A Model Study of In Silico Proficiency Testing for Clinical Next-Generation Sequencing.

Context.--Most current proficiency testing challenges for next-generation sequencing assays are methods-based proficiency testing surveys that use DNA from characterized reference samples to test both the wet-bench and bioinformatics/dry-bench aspects of the tests. Methods-based proficiency testing...

Full description

Bibliographic Details
Published in:Archives of Pathology & Laboratory Medicine Vol. 140; no. 10; pp. 1085 - 1092
Main Authors: Duncavage, Eric J., Abel, Haley J., Merker, Jason D., Bodner, John B., Qin Zhao, Voelkerding, Karl V., Pfeifer, John D.
Format: pictorial research tables/charts Journal Article
Published: College of American Pathologists Oct2016
Online Access:View this record in EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=118521114&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 118521114
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        00039985
        1FS
      jtl: Archives of Pathology & Laboratory Medicine
      issn: 00039985
      maglogo: N
    pubinfo:
      dt: Oct2016
      vid: 140
      iid: 10
      pid: 2550
      pub: College of American Pathologists
      place: Northfield, Illinois
    artinfo:
      ui:
        118521114
        118521114
        118521114
        10.5858/arpa.2016-0194-CP
        118521114
      ppf: 1085
      ppct: 7
      formats:
        fmt:
          @attributes:
            type: P
      tig:
        atl: A Model Study of In Silico Proficiency Testing for Clinical Next-Generation Sequencing.
      aug:
        au:
          Duncavage, Eric J.
          Abel, Haley J.
          Merker, Jason D.
          Bodner, John B.
          Qin Zhao
          Voelkerding, Karl V.
          Pfeifer, John D.
        affil: Departments of Pathology, Washington University School of Medicine, St Louis, Missouri
      sug:
        subj:
          Sequence Analysis Methods
          Proficiency Testing, Laboratory Methods
          Bioinformatics
          Specimen Handling Methods
          Software
          Prospective Studies
          Sensitivity and Specificity
          Surveys
          Human
      ab: Context.--Most current proficiency testing challenges for next-generation sequencing assays are methods-based proficiency testing surveys that use DNA from characterized reference samples to test both the wet-bench and bioinformatics/dry-bench aspects of the tests. Methods-based proficiency testing surveys are limited by the number and types of mutations that either are naturally present or can be introduced into a single DNA sample. Objective.--To address these limitations by exploring a model of in silico proficiency testing in which sequence data from a single well-characterized specimen are manipulated electronically. Design.--DNA from the College of American Pathologists reference genome was enriched using the Illumina TruSeq and Life Technologies AmpliSeq panels and sequenced on the MiSeq and Ion Torrent platforms, respectively. The resulting data were mutagenized in silico and 26 variants, including single-nucleotide variants, deletions, and dinucleotide substitutions, were added at variant allele fractions (VAFs) from 10% to 50%. Participating clinical laboratories downloaded these files and analyzed them using their clinical bioinformatics pipelines. Results.--Laboratories using the AmpliSeq/Ion Torrent and/or the TruSeq/MiSeq participated in the 2 surveys. On average, laboratories identified 24.6 of 26 variants (95%) overall and 21.4 of 22 variants (97%) with VAFs greater than 15%. No false-positive calls were reported. The most frequently missed variants were single-nucleotide variants with VAFs less than 15%. Across both challenges, reported VAF concordance was excellent, with less than 1 % median absolute difference between the simulated VAF and mean reported VAF. Conclusions.--The results indicate that in silico proficiency testing is a feasible approach for methods-based proficiency testing, and demonstrate that the sensitivity and specificity of current next-generation sequencing bioinformatics across clinical laboratories are high.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N