Roche CoaguChek XS System User Manual download pdf (Page 21)

Report 06024: CoaguChek XS system

Technical assessment

Stratified INR data

Stratification of INR results with respect to the values obtained by the PT HS

Plus method showed some small but statistically significant differences between

the CoaguChek XS and Innovin methods at all levels of stratification (Table 8).

It is apparent, however, that the Innovin INR values were consistently lower

than for both CoaguChek XS and PT HS Plus methods, except at higher INR

values and although statistically significant, the differences are small and not

likely to be of clinical significance.

There was broad agreement between CoaguChek XS and PT HS Plus INR

values at all levels of stratification except in the range of about 2.0 – 3.0 INR

units. At these ranges the CoaguChek XS INR values were slightly lower than

the reference method and approached statistical significance. The differences

between the methods were minor and, again, unlikely to be of clinical

significance.

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Roche CoaguChek XS System User Manual Page 21