Validation of assembled nucleic acid‐based tests in diagnostic microbiology laboratories

References

• NPAAC. Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques. National Pathology Accreditation Advisory Council 2000.
   Google Scholar
• Elinifro EM, Ashshi AM, Cooper RJ, Klapper PE. Multiplex PCR: optimisation and application in diagnostic virology. Clin Microbiol Rev 2000; 13: 559–70.
   PubMed Web of Science ®Google Scholar
• NCCLS. Molecular Diagnostic Methods for Infectious Diseases: Approved Guidelines. NCCLS document MM3-A Vol 15 No 22. Wayne, PA: National Committee for Clinical Laboratory Standards; 1995.
   Google Scholar
• Black CM. Current methods of laboratory diagnosis of Chlamydia trachomatis infections. Clin Microbiol Rev 1997; 10: 160–84.
   PubMed Web of Science ®Google Scholar
• Laperche S. Detection of the nucleic acids of Hepatitis B and C viruses and immunodeficiency virus for the biological screening of blood donations. Transfus Clin Biol 1998; 5: 139–46.
   PubMed Web of Science ®Google Scholar
• Monis PT, Andrews RH. Molecular epidemiology: assumptions and limitations of commonly applied methods. Int j Parasitol 1998; 28: 981–7.
   PubMed Web of Science ®Google Scholar
• Johnson G, Nelson S, Petric M, Tellier R. Comprehensive PCR-based assay for detection and species identification of human herpesviruses. J Clin Microbiol 2000; 38: 3274–9.
   PubMed Web of Science ®Google Scholar
• NCCLS. User Protocol for Evaluations of Qualitative Test Perfor-mance; Proposed guideline. NCCLS document EP12-P Vol 20, No 15. Wayne, PA: National Committee for Clinical Laboratory Standards; 2000.
   Google Scholar
• Stewart CE, Koepke JA. Choice of Method and Instrument. In: Basic Quality Assurance Practices for Clinical Laboratories. Philadelphia: JB Lippincott Co, 1987; 39–60.
   Google Scholar
• Percy-Robb IW, Broughton PMG, Jennings RD, et al. A recom-mended scheme for the evaluation of kits in the clinical chemistry laboratory. Ann Clin Biochem 1980; 17: 217–26.
   Google Scholar
• Backhouse J, Caon A, Dimech W, et al. Proposed general protocol for study of serological diagnostic reagents. Aust Microbiol 1994; 15: 37–45.
   Google Scholar
• Simel DL, Samsa GP, Matchar DB. Likelihood ratios with confidence: sample size estimates for diagnostic test studies. J Clin Epidemiol 1991; 44: 763–70.
   Google Scholar
• Farrell DJ. Validation of AMPLICOR Neisseria gonorrhoeae PCR using cppB nested PCR and 16S rRNA PCR. J Gun Microbiol 1999; 37: 386–90.
   Web of Science ®Google Scholar
• NIBSC. Biological Reference Material 2000 catalogue. National Institute for Biological Standards and Controls, Hertfordshire, UK; 2000.
   Google Scholar
• Lelie PN, van Drimmelen HA, Cuypers HT, et al. Sensitivity of HCV RNA and HIV RNA blood screening assays. Transfusion 2002; 42: 527–36.
   PubMed Web of Science ®Google Scholar
• Validation of Nucleic Acid Amplificaion Technology (NAT) for the Detection of Hepatitis C Virus (HCV) RNA in Plasma Pools. European Network of Medicines Control Laboratories, 1999.
   Google Scholar
• Saldanha J, Lelie PN, Heath A, and the WHO Collaborative Study Group. Establishment of the First International Standard for Nucleic Acid Amplification Technology (NAT) assays for HCV-RNA. Vox Sang 2002; 76: 149–58.
   Google Scholar
• Saldanha J, Gerlich W, Lelie PN, et al. An international collaborative study to establish a WHO International standard for Hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 2001; 80: 63–71.
   PubMed Web of Science ®Google Scholar
• Holmes H, Davis C, Heath A, et al. An international collaborative study to establish the 1st International Standard for HIV-1 RNA for use in Nucleic Acid-based Techniques. J Virol Methods 2001; 92: 141–50.
   PubMed Web of Science ®Google Scholar
• Saldanha J, Lelie PN, Yu M-Y, Heath A. Establishment of the first World Heath Organisation international standard for human parvovirus B19 DNA nucleic acid amplification techniques. Vox Sang 2002; 82: 24–31.
   Google Scholar
• Saldanha J. Validation and standardisation of nucleic acid amplifica-tion technology (NAT) assays for the detection of viral contamination of blood and blood products. J Clin Virol 2001; 20: 7–13.
   PubMed Web of Science ®Google Scholar
• Griffiths K, Partis L, Croan D. Review of Technologies for Detecting Genetically Modified Materials in Commodities and Food. Depart-ment of Agriculture, Fisheries and Forestry, Australia, 2002.
   Google Scholar
• General Requirements for the Competence of Testing and Calibration Laboratories. Australian Standard AS ISO/IEC 17025–1999. Stan-dards Australia, 1999.
   Google Scholar
• RCPA/NPAAC Requirements for Registration: Medical Testing. National Association of Testing Authorities, Australia, 1996.
   Google Scholar
• CTS-Final 08-200-10-10. Common Technical Specifications (CTS) for IVD products, defined in Annex II, List A of Directive 98/79/EC.
   Google Scholar