Application value of a novel magnetic particle-based chemiluminescence reagent for detecting cryptococcal capsular polysaccharide_West China Medical Journal

Authors：

TANG Zhuoyun , LIU Ying , WANG Zhonghao , WANG Tingting , ZHOU Dan , AO Keping , WU Chongyang ,  LI Dongdong

Department of Laboratory Medicine, West China Hospital, Sichuan University; Clinical Laboratory Medicine Research Center, West China Hospital, Sichuan University; Sichuan Clinical Research Center for Laboratory Medicine, Chengdu, Sichuan 610041, P. R. China;

Corresponding?author：

LI Dongdong, Email: jiangxili1219@163.com

Keywords：

Magnetic particle; chemiluminescence immunoassay; lateral flow immunoassay; cryptococcal infection; detection performance

DOI：

10.7507/1002-0179.202607035

Video：

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Objective To evaluate the performance of a novel magnetic particle-based chemiluminescence reagent for detecting cryptococcal capsular polysaccharide. Methods Serum and cerebrospinal fluid specimens were collected from patients with suspected cryptococcal infection at West China Hospital, Sichuan University between July 2022 and September 2023. All samples were simultaneously tested by chemiluminescence immunoassay (CLIA) and lateral flow immunoassay (LFA), and the results of the two methods were compared. Results A total of 357 patients with suspected cryptococcal infection were enrolled, including 247 serum samples and 110 cerebrospinal fluid samples. The novel magnetic particle-based CLIA reagent exhibited favorable clinical performance for cryptococcal infection detection. For serum and cerebrospinal fluid specimens, the sensitivity was 96.95% and 100.00%, respectively; the specificity was 99.14% and 100.00%, respectively. It showed high consistency with the LFA reagent (the kappa values were both greater than 0.98 for serum and cerebrospinal fluid samples). Moreover, the CLIA reagent enables quantitative measurement for clinical therapeutic monitoring. Conclusion The novel magnetic particle-based CLIA reagent possesses good diagnostic performance and can provide reliable and supportive laboratory evidence for clinical practice in both early diagnosis and therapeutic monitoring.

Citation： TANG Zhuoyun, LIU Ying, WANG Zhonghao, WANG Tingting, ZHOU Dan, AO Keping, WU Chongyang, LI Dongdong. Application value of a novel magnetic particle-based chemiluminescence reagent for detecting cryptococcal capsular polysaccharide. West China Medical Journal, 2026, 41(8): 1242-1246. doi: 10.7507/1002-0179.202607035 Copy

1.	Burki T. WHO publish fungal priority pathogens list[J]. Lancet Microbe, 2023, 4(2): e74.
2.	Francis VI, Liddle C, Camacho E, et al. Cryptococcus neoformans rapidly invades the murine brain by sequential breaching of airway and endothelial tissues barriers, followed by engulfment by microglia[J]. mBio, 2024, 15(4): e0307823.
3.	謝春紅, 黃連江. 兩種隱球菌莢膜多糖抗原試劑盒在肺隱球菌病診斷的比較分析[J]. 中國醫療器械信息, 2021, 27(23): 165-168.
4.	George IA, Spec A, Powderly WG, et al. Comparative epidemiology and outcomes of human immunodeficiency virus (HIV), non-HIV non-transplant, and solid organ transplant associated cryptococcosis: a population-based study[J]. Clin Infect Dis, 2018, 66(4): 608-611.
5.	Marr KA, Sun Y, Spec A, et al. A multicenter, longitudinal cohort study of cryptococcosis in human immunodeficiency virus-negative people in the United States[J]. Clin Infect Dis, 2020, 70(2): 252-261.
6.	袁余, 王遠芳, 舒玲, 等. 側向層析法檢測隱球菌莢膜多糖抗原在隱球菌感染診斷中的臨床價值[J]. 華西醫學, 2021, 36(8): 1044-1047.
7.	Wang H, Dong J, Zhang J, et al. Diagnostic performance of four lateral flow assays for detecting cryptococcal glucuronoxylomannan antigen[J]. J Microbiol Immunol Infect, 2023, 56(6): 1293-1295.
8.	Chang CC, Harrison TS, Bicanic TA, et al. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM[J]. Lancet Infect Dis, 2024, 24(8): e495-e512.
9.	中華醫學會感染病學分會艾滋病丙型肝炎學組, 陳耀凱, 李太生, 等. 艾滋病合并隱球菌病診療專家共識(2024 年更新版)[J]. 中國艾滋病性病, 2024, 30(5): 447-458.
10.	中華醫學會神經病學分會神經感染性疾病與腦脊液細胞學學組. 非人類免疫缺陷病毒相關隱球菌性腦膜炎診斷的中國專家共識[J]. 中華神經科雜志, 2023, 56(10): 1093-1102.
11.	中華醫學會感染病學分會. 隱球菌性腦膜炎診治專家共識[J]. 中華傳染病雜志, 2018, 36(4): 193-199.
12.	浙江省醫學會呼吸病學分會. 肺隱球菌病診治浙江省專家共識[J]. 中華臨床感染病雜志, 2017, 10(5): 321-326.
13.	Gan Z, Liu J, Wang Y, et al. Performance of metagenomic next-generation sequencing for the diagnosis of cryptococcal meningitis in HIV-negative patients[J]. Front Cell Infect Microbiol, 2022, 12: 831959.
14.	Jani A, Reigler AN, Leal SM Jr, et al. Cryptococcosis[J]. Infect Dis Clin North Am, 2025, 39(1): 199-219.
15.	Zhao Y, Ye L, Zhao F, et al. Cryptococcus neoformans, a global threat to human health[J]. Infect Dis Poverty, 2023, 12(1): 20.
16.	Kong X, Cheng L, Dong Z, et al. Rapid cryptococcus electroporated-lysis and sensitive detection on a miniaturized platform[J]. Biosens Bioelectron, 2024, 250: 116096.
17.	Hevey MA, George IA, Rauseo AM, et al. Performance of the lateral flow assay and the latex agglutination serum cryptococcal antigen test in cryptococcal disease in patients with and without HIV[J]. J Clin Microbiol, 2020, 58(11): e01563-20.
18.	Macrae C, Ellis J, Keddie SH, et al. Diagnostic performance of the IMMY cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid for diagnosis of cryptococcosis in HIV-negative patients: a systematic review[J]. BMC Infect Dis, 2023, 23(1): 209.
19.	李淑妃, 徐云芝, 王同利, 等. 微生物培養、CrAg LFA 和 mNGS 對肺隱球菌病的診斷價值比較[J]. 溫州醫科大學學報, 2025, 55(11): 920-924.
20.	Wang S, Chen X, Shi J, et al. Evaluation of cryptococcal antigen lateral flow assay in human immunodeficiency virus-negative cryptococcosis: a diagnostic accuracy study[J]. Clin Microbiol Infect, 2025, 31(10): 1720-1725.
21.	Tang MW, Clemons KV, Katzenstein DA, et al. The cryptococcal antigen lateral flow assay: a point-of-care diagnostic at an opportune time[J]. Crit Rev Microbiol, 2016, 42(4): 634-642.
22.	Kwizera R, Omali D, Tadeo K, et al. Evaluation of the dynamiker cryptococcal antigen lateral flow assay for the diagnosis of HIV-associated cryptococcosis[J]. J Clin Microbiol, 2021, 59(3): e02421-20.
23.	Noguera MC, Escandón P, Rodríguez J, et al. Comparison of two commercial tests (Immy vs. Dynamiker) for cryptococcal capsular antigen[J]. Rev Soc Bras Med Trop, 2021, 54: e03072021.
24.	王穎, 張園, 杜君洋, 等. 隱球菌莢膜多糖抗原不同檢測方法的干擾因素分析[J]. 臨床檢驗雜志, 2023, 41(1): 68-71.
25.	李娜娜, 施婷, 蔡明豪, 等. 膠體金免疫層析法檢測 CrAg 對非 HIV 感染肺隱球菌病患者療效的評估價值[J]. 中國現代醫學雜志, 2022, 32(16): 14-18.
26.	唐耀敏, 唐貴文. 磁微粒化學發光法與膠體金法檢測 HIV 感染與免疫印跡法確證對照分析[J]. 中國醫學創新, 2025, 22(6): 144-148.
27.	崔一峰. 膠體金法及酶聯免疫法應用于艾滋病抗體檢測的價值分析[J]. 系統醫學, 2024, 9(3): 105-108.
28.	Li J, Guo Y. A sandwich chemiluminescent magnetic microparticle immunoassay for cryptococcal antigen detection[J]. Expert Rev Mol Diagn, 2024, 24(6): 533-540.
29.	黃騰騰. 磁微粒化學發光法檢測肺炎支原體 IgM、IgG 在支原體肺炎早期診斷的應用[J]. 實驗室檢測, 2025, 3(2): 62-64.
30.	周明, 王靜, 秦柯君, 等. 電化學發光法與酶聯免疫吸附試驗檢測乙型肝炎病毒標志物的臨床研究[J]. 實用醫技雜志, 2022, 29(3): 311-313.

1. Burki T. WHO publish fungal priority pathogens list[J]. Lancet Microbe, 2023, 4(2): e74.
2. Francis VI, Liddle C, Camacho E, et al. Cryptococcus neoformans rapidly invades the murine brain by sequential breaching of airway and endothelial tissues barriers, followed by engulfment by microglia[J]. mBio, 2024, 15(4): e0307823.
3. 謝春紅, 黃連江. 兩種隱球菌莢膜多糖抗原試劑盒在肺隱球菌病診斷的比較分析[J]. 中國醫療器械信息, 2021, 27(23): 165-168.
4. George IA, Spec A, Powderly WG, et al. Comparative epidemiology and outcomes of human immunodeficiency virus (HIV), non-HIV non-transplant, and solid organ transplant associated cryptococcosis: a population-based study[J]. Clin Infect Dis, 2018, 66(4): 608-611.
5. Marr KA, Sun Y, Spec A, et al. A multicenter, longitudinal cohort study of cryptococcosis in human immunodeficiency virus-negative people in the United States[J]. Clin Infect Dis, 2020, 70(2): 252-261.
6. 袁余, 王遠芳, 舒玲, 等. 側向層析法檢測隱球菌莢膜多糖抗原在隱球菌感染診斷中的臨床價值[J]. 華西醫學, 2021, 36(8): 1044-1047.
7. Wang H, Dong J, Zhang J, et al. Diagnostic performance of four lateral flow assays for detecting cryptococcal glucuronoxylomannan antigen[J]. J Microbiol Immunol Infect, 2023, 56(6): 1293-1295.
8. Chang CC, Harrison TS, Bicanic TA, et al. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM[J]. Lancet Infect Dis, 2024, 24(8): e495-e512.
9. 中華醫學會感染病學分會艾滋病丙型肝炎學組, 陳耀凱, 李太生, 等. 艾滋病合并隱球菌病診療專家共識(2024 年更新版)[J]. 中國艾滋病性病, 2024, 30(5): 447-458.
10. 中華醫學會神經病學分會神經感染性疾病與腦脊液細胞學學組. 非人類免疫缺陷病毒相關隱球菌性腦膜炎診斷的中國專家共識[J]. 中華神經科雜志, 2023, 56(10): 1093-1102.
11. 中華醫學會感染病學分會. 隱球菌性腦膜炎診治專家共識[J]. 中華傳染病雜志, 2018, 36(4): 193-199.
12. 浙江省醫學會呼吸病學分會. 肺隱球菌病診治浙江省專家共識[J]. 中華臨床感染病雜志, 2017, 10(5): 321-326.
13. Gan Z, Liu J, Wang Y, et al. Performance of metagenomic next-generation sequencing for the diagnosis of cryptococcal meningitis in HIV-negative patients[J]. Front Cell Infect Microbiol, 2022, 12: 831959.
14. Jani A, Reigler AN, Leal SM Jr, et al. Cryptococcosis[J]. Infect Dis Clin North Am, 2025, 39(1): 199-219.
15. Zhao Y, Ye L, Zhao F, et al. Cryptococcus neoformans, a global threat to human health[J]. Infect Dis Poverty, 2023, 12(1): 20.
16. Kong X, Cheng L, Dong Z, et al. Rapid cryptococcus electroporated-lysis and sensitive detection on a miniaturized platform[J]. Biosens Bioelectron, 2024, 250: 116096.
17. Hevey MA, George IA, Rauseo AM, et al. Performance of the lateral flow assay and the latex agglutination serum cryptococcal antigen test in cryptococcal disease in patients with and without HIV[J]. J Clin Microbiol, 2020, 58(11): e01563-20.
18. Macrae C, Ellis J, Keddie SH, et al. Diagnostic performance of the IMMY cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid for diagnosis of cryptococcosis in HIV-negative patients: a systematic review[J]. BMC Infect Dis, 2023, 23(1): 209.
19. 李淑妃, 徐云芝, 王同利, 等. 微生物培養、CrAg LFA 和 mNGS 對肺隱球菌病的診斷價值比較[J]. 溫州醫科大學學報, 2025, 55(11): 920-924.
20. Wang S, Chen X, Shi J, et al. Evaluation of cryptococcal antigen lateral flow assay in human immunodeficiency virus-negative cryptococcosis: a diagnostic accuracy study[J]. Clin Microbiol Infect, 2025, 31(10): 1720-1725.
21. Tang MW, Clemons KV, Katzenstein DA, et al. The cryptococcal antigen lateral flow assay: a point-of-care diagnostic at an opportune time[J]. Crit Rev Microbiol, 2016, 42(4): 634-642.
22. Kwizera R, Omali D, Tadeo K, et al. Evaluation of the dynamiker cryptococcal antigen lateral flow assay for the diagnosis of HIV-associated cryptococcosis[J]. J Clin Microbiol, 2021, 59(3): e02421-20.
23. Noguera MC, Escandón P, Rodríguez J, et al. Comparison of two commercial tests (Immy vs. Dynamiker) for cryptococcal capsular antigen[J]. Rev Soc Bras Med Trop, 2021, 54: e03072021.
24. 王穎, 張園, 杜君洋, 等. 隱球菌莢膜多糖抗原不同檢測方法的干擾因素分析[J]. 臨床檢驗雜志, 2023, 41(1): 68-71.
25. 李娜娜, 施婷, 蔡明豪, 等. 膠體金免疫層析法檢測 CrAg 對非 HIV 感染肺隱球菌病患者療效的評估價值[J]. 中國現代醫學雜志, 2022, 32(16): 14-18.
26. 唐耀敏, 唐貴文. 磁微粒化學發光法與膠體金法檢測 HIV 感染與免疫印跡法確證對照分析[J]. 中國醫學創新, 2025, 22(6): 144-148.
27. 崔一峰. 膠體金法及酶聯免疫法應用于艾滋病抗體檢測的價值分析[J]. 系統醫學, 2024, 9(3): 105-108.
28. Li J, Guo Y. A sandwich chemiluminescent magnetic microparticle immunoassay for cryptococcal antigen detection[J]. Expert Rev Mol Diagn, 2024, 24(6): 533-540.
29. 黃騰騰. 磁微粒化學發光法檢測肺炎支原體 IgM、IgG 在支原體肺炎早期診斷的應用[J]. 實驗室檢測, 2025, 3(2): 62-64.
30. 周明, 王靜, 秦柯君, 等. 電化學發光法與酶聯免疫吸附試驗檢測乙型肝炎病毒標志物的臨床研究[J]. 實用醫技雜志, 2022, 29(3): 311-313.

West China Medical Journal

Application value of a novel magnetic particle-based chemiluminescence reagent for detecting cryptococcal capsular polysaccharide

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