High-sensitivity BK virus detection system using viewRNA in situ hybridization
Chunlan Hu1, Xiaonan Zhang2, Tongyu Zhu3
1Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; Department of Kidney Transplantation, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Diagnostic Microbiology and Infectious Disease
|March 10, 2025
Summary
A new molecular diagnostic system accurately identifies BK virus (BKV) infections. The ViewRNA-ISH method offers improved sensitivity and specificity for detecting BKV-associated pathologies, aiding in clinical diagnosis.
Area of Science:
- Molecular diagnostics
- Virology
- Pathology
Background:
- BK virus (BKV) infections can cause significant pathologies, particularly in immunocompromised individuals.
- Accurate and sensitive detection of BKV is crucial for timely diagnosis and management.
Purpose of the Study:
- To develop and validate a reliable molecular diagnostic system for precise identification of BKV-associated pathologies.
- To enhance the diagnostic performance for BKV detection compared to existing methods.
Main Methods:
- Designed in-situ hybridization (ISH) probes targeting conserved BKV large T antigen sequences.
- Integrated branched DNA signal amplification with probes to create a novel ViewRNA-ISH detection system.
- Validated the system using cellular models and clinical specimens, including renal biopsies.
Main Results:
- The ViewRNA-ISH system demonstrated enhanced diagnostic specificity and sensitivity.
- Achieved 93.75% concordance with immunohistochemical (IHC) findings in 32 clinical samples.
- Identified BKV in two previously IHC-negative renal biopsies, indicating superior detection capability.
Conclusions:
- The developed BKV-LT ViewRNA-ISH system provides dual-mode detection (fluorescent/chemical) of BKV nucleic acids.
- Offers superior diagnostic performance for BKV-associated pathologies.
- Shows potential clinical utility, especially in monitoring renal allograft recipients.


