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Evaluate the performance of anti-EBV BNLF2b antibody

INNODX EBV BNLF2b CMIA Diagnostic Kit for Epstein Barr Virus BNLF2b antibody (Chemiluminescent Microparticle Immunoassay)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069890
Enrollment
Unknown
Registered
2023-03-28
Start date
2021-03-25
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

nasopharyngeal carcinoma

Interventions

Gold Standard:Histopathological examination, imaging examination and other confirmation methods commonly used in clinical practice, etc.
Index test:anti-EBV BNLF2b antibody

Sponsors

Zhongshan City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 94 Years

Inclusion criteria

Inclusion criteria: 1. Gender and age are not limited 2. Subjects have symptoms or signs suspected of NPC 3. Subjects diagnosed with head and neck tumors except NPC 4. Subjects diagnosed with EBV associated benign or malignant disease 5. Subjects being positive for EBV antibodies or EBV DNA 6. Subjects require differential diagnosis of NPC during endoscopic and other imaging examinations 7. Subjects whom the investigator deems appropriate for inclusion based on clinical judgment and experience

Exclusion criteria

Exclusion criteria: 1. Subjects whom the investigator deems inappropriate for inclusion, based on clinical judgment, potential risks, or other concerns 2. Subjects without testing results of reference standard to confirm or exclude of NPC 3. Samples collected from subjects meet any of the following conditions, the subjects should be excluded ?Samples collected from subjects that are severely hemolyzed, deteriorated, chylous, or obviously contaminated by microorganisms, or other experimentally unsuitable samples ?Samples that cannot be traced back or those with incomplete sample information. ?Samples collected from subjects that do not meet the requirements for collection, processing, preservation, and transportation 4. Retain only the earliest sample from each subject for analysis, except for samples from different clinical stages or pre- and post-treatment in NPC cases.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Area under curve;

Secondary

MeasureTime frame
Kappa;

Countries

China

Contacts

Public ContactJi Mingfang

Zhongshan City People's Hospital

jmftbh@sina.com+86 760 8988 0417

Outcome results

None listed

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