Reflections and proposals to assure quality in molecular diagnostics

Acta Clinica Belgica

Volumn 66, Issue 1, 2011, Pages 33-41

  Raymaekers, Marijke ^a   Bakkus, M ^b   Boone, E ^c   De Rijke, B ^d   El Housni, H ^e   Descheemaeker, P ^f   De Schouwer, P ^g   Franke, S ^h   Hillen, F ^a   Nollet, F ^f   Soetens, O ^b   Vankeerberghen, A ⁱ  

^a Klinisch Laboratorium   (Belgium)

^b UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^c Heilig Hart Ziekenhuis   (Belgium)

^d Klinische Biologie   (Belgium)

^e ERASME HOSPITAL   (Belgium)

^f Laboratorium Klinische Biologie   (Belgium)

^g ZiekenhuisNetwerk Antwerpen   (Belgium)

^h UNIVERSITY OF LIÈGE   (Belgium)

ⁱ OLV HOSPITAL   (Belgium)

Author keywords

ISO15189:2007; Molecular diagnostics; PCR; Quality assurance

Indexed keywords

ACCURACY; ARTICLE; CLINICAL ASSESSMENT; DIAGNOSTIC TEST; FALSE POSITIVE RESULT; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; INSTRUMENT VALIDATION; LABORATORY TEST; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MOLECULAR DIAGNOSIS; NONHUMAN; POLYMERASE CHAIN REACTION; PRACTICE GUIDELINE; QUALITY CONTROL; REFRIGERATOR; ULTRAVIOLET IRRADIATION; VOLUMETRY;

EID: 79952588449     PISSN: 00015512     EISSN: None     Source Type: Journal    
DOI: 10.1179/acb.66.1.2062511     Document Type: Article

References (35)

1. Saiki RK, Scharf S, Faloona F, et al. Enzymatic amplification of beta-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anemia. Science 1985; 230: 1350-1354. (Pubitemid 16105164)
2. Medical Laboratories - Particular requirements for quality and competence. International Standard ISO 15189: 2007 2007.
3. Colpaert C, Salgado R. Belgian guidelines for Her2/neu testing in breast cancer. BJMO 2007; 1: 22-24.
4. Millar BC, Xu J, Moore JE. Risk assessment models and contamination management: implications for broad-range ribosomal DNA PCR as a diagnostic tool in medical bacteriology. J Clin Microbiol 2002; 40: 1575-1580. (Pubitemid 34493122)
5. Rys PN and Persing DH. Preventing false positives: quantitative evaluation of three protocols for inactivation of polymerase chain reaction amplification products. J Clin Microbiol 1993; 31: 2356-2360. (Pubitemid 23254200)
6. Belak S and Ballagi-Pordany A. Experiences on the application of the polymerase chain reaction in a diagnostic laboratory. Mol Cell Probes 1993; 7: 241-248. (Pubitemid 23232245)
7. Corless CE, Guiver M, Borrow R, et al. Contamination and sensitivity issues with a real-time universal 16S rRNA PCR. J Clin Microbiol 2000; 38: 1747-1752. (Pubitemid 30253908)
8. Meier A, Persing DH, Finken M, et al. Elimination of contaminating DNA within polymerase chain reaction reagents: implications for a general approach to detection of uncultured pathogens. J Clin Microbiol 1993; 31: 646-652. (Pubitemid 23059882)
9. Espy MJ, Smith TF, Persing DH. Dependence of polymerase chain reaction product inactivation protocols on amplicon length and sequence composition. J Clin Microbiol 1993; 31: 2361-2365. (Pubitemid 23254201)
10. Borst A, Box AT, Fluit AC. False-positive results and contamination in nucleic acid amplification assays: suggestions for a prevent and destroy strategy. Eur J Clin Microbiol Infect Dis 2004; 23: 289-299. (Pubitemid 38669939)
11. Kwok S and Higuchi R. Avoiding false positives with PCR. Nature 1989; 339: 237-238.
12. Prince AM and Andrus L. PCR: how to kill unwanted DNA. Biotechniques 1992; 12: 358-360.
13. Fairfax MR, Metcalf MA, and Cone RW. Slow inactivation of dry PCR templates by UV light. PCR Methods Appl 1991; 1: 142-143.
14. Schoder D, Schmalwieser A, Schauberger G, et al. Novel approach for assessing performance of PCR cyclers used for diagnostic testing. J Clin Microbiol 2005; 43: 2724-2728. (Pubitemid 40827945)
15. Cray C, Rodriguez M, Zaias J, et al. Effects of storage temperature and time on clinical biochemical parameters from rat serum. J Am Assoc Lab Anim Sci 2009; 48: 202-204.
16. Bonroy C, Vankeerberghen A, Boel A, et al. Use of a multiplex real-time PCR to study the incidence of human metapneumovirus and human respiratory syncytial virus infections during two winter seasons in a Belgian paediatric hospital. Clin Microbiol Infect 2007; 13: 504-509. (Pubitemid 46563500)
17. Joss AW, Evans R, Mavin S, et al. Development of real time PCR to detect Toxoplasma gondii and Borrelia burgdorferi infections in postal samples. J Clin Pathol 2008; 61: 221-224. (Pubitemid 351218885)
18. Riffelmann M, Wirsing von Konig CH, Caro V, et al. Nucleic Acid amplification tests for diagnosis of Bordetella infections. J Clin Microbiol 2005; 43: 4925-4929. (Pubitemid 41483986)
19. Smalling TW, Sefers SE, Li H, et al. Molecular approaches to detecting herpes simplex virus and enteroviruses in the central nervous system. J Clin Microbiol 2002; 40: 2317-2322. (Pubitemid 34747326)
20. Tang YW, Mitchell PS, Espy MJ, et al. Molecular diagnosis of herpes simplex virus infections in the central nervous system. J Clin Microbiol 1999; 37: 2127-2136. (Pubitemid 29277768)
21. van der Velden VH, Boeckx N, Gonzalez M, et al. Differential stability of control gene and fusion gene transcripts over time may hamper accurate quantification of minimal residual disease - a study within the Europe Against Cancer Program. Leukemia 2004; 18: 884-886. (Pubitemid 38500215)
22. Rainen L, Arbique J, Deshratn A, et al. Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline MM13-A. Wayne, P.A.: Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS). 2005; 25: 31.
23. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312: 71-72.
24. Price CP. Evidence-based laboratory medicine: supporting decision-making. Clin Chem 2000; 46: 1041-1050. (Pubitemid 30643303)
25. Raymaekers M, Smets R, Maes B, et al. Checklist for optimization and validation of real-time PCR assays. J Clin Lab Anal 2009; 23: 145-151.
26. Rabenau HF, Kessler HH, Kortenbusch M, et al. Verification and validation of diagnostic laboratory tests in clinical virology. J Clin Virol 2007; 40: 93-98. (Pubitemid 47419432)
27. Koidl C, Michael B, Berg J, et al. Detection of transfusion transmitted virus DNA by real-time PCR. J Clin Virol 2004; 29: 277-281. (Pubitemid 38281219)
28. Sloan LM. Real-time PCR in Clinical Microbiology: verification, validation, and contamination control. CMN 2007; 29: 87-95. (Pubitemid 46876696)
29. Espy MJ, Uhl JR, Sloan LM, et al. Real-time PCR in clinical microbiology: applications for routine laboratory testing. Clin Microbiol Rev 2006; 19: 165-256. (Pubitemid 43158452)
30. Madej R, Caliendo A, Day S et al. Quantitative Molecular Methods for Infectious Diseases; Approved Guideline MM6-A. Wayne, P.A.: Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS). 2003; 23: 28.
31. Nolte F, Arbique J, Cockerill F, et al. Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline MM3-A2 -Second Edition. Wayne, P.A.: Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS). 2006; 26: 8.
32. Hughes T, Deininger M, Hochhaus A, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood 2006; 108: 28-37. (Pubitemid 43990609)
33. Branford S, Fletcher L, Cross NC, et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood 2008; 112: 3330-3338.
34. Branford S, Cross NC, Hochhaus A, et al. Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia 2006; 20: 1925-1930. (Pubitemid 44614879)
35. Wolff A, Hammond E, Schwartz J, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. JCO 2007; 25: 118-145. (Pubitemid 350003059)