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Journal of Clinical Microbiology, December 1998, p. 3601-3604, Vol. 36, No. 12
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Comparative Evaluation of the New Gen-Probe Mycobacterium tuberculosis Amplified Direct Test and the Semiautomated Abbott LCx Mycobacterium tuberculosis Assay for Direct Detection of Mycobacterium tuberculosis Complex in Respiratory and Extrapulmonary Specimens

Claudio Piersimoni,1,* Annapaola Callegaro,2 Claudio Scarparo,3 Valeria Penati,4 Domenico Nista,1 Stefano Bornigia,1 Carla Lacchini,4 Mariuccia Scagnelli,3 Gianfranco Santini,2 and Giuseppina De Sio1

Department of Clinical Microbiology, General Hospital Umberto I°-Torrette, Ancona,1 Microbiology-Immunology Service, Pordenone General Hospital, Pordenone,2 Clinical Microbiology Laboratory, San Bortolo Hospital, Vicenza,3 and Institute for Chest Disease and Reference Mycobacteriology Laboratory Villa Marelli, Milan,4 Italy

Received 27 May 1998/Returned for modification 23 July 1998/Accepted 16 September 1998

Two commercial assays that detect Mycobacterium tuberculosis complex (MTB) in clinical specimens by rRNA target amplification (AMTDII) and ligase chain reaction (LCx) were evaluated. The tests were applied to 457 respiratory (n = 273) and extrapulmonary (n = 184) specimens collected from 357 patients. The results were compared with those of acid-fast staining and culture. The combination of culture and clinical diagnosis was considered to be the "gold standard." Seventy specimens were from patients with pulmonary tuberculosis and 28 specimens were from patients with extrapulmonary tuberculosis. After resolution of discrepant results, the overall sensitivities, specificities, and positive and negative predictive values for respiratory specimens were 92.8, 99.4, 98.5, and 97%, respectively, for AMTDII and 75.7, 98.8, 96.4, and 90.5%, respectively, for LCx. With extrapulmonary specimens, the overall sensitivities, specificities, and positive and negative predictive values were 78.6, 99.3, 95.6, and 96.2%, respectively, for AMTDII and 53.6, 99.3, 93.7, and 92.1%, respectively, for LCx. The level of agreement between AMTDII and LCx assay results was 78.2%. We conclude that although both nucleic acid amplification methods are rapid and specific for the detection of MTB in clinical specimens, AMTDII is significantly more sensitive than LCx with both respiratory (P = 0.005) and extrapulmonary (P = 0.048) specimens.

* Corresponding author. Mailing address: Department of Clinical Microbiology, General Hospital Umberto I°-Torrette, Via Conca, Ancona, I-60020, Italy. Phone: 39-71-596.4285. Fax: 39-71-596.4184. E-mail: piersim{at}tin.it.

Journal of Clinical Microbiology, December 1998, p. 3601-3604, Vol. 36, No. 12
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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