Serum and urine nucleic acid screening tests for BK polyomavirus-associated nephropathy in kidney and kidney-pancreas transplant recipients

  • 0John Hunter Hospital, Newcastle, Australia.

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Summary

This summary is machine-generated.

Quantitative nucleic acid testing (QNAT) for BK polyomavirus DNA shows good accuracy for detecting BKPyVAN in kidney transplant recipients. Blood QNAT at 10,000 copies/mL demonstrates high sensitivity and specificity, supporting its use in clinical practice.

Area Of Science

  • Nephrology
  • Transplant Immunology
  • Virology
  • Diagnostic Accuracy

Background

  • BK polyomavirus-associated nephropathy (BKPyVAN) is a significant complication following kidney transplantation, potentially leading to graft loss.
  • Early detection of BKPyVAN is crucial for timely intervention, such as reducing immunosuppression, to preserve graft function.
  • Kidney biopsy, the gold standard for BKPyVAN diagnosis, is invasive; thus, non-invasive screening methods like quantitative nucleic acid testing (QNAT) are increasingly utilized.

Purpose Of The Study

  • To assess the diagnostic test accuracy (sensitivity and specificity) of blood and urine QNAT for diagnosing BKPyVAN in transplant recipients.
  • To investigate factors influencing diagnostic accuracy, including study types, publication era, viral load thresholds, and assay variability.

Main Methods

  • A systematic review and meta-analysis were conducted, searching multiple databases (MEDLINE, EMBASE, BIOSIS, Cochrane Register) up to June 2023.
  • Included studies were cross-sectional or cohort studies evaluating blood/plasma/serum or urine BKPyV QNAT against histopathology as the reference standard.
  • Data extraction and quality assessment (QUADAS-2) were performed independently; bivariate random-effects models were used for meta-analysis.

Main Results

  • Thirty-one studies with 6559 participants were included, primarily involving kidney transplant recipients.
  • Blood BKPyV QNAT at a threshold of 10,000 copies/mL showed pooled sensitivity of 0.86 (95% CI 0.78-0.93) and specificity of 0.95 (95% CI 0.91-0.97).
  • Analysis across various thresholds suggested an optimal cut-off around 2000 copies/mL with sensitivity 0.89 and specificity 0.88, though evidence quality was low.

Conclusions

  • Blood BKPyV QNAT, particularly at a threshold of 10,000 copies/mL, demonstrates good diagnostic performance for BKPyVAN and aligns with current recommendations.
  • Urine BKPyV QNAT lacks sufficient data for reliable accuracy estimation and is not recommended as a primary screening tool.
  • Results should be interpreted cautiously due to the low certainty of evidence, potential biases from retrospective studies, and variations in methodology.