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. & - K.,
: , , , (..)
:
: ( , , ) ( , ., , ). : ( , , , ).
, (reliability) . , .
.: (accuracy) (Precision) (reproducibility) (Practicability)). : (Sensitivity) (Specificity)
(Accuracy)
. : (d) () (x) (d = x), R = (d / ) 100). Standard Solutions ( control solutions ) . , . , . . Accuracy .
(precision) : . ().
.
precision accuracy . trueness , accuracy.
( ) 2002/657/ ( ), precision . , fidelity precision. "" ( ) . , fidelity precision .
;
() ()
precision ( accuracy=) =repeatability. . . accuracy .
Precision vs Accuracy E A .
E (consistency). . - Precision , , , , Accuracy .
Reproducibility (reproducibility) , , , , , . - - , . , ,
H _1. (. ).
S Standard Deviation, . ( )
H CV (Coefficient of Variation) SCV= ------- x 100 _ x
() (Standard Deviation). . , . . . (+/-) 95,5% .
(precision) : SD ( S= ). o (coefficient of variation, CV), (S / x ). (coefficient of variation, CV), : CV % = (S / x ) 100. , , . : CV SD _
mg/dl _ _ 2 - ( -) 1 37 1 1 2 33 -3 9 3 40 -4 16. 7 36 0 0 8 35 1 1 _ _ 291:8=36= (-)2 =63 Standard Deviation ( ) S= . 63:7=3 95,5% 36 +/- 6 36-42, . CV=(3:36)100= 8,3% ( *) * %CV
1s,2s,3s
1s,2s,3s
(Practicability)
:. . .. ..
(L,M,H controls) ( standard calibrator solutions).
.
E (sensitivity) (N) (sensitivity) , , .
.
A , (detection limit).E () ()
% ={ /(+)} 100
(SPECIFICITY) - . Hb,Bil, turbidity, medicines, immunoglobulins , cross reactions.. . % () () () . = (/+) 100 100% 100% .
(predictive value) + + . PV(+)={ /+} 100 100, . .
(predictive value) .PV(-)= {AA/+} 100 , 100 . .
(Diagnostic Value) : :
(Diagnostic Value) : () .(vidal-) ( - - . . :H - . (. ), , (PV+ . ).
. . , , (Levey-Jennings,Youden) .
(Quality Assurance of Testing Results) : - , / (day to day) (batch to batch). -K (Internal QC). - (Proficiency Testing) - (External QC). .
(REPLICATES , . () . () .: 1 2 (r = 2,8 s), .
15-20 ( ) _ x s. , _ x (1, 2, ...) .
. 2s ( ) 3s ( ). (control) .
( ). . : 1 (3s) , .
2 () . 10 , .
. .
Levey-Jennings Levey-Jennings . 3 (.. ) (.. ).
Levey-Jennings
Westgard Westgard Levey-Jennings. . : 12s :- 2 3 13s : - 3 22s : 2 3 R4s : 4 41s : 1 _10 X :
O O (Standard Deviation Index SDI) . SDI . SDI -2 2. :
SDI
SDI: . . . . .
SDI . . SDI Levey-Jennings. SDI . SDI . .
SDI SDI . SDI . .
Yoden plot
, . , , .
2 s 4s. / , 2 s . .
Yoden
, . , . T , Laboratory information systems (LIS ) . , , , , , (QC), .. barcodes .
: http://www.esyd.gr/pweb/s/20/files/kanonismoi/kritiriaOdigies/KO_KLINERG.pdf EN ISO 15189:2012 : http://www.esyd.gr/portal/p/esyd/el/article_preview.jsp?arcluid=2985
...
To ... ISO, . .
, , , .. -- .. .. . (, ) ,back up , . , , .
Deadline 01.01.2014 EN ISO 15189:2012.3. (, , ), 31.12.2014, ( EN ISO 15189:2007 EN ISO 15189:2012).4. 01.01.2015 EN ISO 15189:2012.
25
, ISO, , , .
My slideshare.net pagehttp://www.slideshare.net/xartopontikas
,rh,, . HbA1c, g-m CMV, Rubella ,, (Accuracy ) /- ( Precision) - 88, 80,(88-80/88)100=9 ( ( 0) . , ).precision / accuracy -> / | / Quote ( ). , , repeatability (..) , . . (. ) (standard deviation, ..). accuracy (.) , . repeatability, reproducibility. : precision accuracy . trueness (. .), accuracy. ( ) . , . 2002/657/ ( ), precision . , fidelity precision, . "" ( ) . , fidelity precision . , : () : precision: ( , ), ( ). accuracy: . trueness: . () ( ): precision: . accuracy: . trueness: ( ). () ( 2002/ 657/): precision: accuracy: trueness: between days precision: | between run precision: | interlaboratory precision: | intralaboratory precision: | within day precision: | within run precision: ( ). http://www.chem.uoa.gr/vocabulary/vocabularyview.asp?key=precision precision / accuracy -> / | / Quote ( ). , , repeatability (..) , . . (. ) (standard deviation, ..). accuracy (.) , . repeatability, reproducibility. : precision accuracy . trueness (. .), accuracy. ( ) . , . 2002/657/ ( ), precision . , fidelity precision, . "" ( ) . , fidelity precision . , : () : precision: ( , ), ( ). accuracy: . trueness: . () ( ): precision: . accuracy: . trueness: ( ). () ( 2002/ 657/): precision: accuracy: trueness: between days precision: | between run precision: | interlaboratory precision: | intralaboratory precision: | within day precision: | within run precision: ( ). http://www.chem.uoa.gr/vocabulary/vocabularyview.asp?key=precision : (reproducibility) , , , , . - - :