多中心評估證實:即時照護(POC)C反應蛋白(CRP)檢測具備強大的分析性能

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一項多中心研究評估了cobas CRP Test在一線醫療環境中的分析性能。結果顯示,測試的重複性和精密度高(變異系數範圍1.7%-4.5%),且在不同實驗室間具有良好的再現性。血清、毛細血管全血及其他樣本間CRP濃度顯示高度一致性,實驗室與實際臨床樣本的測試結果相符。這證明了cobas CRP Test在點護測試環境中運用於醫療專業人員的可靠性和實用性。

多中心評估一項即時診療CRP測試

A multicenter evaluation of a point of care CRP Test

Scharnhorst V, Noordzij PG, Lutz A, Graser U, Püntener D, Alquézar-Arbé A. A multicenter evaluation of a point of care CRP Test. Clin Biochem. 2019 Sep;71:38-45. doi: 10.1016/j.clinbiochem.2019.06.009. Epub 2019 Jun 21. PMID: 31233734.

https://pubmed.ncbi.nlm.nih.gov/31233734/

Abstract

Background

Point-of-care (POC) C-reactive protein (CRP) testing in the primary healthcare setting is a cost-effective approach for reducing antibiotic prescriptions, but has yet to be widely adopted.

Methods

Analytical performance of the cobas CRP Test on the cobas b 101 system was evaluated at three POC sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison (reference test: CRPNX reagent [cobas c 501 module]) and matrix/lot-to-lot comparison experiments were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions). Usability and reliability were assessed by questionnaire and error reporting.

Results

Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7%-4.0% and 1.9%-4.5%, respectively, for human serum pools containing CRP 4.7-350.7 mg/L; repeatability in clinical samples ranged from 1.6%-5.9% (3.3-360.3 mg/L). CVs for reproducibility ranged from 2.5%-4.0% (4.7-344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Li-heparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma (Pearson’s r ≥ 0.996), and among three CRP Test lots (r ≥ 0.993). Clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent (serum, weighted Deming regression y = 0.97× + 0.11; Pearson’s r ≥ 0.996). The overall mean usability score was 4.18/5 and the error rate across 9378 tests was 1.00%.

Conclusions

The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting.

Keywords

Antibiotic use; C-reactive protein; Diagnostic equipment; Infection; Inflammation; Laboratory medicine; POC CRP Test; Point-of-care testing.

摘要

背景

在初級保健環境中進行的C-反應蛋白(CRP)快速測試是一種降低抗生素處方的成本效益方法,但尚未被廣泛採用。

方法

在三個快速測試點和一個參考實驗室評估了cobas CRP Test在cobas b 101系統上的分析性能。評估了試驗內(重複性)、實驗室內(中間精度)和實驗室間精度(可重複性)。使用從217名成人(表面健康或具有臨床相關狀況)收集的前瞻性血樣進行了方法比較(參考測試:CRPNX試劑[cobas c 501模塊])和基質/批次間比較實驗。通過問卷調查和錯誤報告評估了可用性和可靠性。

結果

重複性和中間精度的變異系數(CV)分別在1.7%-4.0%和1.9%-4.5%範圍內,CRP濃度為4.7-350.7 mg/L的人類血清池;臨床樣本的重複性範圍為1.6%-5.9%(3.3-360.3 mg/L)。可重複性的CV範圍為2.5%-4.0%(4.7-344.3 mg/L)。CRP濃度對於毛細血管全血、血清、Li-肝素全血/血漿、K2和K3 EDTA全血/血漿(Pearson’s r ≥ 0.996)以及三個CRP測試批次(r ≥ 0.993)是可比的。使用CRP Test測量的臨床相關CRP濃度與使用CRPNX試劑測量的濃度(血清,加權Deming回歸y = 0.97× + 0.11; Pearson’s r ≥ 0.996)具有良好的一致性。整體平均可用性得分為4.18/5,9378次測試的錯誤率為1.00%。

結論

cobas CRP Test在cobas b 101系統上表現出在快速測試點由醫療專業人員使用時的穩健分析性能。

關鍵詞

抗生素使用;C-反應蛋白;診斷設備;感染;炎症;實驗室醫學;POC CRP測試;快速測試。