用于检测 NT-proBNP 的化学发光免疫分析。

A chemiluminescence immunoassay for the detection of NT-proBNP.

机构信息

The Fifth Hospital of Xiamen, Xiamen, China.

Department of Gynaecology and Obstetrics, Xiamen Huli District Maternity and Child Care Hospital, Xiamen, 361000, China.

出版信息

Anal Biochem. 2020 Dec 15;611:113950. doi: 10.1016/j.ab.2020.113950. Epub 2020 Sep 11.

DOI:10.1016/j.ab.2020.113950

PMID:32919941

Abstract

BACKGROUND

The aim of the study was to assess the analytical performance of the HISCL NT-proBNP assay, a newly developed chemiluminescence immunoassay, for the detection of NT-proBNP.

METHODS

The within-run and total imprecision of the NT-proBNP assay were determined with HISCL cardiac marker controls. The linear ranges of the NT-proBNP assays were evaluated based on the CLSI EP6-A document using selected serum samples. Two hundred serum samples were evaluated to compare the HISCL NT-proBNP and Elecsys NT-proBNP assays. Five additional high NT-proBNP concentrations serum samples were evaluated to assess if there was high-dose hook effect in the HISCL NT-proBNP assay.

RESULTS

The total and within-run imprecision values of the HISCL NT-proBNP assay were 5.85%, 0.81%, 2.56% and 0.54% and 6.07%, 0.73%, 2.61% and 0.59% at 6.1, 129.83, 3732.84and39737.33 pg/ml, respectively. The assay was verified to be linear for NT-proBNP levels ranging between 6.1 and 39737.33 pg/ml. The assay comparison showed that HISCL NT-proBNP = 0.9803 × Elecsys NT-proBNP -4.383. The sensitivity of HISCL NT-proBNP was 87.23%, and the specificity was 85.61%. The AUC of HISCL NT-proBNP (0.90 (95% CI, 0.86-0.93)) did not differ from that of Elecsys NT-proBNP(0.89 (95% CI, 0.85-0.93)) (P = 0.638). The results of five high NT-proBNP concentrations samples (44448, 54206, 55634, 55728 and 109406 pg/ml, measured with the Elecsys NT-proBNP assay) tested with HISCL NT-proBNP assay were all displayed with ">40000 pg/ml".

CONCLUSIONS

The HISCL NT-proBNP chemiluminescence immunoassay showed good analytical and diagnostic performance for the detection of NT-proBNP and could be used in routine clinical practice.

摘要

背景

本研究旨在评估 HISCL NT-proBNP 检测试剂的分析性能，这是一种新开发的化学发光免疫分析法，用于检测 NT-proBNP。

方法

使用 HISCL 心脏标志物质控品评估 NT-proBNP 检测试剂的批内和总不精密度。根据 CLSI EP6-A 文件，使用选定的血清样本评估 NT-proBNP 检测试剂的线性范围。评估 200 份血清样本，以比较 HISCL NT-proBNP 和 Elecsys NT-proBNP 检测试剂。评估 5 份高 NT-proBNP 浓度的血清样本，以评估 HISCL NT-proBNP 检测试剂是否存在高剂量钩状效应。

结果

HISCL NT-proBNP 检测试剂的总不精密度和批内不精密度值分别为 5.85%、0.81%、2.56%和 0.54%，以及 6.07%、0.73%、2.61%和 0.59%，分别在 6.1pg/ml、129.83pg/ml、3732.84pg/ml 和 39737.33pg/ml。该检测试剂的 NT-proBNP 检测范围验证为 6.1pg/ml 至 39737.33pg/ml。检测试剂比较结果显示 HISCL NT-proBNP=0.9803×Elecsys NT-proBNP-4.383。HISCL NT-proBNP 的灵敏度为 87.23%，特异性为 85.61%。HISCL NT-proBNP 的 AUC（0.90（95%CI，0.86-0.93））与 Elecsys NT-proBNP（0.89（95%CI，0.85-0.93））（P=0.638）没有差异。用 Elecsys NT-proBNP 检测试剂测量的五个高 NT-proBNP 浓度样本（44448、54206、55634、55728 和 109406pg/ml）的 HISCL NT-proBNP 检测试剂检测结果均显示为“>40000pg/ml”。