A Commutable Cytomegalovirus Calibrator Is Required to Improve the Agreement of Viral Load Values between Laboratories

Author:

Caliendo Angela M12,Shahbazian Mona D3,Schaper Carl4,Ingersoll Jessica12,Abdul-Ali Deborah12,Boonyaratanakornkit Jerry3,Pang Xiao-Li5,Fox Julie5,Preiksaitis Jutta5,Schönbrunner E Ralf3

Affiliation:

1. Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA

2. Emory Center for AIDS Research, Emory University, Atlanta, GA

3. AcroMetrix Corporation, Benicia, CA

4. independent statistical consultant, Philadelphia, PA

5. Provincial Laboratory for Public Health, Edmonton, Alberta, Canada

Abstract

Abstract Background: Viral load testing for cytomegalovirus (CMV) is an important diagnostic tool for the management of transplant recipients and immunocompromised individuals; however, inconsistency among laboratories in quantitative measurements of viral load limits interinstitutional comparisons. These inconsistencies stem from the lack of assays cleared by the US Food and Drug Administration, the absence of international standards, the wide variety of CMV-extraction and -detection methods, and differences in materials used for calibration. A critical component of standardization is the use of calibrators that are traceable and commutable. Methods: Bland–Altman plots and prediction ellipses were used to test the commutability of 2 CMV calibrators for 2 different quantification methods. Results: Tests with 2 methods showed 1 calibrator to be commutable and the other to be noncommutable. The results for the commutable calibrator were within the 95% prediction interval of the clinical samples in the Bland–Altman plot and within the 95% prediction ellipse for a simulated commutable calibrator, whereas the results for the noncommutable calibrator were not within these prediction intervals. When used to calibrate patient results, only the commutable calibrator, the OptiQuant® CMVtc Calibration Panel, significantly improved the comparability of viral loads for the 2 different measurement methods. Conclusions: This study demonstrates that an important goal in the effort to improve healthcare for patients with CMV-related disease is the establishment of traceable and commutable reference materials, including both calibrators and controls. .

Publisher

Oxford University Press (OUP)

Subject

Biochemistry (medical),Clinical Biochemistry

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