突破性現場檢測：改進的心肌Troponin-T檢測更加精確可靠

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這項多中心研究評估了羅氏公司開發的CARDIAC POC Troponin T（PoC TnT）檢測在cobas h 232系統上的分析性能。研究比較了PoC TnT與實驗室中的Elecsys®高靈敏度心肌肌鈣蛋白T檢測（lab cTnT-hs），發現兩者具有良好的一致性和較小的批次差異。PoC TnT檢測在不同濃度範圍內表現出穩定的變異係數，並且不受脂肪、膽紅素、血紅蛋白等干擾，顯示其適合於現場診斷使用。

點護心肌肌鈣蛋白T檢測的分析與臨床驗證，以及改進的檢測限度

Analytical and Clinical Validation of a Point-of-Care Cardiac Troponin T Test with an Improved Detection Limit

Carsten Jungbauer, Julian Hupf, Evangelos Giannitsis, Johann Frick, Anna Slagman, Christoph Ehret, Nicolas Herbert, Christine Jung, Rainer Zerback, Thomas Bertsch, Michael Christ
PMID: 28397461 DOI: 10.7754/Clin.Lab.2016.160814

https://pubmed.ncbi.nlm.nih.gov/28397461/

Abstract

The point-of-care test Roche CARDIAC POC Troponin T (PoC TnT) is an improved assay which has been developed for the Roche cobas h 232 system.

We performed a multicentre evaluation (four sites) to assess the analytical performance of the PoC TnT assay and to compare it with the central laboratory Elecsys® troponin T high sensitive (lab cTnT-hs) assay.

The relative mean differences found in method comparisons of PoC TnT vs. lab cTnT-hs ranged from -4.1% to +6.8%. Additionally, there was good concordance between PoC TnT and lab cTnT-hs for the number of samples with troponin T values below the measuring range of 40 ng/L. Lot-to-lot differences of PoC TnT ranged from -8.6% to +4.6%. Within-series coefficients of variation (CV) resulting from 81 ten-fold measurements with patient samples were 9.3%, 11.8%, and 12.9% in the low (40 to < 200 ng/L), medium (200 to < 600 ng/L), and high (600 to 2000 ng/L) measuring range, respectively. Using the system quality control, the mean CV for between-day imprecision was 11.3%. No interference was observed by triglycerides (up to 11.4 mmol/L), bilirubin (up to 376 µmol/L), hemoglobin (up to 0.12 mmol/L), biotin (up to 30 µg/L), rheumatoid factor (up to 200 IU/mL), or with 52 standard or cardiovascular drugs at therapeutic concentrations. There was no influence on the results by varying hematocrit values in a range from 25% to 53%. However, interferences with human anti-mouse antibodies were found. No significant influence on the results was found with PoC TnT by using sample volumes between 135 to 165 µL. High troponin T concentrations up to 500 µg/L did not lead to false low results, indicating no high-concentration hook effect. No cross-reactivity was found between the PoC TnT assay and human skeletal troponin T up to 1000 µg/L (< 0.05%). Diagnostic sensitivity and specificity data of a subpopulation (23 patients) of this study are in agreement with results of another large pre-hospital study.

The PoC TnT assay showed good analytical performance with excellent concordance with the calibration and reference laboratory method. It should therefore be suitable for its intended use in point-of-care settings.

摘要

羅氏CARDIAC POC肌鈣蛋白T（PoC TnT）是一種改良的檢測方法，專為羅氏cobas h 232系統開發。

我們在四個中心進行了多中心評估，以評估PoC TnT檢測的分析性能，並將其與中央實驗室Elecsys®高敏感肌鈣蛋白T（lab cTnT-hs）檢測進行比較。

PoC TnT與lab cTnT-hs方法比較的相對平均差異範圍從-4.1%到+6.8%。此外，PoC TnT與lab cTnT-hs在肌鈣蛋白T值低於40 ng/L的測量範圍內的樣本數量具有良好的一致性。PoC TnT的批次間差異範圍從-8.6%到+4.6%。在低（40至<200 ng/L）、中（200至<600 ng/L）和高（600至2000 ng/L）測量範圍內，使用患者樣本進行的81次十倍測量所得的系列內變異系數（CV）分別為9.3%、11.8%和12.9%。使用系統質量控制，日間不精確度的平均CV為11.3%。未觀察到三酸甘油酯（高達11.4 mmol/L）、膽紅素（高達376 µmol/L）、血紅蛋白（高達0.12 mmol/L）、生物素（高達30 µg/L）、風濕因子（高達200 IU/mL）或52種標準或心血管藥物在治療濃度時的干擾。血液中的血紅細胞比容值在25%至53%的範圍內變化對結果無影響。然而，發現與人抗小鼠抗體的干擾。使用135至165µL樣本量對PoC TnT結果無顯著影響。高達500 µg/L的肌鈣蛋白T濃度未導致假低結果，表明無高濃度掛鉤效應。未發現PoC TnT檢測與人骨骼肌鈣蛋白T之間的交叉反應，高達1000 µg/L（< 0.05%）。本研究的一個亞群體（23名患者）的診斷敏感性和特異性數據與另一項大型院前研究的結果一致。

PoC TnT檢測展示了良好的分析性能，並與校準和參考實驗室方法有極佳的一致性。因此，它應該適合於點護設置中的預定用途。