B-343 Validation of the Diagnostics Biochem Canada Vasoactive Intestinal Peptide (VIP) ELISA
Notice bibliographique
Résumé
Abstract Background Vasoactive intestinal peptide (VIP) is a neuropeptide involved in numerous physiological processes, including vasodilation and immune modulation. Accurate measurement of VIP concentrations is commonly used to diagnose and monitor VIPomas, rare neuroendocrine tumors that secrete VIP. This study aimed to validate the VIP enzyme-linked immunosorbent assay (ELISA) kit from Diagnostics Biochem Canada Inc. (DBC) for clinical testing. Methods Accuracy, linearity, precision, plate drift, analytical sensitivity, reference interval verification, analyte stability, collection tube stability, and dilution verification studies were conducted. Experiments used endogenous patient specimens when available and plasma pools spiked with VIP, as needed (AnaSpec; AS-22873; Fremont, CA). Accuracy was assessed by comparing VIP concentrations in de-identified patient specimens (n=33) using the DBC ELISA method against an existing radioimmunoassay (RIA; DiaSource; Ottignies-Louvain-la-Neuve, Belgium). Linearity was evaluated using percent split dilutions between spiked and blank plasma pools (0, 25, 50, 75, and 100%). Precision was evaluated by testing 4 replicates of each kit-provided control across 5 runs. Plate drift analysis was conducted due to variations noted between controls during validation experiments (average -15.8% change between plate beginning and end). Various pipetting methods were compared (single-channel, 8-channel, 96-channel) to determine if observed plate drift was influenced by differences in incubation times. Analytical sensitivity was verified by running 10 replicates of calibrator A and 3 replicates of calibrator B and analyzing optical density (OD) values using EP Evaluator. The manufacturer-provided reference interval was verified using plasma specimens from healthy donors (n=26; 12 males, 14 females) collected in pre-cooled EDTA tubes following manufacturer-recommended collection protocols. Additional stability conditions (ambient, refrigerated, and freeze/thaw) were evaluated using spiked plasma pools. The effect of temperature on collection was analyzed by aliquoting spiked plasma into EDTA tubes that were pre-cooled for 10 minutes or kept at room temperature and comparing results after 30 minutes. Dilution verification was performed using spiked specimens tested neat and using 1:2 and 1:5 dilutions. Results Accuracy studies showed positive, negative, and overall qualitative agreement of 90.9%, 95.5%, and 93.9%, respectively between the two methods. Quantitative bias of -33.34% was observed compared to the DiaSource RIA method, with larger bias as VIP concentrations increased. Linearity studies demonstrated percent recoveries ranging 82.0-111.8%. Precision studies revealed within-run and total %CVs less than or equal to 16.4%. Plate drift analysis indicated acceptable precision across each plate using different pipetting methods, with results ranging 3.3-6.4%CV. The manufacturer sensitivity claim of 20.0 pg/mL was verified. All healthy donor specimens were within the manufacturer-provided reference interval of 0-89.1 pg/mL. VIP stability was confirmed up to 4 hours ambient temperature, 24 hours refrigerated, and up to 2 freeze/thaw cycles after initial testing. Percent recovery of spiked plasma aliquoted into room temperature EDTA tubes compared to pre-cooled EDTA tubes ranged 82.2-106.1%. Dilution verification studies showed percent recoveries ranged 93.4-115.2% using 1:2 and 1:5 dilutions. Conclusions The DBC VIP ELISA kit demonstrated acceptable performance across all validation parameters. The kit provided reliable and accurate measurement of VIP concentrations, supporting its application for diagnosing and monitoring conditions associated with VIP.
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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 | 0,000 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 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 ».