Sepsis
Conditions
Interventions
Gold Standard:Clinical diagnosis is obtained by the diagnostic investigator based on a combination of key indicators, supporting indicators, and other judgmental criteria.
Index test:Interleukin 1 Receptor 2 (IL-1R2) Assay Kit (Fluorescent Immunochromatography)
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male or female, age>=18 years. (2) Those who meet one of the following conditions can be included in the study. A. Patients diagnosed with sepsis within 72 hours prior to screening. B.Patients diagnosed with an immune risk-related disease within 72 hours prior to screening. C. Apparently healthy individuals, subject to exclusion of the conditions listed below. 1) Known use of medications that may cause immunosuppression within 90 days prior to enrollment, including but not limited to the following types of medications: glucocorticoid analogs, microbial metabolites, antimetabolites, polyclonal and monoclonal anti-lymphocyte antibodies, alkylating agents, etc. 2) Known autoimmune diseases and immunodeficiency diseases. 3) Known hepatitis B virus (HBV), human immunodeficiency virus (HIV), hepatitis C virus (HCV) infection or carriers. (3) Agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who are known to have had chemotherapy or radiotherapy within 90 days prior to screening or who will require chemotherapy or radiotherapy during the trial period; (2) Female patients who are known to be pregnant; (3) Patients who are known to have developed or are developing an autoimmune disease within 14 days prior to screening; (4) Patients who are unable to complete collection of samples required for the trial as requested; (5) Other conditions that, in the judgment of the investigator, make enrollment unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;overall compliance rate;Receiver operating characteristic curve;Differential analysis of assay values between immunosuppressed and non-immunosuppressed groups.; | — |
Countries
China
Contacts
Public ContactChen Jian
Anhui Provincial Hospital
Outcome results
None listed