scholarly journals 655. Patterns of Interferon-Gamma Release Assay (IGRA) Testing for Tuberculosis in Patients Less Than 2 Years Old

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S429-S430
Author(s):  
Mary Tabatneck ◽  
Jeffrey Campbell ◽  
Mingwei Sun ◽  
Wei He ◽  
Gabriella S Lamb ◽  
...  
Keyword(s):  
Primary Care ◽  
Interferon Gamma ◽  
Pearson Correlation ◽  
Negative Control ◽  
Interferon Gamma Release Assay ◽  
Igra Test ◽  
Inpatient Settings ◽  
Control Failure ◽  
Release Assay ◽  
Outpatient Settings

Abstract Background The American Academy of Pediatrics recommends use of Interferon-Gamma Release Assays (IGRAs) to diagnose tuberculosis (TB) infection in patients ≥2 years old. However, IGRAs are not currently recommended in younger patients due to limited data and concerns of invalid/indeterminate test results, which occur if there is a positive or negative control failure. We sought to characterize the patterns of IGRA use in clinical practice and results of IGRAs in patients < 2 years old. Methods We conducted a retrospective cohort study of children < 2 years old at two large health systems in the Boston area who had IGRA and/or tuberculin skin test (TST) performed from October 1, 2015 – January 31, 2021. We reviewed medical records to determine IGRA test type, IGRA result (positive, negative, invalid/indeterminate) and location of testing (outpatient primary care, outpatient subspecialty, inpatient). We summarized test interpretability, location, and changes in proportion of IGRA vs. TST. Results We identified 330 IGRA (268 T-SPOT.TB, 62 QuantiFERON Gold) and 2029 TST results among 1982 patients who were < 2 years old (range: 11 days – 1.9 years). Monthly proportion of IGRAs among all TB tests ordered increased from 2015 to 2021 (Figure 1) (Pearson correlation coefficient 0.85, P < 0.001). Among IGRA results, 314 (95%) were negative, 3 (1%) were positive, and 13 (4%) were invalid/indeterminate (11 T-SPOT.TB, 2 QuantiFERON Gold). Of 324 IGRA tests for which testing location was known, 233 (72%) and 91 (28%) were ordered in outpatient and inpatient settings, respectively. Of tests in outpatient settings, 132 (57%) were ordered in primary care offices, 53 (23%) were ordered in subspecialist offices, and 48 (21%) were obtained in outpatient labs of unidentified clinics. Tuberculosis infection tests and proportion IGRA. Total number of tests and proportion of IGRA:TST obtained by month, from October 2015-January 2021. Conclusion While most TB infection tests in this age group were TSTs, the monthly proportion of tests that were IGRAs increased over time between 2015-2021. IGRAs were obtained in varied clinical settings. In this low-burden setting, rates of invalid/indeterminate IGRAs were low among children < 2 years old, which suggests that IGRAs are reasonable TB testing options for patients < 2 years old, and may be preferred given limitations of TSTs. Disclosures Gabriella S. Lamb, MD, MPH, Nothing to disclose

scholarly journals Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 652 ◽  
Author(s):  
Artem P. Tkachuk ◽  
Evgeniia N. Bykonia ◽  
Liubov I. Popova ◽  
Denis A. Kleymenov ◽  
Maria A. Semashko ◽  
...  
Keyword(s):  
Interferon Gamma ◽  
Phase Ii ◽  
Intracellular Cytokine Staining ◽  
Study Drug ◽  
Controlled Study ◽  
Interferon Gamma Release Assay ◽  
Double Blind ◽  
Igra Test ◽  
Th1 Cytokine ◽  
Release Assay

GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette–Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4+ T-cells, and IgG responses and results support further clinical testing of GamTBvac.

scholarly journals The Relationship between Pre-Pandemic Interferon Gamma Release Assay Test Results and COVID-19 Infection: Potential Prognostic Value of Indeterminate IFN-γ Release Assay Results

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Sermin Borekci ◽  
Fatma Gulsum Karakas ◽  
Serhat Sirekbasan ◽  
Bahar Kubat ◽  
Rıdvan Karaali ◽  
...  
Keyword(s):  
Interferon Gamma ◽  
Smoking History ◽  
Interferon Gamma Release Assay ◽  
Test Results ◽  
Obstructive Pulmonary Disease ◽  
Igra Test ◽  
Release Assay ◽  
Ifn Γ ◽  
Artery Disease ◽  
The Relationship

Objective. To reveal the relationship between interferon-gamma release assay (IGRA) test (Standard ETB-Feron ELISA (TBF)) results performed within 12 months before the COVID-19 pandemic and the frequency of COVID-19 infections and the severity of COVID-19. Methods. The retrospective TBF test results and contact information of 684 patients aged over 18 years who underwent TBF testing between March 11th, 2019, and March 10th, 2020, were obtained. Of the 684 patients contacted by phone, 365 agreed to participate in the study and were enrolled. The patients were divided into three groups (TBF test positive, negative, and indeterminate). The data obtained from the questionnaire were compared statistically. Results. According to the TBF test results, positive (n = 51, 14%), negative (n = 286, 78.3%), and indeterminate (n = 28, 7.7%) groups were compared. The frequency of COVID-19 infections in the indeterminate group was found significantly higher than that in the positive and negative groups ( p = 0.005 ). When the group with COVID-19 (n = 46, 12.6%) was compared with the group without (n = 319, 87.4%), no difference was found in terms of age, sex, body mass index, smoking history and number of cigarettes smoked, TB history, diabetes mellitus, hypertension, coronary artery disease, and biologic and corticosteroid therapy use. Only the frequency of obstructive pulmonary disease was significantly higher in the group without COVID-19 ( p = 0.033 ). Conclusion. The frequency of COVID-19 infection was increased in patients with indeterminate TBF test results. Indeterminate TBF test results may be a guide in terms of risk stratification in groups at risk for COVID-19.

scholarly journals Interferon-gamma release assay levels and risk of progression to active tuberculosis: a systematic review and dose-response meta-regression analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jorge R. Ledesma ◽  
Jianing Ma ◽  
Peng Zheng ◽  
Jennifer M. Ross ◽  
Theo Vos ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Interferon Gamma ◽  
Dose Response ◽  
Active Tuberculosis ◽  
Interferon Gamma Release Assay ◽  
Igra Test ◽  
Risk Of Progression ◽  
Release Assay ◽  
Meta Regression ◽  
Meta Regression Analysis

Abstract Background Identifying and treating individuals with high risk of progression from latent tuberculosis infection to active tuberculosis (TB) disease is critical for eliminating the disease. We aimed to conduct a systematic review and meta-regression analysis to quantify the dose-response relationship between interferon-gamma release assay (IGRA) levels and the risk of progression to active TB. Methods We searched PubMed and Embase from 1 January 2001 to 10 May 2020 for longitudinal studies that reported the risk of progression from latent to active TB as a function of baseline IGRA values. We used a novel Bayesian meta-regression method to pool effect sizes from included studies and generate a continuous dose-response risk curve. Our modeling framework enabled us to incorporate random effects across studies, and include data with different IGRA ranges across studies. The quality of included studies were assessed using the Newcastle-Ottawa scale (NOS). Results We included 34 studies representing 581,956 person-years of follow-up with a total of 788 incident cases of TB in the meta-regression analysis. Higher levels of interferon-gamma were associated with increased risk of progression to active tuberculosis. In the dose-response curve, the risk increased sharply between interferon-gamma levels 0 and 5 IU/ml, after which the risk continued to increase moderately but at a slower pace until reaching about 15 IU/ml where the risk levels off. Compared to 0 IU/ml, the relative risk of progression to active TB among those with interferon-gamma levels of 0.35, 1, 5, 10, 15, and 20 IU/ml were: 1.64 (1.28–2.08), 2.90 (2.02–3.88), 11.38 (6.64–16.38), 19.00 (13.08–26.90), 21.82 (14.65–32.57), and 22.31 (15.43–33.00), respectively. The dose-response relationship remains consistent when limiting the analysis to studies that scored highest in the NOS. Conclusion The current practice of dichotomizing IGRA test results simplifies the TB infection disease continuum. Evaluating IGRA test results over a continuous scale could enable the identification of individuals at greatest risk of progression to active TB.

scholarly journals Role of interferon gamma release assay in the diagnosis and management of Mycobacterium tuberculosis-associated uveitis: a review

2021 ◽  
Vol 6 (1) ◽  
pp. e000663
Author(s):  
Samra Rahman ◽  
Muhammad Irfan ◽  
M A Rehman Siddiqui
Keyword(s):  
Interferon Gamma ◽  
Interferon Gamma Release Assay ◽  
Limited Evidence ◽  
Ocular Tuberculosis ◽  
Diagnosis And Management ◽  
Pubmed Database ◽  
Interferon Gamma Release Assays ◽  
Infectious Uveitis ◽  
Release Assay

Tuberculosis (TB)-associated uveitis is a common cause of infectious uveitis in the developing world. Diagnosis of TB uveitis remains a challenge. The role of interferon gamma release assays (IGRAs) is uncertain. Herein we summarise the available literature on the utility of IGRAs in the diagnosis and management of TB uveitis. We searched PubMed database from 1 August 2010 to 31 July 2020 using the following keywords alone and in combination: ‘interferon-gamma release assay’, ‘QuantiFERON’, ‘T-SPOT.TB’, ‘TB uveitis’, ‘serpiginous like choroiditis’, ‘tuberculoma’, ‘TB vasculitis’, ‘TB panuveitis’ and ‘ocular tuberculosis’. Data from 58 relevant studies were collated. The review is focused on currently marketed versions of IGRA tests: QuantiFERON-TB Gold In-Tube assay, QuantiFERON-TB Gold Plus assay (QFT-Plus) and T-SPOT.TB. We found limited evidence regarding the diagnostic utility of IGRA in patients with uveitis. No study was identified evaluating the newer QFT test—the QFT-Plus—in patients with uveitis. Similarly, there is lack of data directly comparing QFT-Plus with T-SPOT.TB specifically for the diagnosis of TB uveitis.

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