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Chapter 6 : Use of Commercial Amplification Tests in the Clinical Microbiology Laboratory: Test Selection and Quality Assurance
Category: Clinical Microbiology; Bacterial Pathogenesis
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Molecular approaches to the detection of infectious-disease agents in the clinical microbiology laboratory can be performed through the use of commercially available products or by using in-house or “home-brew” procedures. Both types of assays are currently used for the diagnosis of two sexually transmitted organisms, Chlamydia trachomatis and Neisseria gonorrhoeae, for screening of Group B Streptococcus in pregnancy, for nasal screening of methicillin-resistant Staphylococcus aureus (MRSA) and detection of both methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus (MSSA) in wounds and positive blood culture vials, for detection of toxigenic Clostridium difficile in stool samples, and for the detection of Mycobacterium tuberculosis. A description of how to choose and implement a commercially available assay for these agents is provided in this chapter. The chapter talks about implementation of the new assay, and use of commercial assays for M. tuberculosis amplification. Three commercial PCR-based amplification assays have been cleared by Food and Drug Administration (FDA) for the detection of the toxin B gene in stool samples. All of the principles for implementation of a molecular test that have been described in this chapter will also need to be performed for C. difficile amplification assays. After implementation of a molecular assay, monitoring the process and results to be assured of the expected performance of the assay should be ongoing.
Key Concept Ranking
- Aptima Combo 2 Assay
Reporting of C. trachomatis amplification results
Reporting of N. gonorrhoeae amplification results
Comparison of methods for detection of C. trachomatis
Comparison of methods for detection of N. gonorrhoeae
Issues that need to be addressed before and after implementation of a NAAT for C. trachomatis and N, gonorrhoeae