Abstract: TH-PO0943
Usefulness of Trugraf for Diagnosing Subclinical Rejection After Kidney Transplantation: Systematic Review and Meta-Analysis
Session Information
- Transplantation: Clinical - Glomerular Diseases, Infections, and Rejection
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Yamada, Takayuki, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Obata, Shota, Mount Sinai Morningside Hospital, New York, New York, United States
- Tsukamoto, Shunichiro, Yokohama Shiritsu Daigaku Fuzoku Byoin, Yokohama, Kanagawa Prefecture, Japan
- Uneda, Kazushi, Fukushima Kenritsu Ika Daigaku Aizu Iryo Center, Aizuwakamatsu, Fukushima Prefecture, Japan
- Aoi, Tetsuro, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Okada, Kenta, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Nakayama, Kazuki, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Obayashi, Yuki, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Sunahara, Yasuto, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
- Ida, Tomoharu, Omihachiman Shiritsu Sogo Iryo Center, Omihachiman, Shiga Prefecture, Japan
Background
Subclinical rejection (SCR), a histological finding without overt dysfunction after kidney transplantation, predicts graft loss but can only be detected by protocol biopsy. Because many centers do not perform routine biopsies, a reliable non-invasive test is needed. TruGraf, a 57-gene blood test, offers a non-invasive alternative to protocol biopsy for detecting SCR, but its diagnostic accuracy is uncertain.
Methods
We systematically searched electronic databases until April 2025. Studies comparing Trugraf testing with protocol biopsy for SCR in kidney transplant recipients and reporting sensitivity and specificity were included; those lacking biopsy data or using indication biopsies were excluded.
Results
Five studies comprising 794 paired biopsies met inclusion criteria. Pooled sensitivity was 0.39 (95 % CI 0.26–0.54) and specificity 0.84 (0.81–0.86). The summary area under the HSROC curve was 0.82, and the diagnostic odds ratio was 3.41 (1.39–8.36). Sensitivity was highly heterogeneous (I2 = 78 %), whereas specificity was consistent across studies (I2 = 6 %).
Conclusion
TruGraf demonstrates moderate sensitivity and high specificity for SCR; positive results may reliably confirm subclinical rejection, although its sensitivity may limit its effectiveness as a screening tool.