Antigenic and Antibody Detection of Candida

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03766932

Rapid diagnosis

Details and patient eligibility

About

In this study, a multicenter, prospective, synchronous blind, and controlled study was adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG, IgM, and Mn levels in candida infection.

1. the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected population in China were established by comparing the positive results of blood culture of 300 healthy people and 100 patients with positive candida sinensis blood culture as the gold standard and using ROC curve (ROC curve).
2. 100 patients with positive tracheal aspiration culture and 100 patients with positive urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were detected, and sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration and urine were evaluated.
3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to explore the diagnostic value of the detection method.
4. positive candida culture in sputum and positive candida culture in tracheal aspirate were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the two groups, and to explore the diagnostic value of different sampling methods for candida pulmonary infection.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Age: (1) 18-85 years old; (2) Candida positive in aseptic humoral culture

Exclusion Criteria:(1) no informed consent has been signed; (2) patients with severe immune deficiency -

Trial design

500 participants in 4 patient groups

Blood culture candida positive group

Tracheal aspiration candida culture positive group

Urine candida culture positive group

Other aseptic humoral candida positive group