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Chapter 12.2 : General Aspects of Molecular Diagnostics

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Citation: Leber A. 2016. General Aspects of Molecular Diagnostics, p 12.2.1.1-12.2.3.6. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch12.2
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Figures

Image of Figure 12.2.1–1
Figure 12.2.1–1

Schematic representation of unidirectional workflow.

Citation: Leber A. 2016. General Aspects of Molecular Diagnostics, p 12.2.1.1-12.2.3.6. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch12.2
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References

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1. Hall L Wilson JA. 2011. Establishing molecular testing in clinical laboratory environments; approved guideline. MM-19, 3348. CLSI, Wayne, PA.
2. Viana RV Wallis CL. 2011. Good clinical laboratory practice (GCLP) for molecular based tests used in diagnostic laboratories wide spectra of quality control. http://cdn.intechopen.com/pdfswm/23728.pdf. Accessed 14 January 2016.
1. CLSI. 2006. Molecular Diagnostic Methods for Infectious Diseases: Approved Guideline. CLSI document MM3-A2. CLSI, Wayne, PA.
2. CLSI. 2009. Quantitative Molecular Methods for Infectious Diseases: Approved Guideline. CLSI document MM6-A2. CLSI, Wayne, PA.
3. Sloan LM. 2007. Real-time PCR in clinical microbiology: verification, validation and contamination control. Clin Microbiol Newsl 29:8795.
4. Garrett PE. 2001. Quality control for nucleic acid tests: common ground and special issues. J Clin Virol 20:1521.
5. Valentine-Thon E. 2002. Quality control in nucleic acid testing—where do we stand? J Clin Virol 25(Suppl 3):S13S21.
6. Mackay IM. 2004. Real-time PCR in the microbiology laboratory. Clin Microbiol Infect 10:190212.
7. Roder B, Fruhwirth K, Vogl C, Wagner M, Rossmanith P. 2010. Impact of long-term storage on stability of standard DNA for nucleic acid-based methods. J Clin Microbiol 48:42604262.
8. Saldanha J, Gerlich W, Lelie N, Dawson P, Heermann K, Heath A, The WHO Collaborative Study Group. 2001. An international collaborative study to establish a World Health Organization international standard for Hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 80:6371.
9. Niesters HGM. 2002. Clinical virology in real time. J Clin Virol 25(Suppl 3):S3S12.
1. Code of Federal Regulations. 2009. Title 42, Public Health, chapter IV. Centers for Medicare and Medicaid Services, Department of Health and Human Services. Part 493, Laboratory requirements. Section 493.1253, Standard: establishment and verification of performance specifications. U.S. Government Printing Office, Washington, DC.
2. College of American Pathologists, Commission on Laboratory Accreditation. 2015. All Common Checklist. College of American Pathologists, Northfield, IL.
3. College of American Pathologists, Commission on Laboratory Accreditation. 2013. Microbiology Checklist. College of American Pathologists, Northfield, IL.
4. Burd EM. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev 23:550576.
5. Food and Drug Administration. 2007. Guidance for industry and FDA staff: statistical guidance on reporting results from studies evaluating diagnostic tests. Center for Devices and Radiologic Health Diagnostic Devices, U.S. Department of Health and Human Services, Rockville, MD.
6. Halling KC, Schrijver I, Persons DL. 2012. Test verification and validation for molecular diagnostic assays. Arch Pathol Lab Med 136:1113.
7. State of New York Department of Health. 2011. Microbiology Molecular Checklist; Approval of microbiology nucleic acid amplification assays. State of New York Department of Health, Wadsworth Center, Albany, NY.
19. CLSI/NCCLS. 2008. Verification and validation of multiplex nucleic acid assays. Approved guideline. CLSI document MM17-A. CLSI, Wayne, PA.
20. CLSI/NCCLS. 2008. Quantitative molecular methods for infectious diseases. Approved guideline. CLSI document MM06-A. CLSI, Wayne, PA.

Tables

Generic image for table
Table 12.2.3–1

Regulatory guidance on the performance of method verification for molecular tests

Citation: Leber A. 2016. General Aspects of Molecular Diagnostics, p 12.2.1.1-12.2.3.6. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch12.2
Generic image for table
Table 12.2.3–2

Guidance on data analysis following method verification

Citation: Leber A. 2016. General Aspects of Molecular Diagnostics, p 12.2.1.1-12.2.3.6. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch12.2

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