Evaluation of a new tuberculosis-related interferon gamma release assay for tuberculosis infection diagnosis in Huzhou, eastern China

Qian, Fuchu; Wang, Weihong; Qiu, Zhihong; Shen, Yiqun; He, Jiangfang; Li, Dongli; Zhong, Jing; Dai, Licheng

doi:10.4103/0377-4929.118694

Cited by 12 publications

(8 citation statements)

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“…A study from China reported a higher overall sensitivity of 81.4% and up to 86.6% in smear-positive cases, while having a specificity of 97%, which was comparable to our findings. [ 17 ] Another study from Indonesia revealed the sensitivity of QFT-G to be 88.7% in active TB cases, which was higher than our study. [ 18 ] Our study had three advantages: First it was from an intermediate TB-prevalent region and included large numbers of culture-positive, confirmed, TB cases, therefore, it was probably a better representation of the region, with an intermediate prevalence of TB compared to other studies.…”

Section: Discussioncontrasting

confidence: 81%

Diagnostic utility of QuantiFERON-TB gold (QFT-G) in active pulmonary tuberculosis

Anwar

Al-Jahdali

Baharoon

et al. 2015

J Global Infect Dis

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Background:The utility of QuantiFERON-TB Gold In-Tube (QFT-G) test in the diagnosis of tuberculosis disease has been validated in high and low tuberculosis-prevalent (TB) countries. Aim: The aim of this study is to assess the performance of the QFT-G test in the diagnosis of tuberculosis disease among tuberculosis patients in an intermediate prevalent country.Setting and Design:A retrospective study at the King Abdulaziz Medical City-Riyadh (KAMC-R)Materials and Methods:We retrospectively reviewed all the patients with a diagnosis of pneumonia, including tuberculosis, admitted to KAMC-R between 1 January 2009 and 31 December 2013. We included only patients with an available result of the QFT-G test. A total of 142 tuberculosis cases and 226 pneumonia cases were studied, to assess the utility of the QFT-G test in diagnosing tuberculosis cases.Results:Among the tuberculosis (n = 142) cases, the QFT-G tested positive in 68.3%, negative in 23.2%, and indeterminate in 12 cases (8.5%). Of the 226 pneumonia cases, the QFT-G tested positive in only 20.4%, while a majority of 66.4% tested negative, with 30 cases (13.3%) being indeterminate. When we excluded 42 patients with indeterminate results, the QFT-G test achieved a sensitivity of 74.6% [95% CI: 66.09 to 81.65%] and specificity of 76.53 % [95% CI: 69.85 to 82.15%] in the diagnosis of tuberculosis cases.Conclusions:This study concludes that the QFT-G test is a useful tool for detecting tuberculosis disease when used as an adjunct tool for the diagnosis of active TB cases. It certainly cannot be used solely and indiscriminately, separate from other clinical and radiological information, in the diagnosis of active tuberculosis cases.

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Section: Discussioncontrasting

confidence: 81%

Diagnostic utility of QuantiFERON-TB gold (QFT-G) in active pulmonary tuberculosis

Anwar

Al-Jahdali

Baharoon

et al. 2015

J Global Infect Dis

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“…Our analysis shows the likely adverse economic consequences to the healthcare system when IGRAs are utilized to diagnose active TB in areas with high background prevalence of LTBI. Given the growing popularity of IGRAs in other countries such as China, where evidence suggests the tests are also being used to diagnose active TB disease, these economic and healthcare system concerns likely extend to settings beyond India as well [ 11 , 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…In India, QuantiFERON is marketed as “TB Gold,” and another IGRA (Immunoshop, Mumbai, India) as “TB Platinum,” names that provide poorly-trained healthcare providers little guidance as to their intended use. In China, domestic IGRAs are made by several companies, and publications from China suggest their use to diagnose active TB in that setting as well [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Costs and Consequences of Using Interferon-γ Release Assays for the Diagnosis of Active Tuberculosis in India

2015

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BackgroundThere is growing concern that interferon-γ release assays (IGRAs) are being used off-label for the diagnosis of active tuberculosis (TB) disease in many high-burden settings, including India, where the background prevalence of latent TB infection is high. We analyzed the costs and consequences of using IGRAs for the diagnosis of active TB in India from the perspective of the Indian TB control sector.Methods and FindingsWe constructed a decision analytic model to estimate the incremental cost and effectiveness of IGRAs for the diagnosis of active TB in India. We compared a reference scenario of clinical examination and non-microbiological tests against scenarios in which clinical diagnosis was augmented by the addition of either sputum smear microscopy, IGRA, or Xpert MTB/RIF. We examined costs (in 2013 US dollars) and consequences from the perspective of the Indian healthcare sector. Relative to sputum smear microscopy, use of IGRA for active TB resulted in 23,700 (95% uncertainty range, UR: 3,800 – 38,300) additional true-positive diagnoses, but at the expense of 315,700 (95% UR: 118,300 – 388,400) additional false-positive diagnoses and an incremental cost of US$49.3 million (95% UR: $34.9 – $58.0 million) (2.9 billion Indian Rupees). Relative to Xpert MTB/RIF (including the cost of treatment for drug resistant TB), use of IGRA led to 400 additional TB cases treated (95% UR: [-8,000] – 16,200), 370,600 (95% UR: 252,200 – 441,700) more false-positive diagnoses, 70,400 (95% UR: [-7,900] – 247,200) fewer disability-adjusted life years averted, and US$14.6 million (95%UR: [-$7.2] – $28.7 million) (854 million Indian Rupees) in additional costs.ConclusionUsing IGRAs for diagnosis of active TB in a setting like India results in tremendous overtreatment of people without TB, and substantial incremental cost with little gain in health. These results support the policies by WHO and Standards for TB Care in India, which discourage the use of IGRAs for the diagnosis of active TB in India and similar settings.

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“…Among the diagnostic methods examined during the course of M. tuberculosis infection, serological diagnosis has advantages in its rapidity, sensitivity, reliability, noninvasiveness, convenience, and low cost [ 5 , 22 , 23 , 30 , 47 ]. In recent studies, TB-antibody, Luciferase Immunoprecipitation Systems (LIPS), TB related interferon-gamma release assay (TB-IGRA), and QuantiFERON-TB Gold In-Tube (QFT-GIT) were used to detect M. tuberculosis- specific antibodies in the sera or interferon gamma in whole blood samples from humans and rhesus monkeys.…”

Section: Discussionmentioning

confidence: 99%

An alert of <i>Mycobacterium tuberculosis</i> infection of rhesus macaques in a wild zoo in China

et al. 2017

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Mycobacterium tuberculosis, the pathogen that causes tuberculosis (TB), is becoming increasingly recognized as an important cause of fatal chronic illnesses in China. In this study, we report an infectious disease among 84 rhesus macaques at a Chinese zoo. Their clinical signs and symptoms were very similar with the manifestations of TB in humans. To determine the potential pathogens of this outbreak, many methods were used. First, tuberculin skin tests showed that none of the monkeys displayed significant skin reactions. Subsequently, the sera were tested for specific antibody IgG; 29 (34.5%) and 39 (46.4%) blood samples tested positive by TB-IgG and TB-DOT, respectively. Radiographic examination showed characteristic imageology changes in 14 (16.7%) monkeys. One individual determined as positive by the above three methods was euthanized, and histopathological analysis demonstrated typical granulomas and caseous necrosis in the lung, liver, spleen, and intestine. Furthermore, the pathogenic mycobacteria were isolated from lung lobe, cultured on acidic Lowenstein-Jensen culture medium, and identified as M. tuberculosis by real-time PCR and DNA sequencing. Nevertheless, the origin of the infection remained unknown. These findings emphasize the need to strengthen the management and training of staff, especially those working at animal shelters.

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Evaluation of a new tuberculosis-related interferon gamma release assay for tuberculosis infection diagnosis in Huzhou, eastern China

Abstract: TB-IGRA had a high sensitivity and specificity for TB infection; it could be comparable with the QFT-GIT assay. It might be a powerful assisting tool for TB infection diagnosis in the Chinese clinical setting.

Cited by 12 publications

References 0 publications

Diagnostic utility of QuantiFERON-TB gold (QFT-G) in active pulmonary tuberculosis

Diagnostic utility of QuantiFERON-TB gold (QFT-G) in active pulmonary tuberculosis

Costs and Consequences of Using Interferon-γ Release Assays for the Diagnosis of Active Tuberculosis in India

An alert of <i>Mycobacterium tuberculosis</i> infection of rhesus macaques in a wild zoo in China

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