Table 1 Precision study of the Hilab Lens device
Analyte | Reference value | Evaluated Parameters | Summary | Expected results* | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Average | SD | Assay CV | Random Error | Bias | Assay CV | Bias (Average) | Random Error (Max) | Total Error | CV (95% CI) | Bias (95% CI) | Total Error (95% CI) | ||||
Intra | Inter | Intra (Max) | Inter (Max) | ||||||||||||
RBC (x 106 /mm³) | 4.2 | 4.27 | 0.12 | 2.73% | 0.96% | 4.21% | 1.57% | 2.78% | 1.65% | 2.62% | 4.82% | 8.35% | ≼ 3.6% | ≼ 6% | ≼ 8.5% |
2.6 | 2.65 | 0.07 | 2.39% | 1.24% | 3.99% | 2.56% | |||||||||
3.6 | 3.70 | 0.11 | 2.78% | 1.65% | 4.82% | 3.73% | |||||||||
HB (g/dL) | 7.8 | 8.1 | 0.26 | 3.10% | 0.34% | 4.46% | 4.36% | 3.10% | 1.20% | 2.30% | 4.46% | 7.60% | ≼ 2.7% | ≼ 4.3% | ≼ 8.8% |
17.4 | 17.05 | 0.37 | 2.08% | 0.81% | 3.26% | −1.98% | |||||||||
12.2 | 12.7 | 0.36 | 2.71% | 1.20% | 4.35% | 4.23% | |||||||||
PLA (/mm³) | 29,800 | 27,831 | 1,792 | 6.48% | 1.98% | 9.82% | −6.61% | 6.48% | 5.54% | −1.60% | 11.63% | 12.22% | ≼ 7.4% | ≼ 10.9% | ≼ 23.1% |
211,000 | 211,153 | 13,395 | 6.06% | 1.24% | 8.90% | 0.07% | |||||||||
61,000 | 62,065 | 3,225 | 5.04% | 5.54% | 11.63% | 1.75% | |||||||||
WBC (/mm³) | 4,100 | 4,181 | 446 | 10.56% | 3.30% | 16.04% | 1.98% | 10.56% | 3.30% | 3.54% | 16.04% | 22.59% | ≼ 11.9% | ≼ 10.5% | ≼ 30.2% |
6,240 | 6,587 | 498 | 7.37% | 0.71% | 10.60% | 5.56% | |||||||||
16,800 | 17,319 | 1145 | 6.38% | 2.19% | 9.80% | 3.09% | |||||||||
