Further Information: CoaguChek XS system correlation studies and evaluations

The CoaguChek® XS Pro system relies on international reference standards

The CoaguChek® XS strips used on the CoaguChek® XS Plus system and CoaguChek® XS Pro system are the same strips which are used for the CoaguChek® XS patient meter.

All three systems share the same detection system (electrochemical).

To assure comparable system performance across all meters of the CoaguChek family an internal study was conducted to confirm equivalence of the new CoaguChek® XS Pro meter in comparison to the CoaguChek® XS Plus meter over the whole specified hematocrit range.

All acceptance criteria were met for all blood samples. The equivalence of both meter types (CoaguChek® XS Plus system and CoaguChek® XS Pro system) over the whole hematocrit range was shown.

The calibration validation and ISO 17593 compliance of CoaguChek® XS system have been evaluated and published. The results are available online at Thrombosis Research.

The CoaguChek® XS Plus system relies on international reference standards

The CoaguChek® XS strips used on the CoaguChek® XS Plus professional meter are the same strips which are used for the CoaguChek® XS patient meter.

Both the CoaguChek® XS system and CoaguChek® XS Plus system share the same detection system (electrochemical).

An internal evaluation study (LB 157-2005) has proven the high correlation between the results obtained from the CoaguChek® XS Plus system when compared to the CoaguChek® XS system.

Performance Evaluation (LB 157-2005)

The results obtained from both instruments in the study are equivalent. All acceptance criteria based on the draft ISO standard 17593 were met: the PT strips are calibrated versus the reference methods using International Reference Preparations (IRPs) rTF/95 and CRM149S.

The master lot’s ISI is then determined and will be used for further lots production. All produced lots are therefore traceable back to the international reference methods.

The calibration validation and ISO 17593 compliance have been evaluated and published.The results are available online at Thrombosis Research:

Plesch W, et al. Results of the performance verification of the CoaguChek XS system. Thromb Res (2008), doi:10.1016/j.thromres.2008.04.021

From the results of this study, it can be concluded that the CoaguChek® XS system complies with ISO 17593 requirements.

All acceptance criteria were met and the system specifications concerning trueness, accuracy, repeatability, influence of haematocrit and fibrinogen, as well as the specification of the integrated QC function were successfully verified in the external performance evaluation study.

Should you have further questions, please do not hesitate to contact your local Roche representative.

CoaguChek® XS relies on international standards

The CoaguChek® XS strips are calibrated against WHO standards, which is a manual tilt tube reference method using International Reference Preparations (IRPs) rTF/95 and CRM149S. The Masterlot ISI is then determined and will be used for further lots'ISI determination.

The master lot’s ISI is then determined and will be used for further lots production. All produced lots are therefore traceable back to the international reference methods.

The calibration data are contained in a code chip provided with each vial of strips.

No further calibration is needed from the HCP or the patient.

Please refer to the poster (from ISTH 2005, Sydney) hereunder: Poster from ISTH 2005, Sydney

We are pleased to inform you that the CoaguChek® XS systems have been extensively evaluated by independent evaluation bodies ( PASA in the UK, SKUP in Norway).