3
  • 24
    • 84920509712 scopus 로고    scopus 로고
    • Bioinformatics for clinical next generation sequencing
    • Oliver GR, Hart SN, Klee EW. 2015. Bioinformatics for clinical next generation sequencing. Clin Chem 61:124-135. https://doi.org/10.1373/ clinchem.2014.224360.
    • (2015) Clin Chem , vol.61 , pp. 124-135
    • Oliver, G.R.1    Hart, S.N.2    Klee, E.W.3
  • 25
    • 84890558766 scopus 로고    scopus 로고
    • Bacterial genome sequencing in the clinic: Bioinformatic challenges and solutions
    • Fricke WF, Rasko DA. 2014. Bacterial genome sequencing in the clinic: bioinformatic challenges and solutions. Nat Rev Genet 15:49-55. https:// doi.org/10.1038/nrg3624.
    • (2014) Nat Rev Genet , vol.15 , pp. 49-55
    • Fricke, W.F.1    Rasko, D.A.2
  • 26
    • 84926620463 scopus 로고    scopus 로고
    • WGS analysis and interpretation in clinical and public health microbiology laboratories: What are the requirements and how do existing tools compare?
    • Wyres KL, Conway TC, Garg S, Queiroz C, Reumann M, Holt K, Rusu LI. 2014. WGS analysis and interpretation in clinical and public health microbiology laboratories: what are the requirements and how do existing tools compare?. Pathogens 3:437-458. https://doi.org/10 .3390/pathogens3020437.
    • (2014) Pathogens , vol.3 , pp. 437-458
    • Wyres, K.L.1    Conway, T.C.2    Garg, S.3    Queiroz, C.4    Reumann, M.5    Holt, K.6    Rusu, L.I.7
  • 28
    • 84997782882 scopus 로고    scopus 로고
    • Assuring the quality of nextgeneration sequencing in clinical microbiology and public health laboratories
    • Gargis AS, Kalman L, Lubin IM. 2016. Assuring the quality of nextgeneration sequencing in clinical microbiology and public health laboratories. J Clin Microbiol 54:2857-2865. https://doi.org/10.1128/JCM .00949-16.
    • (2016) J Clin Microbiol , vol.54 , pp. 2857-2865
    • Gargis, A.S.1    Kalman, L.2    Lubin, I.M.3
  • 29
    • 84943656196 scopus 로고    scopus 로고
    • Next-generation sequencing for infectious disease diagnosis and management: A report of the Association for Molecular Pathology
    • Lefterova MI, Suarez CJ, Banaei N, Pinsky BA. 2015. Next-generation sequencing for infectious disease diagnosis and management: a report of the Association for Molecular Pathology. J Mol Diagn 17:623-634. https://doi.org/10.1016/j.jmoldx.2015.07.004.
    • (2015) J Mol Diagn , vol.17 , pp. 623-634
    • Lefterova, M.I.1    Suarez, C.J.2    Banaei, N.3    Pinsky, B.A.4
  • 31
    • 84926686219 scopus 로고    scopus 로고
    • Proficiency testing for bacterial whole genome sequencing: An end-user survey of current capabilities, requirements and priorities
    • Moran-Gilad J, Sintchenko V, Pedersen SK, Wolfgang WJ, Pettengill J, Strain E, Hendriksen RS. 2015. Proficiency testing for bacterial whole genome sequencing: an end-user survey of current capabilities, requirements and priorities. BMC Infect Dis 15:174. https://doi.org/10.1186/ s12879-015-0902-3.
    • (2015) BMC Infect Dis , vol.15 , pp. 174
    • Moran-Gilad, J.1    Sintchenko, V.2    Pedersen, S.K.3    Wolfgang, W.J.4    Pettengill, J.5    Strain, E.6    Hendriksen, R.S.7
  • 32
    • 84989187877 scopus 로고    scopus 로고
    • Report from the Standards for Pathogen Identification via Next-Generation Sequencing (SPIN) Workshop
    • Olson ND, Jackson SA, Lin NJ. 2015. Report from the Standards for Pathogen Identification via Next-Generation Sequencing (SPIN) Workshop. Stand Genomic Sci 10:119. https://doi.org/10.1186/s40793-015-0112-z.
    • (2015) Stand Genomic Sci , vol.10 , pp. 119
    • Olson, N.D.1    Jackson, S.A.2    Lin, N.J.3
  • 39
    • 84895096959 scopus 로고    scopus 로고
    • Evaluation of whole genome sequencing for outbreak detection of Salmonella enterica
    • Leekitcharoenphon P, Nielsen EM, Kaas RS, Lund O, Aarestrup FM. 2014. Evaluation of whole genome sequencing for outbreak detection of Salmonella enterica. PLoS One 9:e87991. https://doi.org/10.1371/journal .pone.0087991.
    • (2014) PLoS One , vol.9 , pp. e87991
    • Leekitcharoenphon, P.1    Nielsen, E.M.2    Kaas, R.S.3    Lund, O.4    Aarestrup, F.M.5
  • 40
    • 77954605045 scopus 로고    scopus 로고
    • Validation of laboratory-developed molecular assays for infectious diseases
    • Burd EM. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev 23:550-576. https://doi.org/10 .1128/CMR.00074-09.
    • (2010) Clin Microbiol Rev , vol.23 , pp. 550-576
    • Burd, E.M.1
  • 41
    • 84928209346 scopus 로고    scopus 로고
    • Standards and guidelines for the interpretation of sequence variants: A joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology
    • Richards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, Spector E, Voelkerding K, Rehm HL. 2015. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med 17:405-423. https://doi.org/10.1038/gim.2015.30.
    • (2015) Genet Med , vol.17 , pp. 405-423
    • Richards, S.1    Aziz, N.2    Bale, S.3    Bick, D.4    Das, S.5    Gastier-Foster, J.6    Grody, W.W.7    Hegde, M.8    Lyon, E.9    Spector, E.10    Voelkerding, K.11    Rehm, H.L.12
  • 42
    • 84973621390 scopus 로고    scopus 로고
    • The challenges of implementing next generation sequencing across a large healthcare system, and the molecular epidemiology and antibiotic susceptibilities of carbapenemase-producing bacteria in the healthcare system of the U.S. Department of Defense
    • Lesho E, Clifford R, Onmus-Leone F, Appalla L, Snesrud E, Kwak Y, Ong A, Maybank R, Waterman P, Rohrbeck P, Julius M, Roth A, Martinez J, Nielsen L, Steele E, McGann P, Hinkle M. 2016. The challenges of implementing next generation sequencing across a large healthcare system, and the molecular epidemiology and antibiotic susceptibilities of carbapenemase-producing bacteria in the healthcare system of the U.S. Department of Defense. PLoS One 11:e0155770. https://doi.org/10.1371/ journal.pone.0155770.
    • (2016) PLoS One , vol.11 , pp. e0155770
    • Lesho, E.1    Clifford, R.2    Onmus-Leone, F.3    Appalla, L.4    Snesrud, E.5    Kwak, Y.6    Ong, A.7    Maybank, R.8    Waterman, P.9    Rohrbeck, P.10    Julius, M.11    Roth, A.12    Martinez, J.13    Nielsen, L.14    Steele, E.15    McGann, P.16    Hinkle, M.17
  • 43
    • 84986308268 scopus 로고    scopus 로고
    • Development and characterization of reference materials for genetic testing: Focus on public partnerships
    • Kalman LV, Datta V, Williams M, Zook JM, Salit ML, Han J-Y. 2016. Development and characterization of reference materials for genetic testing: focus on public partnerships. Ann Lab Med 36:513-520. https:// doi.org/10.3343/alm.2016.36.6.513.
    • (2016) Ann Lab Med , vol.36 , pp. 513-520
    • Kalman, L.V.1    Datta, V.2    Williams, M.3    Zook, J.M.4    Salit, M.L.5    Han, J.-Y.6
  • 44
    • 84973444542 scopus 로고    scopus 로고
    • Implementation of whole genome sequencing (WGS) for identification and characterization of Shiga toxin-producing Escherichia coli (STEC) in the United States
    • Lindsey RL, Pouseele H, Chen JC, Strockbine NA, Carleton HA. 2016. Implementation of whole genome sequencing (WGS) for identification and characterization of Shiga toxin-producing Escherichia coli (STEC) in the United States. Front Microbiol 7:766. https://doi.org/10.3389/fmicb .2016.00766.
    • (2016) Front Microbiol , vol.7 , pp. 766
    • Lindsey, R.L.1    Pouseele, H.2    Chen, J.C.3    Strockbine, N.A.4    Carleton, H.A.5
  • 48
    • 84961654824 scopus 로고    scopus 로고
    • Considerations in centralizing whole genome sequencing for microbiology in a public health setting
    • Arnold C. 2016. Considerations in centralizing whole genome sequencing for microbiology in a public health setting. Expert Rev Mol Diagn 16:619-621. https://doi.org/10.1586/14737159.2016.1164039.
    • (2016) Expert Rev Mol Diagn , vol.16 , pp. 619-621
    • Arnold, C.1
  • 50
    • 84966333965 scopus 로고    scopus 로고
    • Practical value of food pathogen traceability through building a whole-genome sequencing network and database
    • Allard MW, Strain E, Melka D, Bunning K, Musser SM, Brown EW, Timme R. 2016. Practical value of food pathogen traceability through building a whole-genome sequencing network and database. J Clin Microbiol 54: 1975-1983. https://doi.org/10.1128/JCM.00081-16.
    • (2016) J Clin Microbiol , vol.54 , pp. 1975-1983
    • Allard, M.W.1    Strain, E.2    Melka, D.3    Bunning, K.4    Musser, S.M.5    Brown, E.W.6    Timme, R.7
  • 51
    • 84925245476 scopus 로고    scopus 로고
    • Integration of whole-genome sequencing into infection control practices: The potential and the hurdles
    • Robilotti E, Kamboj M. 2015. Integration of whole-genome sequencing into infection control practices: the potential and the hurdles. J Clin Microbiol 53:1054-1055. https://doi.org/10.1128/JCM.00349-15.
    • (2015) J Clin Microbiol , vol.53 , pp. 1054-1055
    • Robilotti, E.1    Kamboj, M.2
  • 54
    • 84901417347 scopus 로고    scopus 로고
    • Prokka: Rapid prokaryotic genome annotation
    • Seemann T. 2014. Prokka: rapid prokaryotic genome annotation. Bioinformatics 30:2068-2069. https://doi.org/10.1093/bioinformatics/btu153.
    • (2014) Bioinformatics , vol.30 , pp. 2068-2069
    • Seemann, T.1
  • 57
    • 84899573966 scopus 로고    scopus 로고
    • Real-time whole-genome sequencing for routine typing, surveillance, and outbreak detection of verotoxigenic Escherichia coli
    • Joensen KG, Scheutz F, Lund O, Hasman H, Kaas RS, Nielsen EM, Aarestrup FM. 2014. Real-time whole-genome sequencing for routine typing, surveillance, and outbreak detection of verotoxigenic Escherichia coli. J Clin Microbiol 52:1501-1510. https://doi.org/10.1128/ JCM.03617-13.
    • (2014) J Clin Microbiol , vol.52 , pp. 1501-1510
    • Joensen, K.G.1    Scheutz, F.2    Lund, O.3    Hasman, H.4    Kaas, R.S.5    Nielsen, E.M.6    Aarestrup, F.M.7
  • 58
    • 84939482124 scopus 로고    scopus 로고
    • CLSI; twenty-fifth informational supplement. CLSI document M100-S25. CLSI, Wayne, PA.
    • CLSI. 2015. Performance standards for antimicrobial susceptibility testing; twenty-fifth informational supplement. CLSI document M100-S25. CLSI, Wayne, PA.
    • (2015) Performance Standards for Antimicrobial Susceptibility Testing


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