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Journal of Clinical Microbiology, July 2003, p. 3233-3240, Vol. 41, No. 7
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.7.3233-3240.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Assessment by Meta-Analysis of PCR for Diagnosis of Smear-Negative Pulmonary Tuberculosis

Olga L. Sarmiento,1 Kristen A. Weigle,1,2 Janet Alexander,1 David J. Weber,1,2,3 and William C. Miller1,3*

Department of Epidemiology, School of Public Health,1 Departments of Medicine,3 Pediatrics, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 275992

Received 8 August 2002/ Accepted 23 March 2003

We conducted a meta-analysis to assess the performance of PCR for the diagnosis of smear-negative pulmonary tuberculosis (SPT) and to identify factors that account for differences in the diagnostic accuracy of different studies. Studies published before February 2002 were included if sensitivity and specificity of PCR in smear-negative respiratory or gastric-aspirate specimens could be calculated. Analysis was conducted by using summary receiver operating characteristics models. Sensitivity and specificity ranged from 9 to 100% and from 25 to 100%, respectively. Fewer than 40% of the 50 studies reported results by number of patients, reported clinical characteristics of patients, or used as a reference standard combined culture and clinical criteria. Studies that included bronchial specimens showed higher accuracy than studies that evaluated only sputum specimens or included gastric aspirates. Studies that did not report that tests were applied blindly showed higher accuracy than those reporting blind testing. Increased sensitivity due to the use of DNA purification methods was associated with decreased specificity. Studies published after 1995, using Amplicor or dUTP-UNG, were associated with an increase in specificity at the expense of lower sensitivity. We concluded that PCR is not consistently accurate enough to be routinely recommended for the diagnosis of SPT. However, PCR of bronchial specimens could be useful in highly suspicious SPT cases. Studies not reporting blind testing are likely to overestimate accuracy of PCR. Future evaluation of PCR accuracy should be conducted by patient and type of respiratory specimen, blindly, by using a reference standard that combines culture and clinical criteria and addresses the issue of how patient characteristics affect PCR accuracy.

* Corresponding author. Mailing address: Department of Epidemiology, School of Public Health, CB#7435, 2105F McGavran Greenberg Hall, Chapel Hill, NC 27599. Phone: (919) 966-9407. Fax: (919) 966-2089. E-mail: bill_miller{at}unc.edu.

Journal of Clinical Microbiology, July 2003, p. 3233-3240, Vol. 41, No. 7
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.7.3233-3240.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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