Abstract
External Quality Assessment (EQA)schemes are well-established tools with which to evaluate, monitor and improve the output quality of clinical laboratories, recognising that high quality laboratory medicine is essential for patient care. EQA programs involve the testing of multiple laboratories and the statistical comparison of their results, according to a multistep workflow. New clinical laboratory activities, such as biomarker research, require new EQA schemes. Critical elements in designing EQA programs are choosing the statistical methods and defining reference values and control limits. This article summarizes the key features of an EQA scheme, including designing the study, identifying reference values and control limits for qualitative and quantitative data, and graphically reporting laboratory performance statistics. These steps are illustrated with examples taken from the authors’ experience in national and international quality assessment schemes for biomarker research.
| Original language | English |
|---|---|
| Pages (from-to) | 54-59 |
| Number of pages | 6 |
| Journal | New Biotechnology |
| Volume | 52 |
| DOIs | |
| Publication status | Published - Sep 25 2019 |
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Keywords
- Biomarker
- Cancer
- External Quality Assessment
- Laboratory performance
ASJC Scopus subject areas
- Biotechnology
- Bioengineering
- Molecular Biology
Cite this
Methodological and statistical issues in developing an External Quality Assessment scheme in laboratory medicine : Focus on biomarker research. / Verderio, Paolo; Pizzamiglio, Sara; Ciniselli, Chiara Maura.
In: New Biotechnology, Vol. 52, 25.09.2019, p. 54-59.Research output: Contribution to journal › Short survey
}
TY - JOUR
T1 - Methodological and statistical issues in developing an External Quality Assessment scheme in laboratory medicine
T2 - Focus on biomarker research
AU - Verderio, Paolo
AU - Pizzamiglio, Sara
AU - Ciniselli, Chiara Maura
PY - 2019/9/25
Y1 - 2019/9/25
N2 - External Quality Assessment (EQA)schemes are well-established tools with which to evaluate, monitor and improve the output quality of clinical laboratories, recognising that high quality laboratory medicine is essential for patient care. EQA programs involve the testing of multiple laboratories and the statistical comparison of their results, according to a multistep workflow. New clinical laboratory activities, such as biomarker research, require new EQA schemes. Critical elements in designing EQA programs are choosing the statistical methods and defining reference values and control limits. This article summarizes the key features of an EQA scheme, including designing the study, identifying reference values and control limits for qualitative and quantitative data, and graphically reporting laboratory performance statistics. These steps are illustrated with examples taken from the authors’ experience in national and international quality assessment schemes for biomarker research.
AB - External Quality Assessment (EQA)schemes are well-established tools with which to evaluate, monitor and improve the output quality of clinical laboratories, recognising that high quality laboratory medicine is essential for patient care. EQA programs involve the testing of multiple laboratories and the statistical comparison of their results, according to a multistep workflow. New clinical laboratory activities, such as biomarker research, require new EQA schemes. Critical elements in designing EQA programs are choosing the statistical methods and defining reference values and control limits. This article summarizes the key features of an EQA scheme, including designing the study, identifying reference values and control limits for qualitative and quantitative data, and graphically reporting laboratory performance statistics. These steps are illustrated with examples taken from the authors’ experience in national and international quality assessment schemes for biomarker research.
KW - Biomarker
KW - Cancer
KW - External Quality Assessment
KW - Laboratory performance
UR - http://www.scopus.com/inward/record.url?scp=85065561845&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85065561845&partnerID=8YFLogxK
U2 - 10.1016/j.nbt.2019.05.001
DO - 10.1016/j.nbt.2019.05.001
M3 - Short survey
C2 - 31059865
AN - SCOPUS:85065561845
VL - 52
SP - 54
EP - 59
JO - New Biotechnology
JF - New Biotechnology
SN - 1871-6784
ER -