Commutability of the first world health organization international standard for human cytomegalovirus

Journal of Clinical Microbiology

Volumn 53, Issue 10, 2015, Pages 3325-3333

  Hayden, R T ^a   Preiksaitis, J ^b   Tong, Y ^b   Pang, X ^b,c   Sun, Y ^d   Tang, L ^d   Cook, L ^e   Pounds, S ^d   Fryer, J ^f   Caliendo, A M ^g  

^a Departments of Pathology   (United States)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^c UNIVERSITY OF ALBERTA   (Canada)

^d PROVINCIAL LABORATORY FOR PUBLIC HEALTH   (Canada)

^e UNIVERSITY OF WASHINGTON   (United States)

^f NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^g BROWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL PARAMETERS; ARTICLE; CLINICAL ARTICLE; COMMUTABILITY; FREEZE DRYING; HUMAN; HUMAN CYTOMEGALOVIRUS; INTERNATIONAL COOPERATION; NONHUMAN; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REAL TIME POLYMERASE CHAIN REACTION; STANDARD; WORLD HEALTH ORGANIZATION; CLINICAL TRIAL; CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; EVALUATION STUDY; ISOLATION AND PURIFICATION; MULTICENTER STUDY; PROCEDURES; REPRODUCIBILITY; STANDARDS; VIROLOGY; VIRUS LOAD;

CYTOMEGALOVIRUS; CYTOMEGALOVIRUS INFECTIONS; HUMANS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; VIRAL LOAD; WORLD HEALTH ORGANIZATION;

EID: 84941960285     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.01495-15     Document Type: Article

References (23)

1. Atkinson C, Emery VC. 2011. Cytomegalovirus quantification: where to next in optimising patient management? J Clin Virol 51:223-228. http: //dx. doi. org/10. 1016/j. jcv. 2011. 04. 007.
2. Bieniek R, Kirby JE, Cheng A, Eichelberger K, Qian QF. 2011. Effective use of PCR for the detection of cytomegalovirus viremia and monitoring therapy in immunocompromised patients. LabMedicine 42:339-343.
3. Boeckh M, Ljungman P. 2009. How we treat cytomegalovirus in hematopoietic cell transplant recipients. Blood 113:5711-5719. http://dx. doi . org/10. 1182/blood-2008-10-143560.
4. Kraft CS, Armstrong WS, Caliendo AM. 2012. Interpreting quantitative cytomegalovirus DNA testing: understanding the laboratory perspective. Clin Infect Dis 54:1793-1797. http://dx. doi. org/10. 1093/cid/cis212.
5. Hayden RT, Hokanson KM, Pounds SB, Bankowski MJ, Belzer SW, Carr J, Diorio D, Forman MS, Joshi Y, Hillyard D, Hodinka RL, Nikiforova MN, Romain CA, Stevenson J, Valsamakis A, Balfour HH, Jr, US EBV Working Group. 2008. Multicenter comparison of different real-time PCR assays for quantitative detection of Epstein-Barr virus. J Clin Microbiol 46:157-163. http://dx. doi. org/10. 1128/JCM. 01252-07.
6. Hoffman NG, Cook L, Atienza EE, Limaye AP, Jerome KR. 2008. Marked variability of BK virus load measurement using quantitative realtime PCR among commonly used assays. J Clin Microbiol 46:2671-2680. http://dx. doi. org/10. 1128/JCM. 00258-08.
7. Pang XL, Fox JD, Fenton JM, Miller GG, Caliendo AM, Preiksaitis JK. 2009. Interlaboratory comparison of cytomegalovirus viral load assays. Am J Transplant 9:258-268. http://dx. doi. org/10. 1111/j. 1600-6143. 2008 . 02513. x.
8. Hayden RT, Yan X, Wick MT, Rodriguez AB, Xiong X, Ginocchio CC, Mitchell MJ, Caliendo AM. 2012. Factors contributing to variability of quantitative viral PCR results in proficiency testing samples: a multivariate analysis. J Clin Microbiol 50:337-345. http://dx. doi. org/10. 1128/JCM . 01287-11.
9. Gantzer ML, Miller WG. 2012. Harmonisation of measurement procedures: how do we get it done? Clin Biochem Rev 33:95-100.
10. Holden MJ, Madej RM, Minor P, Kalman LV. 2011. Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing. Expert Rev Mol Diagn 11:741-755. http: //dx. doi. org/10. 1586/erm. 11. 50.
11. Madej RM, Davis J, Holden MJ, Kwang S, Labourier E, Schneider GJ. 2010. International standards and reference materials for quantitative molecular infectious disease testing. J Mol Diagn 12:133-143. http://dx. doi . org/10. 2353/jmoldx. 2010. 090067.
12. Fryer JF, Heath AB, Anderson R, Minor PD, Collaborative Study Group. 2010. Collaborative study to evaluate the proposed 1st WHO International Standard for Human Cytomegalovirus (HCMV) for nucleic acid amplification (NAT)-based assays. WHO/BS/10/2138. World Health Organization, Geneva, Switzerland.
13. Hayden RT, Gu Z, Sam SS, Sun Y, Tang L, Pounds S, Caliendo AM. 2015. Comparative evaluation of three commercial quantitative cytomegalovirus standards by use of digital and real-time PCR. J Clin Microbiol 53:1500-1505. http://dx. doi. org/10. 1128/JCM. 03375-14.
14. Caliendo AM, Shahbazian MD, Schaper C, Ingersoll J, Abdul-Ali D, Boonyaratanakornkit J, Pang XL, Fox J, Preiksaitis J, Schonbrunner ER. 2009. A commutable cytomegalovirus calibrator is required to improve the agreement of viral load values between laboratories. Clin Chem 55: 1701-1710. http://dx. doi. org/10. 1373/clinchem. 2009. 124743.
15. Cattozzo G, Franzini C, d'Eril GV. 2001. Myoglobin and creatine kinase isoenzyme MB mass assays: intermethod behaviour of patient sera and commercially available control materials. Clin Chim Acta 303:55-60. http://dx. doi. org/10. 1016/S0009-8981(00)00370-3.
16. Vesper HW, Miller WG, Myers GL. 2007. Reference materials and commutability. Clin Biochem Rev 28:139-147.
17. Hayden RT, Shahbazian MD, Valsamakis A, Boonyaratanakornkit J, Cook L, Pang XL, Preiksaitis JK, Schonbrunner ER, Caliendo AM. 2013. Multicenter evaluation of a commercial cytomegalovirus quantitative standard: effects of commutability on interlaboratory concordance. J Clin Microbiol 51:3811-3817. http://dx. doi. org/10. 1128/JCM. 02036-13.
18. International Organization for Standardization. 2009. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation. ISO 15194:2009. International Organization for Standardization, Geneva, Switzerland.
19. Clinical and Laboratory Standards Institute. 2010. Characterization and qualification of commutable reference materials for laboratory medicine; approved guideline. EP30-A. Clinical and Laboratory Standards Institute, Wayne, PA.
20. Cattozzo G, Franzini C. 2013. Commutability: a peculiar property of calibration and control materials. Definition and evaluation. Clin Chem Lab Med 51:e167-e168. http://dx. doi. org/10. 1515/cclm-2013-0065.
21. Wolff DJ, Heaney DL, Neuwald PD, Stellrecht KA, Press RD. 2009. Multi-site PCR-based CMV viral load assessment-assays demonstrate linearity and precision, but lack numeric standardization: a report of the Association for Molecular Pathology. J Mol Diagn 11:87-92. http://dx. doi . org/10. 2353/jmoldx. 2009. 080097.
22. Boom R, Sol CJ, Schuurman T, Van Breda A, Weel JF, Beld M, Ten Berge IJ, Wertheim-Van Dillen PM, De Jong MD. 2002. Human cytomegalovirus DNA in plasma and serum specimens of renal transplant recipients is highly fragmented. J Clin Microbiol 40:4105-4113. http://dx . doi. org/10. 1128/JCM. 40. 11. 4105-4113. 2002.
23. Bretaudiere J-P, Dumont G, Rej R, Bailly M. 1981. Suitability of control materials: general principles and methods of investigation. Clin Chem 27:798-805.