尿液和血浆中两种 NGAL 自动化免疫分析的比较评估。

Comparative Evaluation of Two NGAL Automated Immunoassays in Urine and Plasma.

机构信息

Department of Blood Sciences, Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, West Midlands, UK.

Department of Cardiac Anesthesia, Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, West Midlands, UK.

出版信息

J Appl Lab Med. 2022 May 4;7(3):747-761. doi: 10.1093/jalm/jfab167.

DOI:10.1093/jalm/jfab167

PMID:34993540

Abstract

BACKGROUND

Acute kidney injury (AKI), a frequent and serious complication of hospitalized patients, is associated with increased mortality and morbidity. Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker for the early identification of AKI. We report a comparative laboratory verification of the Abbott Diagnostics (ARCHITECT® urine NGAL) and BioPorto Diagnostics (NGAL TestTM) assays including an assessment of the Abbott assay's performance in EDTA plasma.

METHODS

Intra-/interbatch imprecision, linearity, recovery, and limit of quantitation (LoQ) were assessed and an interassay comparison performed (n = 51). Between-laboratory agreement was assessed against other laboratories using the Abbott (n = 48) and BioPorto (n = 94) assays. Plasma NGAL (pNGAL) levels were measured in non-AKI patients with a range of estimated glomerular filtration rates (n = 80).

RESULTS

Coefficients of variation (CVs) for intra- and interbatch imprecision were 0.7%-12.4% and 1.9%-27.5% for the BioPorto assay, respectively, and 1.4%-6.3%/3.4%-6.8%, respectively, for the Abbott assay. The BioPorto assay exhibited a higher LoQ (27.5 ng/mL vs 1.2 ng/mL). Both assays were linear over the range 5-6000 ng/mL. Recovery of recombinant NGAL was 113.1 ± 7.1% and 96.5 ± 7.8% for the Abbott and BioPorto assays, respectively. On average, the Abbott assay gave results 9.2% lower than the BioPorto assay. Mean differences of 0.2% (Abbott) and 20.2% (BioPorto) were observed in the between-laboratory comparison. In patients without AKI, pNGAL levels were inversely proportional to eGFR.

CONCLUSIONS

Performance of the Abbott and BioPorto assays was similar although the latter performed less well at lower NGAL concentrations. The Abbott assay tended to yield lower results, exhibited a lower LoQ and over-recovered NGAL. Although only Conformité Européenne-marked and marketed for use in urine, the Abbott assay demonstrated equivalent performance to the BioPorto assay with EDTA plasma.

摘要

背景

急性肾损伤（AKI）是住院患者常见且严重的并发症，与死亡率和发病率增加有关。中性粒细胞明胶酶相关脂质运载蛋白（NGAL）是早期识别 AKI 的生物标志物。我们报告了 Abbott Diagnostics（ARCHITECT®尿液 NGAL）和 BioPorto Diagnostics（NGAL TestTM）检测的实验室比较验证，包括评估 Abbott 检测在 EDTA 血浆中的性能。

方法

评估批内/批间精密度、线性、回收率和定量下限（LoQ），并进行了实验室间比较（n=51）。使用 Abbott（n=48）和 BioPorto（n=94）检测，与其他实验室评估了实验室间一致性。在肾小球滤过率（eGFR）范围不同的非 AKI 患者中测量了血浆 NGAL（pNGAL）水平（n=80）。

结果

BioPorto 检测的批内和批间精密度变异系数（CV）分别为 0.7%-12.4%和 1.9%-27.5%，而 Abbott 检测分别为 1.4%-6.3%和 3.4%-6.8%。BioPorto 检测的 LoQ 更高（27.5ng/mL 比 1.2ng/mL）。两个检测均在 5-6000ng/mL 范围内呈线性。重组 NGAL 的回收率分别为 Abbott 检测的 113.1%±7.1%和 BioPorto 检测的 96.5%±7.8%。平均而言，Abbott 检测的结果比 BioPorto 检测低 9.2%。实验室间比较中观察到平均差异为 0.2%（Abbott）和 20.2%（BioPorto）。在无 AKI 的患者中，pNGAL 水平与 eGFR 呈反比。

结论

尽管后者在较低的 NGAL 浓度下表现较差，但 Abbott 和 BioPorto 检测的性能相似。Abbott 检测倾向于产生较低的结果，具有较低的 LoQ 和过度回收的 NGAL。尽管 Abbott 检测仅获得 CE 标志并在尿液中使用，但它在 EDTA 血浆中的性能与 BioPorto 检测相当。