Field performance of the Abbott RealTime MTB assay for the diagnosis of extrapulmonary tuberculosis in a low-prevalence setting |
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| Institution: | 1. Microbiology Service, Hospital Clínico Universitario, Instituto de Investigación INCLIVA, Valencia, Spain;2. Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain;3. Microbiology Unit, Hospital Francisco de Borja, Gandía, Spain;4. Microbiology Unit, Hospital de Sagunto, Spain;1. Serviço de Pneumologia, Centro Hospitalar e Universitário de Coimbra- Hospital Geral, Coimbra, Portugal;2. Centro de Diagnóstico Pneumológico de Vila Nova de Gaia, Vila Nova de Gaia, Portugal;3. Serviço de Pneumologia, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal;4. Departamento de Epidemiologia, Faculdade de Medicina, Universidade do Porto, Porto, Portugal;5. Instituto de Saúde Publica, Universidade do Porto, Portugal;1. Department of Tuberculosis, Shenzhen Third People’s Hospital, Southern University of Science and Technology, Shenzhen 518112, China;2. Department of Microbiology, Zhongshan School of Medicine, Key Laboratory for Tropical Diseases Control of the Ministry of Education, Sun Yat-sen University, Guangzhou, 510080, China;3. National Clinical Research Center for Tuberculosis, Guangdong Key Laboratory for Emerging Infectious Diseases, Shenzhen Third People’s Hospital, Southern University of Science and Technology, Shenzhen, 518112, China;4. Guangdong Key Laboratory for Research and Development of Natural Drugs, Guangdong Medical University, Zhanjiang, 524023, China;5. National Clinical Research Center for Tuberculosis and Guangdong Center for Tuberculosis Control, Guangzhou, 510430, China;6. Beckman Research Institute, City of Hope National Cancer Center, Duarte, CA, 92618, USA;7. Department of Microbiology and Immunology, University of Illinois at Chicago, Chicago, IL, 60612, USA;1. Department of Infectious Diseases – Galliera Hospital, Genoa, Italy;2. WHO Collaborating Centre for Tuberculosis & Lung Diseases, Fondazione S. Maugeri, IRCCS, Tradate, Italy;3. Public Health Consulting Group, Lugano, Switzerland |
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| Abstract: | IntroductionThe sensitivities of conventional mycobacterial culture in solid or liquid media and acid-fast bacilli (AFB) smear microscopy for Mycobacterium tuberculosis complex (MTBC) detection in extrapulmonary specimens are suboptimal. We evaluated the field performance of the Abbott RealTime MTB assay for the diagnosis of extrapulmonary tuberculosis in a low-prevalence setting.MethodsThe total number of extrapulmonary specimens with mycobacterial culture and PCR results was 566: sterile fluids (n = 278), non-sterile fluids (n = 147), lymph node material (n = 69) tissue biopsies (n = 63), and abscess aspirates (n = 9). A composite standard consisting of mycobacterial culture results, clinical treatment response to anti-TB drugs, when administered, and histopathology, radiological and laboratory findings were used as a reference for sensitivity and specificity calculations.ResultsMycobacterial cultures and PCR were positive in 17 and 28 specimens, respectively. The overall agreement between culture and PCR was moderate (Cohen's kappa coefficient: 0.549; P = 0.0001). Taking as a reference our composite standard, the sensitivity of the Abbott PCR assay was 77.7%, the specificity 99.5%, the PPV 95.4%, and the NPV 98.8%. In turn, the sensitivity of the mycobacterial culture was 62.9%, the specificity and PPV 100%, and the NPV 97.9%.ConclusionThe good field performance of the Abbott RealTime MTB assay makes it valuable for the diagnosis of extrapulmonary tuberculosis in a low-prevalence setting. The use of molecular methods along with culture improves the diagnosis of extrapulmonary tuberculosis. |
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| Keywords: | Tuberculosis Real-time polymerase chain reaction Extrapulmonary tuberculosis Field study Tuberculosis Reacción en cadena de la polimerasa en tiempo real Tuberculosis extrapulmonar Estudio de campo |
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