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這項研究驗證了Atellica® VTLi 患者側免疫分析儀用於高敏感肌鈣蛋白現場（POC）檢測的可靠性。在152位急性胸痛患者中進行測試，發現毛細血管血樣與靜脈血樣結果具有良好的一致性，為急診或家庭醫生現場快速篩查急性胸痛患者提供了新途徑。
Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics
毛細血管血液中高敏感度肌鈣蛋白-I的即時檢測用於急性冠心症診斷
Bruinen, Anne L., Frenk, Lisa D.S., de Theije, Femke, Kemper, Daniëlle W.M., Janssen, Marcel J.W., Rahel, Braim M., Meeder, Joan G. and van ‘t Hof, Arnoud W.J.. “Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics” Clinical Chemistry and Laboratory Medicine (CCLM), vol. 60, no. 10, 2022, pp. 1669-1674. https://doi.org/10.1515/cclm-2022-0268
https://doi.org/10.1515/cclm-2022-0268
摘要
目的
急性冠心症（ACS）患者應迅速轉送至醫院以降低死亡率和發病率。區分低風險和高風險患者仍是一項診斷挑戰。即時檢測可以幫助更早地對排除ACS的患者做出處置決策。本研究描述了Atellica® VTLi患者端免疫分析儀進行高敏感度肌鈣蛋白即時檢測的驗證。（Atellica VTLi在美國尚未上市。本文提及的產品/功能在所有國家均未全面上市，其未來供應不可保證）。
方法
本研究共納入152名因急性胸痛入院的心臟急診科患者。毛細血管血液樣本與由靜脈穿刺獲得的全血和血漿樣本進行比較。所有樣本均使用Atellica VTLi患者端免疫分析儀進行分析；此外，血漿樣本還使用中央實驗室免疫分析儀進行分析。
結果
使用Atellica VTLi患者端免疫分析儀對靜脈全血與血漿分析的結果無顯著差異。毛細血管血液與靜脈血液之間的差異顯示出7.1%的恆定偏差，對此已實施了修正因子。與標準免疫分析儀分析的血漿相比，毛細血管即時檢測結果無臨床相關差異。
結論
Atellica VTLi患者端免疫分析儀進行的高敏感度肌鈣蛋白分析在所有樣本類型中均顯示出等效結果，包括毛細血管血液。毛細血管即時檢測與中央實驗室結果之間無臨床相關的不一致。隨著進一步的研究，這可能為在救護車或全科醫生診所中快速測試高敏感度肌鈣蛋白鋪平道路，而無需將急性胸痛患者住院。
關鍵字：急性冠心症（ACS）；心臟標誌物；免疫分析；即時檢測；肌鈣蛋白
Abstract
Objectives
Patients with acute coronary syndrome (ACS) should be referred promptly to the hospital to reduce mortality and morbidity. Differentiating between low-risk and high-risk patients remains a diagnostic challenge. Point-of-care testing can contribute to earlier disposition decisions for patients excluded from ACS. This study describes the validation of the Atellica® VTLi. Patient-side Immunoassay Analyzer for high-sensitivity troponin point-of-care (POC) analysis. (The Atellica VTLi is not available for sale in the USA. The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed).
Methods
A total of 152 patients with acute chest pain admitted at the cardiac emergency department (ED) were included in the study. Capillary blood was compared with a whole blood and plasma sample obtained by venipuncture. All samples were analyzed using the Atellica VTLi Patient-side Immunoassay Analyzer; in addition, plasma was analyzed by a central lab immunoassay analyzer.
Results
No significant difference was observed between venous whole blood vs. plasma analyzed by the Atellica VTLi Patient-side Immunoassay Analyzer. The difference between capillary blood and venous blood showed a constant bias of 7.1%, for which a correction factor has been implemented. No clinically relevant differences were observed for the capillary POC results compared to plasma analyzed with a standard immunoassay analyzer.
Conclusions
The Atellica VTLi Patient-side Immunoassay Analyzer for high-sensitivity troponin analysis shows equivalent results for all sample types, including capillary blood. No clinically relevant discordances were observed between capillary POC and central laboratory results. With additional studies, this could pave the way towards rapid testing of high-sensitivity troponin in the ambulance or the general practitioner’s office without the need for hospitalization of patients with acute chest pain.
Keywords: acute coronary syndrome (ACS); cardiac markers; immunoassay; point-of-care; troponin
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