Roche CoaguChek XS System User Manual download pdf (Page 6)

Introduction

The CoaguChek XS System is a point of care device for measuring prothrombin

time (PT) and International Normalised Ratio (INR). It is intended for patient self

monitoring and in specific cases for Healthcare professionals, e.g domicilliary

visits in the monitoring of oral anticoagulant therapy (OAT). The CoaguChek XS

has been CE marked, but has not yet received an independent evaluation in the

UK.

The protocol is based on the general protocol for the critical evaluation of

coagulometers used for point-of-care testing (PoCT) for the Centre for

Evidence-based purchasing (CEP) of the NHS Purchasing and Supply Agency

(PASA), Department of Health. For the purpose of these evaluations, PoCT

instruments are defined as portable coagulometers designed for use in close

proximity to the patient, i.e. at the bedside, in the clinic or by patients

themselves. The evaluation uses the reagents, consumables and conditions

recommended by the manufacturer of the instrument. Performance is compared

to standard laboratory tests on citrated plasma. The definitions of comparability,

imprecision, sensitivity, specificity, and carryover will be similar to those

previously outlined (Giddings et al., 1989; Gardiner et al., 2006).

Description of instrument

CoaguChek XS meter

The instrument consists of a test strip area and measurement chamber cover,

liquid crystal display (LCD) and three buttons (Figure 1). There is a slot for

code-chip insertion and an infrared window for data transmission. Underneath is

a compartment with removable cover for battery power supply.

The test strip area consists of a guide or rail, which holds the test strip, and a

cover that can be removed for cleaning.

Report 06024: CoaguChek XS system

Prior to use one should ensure that the correct chip is inserted in the slot on the

monitor and that it matches the code on the test strip container to be used. The

buttons on the CoaguChek XS instrument are the on/off button, the (M) button

for memory functions and the set button for changing or modifying settings.

The CoaguChek XS Plus is currently being developed for Healthcare

professionals and is expected for release later this year. This upgraded model is

specifically aimed at healthcare workers and will possess additional features to

the CoaguChek XS including an external power supply and increased storage

and connectivity for data management.

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Roche CoaguChek XS System User Manual Page 6