A sandwich chemiluminescent magnetic microparticle immunoassay for cryptococcal antigen detection.
Expert Rev Mol Diagn
; 24(6): 533-540, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38879820
ABSTRACT
BACKGROUND:
Cryptococcosis is a global invasive mycosis associated with significant morbidity and mortality. Cryptococcal antigen (CrAg) testing from serum and cerebrospinal fluid (CSF) has been regarded as a gold standard for early diagnosis. This study aimed to develop and validate a rapid and sensitive sandwich chemiluminescent magnetic microparticle immunoassay (CMIA) for quantitative detection of CrAg in sera. RESEARCH DESIGN ANDMETHODS:
CMIA is based on magnetic beads modified with capture antibodies and biotinylated antibodies and Streptavidin-polyHRP, where biotinylated antibodies functioned as the recognition element and Streptavidin-polyHRP as the signal component. Assay parameters were first optimized, and then assay performances were evaluated.RESULTS:
Under optimized conditions, the total runtime of the CMIA was 22 min. The assay had a wide linear range (2 -10,000 ng/mL) and high analytical sensitivity (0.24 ng/mL), together with acceptable reproducibility, accuracy, and stability. Besides, it exhibited no cross-reactivity with other pathogens. Importantly, the assay showed 92.91% (95% CI, 80.97-93.02%) overall qualitative agreement with a commercial ELISA kit in a retrospective cohort of 55 cases with confirmed cryptococcal infection, and 72 controls without evidence of invasive fungal disease (IFD).CONCLUSION:
These results demonstrated that the present study paved a novel strategy for reliable quantitative detection of CrAg in sera.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cryptococcosis
/
Luminescent Measurements
/
Antigens, Fungal
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Expert Rev Mol Diagn
Journal subject:
BIOLOGIA MOLECULAR
Year:
2024
Document type:
Article
Country of publication:
United kingdom