Assessment of the QuantiFERON-TB Gold In-Tube test for the detection of <i>Mycobacterium tuberculosis</i> infection in United States Navy recruits

<div><p>Background</p><p>Immunologic tests such as the tuberculin skin test (TST) and QuantiFERON^®-TB Gold In-Tube test (QFT-GIT) are designed to detect M<i>ycobacterium tuberculosis</i> infection, both latent <i>M</i>. <i>tuberculosis</i> infection (LTBI) and infection manifesting as active tuberculosis disease (TB). These tests need high specificity to minimize unnecessary treatment and high sensitivity to allow maximum detection and prevention of TB.</p><p>Methods</p><p>Estimate QFT-GIT specificity, compare QFT-GIT and TST results, and assess factor associations with test discordance among U.S. Navy recruits.</p><p>Results</p><p>Among 792 subjects with completed TST and QFT-GIT, 42(5.3%) had TST indurations ≥10mm, 23(2.9%) had indurations ≥15mm, 14(1.8%) had positive QFT-GIT results, and 5(0.6%) had indeterminate QFT-GITs. Of 787 subjects with completed TST and determinate QFT-GIT, 510(64.8%) were at low-risk for infection, 277(35.2%) were at increased risk, and none had TB. Among 510 subjects at low-risk (presumed not infected), estimated TST specificity using a 15mm cutoff, 99.0% (95%CI: 98.2–99.9%), and QFT-GIT specificity, 98.8% (95%CI: 97.9–99.8%), were not significantly different (p>0.99). Most discordance was among recruits at increased risk of infection, and most was TST-positive but QFT-GIT-negative discordance. Of 18 recruits with TST ≥15mm but QFT-GIT negative discordance, 14(78%) were at increased risk. TB prevalence in country of birth was the strongest predictor of positive TST results, positive QFT-GIT results, and TST-positive but QFT-GIT-negative discordance. Reactivity to <i>M</i>. <i>avium</i> purified protein derivative (PPD) was associated with positive TST results and with TST-positive but QFT-GIT-negative discordance using a 10 mm cutoff, but not using a 15 mm cutoff or with QFT-GIT results.</p><p>Conclusions</p><p><i>M</i>. <i>tuberculosis</i> infection prevalence was low, with the vast majority of infection occurring in recruits with recognizable risks. QFT-GIT and TST specificities were high and not significantly different. Negative QFT-GIT results among subjects with TST induration ≥15 mm who were born in countries with high TB prevalence, raise concerns.</p></div

Associations between selected subject characteristics and tuberculin skin test or QuantiFERON^®-TB Gold In-Tube test results.

<p>Associations between selected subject characteristics and tuberculin skin test or QuantiFERON^®-TB Gold In-Tube test results.</p

Test agreement.

<p>Test agreement.</p

Results for various cohort subsets.

<p>Results for various cohort subsets.</p

Outcomes of the QuantiFERON^®-TB Gold In-Tube test versus the tuberculin skin test among 856 U.S. Navy recruits who had blood collected and skin test placed.

<p>Outcomes of the QuantiFERON^®-TB Gold In-Tube test versus the tuberculin skin test among 856 U.S. Navy recruits who had blood collected and skin test placed.</p

Diagram of study participants and testing.

<p>QFT = QuantiFERON^®-TB test; QFT-G = QuantiFERON^®-TB Gold test; QFT-GIT = QuantiFERON^®-TB Gold In-Tube test; TST = tuberculin skin test.</p