Tuberculosis (TB) caused byApproximately nine million new cases of disease and over two million deaths result from tuberculosis (TB) each year (29,56). It is estimated that over one-third of the world's population is infected, with ϳ95% of all cases occurring in developing countries. Global measures attempting to reduce the transmission of TB are currently in place.An essential component of TB control efforts is to identify and treat individuals with active TB disease. The ability to correctly identify individuals with latent TB infection who will progress to active TB disease is vital to this goal (9, 49). Current test procedures are inadequate to accurately detect and identify active TB disease (14,27,30,31,41,44). These shortcomings result in the unnecessary treatment of many individuals who may not need it (3,17,32,45). While the tuberculin skin test (TST) and the QuantiFERON-TB Gold (QFT-G), the traditional methods for latent TB infection screening, rely on the cell-mediated response, the humoral response appears to correlate with the progression of the infection to active TB disease (5,6,11,15,20,21).Many studies have been conducted to evaluate the utility of individual specific Mycobacterium tuberculosis antigens for detecting antibodies in patients with active TB disease (1,7,10,11,20,21,25,26,29,38,39,45,46). Several of these antigens have been developed into commercial assays capable of detecting M. tuberculosis antibodies (4,28,35,53). This study evaluates three commercially available enzyme-linked immunosorbent assays (ELISAs) for their ability to detect immunoglobulin G (IgG) antibodies to M. tuberculosis in patients with active TB disease.
MATERIALS AND METHODSHuman sera. The procedures followed were in accordance with the ethical standards established by the University of Utah and are in accordance with the Helsinki Declaration of 1975. This study was approved by the Institutional Review Board of the University of Utah, IRB 17152. All patient samples included in this study were deidentified to meet the Health Information Portability and Accountability Act (HIPAA) patient confidentiality guidelines.Serum samples were stored at Ϫ70°C until testing commenced and were then stored at 2 to 8°C while testing was performed. The whole-blood samples were processed immediately after collection. Samples with discrepant results were tested again by each respective assay to ensure reproducibility. A total of 209 samples were used and divided into four groups.Risk factors that were evaluated for exposure to TB included work in the health care field, laboratory work (especially in mycobacteriology laboratories and specimen processing), immigration from or travel to an country where TB is endemic, and exposure to persons with known active disease. Work in a mycobacteriology laboratory, exposure to a known active case, or immigration from a country where TV is endemic were considered high risk for exposure. Work in a health care field was considered moderate risk.Group I serum samples consisted of 88 samples from h...