www.pasa.nhs.uk/cep Report 06024 CoaguChekXS system June 2006 Health and social care working together

Instrument details and operation Name CoaguChek XS Manufacturer Roche Diagnostics Ltd. Bell Lane Lewes, East Sussex

Instrument details and operation Operational details Analytical procedure Prior to testing, the operator should ensure that batteries and the correct

Instrument details and operation Figure 4: Image of instrument and test strip, showing matching codes on LCD and test strip container Test strip cont

Report 06024: CoaguChek XS system Technical assessment 10 Methods For reference laboratory testing, venous blood was collected into one-tenth volume

Report 06024: CoaguChek XS system Technical assessment Reference ranges The International sensitivity index (ISI) for each thromboplastin used in the

Report 06024: CoaguChek XS system Technical assessment Table 3: Within-run imprecision for the CoaguChek XS Test 1 Test 2 Test 3 Mean INR % CV

Report 06024: CoaguChek XS system Technical assessment Table 5: Between test strip lots variability using venous blood, all (n = 20) Test Strip A

Report 06024: CoaguChek XS system Technical assessment Table 7: INR values for oral anticoagulant samples within therapeutic range (n = 46) CoaguChe

Report 06024: CoaguChek XS system Technical assessment Figure 5: INR for all oral anticoagulant patients. CoaguChek XS v Innovin Figure 6: INR for a

Report 06024: CoaguChek XS system Technical assessment Figure 7: INR for all oral anticoagulant patients. CoaguChek XS v PT HS Plus 0123456PT HS Plus

About evaluation reports The Centre for Evidence-based Purchasing provides independent and objective evaluations of medical devices available on the

Report 06024: CoaguChek XS system Technical assessment Figure 9: INR values for OAC patients in the therapeutic range and normal subjects on the Coagu

Report 06024: CoaguChek XS system Technical assessment Stratified INR data Stratification of INR results with respect to the values obtained by the P

Report 06024: CoaguChek XS system Technical assessment Table 8: INR subgroups for OAT samples (n = 62) CoaguChek XS Innovin PT HS Plus INR 1.00 –

Report 06024: CoaguChek XS system Technical assessment Effect of haematological parameters on CoaguChek XS We assessed the effects of elevated white

Report 06024: CoaguChek XS system Technical assessment Instrument reliability No mechanical failures were encountered during the evaluation. Only two

Report 06024: CoaguChek XS system Technical assessment Microbiological safety The CoaguChek XS test-strips are single-use and disposable and since t

Discussion The CoaguChek XS is a small, portable device intended primarily for use by patients and non-laboratory based medical staff to generate INR

Discussion values were compared with PT-HS Plus. If the average INR was greater than 4.0 units the results were excluded from this analysis. The regr

Conclusions This study showed that the CoaguChek XS instrument and test strips gave accurate and reproducible INR results when compared with two refer

References CLSI E15-A. User demonstration of performance for precision and accuracy; Approved guideline (2001) Clinical and Laboratory Standards Inst

Evaluation of CoaguChek XS system I Longair, C Gardiner, MA Pescott, IJ Mackie, H Cohen, SJ Machin Department of Health Evaluation Centre 6

Acknowledgements We wish to thank Hilary Erwin and phlebotomy staff as well as the patients at University College Hospital for their help during this

Appendix Electrical safety certificate Report 06024: CoaguChek XS system 28

Appendix Report 06024: CoaguChek XS system 29Manufacturer’s comments

Contents Summary ...2 Introduction...

Summary The CoaguChek XS is a portable, lightweight, point-of-care device which measures Prothrombin time (PT) and International Normalised Ratio (IN

Introduction The CoaguChek XS System is a point of care device for measuring prothrombin time (PT) and International Normalised Ratio (INR). It is

Introduction Figure 1: Image of the CoaguChek XS Instrument and its components LCD screen ON/OFF button Memory functions button SET button Test strip

Introduction Principle components The instrument was provided in a portable case containing the CoaguChek XS meter, user manual, CoaguChek Softclix la

Introduction Sample type and volume We initially compared fresh capillary whole blood and venous non-anticoagulated samples for equivalence using the