Primary EBV Infection,Chronic Active EBV Infection (CAEBV),EBV-Associated Malignancies,Immunocompromised Hosts
Conditions
Interventions
Gold Standard:Comparator reagent: EBV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (NMPA Medical Device Registration Certificate No. 20173403080) manufactured by Guangdong Huayin Medicine
Index test:EB Virus Nucleic Acid Assay kit (fluorescence PCR method)
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People who may be screened for EBV nucleic acid infection, such as primary EBV infection-related diseases (infectious mononucleosis, etc.), chronic active EBV infection, EBV infection-related malignant tumors (nasopharyngeal cancer, etc.), immunocompromised (organ transplant patients, etc.), or immunosuppressive drugs; 2. Considering possible cross-reactivity, select some patients with other herpes-like virus infections, such as hepatitis B virus, influenza A virus, Staphylococcus aureus, Candida albicans and adenovirus and other pathogenic infections for interference samples; 3. The selected subject sample should have clear and complete case information, including traceable sample number, age, gender, sampling date, clinical background information, etc.
Exclusion criteria
Exclusion criteria: 1.Improper sample collection/preservation or insufficient sample volume for testing; 2.Multiple samples collected from the same subject at different time points; 3.Other conditions deemed ineligible by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conformity rate;Negative conformity rate;Total Compliance Rate;Kappa coefficient and its 95% confidence interval; | — |
Countries
China
Contacts
Public ContactChen Mingyuan;Jiang Guanmin
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed