Diagnostic performance of the Dynamiker cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid samples
4 affiliations
- 1Laboratory Department, The First Affiliated Hospital of Yangtze University, Jingzhou, Hubei People’s Republic of China
- 2Innovative Team for Precision Molecular Diagnostics and Biosensing, Health Science Center, Yangtze University, Jingzhou, Hubei People’s Republic of China
- 3Oncology Department, The First Affiliated Hospital of Yangtze University, Jingzhou, Hubei People’s Republic of China
- 4Ophthalmology Department, The First Affiliated Hospital of Yangtze University, Jingzhou, Hubei People’s Republic of China
Abstract
Background: The incidence of cryptococcosis is rising, particularly among immunocompetent individuals. Cryptococcal antigen (CrAg) testing is increasingly used in the diagnosis of cryptococcal infections. However, the diagnostic performance of the Dynamiker CrAg lateral flow assay has been evaluated in only a few studies.
Methods: This study included patients with suspected cryptococcosis who were admitted to the First Affiliated Hospital of Yangtze University between February 1, 2020 and January 31, 2025. A total of 43 confirmed cases were enrolled, including 13 with cryptococcal meningoencephalitis (CM), 26 with pulmonary cryptococcosis (PC), and 4 with asymptomatic cryptococcal antigenemia (ACA), as defined by the revised EORTC/MSG criteria.
Results: The CrAg positivity rate was significantly higher in HIV-positive individuals (12.4%, 12/97) than in HIV-negative individuals (2.1%, 22/1058). Notably, 30.8% (8/26) of PC patients were asymptomatic at diagnosis. Additionally, 3 PC cases and 1 CM case tested negative for serum CrAg but were ultimately confirmed by NGS. In serum, the Dynamiker CrAg LFA demonstrated a sensitivity of 88.2%, specificity of 100%, positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 99.6%. In cerebrospinal fluid (CSF), the assay achieved perfect performance (100% for all metrics). NGS demonstrated a positivity rate of 87.6% (14/16).
Conclusions: The Dynamiker CrAg® LFA shows good diagnostic sensitivity and specificity for cryptococcosis in HIV-negative and HIV-positive patients, with considerably better performance in CSF specimens. The shifting epidemiology toward HIV-negative, immunocompetent individuals further underscores the necessity of integrating CrAg testing into routine diagnostic workflows for pulmonary infections.
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BibTeX
@article{tian2026diagnostic,
title = {{Diagnostic performance of the Dynamiker cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid samples}},
author = {Peng-Peng Tian and Hua-Wei Yi and Tian Wang and Hui Yang and Meng-Yao Du and Li-Sha Zhu and Xian-Mo Wang and Liang-Cai Xie and Qian Wang and Tian Tian},
journal = {BMC Infectious Diseases},
year = {2026},
month = aug,
doi = {10.1186/s12879-026-14162-0},
url = {https://doi.org/10.1186/s12879-026-14162-0},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Diagnostic performance of the Dynamiker cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid samples
AU - Peng-Peng Tian
AU - Hua-Wei Yi
AU - Tian Wang
AU - Hui Yang
AU - Meng-Yao Du
AU - Li-Sha Zhu
AU - Xian-Mo Wang
AU - Liang-Cai Xie
AU - Qian Wang
AU - Tian Tian
PY - 2026
DA - 2026/08/06
JO - BMC Infectious Diseases
DO - 10.1186/s12879-026-14162-0
UR - https://doi.org/10.1186/s12879-026-14162-0
AB - Background: The incidence of cryptococcosis is rising, particularly among immunocompetent individuals. Cryptococcal antigen (CrAg) testing is increasingly used in the diagnosis of cryptococcal infections. However, the diagnostic performance of the Dynamiker CrAg lateral flow assay has been evaluated in only a few studies. Methods: This study included patients with suspected cryptococcosis who were admitted to the First Affiliated Hospital of Yangtze University between February 1, 2020 and January 31, 2025. A total of 43 confirmed cases were enrolled, including 13 with cryptococcal meningoencephalitis (CM), 26 with pulmonary cryptococcosis (PC), and 4 with asymptomatic cryptococcal antigenemia (ACA), as defined by the revised EORTC/MSG criteria. Results: The CrAg positivity rate was significantly higher in HIV-positive individuals (12.4%, 12/97) than in HIV-negative individuals (2.1%, 22/1058). Notably, 30.8% (8/26) of PC patients were asymptomatic at diagnosis. Additionally, 3 PC cases and 1 CM case tested negative for serum CrAg but were ultimately confirmed by NGS. In serum, the Dynamiker CrAg LFA demonstrated a sensitivity of 88.2%, specificity of 100%, positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 99.6%. In cerebrospinal fluid (CSF), the assay achieved perfect performance (100% for all metrics). NGS demonstrated a positivity rate of 87.6% (14/16). Conclusions: The Dynamiker CrAg® LFA shows good diagnostic sensitivity and specificity for cryptococcosis in HIV-negative and HIV-positive patients, with considerably better performance in CSF specimens. The shifting epidemiology toward HIV-negative, immunocompetent individuals further underscores the necessity of integrating CrAg testing into routine diagnostic workflows for pulmonary infections.
SN - 1471-2334
ER -