TY - JOUR
T1 - Statistics for Method Verification of Qualitative Assays in Clinical Microbiology
AU - Wolk, Donna M.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/4/15
Y1 - 2017/4/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85016761909&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85016761909&partnerID=8YFLogxK
U2 - 10.1016/j.clinmicnews.2017.03.008
DO - 10.1016/j.clinmicnews.2017.03.008
M3 - Article
AN - SCOPUS:85016761909
SN - 0196-4399
VL - 39
SP - 59
EP - 68
JO - Clinical Microbiology Newsletter
JF - Clinical Microbiology Newsletter
IS - 8
ER -