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Sample S1

Sample S2

(µg/dL)

D ¹

Z ²

Da% ³

(µg/dL)

D ¹

Z ²

Da% ³

RH01b

RH01

2

5

9.1

-0.4

-0.5

-18%

4.6

-0.4

-1.0

-33%

RH07b

RH07

2

3

9.8

0.3

0.4

13%

5.5

0.5

1.3

42%

RH15

RH15

2

8

8.7

-0.8

-1.1

-35%

5.0

0.0

0.0

0%

CL009

CL009

2

4

9.3

-0.2

-0.3

-9%

5.1

0.1

0.2

8%

CL010

CL010

2

6

11.5

2.0

2.6

88%

4.9

-0.1

-0.2

-8%

CL012

CL012

2

3

10.0

0.5

0.7

22%

3.5

-1.5

-3.8

-125%

CL014a

CL014

2

8

8.7

-0.8

-1.1

-35%

5.1

0.1

0.2

8%

CL015

CL015

2

5

9.2

-0.3

-0.4

-13%

4.6

-0.4

-1.0

-33%

Median of RIA Group

9.3

5.0

Range of RIA Group

8.7 - 11.5

3.5 – 5.5

Robust average⁴ of RIA Group

9.4 ( n = 8 )

4.9 ( n = 8 )

Robust SD⁴ of RIA Group

0.72

0.46

CV of RIA Group

7.7%

9.4%

RH01a

RH01

4

9

9.4

-0.1

-0.1

-4%

5.5

0.5

1.3

42%

RH02c

RH02

4

1

7.3

-2.2

-2.9

-96%

4.1

-0.9

-2.3

-75%

RH06

RH06

4

9

9.3

-0.2

-0.3

-9%

5.0

0.0

0.0

0%

RH07a

RH07

4

2

8.4

-1.1

-1.4

-48%

6.8⁵

1.8

4.5

150%

RH12

RH12

4

2

8.9

-0.6

-0.8

-26%

6.3⁵

1.3

3.3

108%

RH14

RH14

4

14

8.2

-1.3

-1.7

-57%

4.8

-0.2

-0.5

-17%

RH19

RH19

4

2

8.9

-0.6

-0.8

-26%

6.8⁵

1.8

4.5

150%

RH20

RH20

4

7

9.7

0.2

0.3

9%

5.1

0.1

0.2

8%

CL005

CL005

4

9

9.1

-0.4

-0.5

-18%

5.0

0.0

0.0

0%

CL006a

CL006

4

7

10.4

0.9

1.2

39%

6.2

1.2

3.0

100%

CL008

CL008

4

1

7.3

-2.2

-2.9

-96%

4.2

-0.8

-2.0

-67%

CL011

CL011

4

13

9.1

-0.4

-0.5

-18%

5.4

0.4

1.0

33%

CL013

CL013

4

1

7.1

-2.4

-3.2

-105%

3.8

-1.2

-3.0

-100%

Median of CLIA Group

8.9

5.0

Range of CLIA Group

7.1 – 10.4

3.8 – 6.2

Robust average⁴ of CLIA Group

8.7 ( n = 13 )

4.9 ( n = 10,不含Kit 2 ) ⁵

Robust SD⁴ of CLIA Group

1.13

0.80

CV of CLIA Group

13.0%

16.3%

Median of Kit 2 Labs⁵

―

6.8

Range of Kit 2 Labs⁵

―

6.3-6.8

Average of Kit 2 Labs⁵

―

6.6 ( n = 3 )

SD of Kit 2 Labs⁵

―

0.29

CV of Kit 2 Labs⁵

―

4.4

Median of All Labs

9.1

5.0

Range of All Labs

7.1 – 11.5

3.5 – 6.2

Robust average⁴ of All Labs

9.0 ( n = 21 )

4.9 ( n = 18, 不含Kit 2) ⁵

Robust SD⁴ of All Labs

0.92

0.62

CV of All Labs

10.2%

12.7%

Certified target value (Xa)*( µg/dL )

9.5

5.0

Uncertainty (Ua) *

0.09

0.05

Target SD ⁶

0.76

0.40

1. D = X - Xa

2. Z_score = D / Target SD

3. Da% (Your result from target as percentages of allowed deviation) = D/(Xa x MAD) x 100%

4. Robust results were calculated by Algorithm A according to ISO 13528:2005 and IUPAC/CITAC Guide: Selection and use of proficiency testing scheme for a limited number of participants. Pure Appl Chem 2010;82:1099 – 135.

5. This control material (human serum, off-the clot) did show different behavior than similar samples used in European surveys.  The reason for this is not clear up to now.  For the evaluation this was taken into consideration from the target by a separate evaluation of the collective.

6. Maximum allowable deviation (MAD) 24%, Target SD = 8% x Xa

*The Certified Target Value of Thyroxine in Serum was determined using Isotope dilution mass spectrometry (IDMS) reference method by an international certified reference laboratory.

The reference laboratory is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of the International Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates.

The uncertainty stated is the expanded uncertainty obtained by multiplying the standard uncertainty by the coverage factor k. At a t-distribution with v(eff) effective degrees of freedom the value of the measured lies within the assigned range of values with a probability of 95 %. It has been determined in accordance with EA-4/02.

Reference:

Thienpont LM, Van Uytfanghe K, Beastall G, et.al.  Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 3:Total Thyroxine and Total Triiodothyronine. Clin Chem 2010; 56: 921 – 9.

Sample S1

Sample S2

Certified Target Value *

(1 nmol/L = 0.0777 µg/dL)

122.3 nmol/L (9.5 µg/dL)

64.88 nmol/L (5.0 µg/dL)

Expanded uncertainty

1.2 nmol/L (0.09 µg/dL)

0.68 nmol/L (0.05 µg/dL)

Relative expanded uncertainty

1.0%

1.0%

Coverage factor k

2.6

2.6

Effective degrees of freedom v(eff)

5

5

Method Name

Method Code

Laboratory

Radioimmunoassay

( Competitive - type ) 

2

RH01b, RH07b, RH15, CL009, CL010, CL012, CL014a, CL015,

Chemiluminescent Immunoassay

(Competitive - type )

4

RH01a, RH02c, RH06, RH07a, RH12, RH14, RH19, RH20, CL005, CL006a, CL008, CL011, CL013,

Reagent Kit

Reagent Code

Laboratory

Abbott Architect

1

CL008, CL013, RH02c,

Beckman Coulter Access

2

RH07a, RH12, RH19,

Cisbio RIA-gnost

3

CL012, RH07b,

Diasorin

4

CL009,

Immunotech

5

CL015, RH01b,

MP

6

CL010,

Siemens ADVIA Centaur

7

CL006a, RH20,

Siemens COAT-A-COUNT

8

CL014a, RH15,

Siemens Immulite 2000

9

CL005, RH01a, RH06,

Roche

13

CL011,

Johnson & Johnson ortho vitros

14

RH14,