Indeterminate QuantiFERON®-TB Gold Results in a Public Health Clinic Setting.

Abstract

SETTING: Public chest clinics, New York City. OBJECTIVE: To evaluate the association between patient characteristics and indeterminate QuantiFERON ® TB Gold (QFT-G) results and describe follow-up testing. DESIGN: Retrospective cross-sectional multivariate logistic regression analyses of patients receiving QFT-G from October 2006 to June 2008. Analyses were performed separately depending on whether the indeterminate result was due to positive (low mitogen) or negative (high nil) control failure. RESULTS: Of 28 864 individuals tested, 2058 (7%) tested positive, 26 284 (91%) negative, and 522 (2%) were indeterminate (low mitogen, n = 264; high nil, n = 258). Low mitogen results were more frequent among those aged < 10 years (OR(adj) 3.7, 95%CI 2.4-5.9), females (OR(adj) 1.4, 95%CI 1.1-1.8), Asians (OR(adj) 2.1, 95%CI 1.3-3.4) and the US-born (OR(adj) 1.9, 95%CI 1.4-2.6) and less frequent among Hispanics (OR(adj) 0.6, 95%CI 0.4-1.0). High nil results were more frequent among Hispanics (OR(adj) 1.7, 95%CI 1.0-2.8) and less frequent among the US-born (OR(adj) 0.6, 95%CI 0.5- 0.8). Among patients who received a repeat QFT-G (n = 137), 4% tested positive, 64% negative and 32% had a second indeterminate result, always of the same type. CONCLUSION: Age, race/ethnicity and sex were associated with indeterminate QFT-G results. Most follow-up tests were negative, although a modest proportion were repeatedly indeterminate. Further studies evaluating the mechanisms of QFT-G indeterminate results are needed.