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Validatie CS-2500 AKL Lier (Medina Groep)

Johan Claes, Version 01, 1st September 2016

Johan Claes / Francois Richir | Laboratory Diagnostics

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CS-2500 Validatie van het systeem

Actuele situatie • CA-7000 systeem • PT, APTT, D-Dimer, Fib-dev • Stand alone • LIS koppeling: GLIMS

Johan Claes / Francois Richir | Laboratory Diagnostics

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CS-2500 Validatie van het systeem

Nieuwe situatie • CS-2500 systeem • PT, APTT, D-Dimer, Fib • Stand alone • LIS koppeling: I-Lab

Johan Claes / Francois Richir | Laboratory Diagnostics

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CS-2500 Validatie van het systeem

CS-2500 CA-7000

Reagentia stabiliteit + -

PSI + -

Multi-Lot reagentia beheer + -

Control management + -

2D Barcode reader + -

Event Log + -

Snelheid - +

Event Log

Up to 100 users

Trace actions

per user

User-unique

login

10 calibraties per lot mogelijk

10 loten per reagents

Twee calibratiecurves

vergelijken

Johan Claes / Francois Richir | Laboratory Diagnostics

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CS-2500 Validatie Protocol

Parameters • PT • APTT • D-Dimer • Fib

Protocol • Correlatie • Within RUN • Between RUN • Juistheid

Author | Department

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Correlatie

Parameters • PT % • PT INR • APTT • D-Dimer • Fib

Author | Department

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Within - Between RUN

D-Dimer

APTT

PT INR

Fib

Author | Department

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Within - Between RUN

Intra RUN Level 1 (%CV)

Level 2 (%CV)

PT %/INR 0,99 / 0,42 0,69 / 0,52

APTT 0,37 0,30

Fib 2,03 4,06

D-Dimer 5,3 8,52

Inter RUN Level 1 (%CV)

Level 2 (%CV)

PT 3,13 / 1,31 1,45 / 1,16

APTT 0,58 0,53

Fib 2,41 2,9

D-Dimer 6,28 6,91

V V

Author | Department

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Juistheid

Product Target Value % Deviation Total Error (RICOS)

INR Level 1 Citrol 1 1,01 0,97 -3,9 6,06 (7,9)

INR level 2 Cotrol 2 3,04 2,92 -3,9 5,81 (7,9)

APTT Level 1 Citrol 1 25,1 25,5 1,6 2,56 (6,7)

APTT level 2 Cotrol 2 50,5 52,9 4,7 5,57 (6,7)

Fib Level 1 Citrol 1 255 229 -10,2 14,18 (13,06)

Fib level 2 Control P 81 84 3,7 8,48 (13,06)

DD Level 1 DD Control 1 310 319 2,9 13,26 (28,04)

DD level 2 DD Control 2 2600 2777 6,8 18,02 (28,04)

Johan Claes / Francois Richir | Laboratory Diagnostics

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• Placeholders can be filled and then copied. The copied placeholder will keep its formatting

Besluit

Engineering success. Pioneering healthcare.

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Now’s our time

to inspire the future of healthcare together

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