Table 1 Results of clinical performance evaluation of CHI3L1 kit
Minimum Detection Limit | Test 1 | Test 2 | Test 3 |
|---|---|---|---|
M | 73695.70 | 72121.95 | 67874.05 |
SD | 3564.94 | 4028.29 | 5985.90 |
M + 2SD | 80825.57 | 80178.53 | 79845.85 |
LOD(ng/mL) | 1.50 | 1.44 | 1.39 |
Accuracy | Concentration(ng/mL) | Average(ng/mL) | Bias(%) |
3.00 | 3.01 | 5% | |
54.00 | 54.38 | −2% | |
Precision | Average(ng/mL) | Fitted Concentration CV | Deviation of fitted concentration |
3.10 | 4.2% | 3% | |
56.01 | 2.4% | 4% | |
Acceleration Stability | Bias | ||
Time | Test 1 | Test 2 | Test 3 |
1 Day | 2% | 4% | 5% |
2% | −1% | 2% | |
3 Day | −3% | 3% | 6% |
1% | −1% | 2% | |
6 Day | −5% | 3% | 6% |
1% | −3% | 3% | |
10 Day | 2% | 4% | −5% |
3% | 2% | −2% | |
Real-time Stability | CV value | ||
Month | S2 | S4 | S6 |
3 | 5.91% | 2.10% | 5.41% |
6 | 7.67% | 3.92% | 7.70% |
9 | 7.53% | 2.36% | 7.01% |
12 | 5.61% | 1.38% | 5.88% |