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Increased Detection of Mycobacterium tuberculosis Disease Using a Tissue-Based Laboratory-Developed Polymerase Chain Reaction Assay Compared to Standard Diagnostics
ABSTRACT.
Standard diagnostics for Mycobacterium tuberculosis (MTB) including acid-fast bacilli (AFB) smear and culture, and Xpert™ MTB/RIF real-time Polymerase Chain Reaction (RT-PCR; Xpert) have variable sensitivity and/or long turnaround times. We describe the clinical performance of a laboratory-developed tissue-based MTB PCR compared with AFB culture and Xpert using a composite reference standard (CRS). Over an 8-year period, MTB PCR was performed on pulmonary, pleural, or lymph node specimens for 36 patients. Of these, 11 met criteria for confirmed/probable MTB using CRS. MTB PCR was positive in 100% (11/11), AFB cultures were positive in 73% (8/11), and Xpert in 0% (0/4). MTB PCR was negative in 25 cases of “No MTB” (100% specific). The MTB PCR assay resulted faster than positive AFB culture (mean time 4.3 versus 21.2 days). Tissue-based MTB PCR was associated with increased and rapid detection of MTB, improving clinical sensitivity in strongly suspected MTB cases.
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Author Notes
Authors’ addresses: Natalie A. Mackow, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, E-mail: mackowna07@gmail.com. Rita Abi-Raad and Pei Hui, Department of Pathology, Yale University School of Medicine, New Haven, CT, E-mails: rita.abiraad@yale.edu and pei.hui@yale.edu. Christopher A. Kerantzas, Department of Laboratory Medicine, Yale University School of Medicine, New Haven, CT, E-mail: christopher.kerantzas@yale.edu. Maricar Malinis and Marwan M. Azar, Section of Infectious Diseases, Yale University School of Medicine, New Haven, CT, E-mails: maricar.malinis@yale.edu and marwan.azar@yale.edu.