2013 T3 檢驗準確性 ( Accuracy ) 測試結果報告

送檢批號AQ2013-06    調查期間:2013 06 03 ~ 10     參加單位數:21

AQ2013-06 批次 T3 檢驗院際品管統計分佈圖

檢驗單位

代碼

確診醫院

代碼

檢體方

法編碼

檢體試

劑編碼

Sample S1

Sample S2

(ng/dL)

D 1

Z 2

Da% 3

(ng/dL)

D 1

Z 2

Da% 3

RH01b

RH01

2

5

236

-24.0

-1.2

-39%

69

-5.0

-0.8

-28%

RH07b

RH07

2

3

237

-23.0

-1.1

-37%

69

-5.0

-0.8

-28%

RH14

RH14

2

3

246

-14.0

-0.7

-22%

44

-30.0

-5.1

-169%

RH15

RH15

2

8

239

-21.0

-1.0

-34%

53

-21.0

-3.6

-118%

CL009

CL009

2

5

233

-27.0

-1.3

-43%

65

-9.0

-1.5

-51%

CL010

CL010

2

6

279

19.0

0.9

30%

76

2.0

0.3

11%

CL012

CL012

2

3

274

14.0

0.7

22%

44

-30.0

-5.1

-169%

CL013

CL013

2

5

284

24.0

1.2

38%

66

-8.0

-1.4

-45%

CL014a

CL014

2

3

281

21.0

1.0

34%

59

-15.0

-2.5

-84%

CL015

CL015

2

5

282

22.0

1.1

35%

58

-16.0

-2.7

-90%

Median of RIA Group

260

62

Range of RIA Group

233 - 284

44 - 76

Robust average4 of RIA Group

259 ( n = 10 )

60 ( n = 10 )

Robust SD4 of RIA Group

25.4

12.2

CV of RIA Group

9.8%

20.3%

 

RH01a

RH01

4

9

263

3.0

0.1

5%

75

1.0

0.2

6%

RH02c

RH02

4

1

311

51.0

2.5

82%

85

11.0

1.9

62%

RH06

RH06

4

9

261

1.0

0.0

2%

79

5.0

0.8

28%

RH07a

RH07

4

2

256

-4.0

-0.2

-6%

85

11.0

1.9

62%

RH12

RH12

4

2

258

-2.0

-0.1

-3%

96

22.0

3.7

124%

RH19

RH19

4

2

211

-49.0

-2.4

-79%

81

7.0

1.2

39 %

RH20

RH20

4

7

318

58.0

2.8

93%

89

15.0

2.5

84%

CL005

CL005

4

9

256

-4.0

-0.2

-6%

81

7.0

1.2

39%

CL006a

CL006

4

1

273

13.0

0.6

21%

76

2.0

0.3

11%

CL008

CL008

4

1

287

27.0

1.3

43%

80

6.0

1.0

34%

CL011

CL011

4

13

275

15.0

0.7

24%

99

25.0

4.2

141%

Median of CLIA Group

263

81

Range of CLIA Group

211 - 318

75 - 99

Robust average4 of CLIA Group

271 ( n = 11 )

84 ( n = 11 )

Robust SD4 of CLIA Group

28.5

8.2

CV of CLIA Group

10.5%

9.8%

 

Median of All Labs

263

76

Range of All Labs

211 - 318

44 - 99

Robust average4 of All Labs

264 ( n = 21 )

73 ( n = 21 )

Robust SD4 of All Labs

25.4

16.0

CV of All Labs

10.2%

12.7%

Certified target value (Xa)*( µg/dL )

260

74

Uncertainty (Ua) *

2.6

0.7

Target SD5

20.8

5.9

 

1. D = X - Xa

2. Zscore = 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. Maximum allowable deviation (MAD) 24%, Target SD = 8%

 

*The Certified Target Value of Triiodothyronine 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 = 65.1 ng/dL)

4.001 nmol/l (260 ng/dL)

1.139 nmol/l (74 ng/dL)

Expanded uncertainty

0.04 nmol/l (2.6 ng/dL)

0.011 nmol/l (0.7 ng/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, RH14, RH15, CL009, CL010, CL012, CL013, CL014a, CL015,

Chemiluminescent Immunoassay

( Competitive - type )

4

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

 

Reagent Kit

Reagent Code

Laboratory

Abbott Architect

1

CL006a, CL008, RH02c,

Beckman Coulter Access

2

RH07a, RH12, RH19,

Cisbio RIA-gnost

3

CL012, CL014a, RH07b, RH14,

Immunotech

5

CL009, CL013, CL015, RH01b,

MP

6

CL010,

Siemens ADVIA Centaur

7

RH20,

Siemens COAT-A-COUNT

8

RH15,

Siemens Immulite 2000

9

CL005, RH01a, RH06,

Roche

13

CL011,

 

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          updated : 06 Nov, 2013