Further Information: CoaguChek® System correlation studies and evaluations

The CoaguChek Pro II meter relies on international reference standards

The CoaguChek PT strips used on the CoaguChek Pro II have been evaluated against the CoaguChek XS strips used on the CoaguChek XS patient meter.

The CoaguChek Pro II system uses the electrochemical detection system.

To assure comparable system performance across all meters of the CoaguChek family, an internal equivalence verification study was conducted to compare INR results between the CoaguChek PT Test on the CoaguChek Pro II meter and the CoaguChek XS Test on the CoaguChek XS Plus/Pro meter.

The CoaguChek Pro II system uses the CoaguChek PT Test strip which has a broader intended use compared with the predecessor CoaguChek XS Test strip. An external validation study evaluated the analytical performance of the CoaguChek PT Test on the CoaguChek Pro II meter and compared this performance with an approved laboratory method.

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).