Oswald Sonntag, International Scientific and Professional Affairs Manager

2013

 ;
, , ;
.

175

145
121
156
137

128
169

Kalra J. Clin Biochem 2004;37:105262

:

Arch Pathol Lab Med 2010;134:244-55

( ):

1 : 300

( ):

1 : 5,000

1: 5,000

1 : 25,000

() :

1 : 2,000,000

1 : 10,500,000

64%
Kruse-Jarres JD. Lab Med 1994;18:213-6.

70% .
Forsman R. Dark Report 2007

, 70 - 80%

,
.
Foubister V. CAP Today, Sept. 2000
Datta P. Advance for the Administrators of Laboratories, July 2005, p 60


365 19

4 3 vs LC/ID/MS
15.6%

6.2% 3.3%

4.0% 19.7%
Greenberg N et al. Clin Chem 2012;58:391-401

-


,
.

CAP CLIA '88 ,

6
,
,
,

.
, 60
$ 199 $

0.1/ 0.5/
(0.025/ 0.125/).

0.2 0.4 %

0.6 0.8 %

1.0 - 1.2 %

,
,

-
.
=

1483

876 (59.1 %)
607 (40.9 %)
,
.

Miller WG et al. Clin Chem 2011;57:493-501

 II

294

181 (61.6 %)

113 (38.4 %)

1 (16.7 %)

5 (83.3 %)

Modular

112

87 (77.7 %)

25 (22.3 %)

Vitros

156

81 (51.9 %)

75 (48.1 %)

Advia
Dimension

Miller WG et al. Clin Chem 2011;57:493-501

Glucose mmol/L Accu-Check

Frslie KF et al. Clin Biochem 2011;44:14836


uncertainty budget

SI

(IFCC)

,
,

(IFCC)

:
:

34 |

35 |

ISO 15189

4.1.2.3

.
, :
a.
b.
, ,
,
,

c.

d.

e. .
37 |

4.1.2.3

,
,

,
,
.

38 |

4.14.7

,
.

39 |

IFCC
www.ifcc-mqi.com

IFCC
:

5.5.1.4



.


.
2:
,
,
,
, ,
,
.

41 |

5.5.1.4
07/27/11 - 09/14/11

(/)

SD (c)

2 SD (U) (U = 2 x c)

. 1

n = 40

5.7

0.12

0.24 = 0.2

. 2

n = 40

30.8

0.73

1.46 = 1.5

QC

QC . 1: 0.2 / (95.5 % . );
QC . 2: 1.5 / (95.5 % . ).
:
1: 6.8 0.2 / (~95 % . .).
, ~95 % ,
6.6 7.0 /.

2: 32.8 1.5 / (~95 % . .).

, ~95 % ,
31.3 34.3 /.

5.5.2


,
.


,
.



.
43 |

Guder et al, Samples: From the Patient to the Laboratory, Wiley-VCH, Weinheim/D

Guder et al, Samples: From the Patient to the Laboratory, Wiley-VCH, Weinheim/D

5.6.2

5.6.2.1

,

.
: ,
,

46 |

5.6

5.6.1

,
.

47 |

5.6.2.2

,
,
.

,
-
.
1: ,
, ,
, .
2:
, ,
, .
48 |

 FDA
, ,

.
,
.
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material, June 7, 2007

 ????
,
, ,
, , , ,
, ,
, ,
,
?
,
?

.
2

149

138
.

125

.
1

5.6.2.3


.
,
, , ,
,
,

.

,

.
54 |

5.6.2.3

,

.
,
.
: ,

.

55 |

 ?
3 SD

-
: ,
!!!

: (!) - UNITY

5.6.3

,

, ,
,
.
,
,

,
,
, -
.
57 |

5.6.3
5.6.3.2
,
,

.
, ,
.
: :
- ;
- ;
- () ;
- ;
- , ,
.
58 |

5.6.3.3

,

.

,
,
.


.


,
.
59 |

5.6.3.4


.

(.. ),

.
.

,
, .
60 |

5.6.4

,

.

, ,
, .
: ,
,
,
.
61 |

5.6.4

,

(, ),
.

,
,
.
,
.
62 |

Sigma value = (TEa Bias)/CV

,
:

TEa = 7.9%
Bias = 1.6%
Imprecision (CV) = 2%

= (7.9-1.6)/2 = 3.2


2011

>6 ( ) 1
( )
1 : 3,5 s
4 6 ()
,
1 : 2,5 s
3 4 ( )
2

< 3 ()
, ,

 ?
Bio-Rad Unity

- (% )

- ISO 15189

- ISO 15189