Analytical and Clinical Validation of an Automated Microfluidic Interleukin-6 Immunoassay.

IF 1.1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Annals of clinical and laboratory science Pub Date : 2024-05-01

Jianbo Yang, Mustafa A Barbhuiya, Christopher Hamilton, Kimberly Robyak, Yusheng Zhu

{"title":"Analytical and Clinical Validation of an Automated Microfluidic Interleukin-6 Immunoassay.","authors":"Jianbo Yang, Mustafa A Barbhuiya, Christopher Hamilton, Kimberly Robyak, Yusheng Zhu","doi":"","DOIUrl":null,"url":null,"abstract":"Objective: We validated an automated microfluidic interleukin-6 (IL-6) immunoassay on the Ella platform for clinical use.Methods: The assay was validated for precision, lower limit of quantification, analytical measurement range, accuracy, specificity, interference of biotin, tocilizumab, GP130, IL-6Rα, hemolysis, icterus, and lipemia, and establishing the reference value. The clinical performance was evaluated in 96 COVID-19 patients.Results: The within-run and between-run coefficient of variations (CV) ranged 1.8%-4.8%. This assay has an analytical measurement range (AMR) 0.7-2652 pg/ml. There was a moderate correlation between Ella IL-6 assay (y) and a Luminex Quantitative Multiplex Bead Assay in a reference lab (x): y=8.561x-475.38, R=0.5047, SEE=1592.8 pg/mL, N=48). Measurement of IL-6 in plasma samples from 45 healthy adults showed the upper limit of reference of 5.0 pg/mL. 95.83% (95% CI: 89.67%-98.85%) of COVID-19 patients had IL-6 >5.0 pg/mL. This assay is resistant to the interference from hemoglobin up to 1,144 mg/dL, triglyceride 1,699 mg/dL, bilirubin 35 mg/dL, biotin 1000 ng/mL, tocilizumab 240 μg/mL, IL-11 50,000 pg/mL, GP130 50,000 pg/mL, and IL-6Rα 1,000 pg/mL.Conclusions: The IL-6 assay on the Ella platform is robust with minimum manual operation. The analytical and clinical performance characteristics meet the clinical needs.","PeriodicalId":8228,"journal":{"name":"Annals of clinical and laboratory science","volume":"54 3","pages":"388-393"},"PeriodicalIF":1.1000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of clinical and laboratory science","FirstCategoryId":"3","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: We validated an automated microfluidic interleukin-6 (IL-6) immunoassay on the Ella platform for clinical use.

Methods: The assay was validated for precision, lower limit of quantification, analytical measurement range, accuracy, specificity, interference of biotin, tocilizumab, GP130, IL-6Rα, hemolysis, icterus, and lipemia, and establishing the reference value. The clinical performance was evaluated in 96 COVID-19 patients.

Results: The within-run and between-run coefficient of variations (CV) ranged 1.8%-4.8%. This assay has an analytical measurement range (AMR) 0.7-2652 pg/ml. There was a moderate correlation between Ella IL-6 assay (y) and a Luminex Quantitative Multiplex Bead Assay in a reference lab (x): y=8.561x-475.38, R=0.5047, SEE=1592.8 pg/mL, N=48). Measurement of IL-6 in plasma samples from 45 healthy adults showed the upper limit of reference of 5.0 pg/mL. 95.83% (95% CI: 89.67%-98.85%) of COVID-19 patients had IL-6 >5.0 pg/mL. This assay is resistant to the interference from hemoglobin up to 1,144 mg/dL, triglyceride 1,699 mg/dL, bilirubin 35 mg/dL, biotin 1000 ng/mL, tocilizumab 240 μg/mL, IL-11 50,000 pg/mL, GP130 50,000 pg/mL, and IL-6Rα 1,000 pg/mL.

Conclusions: The IL-6 assay on the Ella platform is robust with minimum manual operation. The analytical and clinical performance characteristics meet the clinical needs.

微信好友朋友圈 QQ好友复制链接

本刊更多论文

自动微流控白细胞介素-6 免疫分析仪的分析和临床验证

目的我们对艾拉平台上用于临床的白细胞介素-6（IL-6）自动微流控免疫测定进行了验证：方法：对该测定的精密度、定量下限、分析测量范围、准确度、特异性、生物素、托珠单抗、GP130、IL-6Rα、溶血、黄疸和脂血的干扰进行了验证，并确定了参考值。对96名COVID-19患者的临床表现进行了评估：结果：运行内和运行间变异系数（CV）为 1.8%-4.8%。该测定的分析测量范围（AMR）为 0.7-2652 pg/ml。艾拉 IL-6 分析法（y）与参考实验室的 Luminex 定量多重微珠分析法（x）之间存在中等程度的相关性：y=8.561x-475.38，R=0.5047，SEE=1592.8 pg/ml，N=48）。对 45 名健康成人血浆样本中 IL-6 的测量结果显示，参考上限为 5.0 pg/mL。95.83%（95% CI：89.67%-98.85%）的 COVID-19 患者 IL-6 >5.0 pg/mL。该测定不受血红蛋白高达 1,144 mg/dL、甘油三酯 1,699 mg/dL、胆红素 35 mg/dL、生物素 1000 ng/mL、妥珠单抗 240 μg/mL、IL-11 50,000 pg/mL、GP130 50,000 pg/mL、IL-6Rα 1,000 pg/mL的干扰：艾拉平台上的IL-6测定功能强大，只需最少的人工操作。结论：艾拉平台上的IL-6测定功能强大，手动操作最少，分析和临床性能特点符合临床需求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Annals of clinical and laboratory science 医学-医学实验技术

CiteScore

1.60

自引率

0.00%

发文量

112

审稿时长

6-12 weeks

期刊介绍： The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.