Analytical Performance Evaluation of the New GEM® Premier™ 5000 in Comparison to the Epoc® Blood Gas Analyzer in Horses
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Animals
2.2. Sample Collection
2.3. Sample Analysis
2.4. Instruments
2.5. Statistical Analysis
3. Results
3.1. Animals and Samples
3.2. Precision (Repeatability)
3.3. Agreement
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Measured Variables | GEM5000 | |||
---|---|---|---|---|
Mean ± SD of the 1st Sample | CV (%) of the 1st Sample | Mean CV (%) of All Duplicates | Precision Target (CV%) | |
pH | 7.53 ± 0.025 | 0.33 | 0.07 | <0.1 [13,16] |
pCO2 (mmHg) | 38 ± 2 | 5.26 | 0.87 | <2.4 [12,16] |
pO2 (mmHg) | 79.5 ± 8.5 | 10.69 | 3.18 | <4.8 [12,16] |
Na+ (mmol/L) | 132 ± 0 | 0 | 0.3 | <0.3 [12,16] |
Cl− (mmol/L) | 95.5 ± 0.5 | 0.52 | 0.42 | <0.6 [14,16] |
iCa2+ (mmol/L) | 1.67 ± 0.01 | 0.59 | 1.1 | <0.9 [14,16] |
K+ (mmol/L) | 4.65 ± 0.15 | 3.22 | 0.8 | <2.3 [14,16] |
PCV (%) | 31.5 ± 1.5 | 4.76 | 3.84 | <1.35 [14,16] |
tHb (g/dL) | 10.7 ± 0.5 | 4.47 | 4.84 | <1.43 [14,16] |
BE (mmol/L) | 8.8 ± 0.6 | 6.82 | 34.8 | <38.2 [16] |
SO2 (%) | 96.75 ± 1.15 | 1.19 | 1.04 | <5 [23] |
HCO3− (mmol/L) | 32.05 ± 1.15 | 0.47 | 1.74 | <5 [23] |
Measured Variables | epoc | GEM5000 | ||
---|---|---|---|---|
Mean ± SD | Range | Mean ± SD | Range | |
pH | 7.390 ± 0.056 | 7.280–7.545 | 7.390 ± 0.052 | 7.270–7.510 |
pCO2 (mmHg) | 48.7 ± 7.7 | 24.1–64.9 | 48.9 ± 6.6 | 27.0–65.0 |
pO2 (mmHg) | 117.9 ± 111.3 | 21.0–366.2 | 120.2 ± 109.7 | 22.0–372.0 |
Na+ (mmol/L) | 136 ± 3 | 129–144 | 134 ± 3 | 128–139 |
Cl− (mmol/L) | 100 ± 4 | 90–113 | 101 ± 4 | 92–111 |
iCa2+ (mmol/L) | 1.53 ± 0.16 | 1.14–1.78 | 1.57 ± 0.12 | 1.25–1.79 |
K+ (mmol/L) | 3.6 ± 0.6 | 2.5–5.2 | 3.7 ± 0.5 | 2.5–4.8 |
Hct (%) | 34 ± 11 | 16–59 | 30 ± 9 | 15–56 |
tHb (g/dL) | 11.5 ± 3.7 | 5.5–20.2 | 10.2 ± 3.3 | 5.1–19.0 |
BE (mmol/L) | 3.8 ± 4.1 | −12.6–10.7 | 4.0 ± 4.1 | −10.8–12.0 |
SO2 (%) | 80.4 ± 22.0 | 29.3–100.0 | 82.7 ± 20.1 | 33.8–100.0 |
HCO3− (mmol/L) | 29.5 ± 3.9 | 13.1–35.8 | 29.5 ± 4.1 | 13.6–37.5 |
Measured Variables | Concordance Correlation Analysis | |||
---|---|---|---|---|
Lin’s rccc (95% CI) | Precision ρ | Accuracy Cb | ||
pH | 0.956 (0.923 to 0.976) | 0.960 | 0.997 | substantial agreement |
pCO2 (mmHg) | 0.935 (0.889 to 0.962) | 0.946 | 0.989 | moderate agreement |
pO2 (mmHg) | 0.996 (0.992 to 0.998) | 0.996 | 1.000 | almost perfect agreement |
Na+ (mmol/L) | 0.720 (0.569 to 0.824) | 0.833 | 0.865 | poor agreement |
Cl− (mmol/L) | 0.811 (0.685 to 0.890) | 0.839 | 0.967 | poor agreement |
iCa2+ (mmol/L) | 0.837 (0.739 to 0.901) | 0.897 | 0.933 | poor agreement |
K+ (mmol/L) | 0.875 (0.785 to 0.929) | 0.895 | 0.977 | poor agreement |
Hct (%) | 0.865 (0.779 to 0.920) | 0.925 | 0.936 | poor agreement |
tHb (g/dL) | 0.814 (0.699 to 0.888) | 0.885 | 0.921 | poor agreement |
BE (mmol/L) | 0.922 (0.862 to 0.957) | 0.923 | 0.999 | moderate agreement |
SO2 (%) | 0.979 (0.965 to 0.988) | 0.989 | 0.990 | substantial agreement |
HCO3− (mmol/L) | 0.926 (0.869 to 0.959) | 0.927 | 0.999 | moderate agreement |
Measured Variables | Passing–Bablok Regression | Bland–Altman Plot | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Intercept (95% CI) | Slope (95% CI) | Residual Standard Deviation (95% CI) | Bias (95% CI) | Lower Limit of Agreement (95% CI) | Upper Limit of Agreement (95% CI) | Passing Bablok | Bland–Altman | |||
pH | 0.67 (−0.07 to 1.31) | 0.91 (0.82 to 1.01) | 0.011 (−0.022 to 0.022) | −0.001 (−0.006 to 0.004) | −0.032 (−0.040 to −0.024) | 0.031 (0.022 to 0.039) | no significant constant bias | no significant proportional bias | no significant systematic bias | p = 0.7682 |
pCO2 (mmHg) | 7.13 (2.38 to 11.30) | 0.85 (0.76 to 0.95) | 1.690 (−3.312 to 3.312) | −0.1 (−0.7 to 0.9) | −4.9 (−6.3 to −3.6) | 5.2 (3.8 to 6.6) | significant constant bias | significant proportional bias | no significant systematic bias | p = 0.7512 |
pO2 (mmHg) | 2.84 (0.24 to 5.00) | 1.01 (0.98 to 1.04) | 7.253 (−14.215 to 14.215) | 2.3 (−0.7 to 5.3) | −17.0 (−22.2 to −11.8) | 21.6 (16.4 to 26.8) | significant constant bias | no significant proportional bias | no significant systematic bias | p = 0.1356 |
Na+ (mmol/L) | −2.0 (−2.00 to 15.50) | 1.0 (0.88 to 1.00) | 1.230 (−2.410 to 2.410) | −1.6 (−2.1 to −1.1) | −4.8 (−5.7 to −4.0) | 1.7 (0.8 to 2.6) | no significant constant bias | no significant proportional bias | significant systematic bias | p < 0.0001 |
Cl− (mmol/L) | 14.86 (1.00 to 27.82) | 0.86 (0.73 to 1.00) | 1.614 (−3.163 to 3.163) | 0.8 (0.1 to 1.5) | −3.8 (−5.1 to −2.6) | 5.4 (4.1 to 6.7) | significant constant bias | no significant proportional bias | significant systematic bias | p = 0.0364 |
Ca2+ (mmol/L) | 0.34 (0.18 to 0.51) | 0.81 (0.70 to 0.90) | 0.045 (−0.088 to 0.088) | 0.04 (0.02 to 0.06) | −0.10 (−0.14 to −0.06) | 0.18 (0.14 to 0.22) | significant constant bias | significant proportional bias | significant systematic bias | p = 0.0006 |
K+ (mmol/L) | 0.10 (−0.26 to 0.10) | 1.00 (1.00 to 1.11) | 0.180 (−0.352 to 0.352) | 0.11 (0.03 to 0.19) | −0.38 (−0.51 to −0.25) | 0.60 (0.47 to 0.74) | no significant constant bias | no significant proportional bias | significant systematic bias | p = 0.0056 |
HTC (%) | −0.47 (−3.00 to 2.90) | 0.92 (0.81 to 1.00) | 2.840 (−5.566 to 5.566) | −3.5 (−4.7 to −2.2) | −11.6 (−13.8 to −9.4) | 4.7 (2.5 to 6.9) | no significant constant bias | no significant proportional bias | significant systematic bias | p < 0.0001 |
tHb (g/dL) | −0.04 (−1.23 to 1.12) | 0.91 (0.79 to 1.02) | 1.212 (−2.376 to 2.376) | −1.4 (−1.9 to −0.8) | −4.7 (−5.7 to −3.8) | 2.0 (1.1 to 2.9) | no significant constant bias | no significant proportional bias | significant systematic bias | p < 0.0001 |
BE (mmol/L) | −0.10 (−1.45 to 0.34) | 1.07 (0.91 to 1.33) | 1.163 (−2.279 to 2.279) | 0.1 (−0.4 to 0.6) | −3.0 (−3.9 to −2.2) | 3.3 (2.4 to 4.1) | no significant constant bias | no significant proportional bias | no significant systematic bias | p = 0.6059 |
SO2 (%) | 12.97 (6.10 to 15.73) | 0.87 (0.84 to 0.94) | 2.372 (−4.649 to 4.649) | 2.3 (1.1 to 3.4) | −4.9 (−6.9 to −3.0) | 9.4 (7.5 to 11.4) | no significant constant bias | significant proportional bias | significant systematic bias | p = 0.0002 |
HCO3− (mmol/L) | −3.46 (−11.04 to 1.27) | 1.12 (0.96 to 1.38) | 1.116 (−2.188 to 2.188) | 0.0 (−0.4 to 0.5) | −3.0 (−3.8 to −2.2) | 3.1 (2.3 to 3.9) | no significant constant bias | no significant proportional bias | no significant systematic bias | p = 0.8377 |
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Sandersen, C.; Dmitrovic, P.; Dupont, J.; Cesarini, C.; Guyot, H.; Serteyn, D.; Kirsch, K. Analytical Performance Evaluation of the New GEM® Premier™ 5000 in Comparison to the Epoc® Blood Gas Analyzer in Horses. Vet. Sci. 2023, 10, 114. https://doi.org/10.3390/vetsci10020114
Sandersen C, Dmitrovic P, Dupont J, Cesarini C, Guyot H, Serteyn D, Kirsch K. Analytical Performance Evaluation of the New GEM® Premier™ 5000 in Comparison to the Epoc® Blood Gas Analyzer in Horses. Veterinary Sciences. 2023; 10(2):114. https://doi.org/10.3390/vetsci10020114
Chicago/Turabian StyleSandersen, Charlotte, Petra Dmitrovic, Julien Dupont, Carla Cesarini, Hugues Guyot, Didier Serteyn, and Katharina Kirsch. 2023. "Analytical Performance Evaluation of the New GEM® Premier™ 5000 in Comparison to the Epoc® Blood Gas Analyzer in Horses" Veterinary Sciences 10, no. 2: 114. https://doi.org/10.3390/vetsci10020114