Quality assurance and quality control in the routine molecular diagnostic laboratory for infectious diseases

Clinical Chemistry and Laboratory Medicine

Volumn 50, Issue 7, 2012, Pages 1153-1159

  Kesslera, Harald H ^a   Raggam, Reinhard B ^a  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

Author keywords

Molecular diagnostics; Quality assurance; Quality control

Indexed keywords

ACCREDITATION; CALIBRATION; CLINICAL COMPETENCE; CORRELATION ANALYSIS; GOOD LABORATORY PRACTICE; HUMAN; INFECTION; LABORATORY DIAGNOSIS; LABORATORY TEST; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MOLECULAR DIAGNOSIS; PRIORITY JOURNAL; PROFESSIONAL COMPETENCE; QUALITY CONTROL; REAL TIME POLYMERASE CHAIN REACTION; REPRODUCIBILITY; REVIEW; VALIDATION PROCESS;

COMMUNICABLE DISEASES; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; QUALITY ASSURANCE, HEALTH CARE; QUALITY CONTROL;

EID: 84867757618     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2011-0707     Document Type: Review

References (17)

1. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Off J Eur Communities 1998;L331:1-37.
2. Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices. Off J Eur Communities 2002; L131:17-30.
3. Emmadi R, Boonyaratanakornkit JB, Selvarangan R, Shyamala R, Zimmer BL, Williams L, et al. Molecular methods and platforms for infectious diseases testing. A review of FDA-approved and cleared assays. J Mol Diagn 2011;13:583-604.
4. Payne DA, Mamotte CD, Gancberg D, Pazzagli M, Van Schaik RH, Schimmel H, et al., on behalf of the IFCC Committee for Molecular Diagnostics (C-MD). Nucleic acid reference materials (NARMs): definitions and issues. Clin Chem Lab Med 2010;48:1531-5.
5. Madej RM, Davis J, Holden MJ, Kwang S, Labourier E, Schneider GJ. International standards and reference materials for quantitative molecular infectious disease testing. J Mol Diagn 2010;12:133-43.
6. Rousseau F, Gancberg D, Schimmel H, Neumaier M, Bureau A, Mamotte C, et al. Considerations for the development of a reference method for sequencing of haploid DNA - an opinion paper on behalf of the IFCC Committee on Molecular Diagnostics. Clin Chem Lab Med 2009;47:1343-50.
7. Ten Bosch JR, Grody WW. Keeping up with the next generation: massively parallel sequencing in clinical diagnostics. J Mol Diag 2008;6:484-92.
8. Orlando C, Verderio P, Maatman R, Danneberg J, Ramsden S, Neumaier M, et al. EQUAL-qual: a European program for external quality assessment of genomic DNA extraction and PCR amplification. Clin Chem 2007;53:1349-57.
9. Raymaekers M, De Rijke B, Pauli I, Van Den Abeele AM, Cartuyvels R. Timely diagnosis of respiratory tract infections: evaluation of the performance of the Respifinder assay compared to the xTAG Respiratory Viral Panel assay. J Clin Virol 2011;52:314-6.
10. Leveque N, Van Haecke A, Renois F, Boutolleau D, Talmud D, Andreoletti L. Rapid virological diagnosis of central nervous system infections by use of a multiplex reverse transcription-PCR DNA microarray. J Clin Microbiol 2011;49:3874-9.
11. De Pagter PJ, Schuurman R, De Vos NM, Mackay W, Van Loon AM. Multicenter external quality assessment of molecular methods for detection of human herpesvirus 6. J Clin Microbiol 2010;48:2536-40.
12. De Vries JJ, Claas EC, Kroes AC, Vossen AC. Evaluation of DNA extraction methods for dried blood spots in the diagnosis of congenital cytomegalovirus infection. J Clin Virol 2009;46(Suppl 4):37-42.
13. Mackay WG, Van Loon AM, Niedrig M, Meijer A, Lina B, Niesters HG. Molecular detection and typing of influenza viruses: are we ready for an influenza pandemic? J Clin Virol 2008;42:194-7.
14. Fagan EJ, Moore C, Jenkins C, Rossouw A, Cubie HA, James VL. External quality assessment for molecular detection of human papillomaviruses. J Clin Virol 2010;48:251-4.
15. Chalker VJ, Rossouw A, Mee Z, Patel P, Vaughan H, James VL. External quality assessment for the molecular detection of hepatitis C virus. J Clin Virol 2007;39:141-4.
16. Reischl U, Straube E, Unemo M. The Swedish ne variant of Chlamydia trachomatis (nvCT) remains undetected by many European laboratories as revealed in the recent PCR/NAT ring trial organized by INSTAND e. V., Germany. Euro Surveill 2009;14:1-4.
17. Linnet K, Boyd JC. Selection and analytical evaluation of methods - with statistical techniques. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry and molecular diagnostics, 4th ed. St. Louis, MO: Saunders, 2006:353-407.