Hepatitis E
Conditions
Interventions
Gold Standard:RT qPCR detection method: HEV RNA copy number in serum and fecal samples is detected by RT qPCR method.
Index test:Anti HEV IgM/Ig G: ELISA
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Suspected HEV infected patients: 1. Age >= 18 years old; 2. Clinical manifestations: suspected symptoms of hepatitis E, such as fatigue, loss of appetite, jaundice, etc; 3. Liver function test: Abnormal liver function indicators such as ALT and AST; 4. Serological examination: Hepatitis E virus IgM antibody positive or HEV RNA positive; 5. The patient understands and agrees to participate in the study, and signs an informed consent form; Control group 1. Age >= 18 years old; 2. Normal physical examination results: including routine physical examination and basic laboratory tests with no abnormal findings. 3. Voluntarily participate in the research and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Suspected HEV infected patients: 1. Age< 18 years old; 2. Patients with mental illness or those unable to cooperate with the study; 3. Patients who have received the hepatitis E vaccine in the past; 4. Severe renal insufficiency patients; 5. Patients with diabetes insipidus or other diseases or medication use that may significantly affect urine concentration and excretion; Health control group: 1. Have a history of hepatitis or currently have any type of liver disease. 2. Serological examination shows HEV infection (such as HEV IgM or IgG antibody positivity). 3. Abnormal liver function tests (such as elevated ALT, AST, bilirubin and other indicators). 4. Have chronic diseases that may affect liver function or immune system (such as diabetes, autoimmune diseases, etc.). 5. Have a history of infectious diseases recently (e.g. within 3 months). 6. Long term history of alcohol or drug abuse. 7. Currently taking medication that may affect liver function or immune system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HEV Ag;Reference Standard:HEV RNA;Sensitivity;Specificity;Positive Predictive Value (PPV);Negative Predictive Value (NPV);Accuracy; | — |
Countries
China
Contacts
Public ContactLiang Chen
Shanghai Public Health Clinical Center
Outcome results
None listed