Karen Rego1, Kristen Pereira1, James MacDougall2, William Cruikshank3. 1. Oxford Immunotec, 700 Nickerson Rd, Marlborough, MA 01752, USA. 2. BioBridges, 167 Worcester St, Wellesley, MA 02481, USA. 3. Oxford Immunotec, 700 Nickerson Rd, Marlborough, MA 01752, USA. Electronic address: WCruikshank@oxfordimmunotec.com.
Abstract
BACKGROUND: Accurate identification of individuals with TB infection, is required to achieve the WHO's End TB Strategy goals. While there is general acceptance that the T-SPOT.TB test borderline category provides an opportunity to increase test resolution of results around the test cut-off point, this has not been investigated. METHODS: 645,947 tests were analyzed to determine frequency of borderline results, effect of age and time between tests and associations between subjects' clinical risk factors and retest results. RESULTS: 645,947 tests produced 93.5% negatives, 4% positives, 0.6% invalids, and 1.8% borderlines. Within the borderline results, 5044 were repeated, with 59.2%, 20.0% and 20.2% resolving to negative, positive and borderline, respectively. Age of subject did not affect retest results; however, time between tests indicated that retest resolution occurred with greatest frequency after 90 days. TB risk factors were provided for 2640 subjects and 17% of low risk subjects with a high initial borderline resolved to negative while 27.6% of subjects with high risk and an initial low borderline resolved to positive, suggesting that these subjects could have been inappropriately classified if using a single cut-off point test with no borderline category. CONCLUSION: This study demonstrates the utility of the T-SPOT.TB test's borderline category to increase test resolution around the test cut-off point.
BACKGROUND: Accurate identification of individuals with TB infection, is required to achieve the WHO's End TB Strategy goals. While there is general acceptance that the T-SPOT.TB test borderline category provides an opportunity to increase test resolution of results around the test cut-off point, this has not been investigated. METHODS: 645,947 tests were analyzed to determine frequency of borderline results, effect of age and time between tests and associations between subjects' clinical risk factors and retest results. RESULTS: 645,947 tests produced 93.5% negatives, 4% positives, 0.6% invalids, and 1.8% borderlines. Within the borderline results, 5044 were repeated, with 59.2%, 20.0% and 20.2% resolving to negative, positive and borderline, respectively. Age of subject did not affect retest results; however, time between tests indicated that retest resolution occurred with greatest frequency after 90 days. TB risk factors were provided for 2640 subjects and 17% of low risk subjects with a high initial borderline resolved to negative while 27.6% of subjects with high risk and an initial low borderline resolved to positive, suggesting that these subjects could have been inappropriately classified if using a single cut-off point test with no borderline category. CONCLUSION: This study demonstrates the utility of the T-SPOT.TB test's borderline category to increase test resolution around the test cut-off point.
Authors: Friederike von Streit; Christoph Bartels; Thorsten Kuczius; Christoph Cassier; Joachim Gardemann; Frieder Schaumburg Journal: PLoS One Date: 2019-03-26 Impact factor: 3.240
Authors: Tae Yeul Kim; Ho Eun Chang; Seong-Wook Lee; Soo Hyun Seo; Yun Ji Hong; Jeong Su Park; Kyoung Un Park Journal: PLoS One Date: 2019-09-25 Impact factor: 3.240