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中华临床实验室管理电子杂志

中华临床实验室管理电子杂志 ›› 2022, Vol. 10 ›› Issue (03) : 132 -136. doi: 10.3877/cma.j.issn.2095-5820.2022.03.002

实验研究

基于自动化系统的曲霉半乳甘露聚糖检测及评价
刘勇1, 党文强2, 张园3, 张磊1,†()   
  1. 1. 510005　广东广州，广州金域医学检验中心；510182　广东广州，广州医科大学金域检验学院
    2. 510005　广东广州，广州金域医学检验中心
    3. 300467　天津，侵袭性真菌疾病机制研究与精准诊断重点实验室　北京市重点实验室丹娜生物分中心；300467　天津，天津市侵袭性真菌病精准诊断技术企业重点实验室
  • 收稿日期:2022-03-14 出版日期:2022-08-28
  • 通信作者: 张磊
  • 基金资助:
    广东省科技计划项目粤港澳呼吸系统传染病联合实验室(2019B121205010)

Aspergillus galactomannan detection and evaluation based on automated system

Yong Liu1, Wenqiang Dang2, Yuan Zhang3, Lei Zhang1,†()   

  1. 1. Guangzhou Kingmed Center for Clinical Laboratory,Guangzhou Guangdong 510005,China; KingMed School of Laboratory Medicine, Guangzhou Medical University,Guangzhou Guangdong 510182,China
    2. KingMed School of Laboratory Medicine, Guangzhou Medical University,Guangzhou Guangdong 510182,China
    3. Dynamiker Sub-Center of Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Disease, Tianjin 300467, China
  • Received:2022-03-14 Published:2022-08-28
  • Corresponding author: Lei Zhang
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刘勇, 党文强, 张园, 张磊. 基于自动化系统的曲霉半乳甘露聚糖检测及评价[J]. 中华临床实验室管理电子杂志, 2022, 10(03): 132-136.

Yong Liu, Wenqiang Dang, Yuan Zhang, Lei Zhang. Aspergillus galactomannan detection and evaluation based on automated system[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2022, 10(03): 132-136.

目的

将自动化检测系统应用于曲霉半乳甘露聚糖（GM）检测，探讨其在规模化中心临床实验室中的应用价值。

方法

选取临床血清样本66例，肺泡灌洗液（BALF）样本54例以及15例美国病理学家协会（CAP）室间质评样本，通过DNK-A600全自动微生物联合检测仪进行GM检测，并与美国Bio-Rad GM检测（Platelia? Aspergillus Ag）手工操作试剂盒的检测结果进行一致性比较。

结果

120例样本中DNK-A600系统和Bio-Rad GM检测试剂总符合率95.00%，Kappa值0.90。DNK-A600系统GM检测批内和批间精密度均符合标准，CV值低于15%，正确度符合率100%，检出限符合临床使用要求。

结论

基于DNK-A600全自动微生物联合检测系统的GM检测试剂盒结果准确、可靠、可实现与传统手工检测GM结果的互认。

关键词: 曲霉半乳甘露聚糖, GM试验, 全自动微生物检测系统
Objective

The automated detection system was applied to the detection of Aspergillus galactomannan (GM), and its application value in large-scale clinical laboratories was discussed.

Methods

A total of 66 serum samples, 54 bronchoalveolar lavage fluid (BALF) samples and 15 college of American Pathologists (CAP) PT samples were collected. All samples were tested by automatic microbiology analyzer DNK-A600 and the Bio-Rad Platelia? Aspergillus Ag kit for manual operation for the detection of GM, and the results were compared for consistency.

Results

The total coincidence rate of the two assays was 95.00% among the 120 samples, and the Kappa value was 0.90. The intra-batch and inter-batch precision of DNK-A600 system for GM detection were in line with the industry standard, and the CV value was lower than 15%, and the accuracy coincidence rate was 100%. The verification of the detection limits and cut-off value were all in line with the experimental requirements.

Conclusions

The results of GM detection based on DNK-A600 automatic combined microbial detection system are accurate and reliable, which could realize mutual recognition of GM results with traditional manual detection.

Key words: Galactomannan, GM test, Fully automatic microbial detection system
表1 Bio-Rad和DNK-A600的GM检测一致性评价结果
项目 例数 阳性符合率［%（95% CI）］ 阴性符合率［%（95% CI）］ 总符合率［%（95% CI）］ Kappa值
血清 66 97.1（85.47~99.49） 100.0（88.97~100.00） 98.48（91.90~99.73） 0.97
BALF 54 89.2（72.80~96.29） 92.3（75.86~97.86） 90.74（80.09~95.98） 0.81
血清+BALF 120 93.6（84.78~97.50） 96.4（88.08~99.03） 95.00（89.52~97.69） 0.90
图1 Bio-Rad GM和DNK-A600 GM检测一致性分析
表2 DNK-A600 GM检测对高、低浓度血清样本进行批内、批间精密度测定结果
项目 平均值 标准差 CV值（%） 参考CV值（%）
批内 批间 批内 批间 批内 批间 批内 批间

高浓度

样本

 2.555 2.634 0.149 0.160 5.832 6.074 15 20

低浓度

样本

 0.098 0.104 0.005 0.009 5.102 8.654 15 20
表3 室间质评样本检测偏倚分析
检测结果 Bio-Rad DNK-A600 偏倚（%）
阳性 2.0851 2.1487 3.05
阴性 0.0950 0.1332 40.21
总计 1.421733 1.476867 3.88
表4 检出限验证结果
样本编号 Ⅰ值 样本编号 I值
1 0.558 11 0.625
2 0.610 12 0.628
3 0.630 13 0.612
4 0.649 14 0.523
5 0.641 15 0.517
6 0.637 16 0.507
7 0.575 17 0.533
8 0.513 18 0.566
9 0.570 19 0.603
10 0.575 20 0.537
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