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Limited added value of T-SPOT.TB blood test in diagnosing active TB: a prospective bayesian analysis.

ABSTRACT: To determine the diagnostic value of a blood interferon-gamma release assay in suspected active tuberculosis (TB).136 subjects with suspected pulmonary TB (pTB) at a single London centre with intermediate TB incidence, were clinically graded into low (<25%), medium, or high (>75%) likelihood of active pTB and then tested by T-SPOT®.TB assay. The diagnosis was confirmed by culture (n = 33), treatment response (n = 13) or a firm alternative diagnosis (n = 90).Overall, the T-SPOT.TB sensitivity was 74% (95% confidence intervals 60-84%), positive predictive value (PPV) 56% (43-68%), negative predictive value (NPV) 83% (71-90%), positive likelihood ratio (PLR) 1.75 and negative likelihood ratio (NLR) 0.45. Results for high pTB likelihood subjects: PPV 100%, NPV 25% (7-60%), PLR >69, NLR 0.31. Results for intermediate pTB likelihood subjects: PPV 67% (41-85%), NPV 88% (65-96%), PLR 2.39, NLR 0.26. Results for low pTB likelihood subjects: PPV 15% (6-34%), NPV 92% (79-97%), PLR 1.23, NLR 0.80. False negatives occurred in 24% of cases of active tuberculosis (4 smear and culture-positive, 3 smear negative and culture-positive, and 4 culture negative).The predictive values and likelihood ratios show the T-SPOT.TB test does not assist in confidently confirming or excluding active TB, regardless of the pre-test probability of disease.

SUBMITTER: Boyd AE

PROVIDER: S-EPMC3116095 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Limited added value of T-SPOT.TB blood test in diagnosing active TB: a prospective bayesian analysis.

Boyd Aileen E AE Ashcroft Anthony A Lipman Marc M Bothamley Graham H GH

The Journal of infection 20110415 6

<h4>Objectives</h4>To determine the diagnostic value of a blood interferon-gamma release assay in suspected active tuberculosis (TB).<h4>Methods</h4>136 subjects with suspected pulmonary TB (pTB) at a single London centre with intermediate TB incidence, were clinically graded into low (<25%), medium, or high (>75%) likelihood of active pTB and then tested by T-SPOT®.TB assay. The diagnosis was confirmed by culture (n = 33), treatment response (n = 13) or a firm alternative diagnosis (n = 90).<h4 ...[more]

PMID: 21570124

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Project description:BackgroundDiagnosing an anterior cruciate ligament (ACL) rupture based on a physical examination remains a challenge for both surgeons and physical therapists. The lever sign test was developed to overcome the practical limitations of other tests and to optimize diagnosis. An evaluation of the measurement properties of the lever sign test is needed to make adequate interpretations in practice.PurposeTo evaluate the reliability and diagnostic value of the lever sign test.Study designCohort study (diagnosis); Level of evidence, 2.MethodsA total of 94 patients were recruited between November 2014 and July 2016. Patients were included if they were at least 16 years old, suffered from knee trauma, and had indications for knee arthroscopic surgery. Lever sign, anterior drawer, Lachman, and pivot-shift test outcomes were examined by an orthopaedic/trauma surgeon and a physical therapist. A test-retest design was used to investigate interrater reliability. Moreover, the lever sign test outcomes, alone and in combination with the other diagnostic tests, were compared with arthroscopic results, which served as the gold standard for the test's diagnostic value.ResultsThe lever sign test and pivot-shift test had kappa values exceeding 0.80 for interrater reliability. The kappa values for the anterior drawer test and Lachman test were 0.80 and 0.77, respectively. The lever sign test showed the highest specificity (100%) and the lowest sensitivity (39%) when compared with the other 3 tests. Moreover, its positive and negative predictive values were 100% and 65%, respectively, while an accuracy of 71% was calculated. Clustering the lever sign test parallel with the other 3 tests resulted in the highest accuracy of 91%.ConclusionThe lever sign test appears to have high interrater reliability and is the most specific test, showing a maximal positive predictive value. A positive lever sign test result indicates an ACL rupture. These results support the added value of the lever sign test for diagnosing ACL ruptures.

Project description:BackgroundTackling tuberculosis requires testing and treatment of latent tuberculosis in high-risk groups. The aim of this study was to estimate the predictive values of the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs) for the development of active tuberculosis in high-risk groups-ie, people in recent contact with active tuberculosis cases and from high-burden countries.MethodIn this prospective cohort study, we recruited participants from 54 centres (eg, clinics, community settings) in London, Birmingham, and Leicester in the UK. Participants were eligible if they were aged 16 years or older and at high risk for latent tuberculosis infection (ie, recent contact with someone with active tuberculosis [contacts] or a migrant who had arrived in the UK in the past 5 years from-or who frequently travelled to-a country with a high burden of tuberculosis [migrants]). Exclusion criteria included prevalent cases of tuberculosis, and participants who were treated for latent tuberculosis after a positive test result in this study. Each participant received three tests (QuantiFERON-TB Gold-In Tube, T-SPOT.TB, and a Mantoux TST). A positive TST result was reported using three thresholds: 5 mm (TST-5), 10 mm (TST-10), and greater than 5 mm in BCG-naive or 15 mm in BCG-vaccinated (TST-15) participants. Participants were followed up from recruitment to development of tuberculosis or censoring. Incident tuberculosis cases were identified by national tuberculosis databases, telephone interview, and review of medical notes. Our primary objective was to estimate the prognostic value of IGRAs compared with TST, assessed by the ratio of incidence rate ratios and predictive values for tuberculosis development. The study was registered with ClinicalTrials.gov, NCT01162265, and is now complete.FindingsBetween May 4, 2010, and June 1, 2015, 10 045 people were recruited, of whom 9610 were eligible for inclusion. Of this cohort, 4861 (50·6%) were contacts and 4749 (49·4%) were migrants. Participants were followed up for a median of 2·9 years (range 21 days to 5·9 years). 97 (1·0%) of 9610 participants developed active tuberculosis (77 [1·2%] of 6380 with results for all three tests). In all tests, annual incidence of tuberculosis was very low in those who tested negatively (ranging from 1·2 per 1000 person-years, 95% CI 0·6-2·0 for TST-5 to 1·9 per 1000 person-years, 95% CI 1·3-2·7, for QuantiFERON-TB Gold In-Tube). Annual incidence in participants who tested positively were highest for T-SPOT.TB (13·2 per 1000 person-years, 95% CI 9·9-17·4), TST-15 (11·1 per 1000 person-years, 8·3-14·6), and QuantiFERON-TB Gold In-Tube (10·1 per 1000 person-years, 7·4-13·4). Positive results for these tests were significantly better predictors of progression than TST-10 and TST-5 (eg, ratio of test positivity rates in those progressing to tuberculosis compared with those not progressing T-SPOT.TB vs TST-5: 1·99, 95% CI 1·68-2·34; p<0·0001). However, TST-5 identified a higher proportion of participants who progressed to active tuberculosis (64 [83%] of 77 tested) than all other tests and TST thresholds (≤75%).InterpretationIGRA-based or BCG-stratified TST strategies appear most suited to screening for potential disease progression among high-risk groups. Further work will be needed to assess country-specific cost-effectiveness of each screening test, and in the absence of highly specific diagnostic tests, cheap non-toxic treatments need to be developed that could be given to larger groups of people at potential risk.FundingNational Institute for Health Research Health Technology Assessment Programme 08-68-01.

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Limited added value of T-SPOT.TB blood test in diagnosing active TB: a prospective bayesian analysis.

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Limited added value of T-SPOT.TB blood test in diagnosing active TB: a prospective bayesian analysis.

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