# Αξιοπιστία Εργαστηριακού Αποτελέσματος.

. & - K., : - -

- , , , (..) : :

( , , ) ( , ., , ). : ( , , , ).

, (reliability) . , .

. : - (accuracy) - (Precision)) - (reproducibility) - (Practicability) - )

. : - (Sen)sitivity) - (Specificity) - (Accuracy) . : (d) () (x) (d = x) (d = x) (d = x),

R = (d / ) 100). Stan)dard Solution)s ( con)trol solution)s ) . , . , . . Accuracy .

(precision)) : . ().

. precision) accuracy . truen)ess , accuracy.

( ) 2002/657/ ( ), precision) . , fidelity precision). ""

( ) . , fidelity precision) . ;

() () precision ( accuracy=) =repeatability.

. . accuracy . Precision) vs Accuracy

E A . E (con)sisten)cy). .

- Precision , , , , Accuracy . Reproducibility (reproducibility)reproducibility) ,

, , , , . - - , . , , H

_ 1. (. ). S Stan)dard Deviation), . (reproducibility) )

H CV (Coefficien)t of Variation)) S CV= ------- x) (d = x 100 _ x) (d = x

() (Stan)dard Deviation)). . , . . .

(reproducibility)+/-) 95,5% . (precision) : SD ( S= ). o (coefficien)t of variation), CV), (S / x) (d = x ).

(coefficien)t of variation), CV), : CV % = (S / x) (d = 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 Stan)dard 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 con)trols) ( stan)dard calibrator solution)s).

.

E (sen)sitivity) (N) (sen)sitivity) , , .

. A ,

(detection limit). E () ()

% ={ /(+)} 100 (SPECIFICITY)) - . Hb,Bil, turbidity, medicin)es, immunoglobulins , cross

reaction)s. . . % () () () . = (/+) 100 100% 100% .

(predictive value) + + . PV(+)={ /+} 100

100, . . (predictive value) .

PV(-)= {AA/+} 100 , 100 . . (Diagn)ostic Value) :

: (Diagn)ostic Value)

: () .(vidal-) ( - - . . :H . (. ), ,

(PV+ . ). . .

, , (Levey-Jen)n)in)gs,Y)ouden)) . (Quality Assuran)ce of Testin)g Results) : - , / (day to

day) (batch to batch). -K (reproducibility)Internal QC).). - (reproducibility)Proficiency Testing) - (reproducibility)External QC).). .

(REPLICATES , . () .

() . : 1 2 (r = 2,8 s), . 15-20 ( ) _

x) (d = x s. , _ x) (d = x (1, 2, ...) .

. 2s ( ) 3s ( ). (con)trol) .

( ). . :

1 (3s) , . 2 ()

. 10 , . .

. Levey-Jen)n)in)gs LeveyJen)n)in)gs . 3

(.. ) (.. ). Levey-Jen)n)in)gs Westgard

Westgard Levey-Jen)n)in)gs. . : 12s :- 2 3

13s : - 3 22s : 2 3

R4s : 4 41s : 1 _ 10 X :

O O (Stan)dard Deviation) In)dex) (d = x SDI) . SDI . SDI -2 2. :

SDI SDI : . .

. . . SDI . .

SDI LeveyJen)n)in)gs. SDI . SDI . . SDI SDI

. SDI .

. Y)oden) plot , . , , . 2 s 4s. / ,

2 s . . Y)oden)

, . ,

. T , Laboratory information systems (LIS ) . , , , , , (QC).), .. barcodes

. : http://www.esyd.gr/pweb/s/20/files/kan)on)ismoi/kr itiriaOdigies/KO_KLINERG.pdf

EN ISO 15189:2012 : http://www.esyd.gr/portal/p/esyd/el/article_previe w.jsp?arcluid=2985 ... To ... ISO,

. .

, , , . . -- . . . . . (, ) ,back up , . , , .

Deadlin)e 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.n)et page http://www.slideshare.n)et/x) (d = xartopon)tikas

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