Tang Zhuo-Yun, Xu Ping, Wang Zhong-Hao, Wang Ting-Ting, Zhou Dan, Ao Ke-Ping, Song Hua-Feng, Yin Xiao-Yun, Li Dong-Dong
Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Department of Clinical Laboratory, The Fifth People's Hospital of Suzhou, Infectious Disease Hospital Affiliated to Soochow University, Suzhou, Jiangsu, China.
Front Cell Infect Microbiol. 2024 Nov 28;14:1451539. doi: 10.3389/fcimb.2024.1451539. eCollection 2024.
This study aimed to assess the efficacy of innovative Chemiluminescence Immunoassay (CLIA) in testing Cryptococcal Antigen (CrAg) across two medical centers, employing the FDA-approved CrAg Lateral Flow Assay (LFA) by IMMY as a reference standard.
The study encompassed patients diagnosed with cryptococcosis at West China Hospital of Sichuan University (HX) between July 2022 and May 2023, and Suzhou Fifth People's Hospital (SZ) from September 2020 to September 2023. All specimens underwent simultaneous detection using the LFA (IMMY, Norman, USA) and CLIA (Chuanglan, Suzhou, China).
A total of 628 patients were enrolled, revealing a remarkable 99.20% concordance between LFA and CLIA (623/628, 99.20%). The LFA exhibited a sensitivity of 96.83% (244/252) and specificity of 98.35% (179/182). Among the 42 patients with unaltered CrAg titers, the changes of Signal-to-Cut-Off ratio (ΔS/CO) results exhibited a noteworthy discrepancy, with 71.43% (30/42) demonstrating a decreasing trend in ΔS/CO of at least 10%.
The CLIA method demonstrated commendable specificity and sensitivity, exhibiting a high level of agreement with the FDA-approved LFA method. Additionally, CLIA demonstrated superior utility for treatment monitoring compared to LFA, offering continuous insight into the fluctuation of CrAg concentrations.
本研究旨在评估创新的化学发光免疫分析法（CLIA）在两个医疗中心检测隐球菌抗原（CrAg）的有效性，采用美国食品药品监督管理局（FDA）批准的IMMY公司的CrAg侧向流动分析法（LFA）作为参考标准。
该研究纳入了2022年7月至2023年5月在四川大学华西医院（HX）以及2020年9月至2023年9月在苏州市第五人民医院（SZ）被诊断为隐球菌病的患者。所有标本同时使用LFA（美国诺曼市的IMMY公司产品）和CLIA（中国苏州的创澜公司产品）进行检测。
共纳入628例患者，LFA与CLIA之间的一致性高达99.20%（623/628，99.20%）。LFA的灵敏度为96.83%（244/252），特异性为98.35%（179/182）。在42例CrAg滴度未改变的患者中，信号与临界值比值（ΔS/CO）结果的变化存在显著差异，71.43%（30/42）的患者ΔS/CO呈现至少10%的下降趋势。
CLIA方法显示出值得称赞的特异性和灵敏度，与FDA批准的LFA方法高度一致。此外，与LFA相比，CLIA在治疗监测方面表现出更优越的效用，能够持续洞察CrAg浓度的波动情况。
