Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult

Aims-To assess the performance of three commercially available Mycobacterium tuberculosis detection systems employing nucleic acid amplification, when applied directly to respiratory and nonrespiratory specimens from patients where the diagnosis of tuberculosis is difficult using clinical and traditional bacteriological methods. Methods-42 respiratory Emd 21 nonrespiratory specimens were concentrated, examined with auramine staining, and cultured on Lowenstein-Jensen slopes. These specimens were also assayed using the Amplicor Mycobacterium tuberculosis test (AM) (Roche Diagnostic Systems), the Amplified Mycobacterium tuberculosis direct test (AMD) (Gen-Probe), and the LCx Mycobacterium tuberculosis assay (LMA) (Abbott Laboratories). Results-All three amplification systems used in this study gave specificities of 100% when used on respiratory specimens. When used ion non-respiratory specimens, AM and LMA gave specificities of 100% and AMD 75%. With respiratory specimens the AIM, AMD, and LMA systems gave sensitivities of 75%, 65.2%, and 79.2%, respectively. With nonrespiratory specimens the sensitivities were 50%, 66.7%, and 60%, while with smear negative, culture positive specimens they were 33.3%, 66.7%, and 55.6%. Positive predictive values of 100% were seen with all specimens except nonrespiratory specimens assayed using AMD where the value was 66.7%. Conclusions-The manufacturers of these systems recommend that they should only be used for the direct analysis of respiratory specimens, and the US Food and Drug Administration has approved them for use only with smear positive specimens. This study confirms that sensitivities are lower for non-respiratory and smear negative specimens, but positive predictive values sere high. Provided they are interpreted with caution, positive results with these tests in respiratory and non-respiratory specimens are useful in tuberculous patients who are otherwise difficult to diagnose. Each amplification has advantages and disadvantages com; pared with the others.