Chapter 12 : Molecular Methods for Diagnosis of Infectious Diseases

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This chapter discusses both home brew assays and commercially available kits and related instrumentation for the detection of infectious agents by molecular methods, and is subdivided into two sections. The first section deals with molecular amplification tests that are performed under home brew assay guidelines using reagents that are commercially available. It is recognized that the use of molecular methods for diagnosis of infectious diseases is a rapidly evolving field, and much of the initial diagnostic work is done with home brew assays developed and validated within each laboratory. The second section of the chapter reviews the commercially available products that make it easier to assemble home brew assays using partial kits and analyte-specific reagents. The integration of commercially available components into home brew molecular assays for detection of pathogens helps to avoid human error and enables standardization of testing procedures, thus increasing the precision and reproducibility of the results. The commercially available nucleic acid detection assays have several important advantages over home brew assays. These assays fall into two general categories: the direct nonamplified nucleic acid detection methods, and the amplified tests. Where possible, the use of commercial Food and Drug Administration (FDA) (or equivalent)-approved nucleic acid tests (NAT) kits and instrumentation is advantageous because of the standardization of results, convenience of use for greater numbers of clinical laboratories, and benefits related to technologist training, support, and savings of hands-on time related to a higher degree of automation.

Citation: Jungkind D, Kessler H. 2002. Molecular Methods for Diagnosis of Infectious Diseases, p 306-323. In Truant A (ed), Manual of Commercial Methods in Clinical Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555817961.ch12
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Commercial target amplification technologies and tests

Citation: Jungkind D, Kessler H. 2002. Molecular Methods for Diagnosis of Infectious Diseases, p 306-323. In Truant A (ed), Manual of Commercial Methods in Clinical Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555817961.ch12
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Examples of commercially available nucleic acid isolation components

Citation: Jungkind D, Kessler H. 2002. Molecular Methods for Diagnosis of Infectious Diseases, p 306-323. In Truant A (ed), Manual of Commercial Methods in Clinical Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555817961.ch12
Generic image for table

Examples of commercially available prepackaged extraction kits

Citation: Jungkind D, Kessler H. 2002. Molecular Methods for Diagnosis of Infectious Diseases, p 306-323. In Truant A (ed), Manual of Commercial Methods in Clinical Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555817961.ch12
Generic image for table

Commercially available hybridization and detection kits

Citation: Jungkind D, Kessler H. 2002. Molecular Methods for Diagnosis of Infectious Diseases, p 306-323. In Truant A (ed), Manual of Commercial Methods in Clinical Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555817961.ch12

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