Clinical suspicion as a primary guidance to use commercial amplification tests for rapid diagnosis of pulmonary tuberculosis.

The Abbott LCx (Abbott Park, IL) Mycobacterium tuberculosis complex is a commercial amplification assay discontinued from the European market in 2002. A prospective clinical study was carried out to evaluate the clinical utility of the above test as applied by specialists for the rapid diagnosis of active pulmonary tuberculosis (PTB). According to the physician's clinical judgment, patients were classified into 3 groups (low, intermediate, and high) aiming to estimate the probability of active disease. The gold standard for final diagnosis was based on microbiologic and clinical information including data from a 6-month follow-up period. Sensitivities and specificities of rapid microbiologic tests were compared with those based on an integrated approach including clinical evaluation plus the above tests. The incidence of PTB in 214 patients was 13.1%. The basis for initial treatment of PTB was smear-positive results in 46%, positive LCx results in 29%, and clinical suspicion in 18%. For the remaining 7%, therapy was started upon receipt of culture results. The sensitivity, specificity, and positive and negative predictive values of the LCx assay were 68%, 99%, 95%, and 95%, respectively. In comparison, they were 93%, 99%, 96%, and 99%, respectively, for the combination of clinical evaluation plus the LCx test. It is concluded that in patients with high-to-moderate pretest probabilities, the combination of clinical judgment and amplification results strongly enhances a rapid and correct diagnosis of PTB.