Roche CoaguChek XS System Bedienungsanleitung PDF herunterladen (Seite 8)

A study was conducted and the precision of duplicates for capillary blood

results was calculated for both trained users and healthcare professionals. The

following results were obtained:

User Professional

Results Results

N 214 249

Mean 2.57 2.52

SD 0.13 0.13

CV 5.13 5.36

Precision:

109876543210

N = 297

PB: y = 1.154x - 0. 2

Slp CI (1.111,1.198)

Int CI (-0.3, -0.2)

Correlation = 0.934

109876543210

N = 463

PB: y = 1.000x + 0.0

Slp CI (1.000,1.030)

Int CI (-0.05, 0)

Correlation = 0.977

3 User Selection Guidelines User Selection Guidelines 3

This study shows that trained users are able to obtain results that are as precise as those

obtained by healthcare professionals trained in the use of the CoaguChek XS System.

During the study, the following error rates were observed:

Visit 1 Visit 2 Visit 3 Overall

Error 6 Test Strip Interference 0.8% 0.9% 0.5% 0.7%

Error 5 Blood Application 31.7% 23.9% 18.9% 25.2%

Error 4 Test Strip Unusable 0.8% 0.0% 2.8% 1.1%

Error 000 Time Exceeded 1.5% 1.3% 0.0% 1.0%

Error QC Quality Control Failure 1.1% 0.0% 0.0% 0.4%

Unknown Error 1.1% 0.0% 0.5% 0.6%

ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 10

1 2 3 4 5 6 7 8 9 10 11 12 13 ... 18 19

Keine Kommentare

Roche CoaguChek XS System Bedienungsanleitung Seite 8