title: Test performance characteristics of quantitative nucleic acid testing for polyomaviruses in kidney and kidney-pancreas transplant recipients.
abstract: Screening for polyoma BK virus (BK) using nucleic testing (NAT) is recommended for kidney and kidney-pancreas transplant recipients, but the performance characteristics of quantitative BK NAT at different thresholds of plasma BK viral loads are unclear. We aim to evaluate the diagnostic accuracy of quantitative BK NAT as an add-on test to qualitative polyoma NAT for the diagnosis of BK virus-associated nephropathy (BKVAN) in kidney and kidney transplant recipients. We calculated the test sensitivity, specificity, and predictive values at the different thresholds of plasma BK viral load for BKVAN. At the recommended threshold of >1 × 10(3) serum BK copies/mL serum for test positivity, the sensitivity for BKVAN was 92.9% (95% confidence intervals [CI]: 66.1-99.8) and specificity 79.1% (95%: CI 67.4-88.1), with corresponding positive and negative predictive values of 42.0% (95% CI: 24.8-57.7%) and 98.6% (95% CI: 98.3-99.9%), respectively. The overall area under curve for the quantitative BK NAT was 0.92 (95% CI: 0.85-0.97). Quantitative BK NAT displays properties of high sensitivity and specificity that are fit for purpose as an add-on test to qualitative polyomavirus NAT for kidney and kidney-pancreas transplant recipients at risk of BKVAN.
authors: Department of Renal Medicine and Transplantation, Westmead Hospital, Westmead, NSW, Australia.
authors: T M M
authors: TM
authors: Myint
authors: R M
authors: RM
authors: Turner
authors: J C
authors: JC
authors: Craig
authors: N B
authors: NB
authors: Cross
authors: K
authors: K
authors: Kable
authors: B J
authors: BJ
authors: Nankivell
authors: J R
authors: JR
authors: Chapman
authors: A C
authors: AC
authors: Webster
authors: P
authors: P
authors: O'Connell
authors: D E
authors: DE
authors: Dwyer
authors: N
authors: N
authors: Jeoffreys
authors: S D
authors: SD
authors: Roger
authors: G
authors: G
authors: Wong
mesh_terms: D000328:Adult; D001739:BK Virus / Q000235:genetics* / Q000302:isolation & purification; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000097:blood / Q000235:genetics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D016035:Pancreas Transplantation; D010182:Pancreatic Diseases / Q000097:blood / Q000175:diagnosis / Q000821:virology; D027601:Polyomavirus Infections / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D011379:Prognosis; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction; D014412:Tumor Virus Infections / Q000097:blood / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral
keywords: BK virus-associated nephropathy; quantitative nucleic acid testing; receiver operating characteristics curve analysis; sensitivity; specificity