B-415 Agreement Between Colorimetric Roche Cobas PRO and ICP-MS Zinc Assays in Blood Samples

IF 8.3 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2026-10-04 DOI:10.1093/clinchem/hvag086.682

Waleed Tamimi, Khaled Ahmad, Monzer Elsafdi, Ahmad Kamaleddine, Mohammed Alabdullatif, Majd Alharbi, Khalid Sumaily, Khalid Al-Qahtani, Ahmed Alakedi, Osamah khojah, Omar Almugren, Mohamed Babiker, Sara Zubair, Kareem Shehata, Duaa BinKhalaf

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Abstract

Background Accurate measurement of zinc concentrations in blood is essential for assessing nutritional status and diagnosing deficiency. This study compared zinc results obtained using the Roche Cobas Pro colorimetric assay with those generated by inductively coupled plasma mass spectrometry (ICP-MS), the analytical reference method. Methods A total of 22 patient serum blood samples collected in royal-blue top tubes, spanning a concentration range of 55–97?µg/dL, were analyzed by both techniques. This study was conducted on January 2026 between the laboratory of King Abdelaziz Medical City and Medical Diagnostic laboratory of Dr Suliman Al-Habib Sahafah Hospital, both in Riyadh of Saudi Arabia. Direct colorimetric test without deproteinization of the sample. At pH 8.6, in a buffered media, zinc reacts with the specific compound (5-Br-PAPS): Bromo-pyridylazo propyl-N-(3-sulfopropyl) amino] phenol, forms a stable-colored complex and measured at wavelength 560nm. The color intensity is proportional to the amount of zinc present in the sample. The results of CAP proficiency samples were also compared for the two assays. Results Method comparison demonstrated strong agreement, with a correlation coefficient of ??= 0.9269, indicating a high degree of linear association across the tested range. There were 6 samples (27%) with zinc deficiency by colorimetric method with 83% agreement with ICP-MS method. On the other hand, a 100% agreement was found in the normal samples between the two assays. The reference interval was verified for the colorimetric Roche Cobas and found to be between 68 to 107 ug/dL. The CAP proficiency of 3 samples (R-01, R-02, R-03) for years 2024 and 2025 have shown a good agreement between the two assays. Conclusion While minor proportional differences were observed, the overall performance of the Cobas colorimetric method showed good concordance with ICP-MS, supporting its suitability for routine clinical zinc measurement when rapid, high-throughput analysis is required.

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罗氏Cobas PRO比色法和ICP-MS测定血液样品锌的B-415一致性

背景准确测量血锌浓度对评估营养状况和诊断缺乏症至关重要。本研究比较了罗氏Cobas Pro比色法与电感耦合等离子体质谱法（ICP-MS）的锌含量测定结果。方法采用宝蓝色顶管采集22例患者血清血样，浓度范围为55 ~ 97？µg/dL，两种技术分析。这项研究于2026年1月在沙特阿拉伯利雅得的阿卜杜勒阿齐兹国王医疗城实验室和Suliman Al-Habib Sahafah医生医院医疗诊断实验室之间进行。直接比色试验，样品不脱蛋白。在pH 8.6时，在缓冲介质中，锌与特定化合物（5-Br-PAPS）：溴吡啶偶氮丙基- n -（3-磺基丙基）氨基]苯酚反应，形成稳定的颜色复合物，并在波长560nm处测量。颜色强度与样品中锌的含量成正比。CAP熟练程度样本的结果也比较了两种分析。结果方法比较结果吻合较好，相关系数为？？= 0.9269，表明在整个测试范围内具有高度的线性关联。比色法测定6份（27%）样品缺锌，与ICP-MS法的符合率为83%。在另一方面，一个100%的协议被发现在正常样品之间的两个分析。验证了罗氏Cobas比色法的参考区间为68 ~ 107 ug/dL。3个样品（R-01, R-02, R-03） 2024年和2025年的CAP熟练度在两种分析之间显示出良好的一致性。结论Cobas比色法与ICP-MS的总体性能具有良好的一致性，虽然比例差异较小，但在需要快速、高通量分析时适用于常规临床锌含量测定。

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.