BK virus-associated nephropathy
Conditions
Interventions
 
3. BKV-associated nephropathy: Kidney biopsy immunohistochemical SV40 large-T positive + Histopathological n
Index test:Test: 
Quantitative 
Gold Standard:Clinical outcome:
1. BKV Positive: Urine/Blood (Serum/Plasma) qPCR positive, or immunohistochemical SV40 large-T positive
2. BKV activation: Viruria >10^7 copies/ml, or viremia >10^4 copies/ml, or immunohistochemical SV40 large-T positive
Immunohistochemistry
In-situ 
hybridization.
Indices: 
in 
and 
serum/plasma 
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Kidney transplant recipients, patients with bladder cancer or infected by HIV at the age of 18-65 years old; 2. >50% BKV positive samples in all kidney biopsies for the retrospective studies; 3. >50% BKV positive samples in all urine samples for the retrospective studies; 4. BKV positive urine from kidney transplant recipients are priority to be included in the prospective studies (>50% urine BKV positive rate of all patients); 5. Urine BKV positive patients with bladder cancer are priority to be included in the prospective studies (>50% urine BKV positive rate of all patients).
Exclusion criteria
Exclusion criteria: 1. Hematuresis samples (Red cells count: >3/hpf in centrifuged urine, >1-2/hpf in urine, or urinary occult blood test positive); 2. Patients with symptoms of urinary tract infection; 3. Redundant BKV negative samples; 4. The samples which are not appropriate for this study determined by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| viruria;viremia;SV40 large-T antigen;BKV large-T nucleic acid In-situ hybridization; | — |
Countries
China
Contacts
Public ContactZHU Tongyu
Shanghai Public Health Clinical Center
Outcome results
None listed