Statistics for Method Verification of Qualitative Assays in Clinical Microbiology

Donna M. Wolk

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Despite improvement over the last decade, inadequate method verification strategies and documentation are still common laboratory inspection deficiencies. Some of the gaps occur because microbiologists may not use scientific experiment concepts, such as experimental design, data validation, biostatistics, and electronic documentation, that can improve their verification strategies for new test methods. Other gaps occur because laboratory resources are often limited. Clinical laboratories face tough choices when they consider implementing a new test method, and this review summarizes the basic statistical concepts that microbiologists need to critically plan and review qualitative method verification with the aim of determining whether a new diagnostic test is fit for patient testing.

Original languageEnglish (US)
Pages (from-to)59-68
Number of pages10
JournalClinical Microbiology Newsletter
Issue number8
StatePublished - Apr 15 2017

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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