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US National TB Controllers Association And Association Of Public Health Laboratories Recommend Using Xpert MTB/RIF To Support Respiratory Isolation Decisions

SUNNYVALE, Calif., May 5, 2016 /PRNewswire/ -- Cepheid CPHD, +1.17% today welcomed publication of new recommendations from the US National Tuberculosis Controllers Association (NTCA) and the Association of Public Health Laboratories (APHL) on the use of Xpert MTB/RIF to support decision-making on using Airborne Infection Isolation (AII), commonly referred to as respiratory isolation, in healthcare settings. Cepheid's Xpert MTB/RIF test received FDA clearance for expanded claims relating to respiratory isolation in February 2015, but this is the first formal set of recommendations by NTCA and APHL on using Xpert MTB/RIF.

Respiratory isolation can be costly and has also been shown, in some cases, to impede the quality of care and patient satisfaction. [1,2] Presently, many patients who are suspected of having active pulmonary Mycobacterium tuberculosis (MTB) infections are placed in respiratory isolation until three respiratory specimens, each collected at least 8 hours apart, are shown to be negative for tuberculosis (TB) using acid-fast smear-microscopy. In a study recently published by Luetkemeyer, et al. in Clinical Infectious Diseases, a single Xpert MTB/RIF test was shown to have a negative predictive value of 99.7%, while a second Xpert test increased overall negative predictive value to 100%, when compared to acid-fast smear-microscopy, suggesting a role in aiding clinical decisions regarding the use of respiratory isolation. In the same study, Xpert MTB/RIF identified all cases of mycobacterial culture-confirmed TB, the current gold standard for tuberculosis diagnosis, and identified the majority of cases with rifampin resistance. [3]

"Respiratory isolation is costly from the hospital's perspective and unpleasant from the patient's point of view. Many acute care hospitals in the United States spend millions of dollars each year on respiratory isolation of pulmonary TB suspects who eventually test negative for TB," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "The increased sensitivity of Xpert MTB/RIF over traditional acid fast smears can assist healthcare facilities in keeping more patients who do have pulmonary TB in respiratory isolation, thereby preventing transmission, while releasing those who do not need to be there."

"While Cepheid's Xpert MTB/RIF test is recognized for its transformative role in TB management in the developing world, it is particularly gratifying to see the test recognized as a potentially valuable and cost-effective aid to managing patients suspected of having TB here in the United States," stated John Bishop, Cepheid's Chairman and Chief Executive Officer. "NTCA and APHL are to be applauded for this recommendation, which could allow many patients to be released from unnecessary isolation and taken off unnecessary...