Biological Variation, A Practical Review, DR C. Ricos PDF
Biological Variation, A Practical Review, DR C. Ricos PDF
Biological Variation, A Practical Review, DR C. Ricos PDF
a practical review
Carmen Rics
Brussels & Amsterdam
2010 Bio-Rad_QC Seminars
C Rics
2010 QC Seminars
Within-subject
biological variation
Age, sex
Diet, physic exercise
Pathology, treatment
Within-day variation, season
variation
Homeostasis
Fraser CG. Biological Variation: from theory to practice. AACC press, 2001
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2010 QC Seminars
Within-subject
biological variation
Fluctuation of the
concentration
of blody fluid components
around the setting point
Fraser CG. Biological Variation: from theory to practice. AACC press, 2001
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2010 QC Seminars
Between-subject
biological variation
Differences in concentration
of the components of
biologic fluids
among persons
Fraser CG. Biological Variation: from theory to practice. AACC press, 2001
C Rics
2010 QC Seminars
How to estimate the
components of BV
Fraser CG. Biological Variation: from theory to practice. AACC press, 2001
C Rics
2010 QC Seminars
How to estimate the
components of BV
2. To eliminate outliers
Cochran test outlier values
Reed test outlier individuals
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2010 QC Seminars
How to estimate the
components of BV
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2010 QC Seminars
Compilation of data on
Biological variation
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What else?
a DATABASE
selective
permanently updated
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Why?
To give information on
quality specifications for
Imprecision (CV,%)
Bias (SE,%)
Total error (TE,%)
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2010 QC Seminars
Material
1. PAPERS SEARCH: BIOS, CURRENT CONTENTS,
EMBASE, MEDLINE, PUBMED
- Calculations Individuality,
Critical differences
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2010 QC Seminars
Method (1)
1. EXCLUSSIONS
Papers with too high analytical variation
(CVA> 0.5 CVW)
Papers not specifically designed to estimate CVW
and CVG
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2010 QC Seminars
Method (2)
2. EXPRESSION (for each analyte)
Papers in ascending order according to the CVW
Search for relationships between CVW and
number of subjects, sex, health status, fasting;
number of samples per subject, time span of the
study
If no relationships are observed: calculation of
the median of CVW and CVG values from all
papers compiled
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2010 QC Seminars
Example: s- Glucose
CVW CVG CVA N Td Ss Mean Unit Year
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Method (3)
3. CALCULATION OF SPECIFICATIONS
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Results
(Database, 2010 update)
319 analytes
59 journals
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Database 2010 update
Example
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2010 QC Seminars
Database 2010 update
References
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2010 QC Seminars
Database - contras
analytes
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2010 QC Seminars
Database - pros
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2010 QC Seminars
Database - Applications
Quality specifications
Delta check
Reference change value
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2010 QC Seminars
Quality specifications
Stockholm international consensus
1999
Professional recommendations
CE Rule Controls/run
1:2s N=2
<2 1:2,5s N=4
1:3s N=6
1:2s N=1
(2-3) 1:3 N=2
1:3,5s N=4
1;2,5s N=1
>3 1:3s N=2
1:3,5s N=4
Hyltoft P et al. Strategies to set global analytical quality specifications
in laboratory medicine. Scand J Clin Lab Invest 1999;57,7
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2010 QC Seminars
Use of Q specifications
2. to evaluate internal QC results
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2010 QC Seminars
Use of Q specifications
3. to evaluate EQA results
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2010 QC Seminars
Use of Q specifications
3. to evaluate EQA results
- SEQC
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2010 QC Seminars
Use of Q specifications
3. to evaluate EQA results
- SEQC
% of results reaching specifications based on BV
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2010 QC Seminars
Delta Check
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2010 QC Seminars
Reference change value
Fraser CG. Biological variation: from principles to practice. Washington DC. AACC Press ,2001
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2010 QC Seminars
Reference change value
SOULD BE USED
For analytes with high individuality
CVI/CVG<0.6
Fraser CG. Biological variation: from principles to practice. Washington DC. AACC Press ,2001
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2010 QC Seminars
Reference change value
SHOULD BE USED
In 276 of the 319 analytes
from the current database
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2010 QC Seminars
Reference change value
Fraser CG. Biological variation: from principles to practice. Washington DC. AACC Press ,2001
C Rics
2010 QC Seminars
Reference change vlaue
Fraser CG. Biological variation: from principles to practice. Washington DC. AACC Press ,2001
C Rics
2010 QC Seminars
Reference change value
- reporting
NINEWELLS HOSPITAL AND MEDICAL SCHOOL
Result Units Ref.
values
Sodium 138 * mmol/L 135-147
Potassium 5.0 mmol/L 3.5-5.0
Urea 9.5 ** mmol/L 3.3-6.6
Creatinine 137 > mmol/L 50-100
Bilirubins 100 >> mmol/L NAME
Albumin 23 << g/L 36-50
Calcium 2.27 ** mmol/L 2.1-2.6
Fraser CG. Biological Variation: From Principles to Practice. Washington, DC, AACC Press, 2001
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2010 QC Seminars
Reference change value
- in pathology
Pathology Analyte CVI (%)
Cancer ovarium CA 125 46
Cancer mamarian CA 15.3 17
C. colorectal CEA 45
Diabetes HbA1C 9
mellitus Microalbumin 36
Hepatic disease -fetoprotein 40
Paget Alkaline phos. 12
Rics C et al. Ann Clin Biochem 2007; 44: 343352
Reference change value
- two analytes combined
VRC combinado
100
Uratos Diferencias (%)
50
-50
-100
-100 -50 0 50 100 150
Creatinina Diferencias (%)
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2010 QC Seminars
References (2)
Hyltoft Petersen P, Sandberg S, Fraser CG, Goldsmith H.
Influence of index of individuality on false positives in repeated
sampling from healthy individuals. Clin Chem Lab med
2001;391:160-165
Comit de garanta de la Calidad y Acreditacin de
Laboratorios. Comisin de Calidad analtica. Base de datos de
Variacin biolgica. Actualizacin del ao 2010.
http://www.seqc.es/es/Sociedad/51/102
Fraser CG, Stevenson HP, Kennedy IMG. Biological variation
data are necessary prerequisites for objective autoverification
of clinical laboratory data. Accred Qual Assur 2002;7:455-460.
Biosca C, Rics C, Lauzurica R, Galimany R et al. Reference
Change Value Concept Combining Two Delta Values to Predict
Crises in Renal Posttransplantation. Clin Chem 2001;47:2146-8
C Rics
2010 QC Seminars
C Rics
2010 QC Seminars