What is the most reliable test for diagnosing early or subclinical acute rejection?

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Last updated: February 18, 2025View editorial policy

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From the Guidelines

The most reliable test for diagnosing early or subclinical acute rejection is US-guided biopsy [ 1 ]. This method is considered the standard for diagnosis of rejection and evaluation of immunosuppression, as it allows for direct examination of the graft tissue.

Key Points

  • US-guided biopsy has a low complication rate, with a reported rate of 0.4% to 1% graft loss in approximately 2,500 biopsies [ 1 ].
  • Other imaging modalities, such as duplex Doppler US, have limited sensitivity and specificity in identifying the cause of functional transplant dysfunction [ 1 ].
  • Renal segmental or intralobar artery resistive indices (RI), measured by duplex Doppler US, are not reliable in identifying the cause of functional transplant dysfunction, with a sensitivity of 13% and a specificity of 100% [ 1 ].
  • CT and CTA may be useful in evaluating renal masses, perinephric fluid collections, and posttransplant lymphoproliferative disease, but have limited data on their usefulness in evaluating transplant vascular complications [ 1 ].

From the Research

Diagnostic Biomarkers for Acute Rejection

The most reliable test for diagnosing early or subclinical acute rejection involves the use of biomarkers. Key findings include:

  • Urinary kidney injury molecule-1 (KIM-1) is a sensitive and specific biomarker for early detection of kidney injury 2, 3, 4, 5, 6
  • KIM-1 levels in urine can detect kidney damage earlier than traditional biomarkers such as plasma creatinine and blood urea nitrogen (BUN) 2, 3
  • KIM-1 has been qualified by the Food and Drug Administration and European Medicines Agency as a biomarker to monitor drug-induced kidney injury 3

Detection Methods

Various detection methods have been developed for urinary KIM-1, including:

  • Enzyme-linked immunosorbent assay (ELISA) 2, 4
  • Immunochromatographic lateral flow assay 3
  • Colloidal gold immunochromatographic strips 4
  • These methods offer rapid and sensitive detection of urinary KIM-1, with some allowing for detection within 5-10 minutes 4 or 15 minutes 3

Clinical Applications

Urinary KIM-1 has potential clinical applications in:

  • Early diagnosis of obstructive acute kidney injury (AKI) 4
  • Detection of kidney injury in preclinical and clinical studies 3, 5
  • Monitoring of drug-induced kidney injury 3, 5
  • Identification of patients at risk of AKI 6

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Kidney injury molecule-1.

Current opinion in critical care, 2010

Research

Biomarkers for Early Detection of Acute Kidney Injury.

The journal of applied laboratory medicine, 2017

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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