Infect Chemother.  2013 Mar;45(1):44-50.

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

• Lee YM
• Kim SM
• Park SJ
• Park KH
• Lee SO
• Choi SH
• Kim YS
• Woo JH
• Kim SH

Abstract

BACKGROUND
The two interferon-gamma 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.

Keyword

Tuberculosis; ELISPOT; Indeterminate response

MeSH Terms

Enzyme-Linked Immunospot Assay
Humans
Interferon-gamma Release Tests
Korea
Lymphopenia
Risk Factors
Tertiary Care Centers
Tuberculosis

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