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基于试剂盒的核酸扩增试验(CBNAAT)在粪便样本中对儿科结核病的诊断准确性。

Diagnostic Accuracy of Cartridge Based Nucleic Acid Amplification Test (CBNAAT) in Stool Samples in Pediatric Tuberculosis.

机构信息

Department of Pediatrics, S.N. Medical College, Agra, 282003, India.

Intermediate Reference Laboratory (IRL) State TB Training and Demonstration Center (STDC), Agra, India.

出版信息

Indian J Pediatr. 2024 Oct;91(10):1021-1026. doi: 10.1007/s12098-023-04849-6. Epub 2023 Sep 25.

Abstract

OBJECTIVES

To find out the diagnostic accuracy of stool Cartridge-based nucleic acid amplification test (CBNAAT) as an alternate method as compared to CBNAAT in gastric aspirate (GA) samples in pediatric tuberculosis (TB).

METHODS

This cross-sectional study was performed at Department of Pediatrics of a tertiary care hospital. Children aged 0-18 y diagnosed as presumptive tuberculosis were consecutively enrolled. Gastric aspirate and corresponding stool sample was subjected to CBNAAT and its performance was compared in both samples using appropriate statistical tests.

RESULTS

Total 100 patients were enrolled in the study. Diagnostic accuracy of CBNAAT was 81% and 80% in gastric aspirate and stool sample respectively. On comparing gastric aspirate with corresponding stool sample there was 97% agreement, with Cohen's kappa value of 0.94. There was a statistically significant association observed between gastric aspirate CBNAAT and stool CBNAAT p <0.001 using chi square test. Sensitivity of gastric aspirate CBNAAT and stool CBNAAT was 75% and 73% respectively and specificity was 100% for both the samples compared against Composite Reference Standard (CRS).

CONCLUSIONS

The diagnostic accuracy of stool CBNAAT is comparable to GA CBNAAT in children and can be used as a good alternative to gastric aspirate for diagnosis of pulmonary and disseminated tuberculosis in children.

摘要

目的

比较粪便基于试剂盒的核酸扩增试验(CBNAAT)与胃抽吸物(GA)样本中 CBNAAT 作为替代方法在儿科结核病(TB)中的诊断准确性。

方法

本横断面研究在一家三级护理医院的儿科进行。连续纳入被诊断为疑似结核病的 0-18 岁儿童。对胃抽吸物和相应的粪便样本进行 CBNAAT,并使用适当的统计检验比较两种样本中的性能。

结果

共有 100 名患者纳入研究。胃抽吸物和粪便样本中 CBNAAT 的诊断准确性分别为 81%和 80%。胃抽吸物与相应粪便样本比较时,一致性为 97%,Cohen's kappa 值为 0.94。胃抽吸物 CBNAAT 和粪便 CBNAAT 之间存在统计学显著关联,卡方检验 p<0.001。胃抽吸物 CBNAAT 和粪便 CBNAAT 的敏感性分别为 75%和 73%,特异性均为 100%,与综合参考标准(CRS)相比。

结论

粪便 CBNAAT 的诊断准确性与 GA CBNAAT 相当,可作为儿童肺和播散性结核病诊断中胃抽吸物的良好替代方法。

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