MR-SH-T-001(2021-03)

Calibrator Traceability Report

Traceability
According to ISO 17511:2020(E), “In vitro diagnostic medical devices — Requirements for
establishing metrological traceability of values assigned to calibrators, trueness control materials
and human samples”.
Cases with reference measurement procedure which traceability to SI (see figure 1);
Case with international conventional reference materials and no international conventional
reference measurement procedure and without metrological traceability to SI, select the reference
materials from World Health Organization (WHO), Community Bureau of Reference (BCR),
Institute of Reference Materials and Measurements (IRMM), and National Institute of Standards
and Technology (NIST) (see figure 2);
Case with manufacturer’s selected measurement procedure but neither international
conventional reference measurement procedure nor international conventional calibrator and
without metrological traceability to SI (see figure 3).

figure 1: Calibration hierarchy - Measurand defined by a RMP calibrated with a particular primary
calibrator; traceable to SI

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figure 2: Calibration hierarchy-Measurand defined by value assignment protocol for

international conventional calibrator (conforming with ISO 15194; no SI traceability).

figure 3: Calibration Hierarchy - Measurand defined by manufacturer’s internal arbitrarily defined

RMs (no primary RMs or CRMs; no RMP; no harmonisation protocol; not traceable to SI).

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Mindray products traceability

Classification Analyte Reference procedure Reference material
FT3 Mindray Internal Standard /

T3 IDMS /

FT4 Mindray Internal Standard /

T4 IDMS /

WHO 3rd International Standard

TSH /
(81/565)

WHO International Standard

Anti-Tg /
(65/093)
Thyroid Function
IRMM reference material
TG /
BCR457

WHO International Standard

Anti-TPO /
(66/387)

WHO International Standard

TRAb /
(08/204)

National standard material

rT3 /
150552-0004
E2 IDMS /

E3 Mindray Internal Standard /

WHO 1st International Standard

FSH /
(92/510)

WHO 2nd International Standard

LH /
(80/552)

PROG IDMS /

WHO 3rd International Standard

Endocrinology PRL /
(84/500)

TESTO IDMS /

AMH Mindray Internal Standard /

DHEA-s Mindray Internal Standard /

WHO 5th International Standard

Total β HCG /
(07/364)

Cortisol IDMS /

ACTH Mindray Internal Standard /

WHO International Standard
Insulin /
(66/304)
Metabolic
WHO International Standard
C-Peptide /
(84/510)

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Folate Mindray Internal Standard /

VB12 Mindray Internal Standard /

VD-T Mindray Internal Standard /

Anaemia and bone WHO International Standard

PTH /
(79/500)

WHO International Standard

CT /
89/620

WHO 1st International Standard

CEA /
(73/601)

AFP / WHO 1st International Standard

CA19-9 Mindray Internal Standard /

CA125 Mindray Internal Standard /

CA15-3 Mindray Internal Standard /

WHO 1st International Standard

FPSA /
(96/668)

WHO 1st International Standard

TPSA /
(96/670)

Tumor CA72-4 Mindray Internal Standard /

Markers PG I Mindray Internal Standard /

PG II Mindray Internal Standard /
Cyfra 21-1 Mindray Internal Standard /

NSE Mindray Internal Standard /

FERP National standard material

/
(Ferritin) FERP 150540

ProGRP Mindray Internal Standard /

SCCA Mindray Internal Standard /
HE-4 Mindray Internal Standard /
CA242 Mindray Internal Standard /
CA50 Mindray Internal Standard /

CK-MB Mindray Internal Standard /

Troplnin I Mindray Internal Standard /

Myoglobin Mindray Internal Standard /

Cardiovascular
BNP Mindray Internal Standard /

hs-cTnI Mindray Internal Standard /

NT-proBNP Mindray Internal Standard /

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PIIINP Mindray Internal Standard /

CIV Mindray Internal Standard /

Hepatic fibrosis
HA Mindray Internal Standard /

LN Mindray Internal Standard /

ALD Mindray Internal Standard /

Blood hypertension ALD II IDMS /

Renin / (WHO) (IRP 68/356)

PCT Mindray Internal Standard /

WHO 1st International Standard

Inflammation IL-6 /
(NIBSC：89/548)

sCD14-ST Mindray Internal Standard /

WHO 2nd International Standard

HBsAg /
(00/588)

WHO 2nd International Standard

Anti-HBs /
(07/164)

Paul-Ehrlich-Institut (PEI)
HBeAg /
National standard material

Paul-Ehrlich-Institut (PEI)
Anti-HBe / National standard material
(Anti-HBe IgG)

WHO International Standard

Anti-HBe Q /
Infection disease (129095/12)

Paul-Ehrlich-Institut (PEI)
Anti-HBc / National standard material
(Anti-HBc IgG)

WHO 1st International Standard

Anti-HBc Q /
((NIBSC 95/522)

Anti-HCV Mindray Internal Standard /

Anti-TP Mindray Internal Standard /

WHO 1st International Standard

HIV /
(90/636)

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WHO International Standard
Toxo IgG /
(01/600)

Toxo IgM Mindray Internal Standard /

WHO International Standard

RV IgG /
(RUBI-1-94)

RV IgM Mindray Internal Standard /

Paul-Ehrlich-Institut (PEI)

ToRCH CMV IgG / National standard material

(136616/17)

CMV IgM Mindray Internal Standard /

HSV-1 IgG Mindray Internal Standard /

HSV-2 IgG Mindray Internal Standard /

HSV-1+2 IgG Mindray Internal Standard /

HSV-1+2 IgM Mindray Internal Standard /