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A Reliable Non Invasive Alternative to Surveillance Renal Allograft Biopsy

R. Jain, S. Thaduri, V. Kumar, C. Kew, B. Julian, G. Towns, S. Ong, F. Ahmed, S. Mehta, G. Agarwal

Transplant Nephrology, University of Alabama Birmingham, Birmingham, AL

Meeting: 2021 American Transplant Congress

Abstract number: 644

Keywords: Kidney, Monitoring, Protocol biopsy, Rejection

Topic: Clinical Science » Biomarkers, Immune Assessment and Clinical Outcomes

Session Information

Session Name: Biomarkers, Immune Assessment and Clinical Outcomes

Session Type: Poster Abstract

Session Date & Time: None. Available on demand.

Location: Virtual

*Purpose:

Surveillance Renal Allograft Biopsy (SAVB) is the standard of care to identify subclinical immunological injury(SCI). However fewer than 25% of transplant centers in the US perform SVAB, as it has a low rate of positive results, involves procedure risks, and has logistical issues. Donor derived cell free DNA (dd-cfDNA) is gaining acceptance as a non-invasive biomarker of immunological injury in renal allografts with a negative predictive value (NPV) exceeding 84%. We propose using a combination of dd-cfDNA and DSA to enhance the NPV as an alternative to SVAB .

*Methods: Retrospective, single center chart review of 174 consecutive patients undergoing SVAB between 02/02/2019 to 09/20/2020 with paired results of dd-cfDNA and DSA.Data regarding patient demographics, induction agents, etiology of ESRD and CPRA status was collected.

Criteria for Positive Test Results
dd-cf DNA >1%
DSA >1500 Mfi
Biopsy Cellular Rejection(Banff Borderline or higher) and/or Antibody Mediated Rejection

*Results: Patient characteristics were comparable to most Renal Transplant centres in the US.Using dd-cf DNA for diagnoses has a higher specificity of 93% at the expense of missing 2.29% patients who could have SCI on SVAB.

Comparing SVAB to dd- cf DNA alone
SVAB Positive SVAB Negative
dd-cf DNA Positive 4 TP 11 FP
dd-cf DNA Negative 7 FN(2%) 152 TN(87%)

Combination of dd-cf DNA with DSA has NPV of 98% and could safely avoid SVAB in up to 77% of the population with a chance of missing SCI in only 1.72% of patients

Comparing SVAB to dd-cf DNA and DSA
SVAB Positive SVAB Negative
dd-cf DNA or DSA Positive 8 TP 29 FP
dd-cf DNA and DSA Negative 3 FN(1.72%) 134 TN(77%)
Identification of SCI
Sensitivity Specificity PPV NPV Accuracy
dd-cf DNA 36% 93% 27% 96% 90%
dd-cf DNA + DSA 73% 82% 22% 98% 82%

*Conclusions:

Use of dd-cfDNA is a useful screen for SCI after transplant with a high NPV. Adding DSA to dd-cfDNA further improves the NPV to 98%. Thus, a combination of negative dd-cfDNA & DSA can be used as a safe non invasive alternative to SVAB.

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To cite this abstract in AMA style:

Jain R, Thaduri S, Kumar V, Kew C, Julian B, Towns G, Ong S, Ahmed F, Mehta S, Agarwal G. A Reliable Non Invasive Alternative to Surveillance Renal Allograft Biopsy [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/a-reliable-non-invasive-alternative-to-surveillance-renal-allograft-biopsy/. Accessed May 9, 2025.

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