使用印度本土纯化蛋白衍生物(PPD)进行的结核菌素测试与国际标准 PPD 的一致性仅为中等水平

IF 1.9 Q3 INFECTIOUS DISEASES
Devasahayam J. Christopher , N. Priya , Deepa Shankar , Barney Isaac , Andrea DeLuca , Sonali Sarkar , Senbagavalli Prakash Babu , Prasanna Samuel , Adithya Cattamanchi , Amita Gupta , Jerrold Ellner , Sudha Srinivasan , Samyra Cox , Balamugesh Thangakunam
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引用次数: 0

摘要

背景印度的潜伏肺结核感染率(LTBI)估计约为 40%。用于诊断 LTBI 的 PPD(纯化蛋白衍生物)有多种配方,其反应可能各不相同。印度市售的 PPD 由 Arkray Healthcare(TST-Arkray)生产。目前还不清楚该产品与其他国际公认的结核菌素(TST-Tubersol)相比是否具有相似的灵敏度。方法收集血液样本用于 QFT-Plus 检测。结果在招募的 512 名参与者中,326 名是医护人员,186 名是结核病患者的家庭接触者。他们同时接受了 TST-Tubersol 和 TST-Arkray 检测,其中 139 人(27%)的 TST-Tubersol 检测结果呈阳性(≥10 mm),而 203 人(40.1%)的 TST-Arkray 检测结果呈阳性。这两项检测结果的吻合度中等,k = 0.58。此外,两种 TST 与 QFT Plus 的一致性较差(Tubersol 的 kappa = 0.19,Arkray 的 kappa = 0.17)。以 QFT-Plus 作为金标准,TST-Tubersol(以 10 mm 为压痕临界值)和 TST- Arkray 的灵敏度、特异性、PPV 和 NPV 分别为 46.8%、76.3%、31.8% 和 85.8%;TST-Arkray 分别为 60.6%、64%、28.5% 和 87.2%。此外,TST 与 QFT plus 测试之间的一致性较差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tuberculin test using Indian indigenous purified-protein derivative (PPD) shows only moderate agreement with international standard PPD

Background

In India, the prevalence of Latent TB infection (LTBI) is estimated to be around 40%. Various formulations of PPD(Purified protein derivative) are available, for diagnosis of LTBI, which may give variable responses. The commercially available PPD in India is by Arkray Healthcare (TST-Arkray). It is unclear if this product may have a similar sensitivity compared to other internationally accepted tuberculins (TST-Tubersol).

Objectives

To assess the performance of the two TSTs compared to Quantiferon-Gold Plus (QFT-Plus).

Methodology

A blood sample was collected for the QFT-Plus test. Both the TSTs were placed in the right and the left volar aspect of the forearms and 48 hrs later, the subjects came back to the study site for reading.

Results

Among the 512 participants who were recruited, 326 subjects were healthcare professionals and 186 subjects were household contacts of patients with tuberculosis. They were tested with both TST-Tubersol and TST-Arkray, 139(27 %) participants tested positive for TST-Tubersol (≥10 mm), whereas 203 participants (40.1 %)tested positive for TST-Arkray. There was moderate agreement between the two tests with k = 0.58. Also, there was only poor agreement between both the TSTs with QFT Plus(kappa = 0.19 for Tubersol and 0.17 for Arkray). With QFT-Plus as gold standard, the sensitivity, specificity, PPV and NPV of TST-Tubersol, ast an induration cut-off of 10 mm was 46.8 %,76.3 %,31.8 % and 85.8 %. respectively and TST- Arkray; 60.6 %, 64 %, 28.5 % and 87.2 % respectively.

Conclusion

The Indian TST (Arkray Diagnostics) has shown moderate agreement with the internationally accepted Tubersol. Additionally, there was poor agreement between the TSTs and QFT plus test.

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来源期刊
Journal of Clinical Tuberculosis and Other Mycobacterial Diseases
Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Medicine-Pulmonary and Respiratory Medicine
CiteScore
4.00
自引率
5.00%
发文量
44
审稿时长
30 weeks
期刊介绍: Journal of Clinical Tuberculosis and Mycobacterial Diseases aims to provide a forum for clinically relevant articles on all aspects of tuberculosis and other mycobacterial infections, including (but not limited to) epidemiology, clinical investigation, transmission, diagnosis, treatment, drug-resistance and public policy, and encourages the submission of clinical studies, thematic reviews and case reports. Journal of Clinical Tuberculosis and Mycobacterial Diseases is an Open Access publication.
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