Whole blood | Artificially depleted plasma | Individual coumarin plasma | Pooled coumarin plasma | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Centre | N | ISI | CV(b) | N | ISI | CV(b) | N | ISI | CV(b) | N | ISI | CV(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. | ||||||||||||
1 | 73 | 1.63 | 4.6 | 68 | 1.95 | 3.5 †(46,58) | 74 | 1.73 | 3.7 | 13 | 1.66 | 15.2 |
2 | 74 | 2.10 | 3.4 | 70 | 2.05 | 4.0 | 75 | 1.79 | 4.8 | 13 | 1.80 | 14.8 |
3 | 70 | 1.70 | 3.2 | 70 | 1.93 | 2.4 | 76 | 1.75 | 3.3 | 13 | 1.79 | 4.2 |
4 | 76 | 1.89 | 3.0* | 70 | 1.96 | 2.0 †(19,26) | 77 | 1.66 | 2.4 | 13 | 1.71 | 2.3 |
5 | 73 | 1.78 | 1.9 | 70 | 1.80 | 1.6 †(21,28) | 75 | 1.72 | 2.5 | 12 | 1.80 | 2.7 |
6 | 77 | 1.52 | 4.7 | 70 | 1.98 | 3.1 | 77 | 1.91 | 3.6 | 13 | 1.98 | 6.4 |
7 | 75 | 1.67 | 2.8 | 71 | 1.88 | 3.9 | 77 | 1.80 | 3.2 | 13 | 1.88 | 5.9 |
8 | 73 | 1.76 | 2.6 | 70 | 1.94 | 2.8 | 76 | 1.81 | 2.7 | 13 | 1.88 | 5.1 |
9 | 71 | 1.92 | 3.6 | 71 | 1.80 | 1.4 | 77 | 1.73 | 2.5 | 13 | 1.91 | 3.1 |
10 | 71 | 1.57 | 3.3 | 71 | 1.92 | 2.0 | 76 | 1.79 | 2.6 | 13 | 1.78 | 3.6 |
Overall | 1.75 | 3.3 | 1.92 | 2.7 | 1.77 | 3.1 | 1.82 | 6.3 | ||||
Mean ISI difference | 0.17 | 0.02 | 0.07 | |||||||||
CI | (0.04 to 0.30) | (−0.14 to 0.17) | (−0.08 to 0.22) | |||||||||
p Value | 0.02 | 0.8 | 0.3 | |||||||||
ISI CV (%) | 10.0 | 4.0 | 3.8 | 5.2 |