Joint Committee for Traceability in Laboratory Medicine
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Transcript of Joint Committee for Traceability in Laboratory Medicine
Joint Committee for Traceability in Laboratory Medicine
Bureau International des Poids et Mesures
JCTLM Approach to Higher Order Standards
R.I. Wielgosz, BIPM
www.bipm.org
JOINT COMMITTEE for TRACEABILITYin LABORATORY MEDICINE (JCTLM)
Declaration of co-operation
establishing
A framework for the international recognition of available higher-order reference materials, measurement procedures and
reference measurement laboratories
Bureau International des Poids et Mesures
JOINT COMMITTEE on TRACEABILITY in JOINT COMMITTEE on TRACEABILITY in LABORATORY MEDICINELABORATORY MEDICINE
Established Established in Sevres on 12 June 2002, in Sevres on 12 June 2002, to meet the need for a worldwide platform to promote and give guidance on internationally recognized and accepted equivalence of measurements in Laboratory Medicine and traceability to appropriate measurement standards.
The Declaration of Cooperation betweenThe Declaration of Cooperation between the International Committee of Weights and Measures (CIPMCIPM), the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC),and the International Laboratory Accreditation Cooperation (ILAC(ILAC) for establishment of the JCTLM can be found at http://www.bipm.org/en/committees/jc/jctlm/declaration.html
JCTLM - StructureJCTLM - Structure
JCTLM ExecutiveJCTLM ExecutiveChair: J. Thijssen (IFCC)Executive Secretary: R. Wielgosz (BIPM)
Priority setting Approval of WG’s results
JCTLM Working GroupsJCTLM Working Groups: Task oriented 1. 1. Reference Materials and Reference MethodsReference Materials and Reference Methods
Co-Chairs: W.E. May (NIST), H. Schimmel (IRMM)
2. 2. Reference Laboratories - NetworksReference Laboratories - Networks
Co-Chairs: L. Siekmann (U. Bonn), L. Thienpont (U. Gent)
Bureau International des Poids et Mesures
JCTLM Working Group I on Reference Materials and Reference Measurement Procedures
Charged with:Charged with:
• establishing a process for identifying, and reviewing against agreed upon criteria “higher order” Certified Reference Materials and Reference Measurement Procedures required for IVD industry compliance with the EC IVD Directive regarding in vitro diagnostic medical devices.
• publishing a List of “higher order” Certified Reference Materials and Reference Measurement Procedures required for IVD industry compliance with the EC IVD Directive regarding in vitro diagnostic medical devices.
Co-Chairs: W.E. May (NIST), H. Schimmel (IRMM)
“.... the traceability of values assigned to calibrators and control materials must be assured through available reference measurement procedures and/or reference materials of a higher order ...” Annex 1 (3) 2nd para
IVD Manufacturers have requested that NMIs develop internationally recognized
reference methods and CRMs to meet this assist them in meeting this traceability
requirement.
Bureau International des Poids et Mesures
Relevant ISO Standards
ISO 17511 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 15193 Presentation of reference measurement procedures
ISO 15194 Description of reference materials
ISO 15195 Reference Measurement Laboratories
ISO 18153 Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
Definitions (International Vocabulary of Basic and General Terms in Metrology –VIM)
(Metrological) traceability property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties
Uncertainty parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand
Quantity attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined quantitatively
Bureau International des Poids et Mesures
SI traceability - Primary Calibrators (ISO 17511)
Bureau International des Poids et Mesures
Traceability to an international conventional calibrator (ISO 17511)
Bureau International des Poids et Mesures
Traceability to manufacturer’s selected measurement procedure (ISO 17511)
Bureau International des Poids et Mesures
JCTLM WG1 Review Process (ISO 15194)
Bureau International des Poids et Mesures
8
9
J K L M N O P Q R S
Matrix Category
MatrixIdentifier / Number
NameCertifying
Organization
Mode / approach used for value assignment (if
not clearly stated in
certificate)
CommentsIssued by NMI with
Certificate
Certificate from other
RM provider ?
RM listed in BIPM
Database?
Matrix RM
8
9
A B C D E F G H I
Analyte CategoryAnalyte Name
IUPAC/IFCC
Number
List I or II?
Traceable to SI ?
Procedurally-defined
(if so, name/cite procedure)
Traceable to an international
(WHO or other) standard? If so name standard
Unique Nomination
Number
Analyte / Parameter
Date Nomination
Filed
Basis for Traceability
Bureau International des Poids et Mesures
JCTLM Reference Materials Nominations Template (1/3)
JCTLM Reference Materials Nominations Template (2/3)
8
9
T U V W X Y Z AA AB AC AD AE AF
From To Unit From To UnitLev. of conf. (%)
Physical form of RM matrix
RM fortified with analyte or
naturally incurred
Applicable analyte
characteristics (e.g., isoform(s);
free/bound, total)
Other relevant factors (list)
Citation of specific
publication / reference if
available
Range of Analyte Certified / Assigned
Value and Unit
Range of Expanded Uncertainty for Analyte
Certified/Assigned ValueInformation for Assessing Commutability
Quantity
8
9
AG AH AI AJ AK AL AM
Expression of
Uncertainty
Justification of source
of reference material
Are intended use and
instructions for use
available?
Are dates of
authorization and revision given?
Are safety precautions listed?
Validation report
available?
Congruent with other critical factors in ISO 15194 (list other relevant factors)?
Additional Comments
Bureau International des Poids et Mesures
JCTLM Reference Materials Nominations Template (3/3)
8
9
AN AO AP AQ AR AS AT AU AV AW AX AY AZ
Hyperlink to Comparability Assessment
Studies Among listed RMs
Other relevant publications
CommentsProducer
nameCountry Website
email address
Phone number
Fax number
Nameemail
addressPhone
number
How to obtain
certificate?
Contact information for publication in the JCTLM DBContact Information for additional
details (for review process)CRM information for publication in the JCTLM DB
7
8
9
BA BB BC BD BE BF BG
FOR REVIEW COMMITTEE USE
Recommended for publication in the JCTLM
DB?
Manufacturer Comment (in
case of delisting)
Review team name
Review Word
Document
Does RM value-assignment
approach meet traceability
requirements of IVDD industry and
regulatory community ?
Additional Reviewer
Comments
Is there a sustainable source
for the material?
Bureau International des Poids et Mesures
Priority Analyte Areas for Cycle I Review Process (Sept 2002 – March 2004)
Review Teams established with worldwide representation from Lab Accreditation Organizations, NMIs, Professional Societies, and IVD Industry in order to facilitate a fair and transparent review process.
Electrolytes EnzymesMetabolites and Substrates ProteinsNucleic Acids DrugsHormones Coagulation FactorsQuality Systems and Implementation Protocols
Additional Priority Areas for Cycle II Review Process (April 2004 - Dec 2004)
Blood Grouping/ Typing Blood Gases Microbial Serology Non-Electrolyte Metals Vitamins and Micronutrients
Bureau International des Poids et Mesures
Initial Provisional Lists of Higher Order Reference Materials and Reference Measurement Procedures
I.I. Certified Reference Materials and Reference Measurement Certified Reference Materials and Reference Measurement ProceduresProcedures for well-defined chemical entities or internationally recognized reference method-defined measurands, such as enzymes. Reference Materials included in this category are those that are traceable to the SI units. [Electrolytes, Drugs, Metabolites and Substrates, Non-Peptide Hormones, Enzymes and some
Proteins]
II.II. Reference MaterialsReference Materials that are value-assigned using an internationally agreed upon protocol e.g., reference materials for Blood Typing, Coagulation Factors, Microbial Serology, Nucleic Acids, and some Proteins. The values of the measurands in the reference materials on this List are not SI-traceable and/or no internationally-recognized reference measurement procedures exist.
Bureau International des Poids et Mesures
Initial Lists of Higher Order Reference Materials and Reference Measurement Procedures published
01 April 2004
Certified Reference Materials and Reference Measurement Certified Reference Materials and Reference Measurement ProceduresProcedures for well-defined chemical entities or internationally recognized reference method-defined measurands, such as enzymes. Reference Materials included in this category are those that are traceable to the SI units. [Electrolytes, Drugs, Metabolites and Substrates, Non-Peptide Hormones, Enzymes and some
Proteins]
approximately 100 Reference Measurement Procedure entries for 58 different health status markers
approximately 150 Reference Material entries for 96 measurands
http://www.bipm.org/en/committees/jc/jctlm/jctlm-db/Bureau International des Poids et Mesures
List updated in January 2005 to include – based on List updated in January 2005 to include – based on Cycle I nominations:Cycle I nominations:
Reference Materials that are value-assigned using an Reference Materials that are value-assigned using an internationally agreed upon protocolinternationally agreed upon protocol e.g., reference materials for e.g., reference materials for Blood Typing, Coagulation Factors, Microbial Serology, Nucleic Blood Typing, Coagulation Factors, Microbial Serology, Nucleic Acids, and some Proteins. The values of the measurands in the Acids, and some Proteins. The values of the measurands in the reference materials on this List are not SI-traceable and/or no reference materials on this List are not SI-traceable and/or no internationally-recognized reference measurement procedures exist. internationally-recognized reference measurement procedures exist.
• 10 CRMs for Coagulation Factors• 7 CRMs for Proteins
Hereafter, Lists I and II to be updated in April of each year
Bureau International des Poids et Mesures
Bureau International des Poids et Mesures
Database of higher-order reference materials and reference measurement procedures
List I : Certified Reference Materials and Reference Measurement Procedures for well-defined chemical entities or internationally recognized reference method-defined measurands.Reference Materials and Measurement Procedures included in this category are those that provide values that are traceable to the SI units; e.g., electrolytes, enzymes, drugs, metabolites and substrates, non-peptide hormones and some proteins.
List II: Reference Materials (e.g. reference materials for blood typing, coagulation factors, microbial serology, nucleic acids, and some proteins) that are value-assigned using an internationally agreed upon protocol. The values of the measurands in the reference materials on this List are not SI-traceable and/or no internationally-recognized reference measurement procedure exist. List II also contains a group of purified substances that due to the absence of reference measurement procedures should not be directly used for calibration unless commutability is established.
Search the database
JCTLM Database: Laboratory medicine and in vitro diagnostics
JCTLM-DB- JCTLM-DB home
- Search form
- Preamble
- Quality manual
- Review Teams
- Nomination forms
- JCTLM
Useful links
- ILAC
- IFCC
- KCDB
- Metrologia
Contact
-JCTLM Secretariat
Home page
Higher-order reference materials
Results of the search
Cholesterol in human serumNational Institute of Standards and Technology (NIST), United States
Name of reference material: SRM 1951a, lipids in frozen human serum
Quantity: Amount-of-substance concentration
Range of analyte certified/assigned value: 4.7109 mmol/l to 7.1554 mmol/l
Range of expanded uncertainty at a 95% level of confidence: 0.0116 mmol/l to 0.0142 mmol/l
Traceability: SI
CRM listing: List IRM
-Create a .PDF file
-Modify your selection
-Refine your search
-RM no longer listed
Bureau International des Poids et Mesures
JCTLM Database: Results of the search
JCTLM-DB- JCTLM-DB home
- Search form
- Preamble
- Quality manual
- Review Teams
- Nomination forms
- JCTLM
Useful links
- ILAC
- IFCC
- KCDB
- Metrologia
Contact
-JCTLM Secretariat
RM Producer’s Contact Information
NIST, United StatesWebsite: http://www.nist.gov/srmEmail:[email protected]: (301)975-6776Fax: (301)948-3730
Create a .PDF file
Cholesterol in human serum (lyophilized)National Institute of Standards and Technology (NIST), United States
Name of reference material: SRM 909b, human serum
Quantity: Amount-of-substance concentration
Range of analyte certified/assigned value: 3.787 mmol/l to 6.084 mmol/l
Range of expanded uncertainty at a 95% level of confidence: 0.047 mmol/l to 0.077 mmol/l
Comparability assessment study among listed RMs: See summary of Comparability Assessment for Cholesterol in Human Serum CRMs on JCTLM List I at http://www1.bipm.org/utils/en/pdf/jctlm_preamble.pdf
Other relevant publication(s) : Certification process: Fresenius’ J. Anal. Chem. 361:2 71-80 (1998); Method used for certification: Anal Chem 61, 1718-1723 (1989)
Traceability: SI
CRM listing: List I
RMP
-Create a .PDF file
-Modify your selection
-Refine your search
-RMP no longer listed
Bureau International des Poids et Mesures
JCTLM Database: Results of the search
JCTLM-DB- JCTLM-DB home
- Search form
- Preamble
- Quality manual
- Review Teams
- Nomination forms
- JCTLM
Useful links
- ILAC
- IFCC
- KCDB
- Metrologia
Contact
-JCTLM Secretariat
Create a .PDF file
Higher-order reference measurement procedures
Results of the search
CDCAbell-Kendall method for cholesterolCholesterol in blood serumApplicable matrices: human serum; lyophilized, fresh or frozen serumMeasurement principles: SpectrophotometryCitation(s): Clin Chem, 1986, 32, 921-929Comparability assessment studies: Clin Chem, 1990, 36, 370-375
DGKC definitive Method for Serum CholesterolCholesterol in blood serumApplicable matrices: human serum or plasma; lyophilized, fresh or frozenMeasurement principles: ID/GC/MSCitation(s): Z. anal Chem, 1976, 279, 145-146
Comparability assessment studies: See CCQM-P6 results in CCQM-K6 Report
NIST definitive method for serum cholesterolCholesterol in blood serumApplicable matrices: human serum: lyophilized, fresh or frozen serumMeasurement principles: ID/GC/MSCitation(s): Anal Chem, 1989, 61, 1718-1723
Comparability assessment studies: CCQM-K6 Final Report, Clin Chem, 1990, 36, 370-375
All Listed Reference Materials will be assessed for comparability by a reference measurement procedure under repeatability conditions:
• to assess veracity of the Normative Standards-Based Review Process• To establish bias that could be introduced by randomly selecting any material from
the List
Fig 1: The vertical axis reports the ratio between the measured and certified values of each CRM, Xi/Ci. The dark vertical
lines represent the approximate 95% CI about the ratios. The light horizontal lines represent the certified 95% CIs. The dotted line represents the expected ratio for the suite of all materials given the observed identity between the measured and certified values. (CI = Confidence Interval)
Fig 2: The data demonstrate that these CRMs are comparable over a wide concentration range. The horizontal axis reports the certified values, Ci; the vertical reports the average measured values, Xi. Each level of each CRM is
displayed as approximate 95% CIs along both axes. The intersection of these intervals is bounded by an open circle to aid visual inspection.
Example: Potassium in Human Serum CRMs on provisional JCTLM List 1 were assessed for comparability by a single laboratory (NIST) using a reference measurement procedure under repeatability conditions.
Fig 1: Ratio Display Fig 2: Scattergram Display
Lev3956aSRM
Lev2956aSRM
Lev1956aSRM
Lev2909bSRM
Lev1909bSRM
H111-5
JCCRM
M111-5
JCCRM
L111-5
JCCRM0.98
0.99
1.00
1.01
1.02
Mea
sure
d / C
ertif
icat
e
Certified 95% CI Average Ratio Ratio ~95% CI
956a 3
956a 2
956a 1909b 2
909b 1
111-5 H
111-5 M
111-5 L
1
2
3
4
5
6
1 2 3 4 5 6
Certified [Potassium], C i , nmol/L
Mea
sure
d [P
otas
sium
], X
i, n
mol
/L
X i = (0.003 ±0.013) + (0.9993 ±0.0028)×C i
CRM comparability independent of
analyte level
The measured/certified ratios for this set of CRMs are:
• ~ normally distributed• with a standard deviation of ~0.7%
150 200 250 300
150
200
250
300
JCCRM H
JCCRM M
SR
M 9
09
b l-
1
SRM 909b l-2
SRM 968c l-1
SRM 968c l-2
SRM 1589a
SRM 1951a l-1
SRM 1951a l-2
SRM 1952a l-1
SRM 1952a l-2
SRM 1952a l-3
Certificate Value, mg/dL
Me
asu
red
Va
lue
, mg
/dL
Comparability of Cholesterol in Serum CRMs on JCTLM LIST
U(Med) = 0.0055
Med:s = 0.0069Med = 0.9933
1.01
1.00
0.99
0.98
SR
M 1
952a
l-3
SR
M 1
952a
l-2
SR
M 1
952a
l-1
SR
M 1
951a
l-2
SR
M 1
951a
l-1
SR
M 1
589a
SR
M 9
68c
l-2
SR
M 9
68c
l-1
SR
M 9
09b
l-2
SR
M 9
09b
l-1
JCC
RM
M
JCC
RM
H
Me
as
ure
d /
Ce
rtif
ied
Va
lue
Bureau International des Poids et Mesures
Upcoming JCTLM MeetingsUpcoming JCTLM Meetings
• JCTLM WG1+WG2– September 19-20, IRMM, Geel, Belgium
• JCTLM Members meeting – September 21, IRMM
• JCTLM WG2 – July 27, AACC/IFCC meeting, Orlando USA
Bureau International des Poids et Mesures