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Clinical trial of cryptococcal capsular polysaccharide detection kit (magnetic particle chemiluminescence)

Clinical trial of cryptococcal capsular polysaccharide detection kit (magnetic particle chemiluminescence) - NA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075989
Enrollment
Unknown
Registered
2023-09-21
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcal meningitis, cryptococcal disease

Interventions

Gold Standard:Cryptococcal pneumonneumococcal infection: diagnosis is confirmed primarily by histopathological examination and aetiological smear and culture of intralesional pus aspiration specimens.
Index test:The main index of the detection in this clinical trial was cryptococcus capsular polysaccharide, which was expected to have a sensitivity of 98% and a specificity of 99%. CSF detection sens
If the concentration of capsular polysaccharides = 2 ng/mL, it is considered positive, indicating a higher risk of infection with cryptococcus. tases.

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: Serum sample inclusion criteria 1) The background information of the sample source case should meet the requirements (including immunocompetent people and immunocompromised people): a) or be a case of clinically diagnosed cryptococcal infection. b) or suspected cases of cryptococcal infection (including patients with suspected cryptococcal infection in various parts of the lungs, central nervous system, or skin). c) or some rheumatoid factor positive cases, systemic lupus erythematosus cases, and cases of Trichosporidium infection. 2) Sample content= 0.4mL. Criteria for selection of cerebrospinal fluid samples 1) Background information requirements for sample source cases (including immunocompetent people and immunocompromised people): a) or a case of clinically diagnosed cryptococcal meningitis. b) or suspected case of cryptococcal meningitis. c) or cases of bacterial meningitis (gram-positive and gram-negative should be included), tuberculous meningitis, viral meningitis, and autoimmune encephalitis. 2) Sample content= 0.4mL.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Serum samples of severe hemolysis and lipidemia; 2) Lipid-cloudy cerebrospinal fluid sample; 3) The investigator believes that the sample does not meet the requirements of the testing requirements.

Design outcomes

Primary

MeasureTime frame
Capsular polysaccharide concentration;Accuracy ;Sensitivity ;Specificity ;Positive predicative value;

Countries

China

Contacts

Public ContactLIXI

Zhejiang Provincial People's Hospital

lixi418@163.com+86 187 5819 3899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026