Table 2

ISI Calibration results: CoaguChek Mini and RBT/90

Whole bloodArtificially depleted plasmaIndividual coumarin plasmaPooled coumarin plasma
CentreNISICV(b)NISICV(b)NISICV(b)NISICV(b)
The values shown are the ISI derived from the calibration slope b, the CV (%) of the calibration slope, and the number of samples used in the calibration (N). The “Overall” row gives the mean CV(b) and ISI at the 10 centres. The ISI CV% row gives the between centre CV (%) of the ISI. Mean ISI difference (lyophilised plasma ISI – whole blood ISI) and corresponding confidence interval (CI) and p value are provided.
*CV(b) is greater than 3.0 but less than 3.05; †significant displacement at the 1% level using Tomenson’s test.13 The absolute % INR deviations from theoretical INR of 2.0 and 4.5, respectively, are given in parentheses. See World Health Organisation guidelines11 for further details.
CV, coefficient of variation; ISI, international sensitivity index; RBT/90, rabbit plain international reference preparation.
1731.634.6681.953.5 †(46,58)741.733.7131.6615.2
2742.103.4702.054.0751.794.8131.8014.8
3701.703.2701.932.4761.753.3131.794.2
4761.893.0*701.962.0 †(19,26)771.662.4131.712.3
5731.781.9701.801.6 †(21,28)751.722.5121.802.7
6771.524.7701.983.1771.913.6131.986.4
7751.672.8711.883.9771.803.2131.885.9
8731.762.6701.942.8761.812.7131.885.1
9711.923.6711.801.4771.732.5131.913.1
10711.573.3711.922.0761.792.6131.783.6
Overall1.753.31.922.71.773.11.826.3
Mean ISI difference0.170.020.07
CI(0.04 to 0.30)(−0.14 to 0.17) (−0.08 to 0.22)
p Value0.020.80.3
ISI CV (%)10.04.03.85.2