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de la prueba de HbA1c
Trazabilidad metrolgica de la prueba de HbA1c
CALIBRATION 2 DE 27
MATERIAL VALUE ASSIGNMENT PROCEDURE IMPLEMENTATION uc(y)
a) Definition of SI
unity byCGPM
e) Secondary calibrator
f) manufacturers selected NMI, ARML, ML
measurement procedure
ML
g) manufacturers
working calibrator h) manufacturers standing ML
measurement procedure
ML
i) manufacturers
product calibrator ML
RESULT
Trazabilidad metrolgica de la prueba de HbA1c
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1. Porras-Caicedo, Ada. (Febrero 28 de 2017) . Trazabilidad metrolgica en el Laboratorio: Aida Porras Caicedo . (Directora cientfica QUIKSAS), simposio tpicos relacionados
con el paciente en dilisis llevado a cabo en Medellin, Colombia.
3. BIPM, I., et al. (2012). The international vocabulary of metrologybasic and general concepts and associated terms (VIM)(3rd edn) JCGM 200, entry 1.16.
4. ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control
materials. ISO, 2003.
5. ISO 18153:2003 In vitro diagnostic medical devices Measurement of quantities inbiological samples Metrological traceability of values for catalytic concentration of
enzymes assigned calibrators and control materials. ISO, 2003.
7. ISO 15193:2009 In vitro diagnostic medical devices Measurement of quantities insamples of biological origin Requirements for content and presentation of reference
measurement procedures. ISO, 2009.
8. ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the
content of supporting documentation. ISO, 2009.
9. ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories. ISO, 2003.
10. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. ISO, 2005.
11. Jones, G. R. and C. Jackson (2016). "The Joint Committee for Traceability in Laboratory Medicine (JCTLM)its history and operation." Clinica Chimica Acta 453: 86-94.
12. Pessoa, M. C. F. and O. C. Ferreira Jr (2016). "Metrological traceability in clinical laboratory." Jornal Brasileiro de Patologia e Medicina Laboratorial 52(3): 157-164.
13. Siekmann, L. (2013). "Metrological traceabilitya concept for standardization in laboratory medicine." Clinical chemistry and laboratory medicine 51(5): 953-957.
14. Thienpont, L. (2013). An introduction to metrological traceability in laboratory medicine. CIRME 7th International Scientific Meeting Metrological traceability and assay
standardization. Stresa, Italy.
Trazabilidad metrolgica de la prueba de HbA1c
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3. Laboratorio de Referencia
Trazabilidad metrolgica de la prueba de HbA1c
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December 2003
T. J.Quinn (BIPM), M. M. Mller (IFCC) and M Peet (ILAC).
Trazabilidad metrolgica de la prueba de HbA1c
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Trazabilidad metrolgica de la prueba de HbA1c
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MATERIALES DE REFERENCIA
Variable Cantidad
MTODOS DE REFERENCIA
SERVICIOS DE REFERENCIA
Variable Cantidad
It It ItAnalito It AnalitoAnalito
It It Analito Analito
It It
It Analito Analito
It AnalitoAnalito
Analito
1 1 acid glycoprotein
41 chloride (AAG) 121 nitrate
81 immunoglobulin 161 triglycerides
21 anti-myeloperoxidase
A (IgA) 61 ethanol 141 168 urea glucuronide
testosterone
immunoglobulin
101 L-phenylalanine G
MATERILES 2 1 antitrypsin (AAT)
42 cholesterol 122 perchlorate
162 trimethylarsine oxide
22 apolipoprotein 142
A1 (apo
62 ethosuximide testosterone sulfate
A I) 169 uric acid
82 immunoglobulin G (IgG) 102 L-proline
3 17-estradiol 123 phencyclidine
163 triolein
23 arginine63 fructose 143 thallium
170 valine
43 chromium
83 immunoglobulin M (IgM) 103 L-serine
164 tripalmitin
124 phenobarbital 171 valproic acid
144 THC-9-COOH
4 19-norandrosterone
44 cobalt
84 iodine125 phenylalanine 24 arsenic 64 galactose104 L-threonine
165 tyroglobulin (human) 172 vanadium
145 theophylline
5 2 macroglobulin
45 cocaine (A2M)
85 isoleucine 25
166 tyrosine arsenic acid
65 gamma-tocopherol
105 L-tyrosine 173 xylose
126 phenytoin 146 thorium
6 3,3',5-triiodothyronine
46 codeine (T3)
86 lactate dehydrogenase
127 26(LDH)
167 uranium
platinum arsenocholine
66 glucose
106 L-valine 174 zinc
147 threonine
7 4-hydroxy-
47 3-methoxymandelic
complement
87 lactose 3c acid
128(C3c)
potassium 27 arsenous 67acid glutamic acidthromboplastin
107 lysine
148
8 5-methyltetrahydrofolic
48 complement acid
(C4)primidone 28 aspartate
4129
88 L-alanine 68transaminase 149(AST
-glutamyltransferase
108 magnesium - ASAT)
thyroxine (GGT)
(T4)
9 acid phosphatase
49 copper (prostatic)
89 L-aspartic (PAP)
130 progesterone
acid 29 aspartic acid
69 glycated
Listado 109 150 total beta-carotene
hemoglobin
de manganese
materiales, (HbA1c)
mtodos y
10 alanine50 cortisol
90 L-cystine131 proline 30 barium servicios
70 glycine 151 total beta-cryptoxanthin
de referencia
110 MDA aprobados por el
11 albumin51 C-peptide
91 LDL cholesterol 31 antigen
132 prostate specific JCTLM
BCR-ABL 71b3a2 a111 152
Julio,
transcript
MDMA total cholesterol
2016.
haemiglobincyanide
12 albumin52(ALB) 133 selenium 32 benzoylecgonineFuente: Elaboracin C-peptidea partir de
153 totalpropia
92 leadprotein
C-reactive (CRP) 112
72 haptoglobin mercury (HPT)
13 alkaline53phosphatase 134 serine
(ALP) la pgina
33 beryllium de latotal
154
webmercury glycerides
JCTLM
93 leucine
creatine kinase (CK) 73 HbA1c 113 (total)
135 sirolimus 155 total lutein
14 alphafoetoprotein94 L-glutamic
54 creatinine acid 34 beta-2-microglobulin
74 114
HDL methamphetamine
cholesterol
136 sodium 156 total retinol
15 alpha-tocopherol 95 L-histidine
55 cystatin C 137 sodium diclofenac 35 bovine serum
75 heroinalbumin
115 methionine
157 total zeaxanthin
16 amphetamine 96
56 cystine L-isoleucine
138 sucrose 36 cadmium 116 metronidazole
76 histidine158 transferrin (TRF)
17 amylase 97 lithium
57 d3-testosterone 139 tacrolimus 37 captopril
77 HIV 117molecular
molybdenummarker (TTR)
159 transthyretin
18 anti-c antibodies98 L-leucine
58 digoxin 140 testosterone 38 carbamazepine 78 HLA 118 specific
monomethylarsonic
160 triglyceride
allo-antibodies acid
19 anti-D antibodies99 L-lysine acid
59 dimethylarsinic 39 carbohydrate
monohydrochloride deficient
119
79 homocysteine transferrin
morphine
20 antimony 100 L-methionine
60 epitestosterone 40 cesium 80 human 120 nickel
cardiac troponin I (cTnI)
Trazabilidad metrolgica de la prueba de HbA1c
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It Analito It Analito
MTODOS 1 17-estradiol It Analito 21 C-peptide It Analito
2 41 glucose
17-hydroxyprogesterone 22 cadmium 61 phenytoin
3 42
19-norandrosterone glycoprotein 23 calcium 62 potassium
4 43 haptoglobin
5-methyltetrahydrofolic acid (HPT) 24 ceruloplasmin63 progesterone
5 44 HbA1c
5-formyltetrahydrofolic acid 25 chloride 64 sodium
6 45
25-hydroxyvitamin HDL
D2 cholesterol 26 cobalt 65 testosterone
7 46
25-hydroxyvitamin hemoglobin
D3 27 complement 66 theophylline
3c (C3c)
8 47
a2-macroglobulin homocysteine 28 complement 67 4 (C4) thrombocyte
9 acetaminophen48 immunoglobulin A (IgA)29 copper 68 topiramate
10 49 immunoglobulin
alanine aminotransferase (ALT) G (IgG) 30 cortisol 69 total cholesterol
11 aldosterone 50 immunoglobulin M (IgM)31 70
C-reactive protein total glycerides
12 albumin 51 lactate dehydrogenase (LDH)
32 71 (CK)
creatine kinase total testosterone
13 52 lamotrigine
alkaline phosphatase (ALP) 33 creatinine 72 total thyroxine (TT4)
14 alpha-amylase53 LDL cholesterol 34 digoxin 73 total triiodothyronine
15 amyloid beta541-42 lead 35 74 transferrin (TRF)
estriol (non conjugated)
16 arsenic 55 lithium 36 estrone 75 transthyretin (TTR)
17 56 magnesium
a1-anti chymotrypsin 37 folic acid 76 triglycerides
18 57
a1-anti trypsin mercury 38 free glycerol77 urea
19 58 norandrosterone
aspartate transaminase (ASTo ASAT) 39 free thyroxine78 uric acid
20 bilirubin 59 ortho-phosphate 40 79 vancomycin
gamma-glutamyltransferase (GGT)
60 phenobarbital 80 zinc
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Materiales de
Referencia
Trazabilidad metrolgica de la prueba de HbA1c
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Mtodo de
Referencia
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Mtodo de Laboratorio de
Country Material Referencia
Continent
Referencia
China 1 6 sia
Germany 0 3 5 Europa
Japan 2 1 1 sia
United Kingdom 2 1 Europa
Belgium 0 1 1 Europa
France 1 1 Europa
Italy 0 1 Europa
Spain 0 1 Europa
3 Norte
United States 1 0
Amrica
Australia 1 0 Oceania
Brazil 1 0 Latam
European Union 1 0 Europa
Mxico 1 0 Latam
Singapore 1 0 sia
9 No
No especifica 0 0
especifica
IFCC 1
TOTAL 12 18 17
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Nmero de NUMERO DE
PRODUCTOR DE MTODOS DE LABORATORIOS DE REFERENCIA
PRODUCTOR DE MATERIAL DE REFERENCIA
ANALITOS
materiales de
REFERENCIA 1 Beijing Aerospace General Hospital
referencia 1 AAS 1
1 CENAM (Centro Nacional de Metrologa), 5 2 1 Reference Laboratory, China
AACC
Mexico 3 13 2 CIRME, Italy
CDC
2 HSA (Health Sciences Authority), Singapore 8 4 26 3 CLNU, China
DGKC
3 INMETRO (Instituto Nacional de 3 5 IFCC 24 4 DGKL, Germany
Metrologia, Normalizao e Qualidade 6 9 5 Guangdong Provincial Hospital of Chinese
INSTAND
Industrial 7 JSCC 2 Medicine (GPHCM), China
(National Institute of Metrology, 8 3 6 Instand e.V., Germany
LGC
Standardization and Industrial Quality)), 9 4 7 LNE, France
MAYO
Brazil 10 NCCL 2 8 LREC, Spain Phone : +34 935 811 575
4 IRMM (Institute for Reference Materials 60 11 NIM 2 9 Maccura, China
and Measurements), European Union 12 NIST 59 10 National Center for Clinical Laboratories
13 PTB 2 (NCCL), China
5 LGC (LGC Limited), United Kingdom 19 14 ROCHE 2 11 PTB, Germany
6 LNE (Laboratoire National de Mtrologie et 6 15 University of Ghent 20 12 ReCCS, Japan Phone : +81 (0)44 850
d'Essais), France 16 ID/SERS 1 3140
7 NIBSC (National Institute for Biological 4 17 2D-UPLC-tandem mass spectrometric method for analysis of
1 13 RfB-DGKL, Germany Phone : +49 (0)511
amyloid beta 1-42 in human CSF
Standards and Control), United Kingdom 532 3862
18 Analysis of Ca by ICP-OES, Inorg-012 1
8 NIM (National Institute of Metrology), 9 14 Roche Diagnostics GmbH (RDG),
19 Cyanmethemoglobin 1 Germany
China
20 Doumas reference method for total bilirubin 1 15 Shanghai Center for Clinical Laboratory
9 NIST (National Institute of Standards and 127
21 Isotope dilution of Ca by ICP-MS, Inorg-012 1 (SCCL), China
Technology), United States
22 Isotope dilution of cholesterol by LCMS, Org-005 1 16 UGent - Ref4U, Belgium
10 NMIA (National Measurement Institute, 13
23 Mass spectrometry-based candidate reference measurement 1 17 WEQAS, United Kingdom
Australia), Australia procedure for quantification of A42 in cerebrospinal fluid
11 NMIJ (National Metrology Institute of 31 24 Reference method for diabetes control and complications
1
trial
Japan), Japan
179
12 ReCCS (Reference Material Institute for 13
Clinical Chemistry Standards), Japan
298
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Trazabilidad metrolgica de la prueba de HbA1c
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Tabla 1. Magnitudes con material y mtodo de referencia 11 complement 3c (C3c) 26 lactate dehydrogenase (LDH) 41 transferrin (TRF)
Fuente: Elaboracin propia a partir de la pgina web de la 12 complement 4 (C4) 27 LDL cholesterol 42 transthyretin (TTR)
JCTLM 13 copper 28 lead 43 triglycerides
14 cortisol 29 lithium 44 urea
15 creatine kinase (CK) 30 magnesium 45 uric acid
46 zinc
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CALIBRATION
MATERIAL VALUE ASSIGNMENT PROCEDURE IMPLEMENTATION uc(y)
Primary reference
Definition of SI unit by measurement procedure
b)
a) CGPM
1. Cation-exchange HPLC using
mmol/mol Bio-Rex 70 resin
2. Hemoglobin samples treated
BIPM,NMIa, ARMLa
with endoproteinase Glu-C
followed by HPLC and BIPM,NMIa
Primary calibrator
c
1. JDS HbA1c Lot 2 Secondary reference NMI, ARML
)
d) measurement procedure
METROLOGICAL TRACEABILITY
N/A
Secondary calibrator NMI, ARML, ML
e)
IFCC reference manufacturers selected
materials f) measurement procedure ML
manufacturers
g working calibrator HPLC
Inserto del
) HbA1c Calibrator Level 1
HbA1c Calibrator Level 2 manufacturers standing ML Manufacturador
h) measurement procedure
manufacturers product ML
i) calibrator HPLC ML
HbA1c Calibrator Level 1
HbA1c Calibrator Level 2
j) end-users routine Manufacturer
and/or end-user
measurement procedure
Calibraciones hechas
end-user
routine sample en mi laboratorio
end-user
RESULT
Trazabilidad metrolgica de la prueba de HbA1c
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Trazabilidad metrolgica de la prueba de HbA1c
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Trazabilidad metrolgica de la prueba de HbA1c
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Trazabilidad metrolgica de la prueba de HbA1c
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Harmonization means results are traceable to some declared reference but accepted
higher order reference materials and/or methods are not available and SI units are not
applicable.
HbA1c
Normal: <5,6%
Nivel decisin Pre diabtico: 5,7-6,4%
basados en la ADA Diabtico: >=6,5
2017 Diabtico No controlado: >=7
VARIABILIDAD BIOLGICA
VB MIN VB DES VB OPT RILIBAK RCPA NGSP