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Comparative performance evaluation of QIAreach QuantiFERON-TB and tuberculin skin test for diagnosis of tuberculosis infection in Viet Nam.

ABSTRACT: Current WHO-recommended diagnostic tools for tuberculosis infection (TBI) have well-known limitations and viable alternatives are urgently needed. We compared the diagnostic performance and accuracy of the novel QIAreach QuantiFERON-TB assay (QIAreach; index) to the QuantiFERON-TB Gold Plus assay (QFT-Plus; reference). The sample included 261 adults (≥ 18 years) recruited at community-based TB case finding events. Of these, 226 underwent Tuberculin Skin Tests and 200 returned for interpretation (TST; comparator). QIAreach processing and TST reading were completed at lower-level healthcare facilities. We conducted matched-pair comparisons for QIAreach and TST with QFT-Plus, calculated sensitivity, specificity and area under a receiver-operating characteristic curve (AUC), and analyzed concordant-/discordant-pair interferon-gamma (IFN-γ) levels. QIAreach sensitivity and specificity were 98.5% and 72.3%, respectively, for an AUC of 0.85. TST sensitivity (53.2%) at a 5 mm induration threshold was significantly below QIAreach, while specificity (82.4%) was statistically equivalent. The corrected mean IFN-γ level of 0.08 IU/ml and corresponding empirical threshold (0.05) of false-positive QIAreach results were significantly lower than the manufacturer-recommended QFT-Plus threshold (≥ 0.35 IU/ml). Despite QIAreach's higher sensitivity at equivalent specificity to TST, the high number of false positive results and low specificity limit its utility and highlight the continued need to expand the diagnostic toolkit for TBI.

SUBMITTER: Vo LNQ

PROVIDER: S-EPMC10502094 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Comparative performance evaluation of QIAreach QuantiFERON-TB and tuberculin skin test for diagnosis of tuberculosis infection in Viet Nam.

Vo Luan Nguyen Quang LNQ Tran Thi Thu Phuong TTP Pham Hai Quang HQ Nguyen Han Thi HT Doan Ha Thu HT Truong Huyen Thanh HT Nguyen Hoa Binh HB Nguyen Hung Van HV Pham Hai Thanh HT Dong Thuy Thi Thu TTT Codlin Andrew A Forse Rachel R Mac Tuan Huy TH Nguyen Nhung Viet NV

Scientific reports 20230914 1

Current WHO-recommended diagnostic tools for tuberculosis infection (TBI) have well-known limitations and viable alternatives are urgently needed. We compared the diagnostic performance and accuracy of the novel QIAreach QuantiFERON-TB assay (QIAreach; index) to the QuantiFERON-TB Gold Plus assay (QFT-Plus; reference). The sample included 261 adults (≥ 18 years) recruited at community-based TB case finding events. Of these, 226 underwent Tuberculin Skin Tests and 200 returned for interpretation ...[more]

PMID: 37709844

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Project description:BackgroundWorld Health Organization (WHO) recommends systematic screening of high-risk populations, including household contacts (HHCs) of adult pulmonary tuberculosis (TB) patients, as a key strategy for elimination of TB. QuantiFERON-TB Gold In-Tube (QFT-GIT) assay and tuberculin skin test (TST) are two commonly used tools for the detection of latent tuberculosis infection (LTBI) but may yield differential results, affecting eligibility for TB preventive therapy.Materials and methodsA prospective cohort study of adult pulmonary TB patients and their HHCs were recruited in 2 cities of India, Pune and Chennai. HHCs underwent QFT-GIT (QIAGEN) and TST (PPD SPAN 2TU/5TU). A positive QFT-GIT was defined as value ≥0.35 IU/ml and a positive TST as an induration of ≥5 mm. A secondary outcome of TST induration ≥10mm was explored. Proportion positive by either or both assays, discordant positives and negatives were calculated; test concordance was assessed using percentage agreement and kappa statistics; and risk factors for concordance and discordance including age categories were assessed using logistic regression. Sensitivity and specificity was estimated by latent class model.ResultsOf 1048 HHCs enrolled, 869 [median (IQR) age: 27 years (15-40)] had both TST and QFT-GIT results available and prevalence of LTBI by QFT-GIT was 54% [95% CI (51, 57)], by TST was 55% [95% CI (52, 58)], by either test was 74% [95% CI (71, 77) and by both tests was 35% [95% CI (31, 38)]. Discordance of TST+/QFT-GIT- was 21% while TST-/QFT-GIT+ was 26%. Poor to fair agreement occurred with TST 5mm or 10mm cutoff (60 and 61% agreement with kappa value of 0.20 and 0.25 respectively). Test agreement varied by age, TST strength and induration cut-off. In multivariate analysis, span PPD was a risk factor for QFT-GIT+ and TST- while absence of BCG scar was for TST+ and QFT-GIT-. Being employed and exposure to TB case outside the household case were associated with positivity by both the tests. Sensitivity of TST and QFT-GIT to diagnose LTBI was 77% and 69%. Probability of having LTBI was >90% when both tests were positive irrespective of exposure gradient.ConclusionPrevalence of LTBI among HHCs of adult pulmonary TB patients in India is very high and varies by test type, age, and exposure gradient. In our high TB burden setting, a strategy to treat all HHCs or a targeted strategy whereby an exposure index is used should be assessed in future preventive therapy and vaccine studies as HHCs have several factors that place them at high risk for progression to TB disease.

Project description:BACKGROUND: Interferon-gamma release assays have emerged as a more specific alternative to the tuberculin skin test (TST) for detection of tuberculosis (TB) infection, especially in Bacille Calmette-Guérin (BCG) vaccinated people. We determined the prevalence of Mycobacterium tuberculosis infection by TST and QuantiFERON®-TB Gold In-Tube (QFT-GIT) and assessed agreement between the two test methods and factors associated with positivity in either test in Warao Amerindian children in Venezuela. Furthermore, progression to active TB disease was evaluated for up to 12 months. METHODS: 163 HIV-negative childhood household contacts under 16 years of age were enrolled for TST, QFT-GIT and chest X-ray (CXR). Follow-up was performed at six and 12 months. Factors associated with TST and QFT-GIT positivity were studied using generalized estimation equations logistic regression models. RESULTS: At baseline, the proportion of TST positive children was similar to the proportion of children with a positive QFT-GIT (47% vs. 42%, p = 0.12). Overall concordance between QFT-GIT and TST was substantial (kappa 0.76, 95% CI 0.46-1.06). Previous BCG vaccination was not associated with significantly increased positivity in either test (OR 0.68, 95% CI 0.32-1.5 for TST and OR 0.51, 95% CI 0.14-1.9 for QFT-GIT). Eleven children were diagnosed with active TB at baseline. QFT-GIT had a higher sensitivity for active TB (88%, 95% CI 47-98%) than TST (55%, 95% CI 24-83%) while specificities were similar (respectively 58% and 55%). Five initially asymptomatic childhood contacts progressed to active TB disease during follow-up. CONCLUSION: Replacement of TST by the QFT-GIT for detection of M. tuberculosis infection is not recommended in this resource-constrained setting as test results showed substantial concordance and TST positivity was not affected by previous BCG vaccination. The QFT-GIT had a higher sensitivity than the TST for the detection of TB disease. However, the value of the QFT-GIT as an adjunct in diagnosing TB disease is limited by a high variability in QFT-GIT results over time.

Project description:Tumor-necrosis-factor-α inhibitors (anti-TNF-α) are associated with an increased risk of tuberculosis (TB) disease, primarily due to reactivation of latent TB infection (LTBI). We assessed the performance of parallel LTBI screening with tuberculin skin test (TST) and QuantiFERON-TB Gold In-Tube assays (QFT-GIT) before anti-TNF-α treatment in children with immune-mediated inflammatory disorders in a low TB-burden setting. We conducted a multicenter cohort study involving 17 pediatric tertiary centers in Spain. LTBI was defined as the presence of a positive TST and/or QFT-GIT result without clinical or radiological signs of TB disease. A total of 270 patients (median age:11.0 years) were included, mainly with rheumatological (55.9%) or inflammatory bowel disease (34.8%). Twelve patients (4.4%) were diagnosed with TB infection at screening (LTBI, n = 11; TB disease, n = 1). Concordance between TST and QFT-GIT results was moderate (TST+/QFT-GIT+, n = 4; TST-/QFT-GIT+, n = 3; TST+/QFT-GIT-, n = 5; kappa coefficient: 0.48, 95% CI: 0.36-0.60). Indeterminate QFT-GIT results occurred in 10 patients (3.7%) and were associated with young age and elevated C-reactive protein concentrations. Eleven of 12 patients with TB infection uneventfully completed standard LTBI or TB treatment. During a median follow-up period of 6.4 years, only 2 patients developed TB disease (incidence density: 130 (95% CI: 20-440) per 100,000 person-years), both probable de novo infections.ConclusionA substantial number of patients were diagnosed with LTBI during screening. The dual strategy identified more cases than either of the tests alone, and test agreement was only moderate. Our data show that in children in a low TB prevalence setting, a dual screening strategy with TST and IGRA before anti-TNF-α treatment is effective.What is known• The optimal screening strategy for latent tuberculosis in children with immune-mediated inflammatory disorders remains uncertain. • Children receiving anti-TNF-α drugs are at increased risk of developing severe tuberculosis disease.What is new• A dual screening strategy, using TST and an IGRA assay, identified more children with latent tuberculosis than either of the tests alone. • Identification and treatment of latent tuberculosis before initiation of anti-TNF-α therapy averted incident tuberculosis cases.

Dataset Information

Comparative performance evaluation of QIAreach QuantiFERON-TB and tuberculin skin test for diagnosis of tuberculosis infection in Viet Nam.

Publications

Comparative performance evaluation of QIAreach QuantiFERON-TB and tuberculin skin test for diagnosis of tuberculosis infection in Viet Nam.

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