Indeterminate T-SPOT.TB Test Results in Patients with Suspected Extrapulmonary Tuberculosis in Routine Clinical Practice.

Abstract

BACKGROUND:

The two interferon-γ release assays such as QuantiFERON-TB Gold / In-Tube (QFT-TB) and T-SPOT.TB-are useful tools for the rapid diagnosis of tuberculosis (TB) but can yield indeterminate test results (ITRs). While some studies have identified risk factors for ITRs in the QFT-TB test, there have been few such studies for the T-SPOT.TB test. The aim of this study was to investigate the risk factors associated with ITRs in the T-SPOT.TB test.

MATERIALS AND METHODS:

From April 2008 to August 2010, all patients with suspected extrapulmonary tuberculosis (E-TB) were enrolled in a tertiary hospital in Korea. ITR was defined as < 20 spots in the positive control well or > 10 spots in the negative control well.

RESULTS:

Out of a total of 368 patients, 32 (8.7%, 95% CI, 6.0% to 11.7%) had ITRs in their T-SPOT.TB tests. The ITRs were due to a low mitogen response in 13 (40.6%) patients and to a high nil response in the other 19 (59.4%) patients. Statistical analysis revealed that old age, underlying diseases, immunosuppressive treatment, lymphopenia, and clinical manifestations of E-TB were not significantly associated with ITRs.

CONCLUSIONS:

Indeterminate results in the T-SPOT.TB test are not affected by age, underlying disease, immunosuppressive treatment, lymphopenia, or clinical manifestations of E-TB, which are known risk factors for indeterminate results in the QFT-TB test.

• Authors: Yu-Mi Lee, Sun-Mi Kim, Su Jin Park, Ki-Ho Park, Sang-Oh Lee, Sang-Ho Choi, Yang Soo Kim, Jun Hee Woo, Sung-Han Kim
• Journal: Infection & chemotherapy (Infect Chemother) Vol. 45 Issue 1 Pg. 44-50 (Mar 2013) ISSN: 2093-2340 [Print] Korea (South)
• PMID: 24265949 (Publication Type: Journal Article)