A-349 Evaluation of <i>i-STAT</i>® Point of Care Blood Gas Cartridges and Competitor Blood Gas Devices Against Reference Standard for <i>P</i>CO2 and <i>P</i>O2
Notice bibliographique
Résumé
Abstract Background The i-STAT System provides laboratory quality results in minutes at the patient’s bedside. Accurate and rapid test results are critical for clinical decision making in the presence of blood gas disorders, including oxygenation and acid-base status, where the partial pressure oxygen (PO2) and partial pressure carbon dioxide (PCO2) are needed. The purpose of this study was to compare the analytical performance of the PO2 and PCO2 tests in the i-STAT G3+ and i-STAT CG8+ cartridges to the theoretical PO2 and PCO2 in prepared reference standards. Two other blood gas instruments, a benchtop device and a laboratory device were also compared to the reference PO2 and PCO2. Methods Venous whole blood samples were contrived using saturation tonometry with U.S. NIST (National Institute of Science and Technology) traceable gas tanks to prepare the reference standards, which were value assigned to theoretical PO2 or PCO2 levels based on the molar composition of the gas mixture used. Eleven levels spanning the reportable range of each PO2 (5 mmHg - 800 mmHg) and PCO2 (5 mmHg - 130 mmHg) were prepared and tested in duplicate on the i-STAT G3+ and i-STAT CG8+ cartridges, benchtop device, and the laboratory device. Passing-Bablok linear regression analysis was performed to evaluate the slope and correlation coefficient, comparing each blood gas device against the reference PO2 and PCO2 values. Study designs followed CLSI (Clinical and Laboratory Standards Institute) EP09C-ED3:2018, Measurement Procedure Comparison and Bias Estimation using Patient Samples, 3rd Edition. Passing-Bablok regression analysis was also performed for the i-STAT cartridges and benchtop device against the laboratory device. Results The regression analysis was performed against the reference standards. For PO2, slopes for the i-STAT cartridges ranged from 0.93 - 0.97, the slope for the benchtop device was 0.99, and the slope for the laboratory device was 0.97. Correlation coefficients for all devices were 1.00. For PCO2, slopes for the i-STAT cartridges ranged from 0.98 - 1.02, the slope for the benchtop device was 0.85, and the slope for the laboratory device was 1.01. Correlation coefficients were 1.00 for the i-STAT cartridges and laboratory device, and 0.99 for the benchtop device. The regression analysis was also performed against the laboratory device. For PO2, slopes for the i-STAT cartridges ranged from 0.96 - 1.00, and the slope for the benchtop device was 1.02. Correlation coefficients for all devices were 1.00. For PCO2, slopes for the i-STAT cartridges ranged from 0.97 - 1.01, and the slope for the benchtop device was 0.85. Correlation coefficients were 1.00 for the i-STAT cartridges and 0.99 for the benchtop device. Conclusions The study demonstrated that the i-STAT G3+ and i-STAT CG8+ cartridges used with the i-STAT System were shown to provide laboratory quality results within 2 minutes, showing good agreement to both reference standards and laboratory quality devices. For PCO2, the i-STAT System was shown to have better agreement to both theoretical reference standards and the laboratory device than the benchtop device. These studies were funded by Abbott Laboratories.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».