TB PCR Sputum The Cepheid Xpert MTB/RIF Assay uses nested real-time PCR to detect MTB-complex DNA and rifampin-resistance associated mutations of the MTB-complex rpoB gene. The Xpert MTB/RIF Assay has been cleared by the U.S. Food and Drug Administration (FDA) and the performance characteristics were validated by the Rhode Island State Health Laboratories. Non-Sputum respiratory specimens (bronchial washing/lavage, bronchioalveolar lavage, lung washing, bronchial brushing) The Cepheid Xpert MTB/RIF Assay used nested real-time PCR to detect MTB-complex DNA and rifampin-resistance associated mutations of the MTB-complex rpoB gene. The performance of the Xpert MTB/RIF Assay was validated by the Rhode Island State Health Laboratories for additional non-sputum respiratory specimens that have not been approved nor cleared by the U.S. Food and Drug Administration (FDA). Namely, bronchial washing/lavage, bronchioalveolar lavage, lung washing, and bronchial brushing. AFB confirmation The Cepheid Xpert MTB/RIF Assay uses nested real-time PCR to detect MTB-complex DNA and rifampin-resistance associated mutations of the MTB-complex rpoB gene. The performance of the Xpert MTB/RIF Assay for the identification of MTB-complex isolates for AFB positive culture was validated by the Rhode Island State Health Laboratories. The testing of AFB positive cultures using this assay has not been approved nor cleared by the U.S. Food and Drug Administration (FDA). Nontuberculous Mycobacteria ID: Bruker MALDI-TOF Mass Spectrometer The Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) Biotyper (Bruker Daltonics Inc.) and its nontuberculous mycobacteria (NTM) research use only (RUO) reference library of species were verified by the RISHL for the identification of NTM. The MALDI-TOF NTM RUO library has not been cleared by the FDA RESULT INTERPRETATION Refer to "https://health.ri.gov/publications/guidance/TBNucleicAcidImplificationTestingInterpretation.pdf"
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