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We evaluated an in vitro test of cell-mediated immunity, the tuberculin gamma interferon assay, QuantiFERON-TB (QIFN), in 455 individuals from three groups: group I, 237 immigrants from high-risk countries; group II, 127 health care workers undergoing Mantoux testing; group III, 91 patients being investigated for possible active tuberculosis (79 pa...
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Context 1
... the 237 immigrants in group I, for whom a positive Mantoux reaction was defined as a 10-mm-diameter indura- tion (2), the agreement was 89 and 64% for Mantoux-negative and -positive individuals, respectively, with a kappa statistic of 0.55 (Table 1) For the 127 HCWs in group II, if 10-mm-diameter indu- ration was defined as a positive Mantoux test result, the agree- ment was 81 and 67% for Mantoux-negative and -positive individuals, respectively, with a kappa statistic of 0.48 (Table 1). When the CDC guidelines for the interpretation of Man- toux reactions were followed, i.e., 15-mm-diameter indura- tion was considered positive (2), the agreement was 70 and 68% in the Mantoux-negative and -positive individuals, respec- tively, with a kappa statistic of 0.26. ...
Context 2
... the 237 immigrants in group I, for whom a positive Mantoux reaction was defined as a 10-mm-diameter indura- tion (2), the agreement was 89 and 64% for Mantoux-negative and -positive individuals, respectively, with a kappa statistic of 0.55 (Table 1) For the 127 HCWs in group II, if 10-mm-diameter indu- ration was defined as a positive Mantoux test result, the agree- ment was 81 and 67% for Mantoux-negative and -positive individuals, respectively, with a kappa statistic of 0.48 (Table 1). When the CDC guidelines for the interpretation of Man- toux reactions were followed, i.e., 15-mm-diameter indura- tion was considered positive (2), the agreement was 70 and 68% in the Mantoux-negative and -positive individuals, respec- tively, with a kappa statistic of 0.26. ...
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Citations
... Correlation between autoantibody levels were analyzed using the Spearman's rank correlation test. Agreement between the 3 Screen ICA and individual autoantibodies was assessed with the j statistic, which measures the strength of agreement between two raters on a scale from 0 to 1 11 . Additionally, accuracy parameters such as positive predictive values (PPV), negative predictive values (NPV), the likelihood ratio of a positive test result (LR+), the likelihood ratio of a negative test result (LR-), and diagnostic odds ratio 12 were calculated. ...
Aim/introduction:
This study aimed to investigate the clinical utility of 3 Screen ICA ELISA in identifying immune-mediated type 1 diabetes in Japanese subjects.
Methods:
We compared the positivity of 3 Screen ICA were compared with autoantibodies against GAD, IA-2, and ZnT8 in 638 patients with type 1 diabetes and 159 healthy control subjects.
Results:
With a cut-off value of 20.0 index, 67.4% of acute-onset type 1 diabetic patients, 71.8% of slowly progressive type 1 diabetic (SPIDDM) patients, and none of the fulminant type 1 diabetic patients showed 3 Screen ICA levels above this threshold. The prevalence of 3 Screen ICA was 14.2% higher in acute-onset type 1 diabetes and 1.6% higher in SPIDDM than in GADA. 3 Screen ICA-positive cases were found in 4.8% of cases of individual autoantibody-negative acute-onset type 1 diabetes and 3.8% of SPIDDM, indicating improved diagnostic sensitivity with the 3 Screen ICA. Among individual autoantibody-negative patients, the sum of each autoantibody level was significantly lower in fulminant type 1 diabetes than in acute onset type 1 diabetes and in SPIDDM (P < 0.0001). Additionally, 84.2% of patients negative for individual autoantibodies but positive for 3 Screen ICA had a sum of individual autoantibody levels of ≥4.7 U/mL. Furthermore, 3 Screen ICA levels were significantly higher in patients with type 1 diabetes with other autoimmune diseases than in those without (P < 0.0001).
Conclusion:
Our findings suggest that the 3 Screen ICA ELISA may be a valuable screening tool for Japanese patients with type 1 diabetes, potentially increasing the diagnostic sensitivity and accuracy beyond the existing GADA, IA-2A, and ZnT8A tests.
... The gold standard test for diagnosing tuberculosis, microbiological culture, is extremely time-consuming. (10). In most poor countries, the tuberculin skin test on the basis of purified protein derivative (PPD) is currently the only immune-based analytic test accessible for clinical use. ...
Background: Tuberculosis (TB) is as yet quite possibly the most over the top dreadful sickness, primarily in Southeast Asia, with the highest incidence in five countries i.e. India, Indonesia followed by China, Philippines, and Pakistan (in that order). In order to combat the rising tuberculosis (TB) load, new diagnostic tests are urgently needed. Because immunoassays are fast, quite simple, and cheap and may suggest the prospect of identifying cases overlooked by routine sputum smear microscopy, an efficient in vitro diagnostic test of tuberculosis based on serological approaches would be considered as an appealing advancement. Lipolytic enzymes, like lipases and esterases, are more important for mycobacterial survival. Lipolytic enzymes, including as lipases and phospholipases, have been found to help M. tuberculosis access host lipids. The main purpose of the current study was to compare the level of antibodies against membrane bound lipolytic enzymes in Tuberculosis patients and control subjects. Methods: To detect serum IgG antibodies against lipolytic enzymes, recombinant proteins were created and employed in an ELISA test. LipL antibody assay were done in serum samples of patients of tuberculosis (PTB, EPTB & MDR TB) and healthy controls.
... Continuous and categorical data were expressed as mean ± SD (standard deviation) and number (% A significant correlation has been reported between IFN-γ and the PPD-Skin test (19,20). Several studies have reported the activation of host immune system as Th1 and ...
Background:
Ecological studies showed that countries with national Bacillus Calmette-Guerin (BCG) vaccination programs for tuberculosis prevention reported lower incidences of severe and fatal COVID-19 than countries without such programs. Several studies have demonstrated that the BCG vaccine can induce long-term trained Immunity in bone marrow progenitor cells. In this study, we tried to evaluate the relationship between tuberculin skin test results, BCG scar, and COVID-19 outcomes among patients with confirmed COVID-19.
Materials and methods:
This was a cross-sectional study. Cases included 160 patients with confirmed COVID-19 in Zahedan hospitals (southeast Iran) in 2020, selected by convenient sampling. PPD test was performed for all patients through the intradermal technique. Collected data included demographic information, underlying conditions, PPD test results, and COVID-19 outcome. Analysis was conducted utilizing ANOVA, χ2 test, and multivariate analysis (logistic regression).
Results:
The univariate analysis showed a positive relationship between older age, having underlying diseases, and positive tuberculin skin test results with the outcome of COVID-19. We also found a lower frequency of BCG scar among patients with death outcomes than recovered ones. In the multivariate analysis by logistic regression through the backward method, only age and underlying diseases remained predictors of death.
Conclusion:
Tuberculin test results might be dependent on age and underlying conditions. Our study did not show relationship between BCG vaccine and mortality in COVID-19 patients. Further investigations in different settings are required to reveal the efficacy of the BCG vaccine in preventing this devastating disease.
... Measurement of the response-the size of a skin induration-is subject to misclassification. 3 TST can crossreact with nontuberculous mycobacteria and with the BCG antituberculosis vaccine, routinely given to neonates in many countries outside the USA, and sometimes to older children as a booster shot. 4 IFNγ release assays use blood samples collected at a single visit that a laboratory must process within a required timeframe. ...
... 24 Studies that used a higher TST cutoff of 15 mm (or 10 mm for close contacts) or had a high proportion of participants from regions with high tuberculosis incidence (eg, Africa or India) more often had equal or higher proportions of positive results by IFNγ release assay than by TST. 3,25 Studies that used a 5 mm or 10 mm TST cutoff, had fewer immigrants from regions with high tuberculosis incidence, or did not include chest radiograph signs of previous tuberculosis (eg, fibrosis) were more likely to have a higher proportion of positive results by TST. 13,26 The proportions of positive tests reported in this study are higher than those reported in the most recent NHANES, but in line with previously published estimates of the global burden of latent tuberculosis infection. ...
Background
Treatment of latent tuberculosis infection is an important strategy to prevent tuberculosis disease. In the USA, three tests are used to identify latent tuberculosis infection: the tuberculin skin test (TST) and two IFN-γ release assays (T-SPOT.TB and QuantiFERON). To our knowledge, few large studies have compared all three tests among people at high risk of latent tuberculosis infection or progression to tuberculosis disease. We aimed to assess test agreement between IFN-γ release assays and TST to provide guidance on their use in important risk groups.
Methods
In this observational cohort study, we enrolled participants at high risk of latent tuberculosis infection or progression to tuberculosis disease at ten US sites with 18 affiliated clinics, including close contacts of infectious tuberculosis cases, people born in countries whose populations in the USA have high (≥100 cases per 100 000 people) or moderate (10–99 cases per 100 000 people) tuberculosis incidence, and people with HIV. Participants were interviewed about demographics and medical risk factors, and all three tests were administered to each participant. The primary endpoints for this study were the proportions of positive test results by test type stratified by risk group and test concordance by risk group for participants with valid results for all three test types. The study is registered at ClinicalTrials.gov, NCT01622140.
Findings
Between July 12, 2012, and May 5, 2017, 26 292 people were approached and 22 131 (84·2%) were enrolled in the study. Data from 21 846 (98·7%) participants were available for analysis, including 3790 (17·3%) born in the USA and 18 023 (82·5%) born outside the USA. Among non-US-born participants overall, the RR comparing the proportions of TST-positive results (7476 [43·2%] of 17 306 participants) to QuantiFERON-positive results (4732 [26·5%] of 17 882 participants) was 1·6 (95% CI 1·6–1·7). The risk ratio (RR) for the comparison with the proportion of T-SPOT.TB-positive results (3693 [21·6%] of 17 118 participants) was 2·0 (95% CI 1·9–2·1). US-born participants had less variation in the proportions of positive results across all tests. The RRs for the proportion of TST-positive results (391 [10·9%] of 3575 participants) compared with the proportion of QuantiFERON-positive results (445 [12·0%] of 3693 participants) and T-SPOT.TB-positive results (295 [8·1%] of 3638 participants) were 0·9 (95% CI 0·8–1·0) and 1·3 (1·2–1·6), respectively. 20 149 (91·0%) of 21 846 participants had results for all three tests, including 16 712 (76%) non-US-born participants. Discordance between TST and IFN-γ release assay results varied by age among non-US-born participants and was greatest among the 848 non-US-born children younger than 5 years. 204 (87·2%) of 234 non-US-born children younger than 5 years with at least one positive test were TST-positive and IFN-γ release assay-negative. The proportion of non-US-born participants who were TST-negative but IFN-γ release assay-positive ranged from one (0·5%) of 199 children younger than 2 years to 86 (14·5%) of 594 participants aged 65 years and older (ptrend<0·0001). Test agreement was higher between the two IFN-γ release assays than between TST and either IFN-γ release assay, regardless of birthplace. κ agreement was particularly low between TST and IFN-γ release assays in non-US-born children younger than 5 years.
Interpretation
Our findings support the preferential use of IFN-γ release assays for the diagnosis of latent tuberculosis in high-risk populations, especially in very young and older people born outside the USA.
Funding
US Centers for Disease Control and Prevention.
... The tuberculin skin reaction named after Charles Mantoux, though developed from earlier work by Koch and von Pirquet, became available in 1907. The accuracy of this test improved as the tuberculin protein was progressively purified, but currently may be replaced by the Gamma Interferon test [9]. Radiology was well established by 1930 as a diagnostic tool for pulmonary tuberculosis, especially when apical cavity formation is visible. ...
... The Cohen's kappa coefficient (κ) statistic [37,38] was used to assess the strength of intermethod agreement for diagnosis results. The value of kappa coefficient statistic over 0.75, between 0.75 to 0.40, or below 0.40 indicates excellent agreement, good to fair agreement, and poor agreement, respectively [39,40]. ...
Taiwan is an island located in the south Pacific, a subtropical region that is home to 61 species of snakes. Of these snakes, four species—Trimeresurus stejnegeri, Protobothrops mucrosquamatus, Bungarus multicinctus and Naja atra—account for more than 90% of clinical envenomation cases. Currently, there are two types of bivalent antivenom: hemorrhagic antivenom against the venom of T. stejnegeri and P. mucrosquamatus, and neurotoxic antivenom for treatment of envenomation by B. multicinctus and N. atra. However, no suitable detection kits are available to precisely guide physicians in the use of antivenoms. Here, we sought to develop diagnostic assays for improving the clinical management of snakebite in Taiwan. A two-step affinity purification procedure was used to generate neurotoxic species-specific antibodies (NSS-Abs) and hemorrhagic species-specific antibodies (HSS-Abs) from antivenoms. These two SSAbs were then used to develop a sandwich ELISA (enzyme-linked immunosorbent assay) and a lateral flow assay comprising two test lines. The resulting ELISAs and lateral flow strip assays could successfully discriminate between neurotoxic and hemorrhagic venoms. The limits of quantification (LOQ) of the ELISA for neurotoxic venoms and hemorrhagic venoms were determined to be 0.39 and 0.78 ng/ml, respectively, and the lateral flow strips were capable of detecting neurotoxic and hemorrhagic venoms at concentrations lower than 5 and 50 ng/ml, respectively, in 10–15 min. Tests of lateral flow strips in 21 clinical snakebite cases showed 100% specificity and 100% sensitivity for neurotoxic envenomation, whereas the sensitivity for detecting hemorrhagic envenomation samples was 36.4%. We herein presented a feasible strategy for developing a sensitive sandwich ELISA and lateral flow strip assay for detecting and differentiating venom proteins from hemorrhagic and neurotoxic snakes. A useful snakebite diagnostic guideline according to the lateral flow strip results and clinical symptoms was proposed to help physicians to use antivenoms appropriately. The two-test-line lateral flow strip assay could potentially be applied in an emergency room setting to help physicians diagnose and manage snakebite victims.
... For example, Neuvonen et al. tested the recommended antigens by the WHO for delayed hypersensitivity skin test in a large cohort of healthy population thus setting references for assessing the immune-competence in patients (73). In like manner, Pottumarthy et al. used healthy responses to evaluate the potentials of replacing the traditional skin test with tuberculin gamma interferon assay (74). While, Ulrichs et al. tried to grade the use of ESAT-6 as specific antigen in the development of the IGRA test comparing stimulations of healthy and patients with tuberculosis (75). ...
The immune response is a dynamic system that maintains the integrity of the body, and more specifically fight against infections. However, an unbalanced host immune response is highlighted in many diseases. Exacerbated responses lead to autoimmune and allergic diseases, whereas, low or inefficient responses favor opportunistic infections and viral reactivations. Conflicting situations may also occur, such as in sepsis where inflammation and compensatory immunosuppression make it difficult to deploy the appropriate drug treatment. Until the current day, assessing the immune profile of patients remains a challenge. This is especially due to the inter-individual variability—a key feature of the immune system—which hinders precise diagnosis, prognosis, and therapeutic stratification. Our incapacity to practically interpret the host response may contribute to a high morbidity and mortality, such as the annual 6 million worldwide deaths in sepsis alone. Therefore, there is a high and increasing demand to assess patient immune function in routine clinical practice, currently met by Immune Functional Assays. Immune Functional Assays (IFA) hold a plethora of potentials that include the precise diagnosis of infections, as well as prediction of secondary and latent infections. Current available products are devoted to indirect pathogen detection such as Mycobacteria tuberculosis interferon gamma release assays (IGRA). In addition, identifying the status and the underlying factors of immune dysfunction (e.g., in septic patients) may guide immune targeted therapies. Tools to monitor and stratify the immune status are currently being studied but they still have many limitations such as technical standardization, biomarkers relevance, systematic interpretation and need to be simplified, in order to set the boundaries of “healthy,” “ill,” and “critically ill” responses. Thus, the design of new tools that give a comprehensive insight into the immune functionality, at the bedside, and in a timely manner represents a leap toward immunoprofiling of patients.
... Diagnosis is also more challenging as common symptoms used for diagnosis are less prominent in older populations [21] and the common Mantoux skin test tends to produce false negative results in older patients. [21][22][23][24] Furthermore, vulnerability among older adults is increased due to increased rates of compromised immune systems due to co-morbidity such as diabetes [25] and cancers [5]. ...
Background
The 2010 Global Burden of Disease estimates show that 57% of all TB deaths globally occurred among adults older than 50 years of age. Few studies document the TB burden among older adults in Southern Africa. We focused on adults older than 55 years to assess the relative TB burden and associated demographic factors.
Methods
A cross sectional nationally representative TB prevalence survey conducted of Zambian residents aged 15 years and above from 66 clusters across all the 10 provinces of Zambia. Evaluation included testing for TB as well as an in-depth questionnaire. We compared survey data for those aged 55 and older to those aged 15–54 years. Survey results were also compared with 2013 routinely collected programmatic notification data to generate future hypotheses regarding active and passive case finding.
Results
Among older adults with TB, 30/ 54 (55.6%) were male, 3/27 (11.1%) were HIV infected and 35/54 (64.8%) lived in rural areas. TB prevalence was higher in those aged ≥55 (0.7%) than in the 15–54 age group (0.5%). Males had higher rates of TB across both age groups with 0.7% (15–54) and 1.0% (≥55) compared with females 0.4% (15–54) and 0.6% (≥55). In rural areas, the prevalence of TB was significantly higher among older than younger adults (0.7% vs 0.3%), while the HIV infection rate was among TB patients was lower (11.1% vs 30.8%). The prevalence survey detected TB in 54/7484 (0.7%) of older adults compared to 3619/723,000 (0.5%) reported in 2013 programmatic data.
Conclusion
High TB rates among older adults in TB endemic areas justify consideration of active TB case finding and prevention strategies.
... A kappa statistic of >0.75 represents excellent agreement, 0.40-0.75, good to fair agreement, and <0.40, poor agreement (Pottumarthy et al. 1999). ...
A fusion protein SBP-Cap∆41, consisting of Cap∆41 (without 41 amino acids at the N-terminus) protein of porcine circovirus 2 (PCV2) and a streptavidin binding peptide (SBP), was constructed. This fusion protein binds to HRP-labeled streptavidin (HRP-SA) through high affinity between SBP and SA, forming an HRP-streptavidin bound antigen (Hsb-Ag) with both immunoreactivity and enzymatic activity, which can be used in a double-antigen sandwich ELISA for detection of PCV2 antibodies. Comparison of the characteristics of the HSb-Cap∆41 and chemical conjugates of the recombinant Cap∆41 protein showed that the HSb-Cap∆41 based double-antigen sandwich ELISA (HBDS-ELISA) had higher specificity and sensitivity. Use of the HBDS-ELISA detected PCV2-IgG in 9 injected pigs as early as 10 days p.i., 3 days earlier than both a double-antigen sandwich ELISA (DS-ELISA) based on a chemically conjugated antigen, and a commercial indirect ELISA kit.
Electronic supplementary material
The online version of this article (doi:10.1186/s13568-017-0473-3) contains supplementary material, which is available to authorized users.
... The nucleotide MALDI-TOF MS test is a simple, rapid and multiplexed method with high specificity, sensitivity and flexibility in many research fields, including mutation and SNP analysis, sequencing, and microorganism detection [11][12][13][14][15][16][17][18] . Compared with other detection systems, MALDI-TOF MS acquires the absolute mass value, which represents an intrinsic property of a molecule, while others depend on signals of a relative electrophoretic mobility or a hybridization event. ...
... When testing for MTB at an early stage, the sensitivity, specificity, positive prediction value (PPV), and negative prediction value (NPV) are comparable with other currently used methods (Table 3). Compared with the limit of traditional testing methods such as the sensitivity of microscopic examination (22-65%) or bacillus culture (approximately 10-20% unsuccessful), MALDI-TOF MS provided a solution for disease control and management 15,19,20 . Furthermore, the rapid diagnosis of MTB infections is critical for successful treatment. ...
The increasing incidence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) Mycobacterium tuberculosis (MTB) adds further urgency for rapid and multiplex molecular testing to identify the MTB complex and drug susceptibility directly from sputum for disease control. A nucleotide matrix-assisted-laser-desorption-ionization time-of-flight mass spectrometry (MALDI-TOF MS)-based assay was developed to identify MTB (MTBID panel) and 45 chromosomal mutations for resistance to eight antibiotics (MTBDR panel). We conducted a 300 case trial from outpatients to evaluate this platform. An MTBID panel specifically identified MTB with as few as 10 chromosome DNA copies. The panel was 100% consistent with an acid-fast stain and culture for MTB, nontuberculous mycobacteria, and non-mycobacteria bacteria. The MTBDR panel was validated using 20 known MDR-MTB isolates. In a 64-case double-blind clinical isolates test, the sensitivity and specificity were 83% and 100%, respectively. In a 300-case raw sputum trial, the MTB identification sensitivity in smear-negative cases using MALDI-TOF MS was better than the COBAS assay (61.9% vs. 46.6%). Importantly, the failure rate of MALDI-TOF MS was better than COBAS (11.3% vs. 26.3%). To the best of our knowledge, the test described herein is the only multiplex test that predicts resistance for up to eight antibiotics with both sensitivity and flexibility.
