一种用于脓毒症辅助诊断的检测试剂盒及其制备方法

By combining nuclear membrane-protected cell nuclear extraction technology with CD63 flow cytometry antibody detection, the problem of false positives caused by nuclear membrane damage has been solved, enabling accurate detection of CD63 expression levels in neutrophil nuclear membranes and improving the specificity and sensitivity of early diagnosis of sepsis.

CN122218209BActive Publication Date: 2026-07-17THE FIRST AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
THE FIRST AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY
Filing Date
2026-05-21
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

In existing technologies, the detection of CD63 in the nuclear membrane of neutrophils suffers from a high false positive rate, mainly due to CD63 leakage caused by nuclear membrane damage and false positive signals generated by commercial CD63 antibodies penetrating the nuclear membrane, resulting in a lack of specificity and accuracy for early diagnosis.

Method used

Nuclear membrane protected extraction technology was employed, using a nuclear membrane protected cell nuclear extraction reagent composed of specific blood-free negative selection magnetic beads and cytoplasmic temperature lysis buffer A. Combined with the synergistic detection of CD63 flow cytometry antibody and Lamin B1 antibody, a nuclear membrane integrity detection control was introduced. Fluorescent groups were linked through PEG flexible spacer arms to reduce steric hindrance, and artificially induced positive controls were set up for quality control.

Benefits of technology

It effectively eliminates interference from nuclear membrane damage, improves the specificity and sensitivity of the detection, ensures the accuracy of CD63 expression levels in neutrophil nuclear membranes, and enhances the early auxiliary diagnostic capability of sepsis.

✦ Generated by Eureka AI based on patent content.

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Abstract

本发明属于体外诊断技术领域,具体涉及一种用于脓毒症辅助诊断的检测试剂盒及其制备方法,所述检测试剂盒包括纸质外包装盒和检测试剂,所述检测试剂包括抗凝全血预处理液0.5‑2 mL、特异性无血源阴性选择磁珠混合物0.1‑0.5 mL、细胞质温和裂解液A 0.2‑1 mL、核膜洗涤液B 0.5‑2 mL、CD63流式抗体5‑20 μL、核膜特异性抗体5‑20 μL、DAPI核酸染料10‑30 μL和阳性对照品42 mg,所构建的检测试剂盒基于核膜保护‑空间位阻抗体‑核膜质控三方协同,显著提升脓毒症早期预测价值,且制备方法简便,适用于临床检测。
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