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Comparison of a Whole-Blood Interferon Assay With Tuberculin Skin Testing for Detecting Latent Mycobacterium tuberculosis Infection

Gerald H. Mazurek, MD; Philip A. LoBue, MD; Charles L. Daley, MD; John Bernardo, MD; Alfred A. Lardizabal, MD; William R. Bishai, MD, PhD; Michael F. Iademarco, MD, MPH; James S. Rothel, PhD

JAMA. 2001;286:1740-1747.

Context  Identifying persons with latent tuberculosis infection (LTBI) is crucial to the goal of TB elimination. A whole-blood interferon (IFN-) assay, the QuantiFERON-TB test, is a promising in vitro diagnostic test for LTBI that has potential advantages over the tuberculin skin test (TST).

Objectives  To compare the IFN- assay with the TST and to identify factors associated with discordance between the tests.

Design and Setting  Prospective comparison study conducted at 5 university-affiliated sites in the United States between March 1, 1998 and June 30, 1999.

Participants  A total of 1226 adults (mean age, 39 years) with varying risks of Mycobacterium tuberculosis infection or documented or suspected active TB, all of whom underwent both the IFN- assay and the TST.

Main Outcome Measure  Level of agreement between the IFN- assay and the TST.

Results  Three hundred ninety participants (31.8%) had a positive TST result and 349 (28.5%) had a positive IFN- assay result. Overall agreement between the IFN- assay and the TST was 83.1% ( = 0.60). Multivariate analysis revealed that the odds of having a positive TST result but negative IFN- assay result were 7 times higher for BCG-vaccinated persons compared with unvaccinated persons. The IFN- assay provided evidence that among unvaccinated persons with a positive TST result but negative IFN- assay result, 21.2% were responding to mycobacteria other than M tuberculosis.

Conclusions  For all study participants, as well as for those being screened for LTBI, the IFN- assay was comparable with the TST in its ability to detect LTBI, was less affected by BCG vaccination, discriminated responses due to nontuberculous mycobacteria, and avoided variability and subjectivity associated with placing and reading the TST.

Author Affiliations: Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, and Pulmonary and Critical Care Division, Department of Medicine, Emory University School of Medicine (Drs Mazurek and Iademarco), Atlanta, Ga; Pulmonary and Critical Care Division, University of California at San Diego (Dr LoBue); Pulmonary and Critical Care Division, University of California at San Francisco (Dr Daley); Pulmonary Center, Boston University School of Medicine, Mass (Dr Bernardo); New Jersey Medical School National Tuberculosis Center, Newark (Dr Lardizabal); Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Md (Dr Bishai); and Biosciences Division, CSL Limited, Parkville, Australia (Dr Rothel). Dr LoBue is now with the Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Ga, and assigned to the San Diego County Tuberculosis Control Program; Dr Rothel is now with Cellestis Limited, St Kilda, Australia.

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