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Journal of Clinical Microbiology, October 1999, p. 3102-3107, Vol. 37, No. 10
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Multicenter Evaluation of the Abbott LCx Mycobacterium tuberculosis Ligase Chain Reaction Assay

Richard Lumb,1,* Kirsten Davies,2 David Dawson,3 Robert Gibb,3 Thomas Gottlieb,2 Clair Kershaw,4 Katherine Kociuba,4 Graeme Nimmo,3 Norma Sangster,1 Michele Worthington,4 and Ivan Bastian1

Infectious Diseases Laboratories, Institute of Medical and Veterinary Science, Adelaide, South Australia,1 Department of Microbiology and Infectious Diseases, Concord Hospital, Concord, New South Wales,2 Queensland Health Pathology Services, Brisbane, Queensland,3 and Department of Microbiology and Infectious Diseases, South Western Area Pathology Services, Liverpool, New South Wales,4 Australia

Received 2 April 1999/Returned for modification 10 May 1999/Accepted 28 June 1999

Four Australian hospital laboratories evaluated the performance of the Abbott LCx Mycobacterium tuberculosis assay with 2,347 specimens (2,083 respiratory and 264 nonrespiratory specimens) obtained from 1,411 patients. A total of 152 specimens (6.5%) were culture positive for Mycobacterium tuberculosis complex (MTBC); of these, 79 (52%) were smear positive. After resolution of discrepant data, the overall sensitivity, specificity, and positive and negative predictive values for the LCx assay were 69.7, 99.9, 99.1, and 97.7% respectively. For smear-positive respiratory specimens that were culture positive for MTBC, the values were 98.5, 100, 100, and 98.4%, respectively, while the values for smear-negative respiratory specimens were 41.5, 99.9, 96.4, and 98%, respectively. Relative operating characteristic curves were constructed to demonstrate the relationship between sensitivity and specificity for a range of possible cutoff values in the LCx assay. These graphs suggested that the assay sensitivity for respiratory samples could be increased from 70.2 to 78.6%, while the specificity would be reduced from 99.9 to 99.4% by inclusion of a grey zone (i.e., LCx assay values of between 0.2 and 0.99). An algorithm is presented for the handling of specimens with LCx assay values within this grey zone.

* Corresponding author. Mailing address: Mycobacterium Reference Laboratory, Infectious Diseases Laboratories, Institute of Medical and Veterinary Science, Box 14, Rundle Mall, Adelaide, South Australia, 5000. Phone: 08 8222 3579. Fax: 08 8222 3543. E-mail: richard.lumb{at}imvs.sa.gov.au.

Journal of Clinical Microbiology, October 1999, p. 3102-3107, Vol. 37, No. 10
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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