Xu-Hui Liu1, Lu Xia2, Bin Song3, Heng Wang4, Xue-Qin Qian2, Jian-Hao Wei2, Tao Li2, Xiu-Hong Xi2, Yuan-Lin Song5, Shan-Qun Li5, Douglas B Lowrie2, Xiao-Yong Fan6, Shui-Hua Lu7. 1. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; Shanghai Zhongshan Hospital, Fudan University, Shanghai, China. 2. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China. 3. Wuhan Jinyintan Hospital, Wuhan, China. 4. Guiyang Pulmonary Hospital, Guiyang, China. 5. Shanghai Zhongshan Hospital, Fudan University, Shanghai, China. 6. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; Wenzhou Medical University, Wenzhou, China; TB Center, Shanghai Emerging and Re-emerging Institute, 2901, Caolang Rd, Jinshan, Shanghai 201508, China. Electronic address: xyfan008@126.com. 7. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; Wenzhou Medical University, Wenzhou, China; TB Center, Shanghai Emerging and Re-emerging Institute, 2901, Caolang Rd, Jinshan, Shanghai 201508, China. Electronic address: lushuihua66@126.com.
Abstract
OBJECTIVES: To evaluate the diagnostic efficacy of stool-based Xpert MTB/RIF Ultra assay versus other assays for the detection of paediatric pulmonary tuberculosis (PTB). METHODS: A prospective head-to-head comparative study was conducted from Dec 2017 to May 2019 in Shanghai Public Health Clinical Centre. Samples were collected from children (< 15 years) with abnormal chest imaging (X-ray or CT scan) results for the following tests: Ultra on stool sample (Ultra-Stool), Ultra on respiratory tract sample (Ultra-RTS), Xpert MTB/RIF assay (Xpert) on RTS (Xpert-RTS), acid-fast bacilli smear on RTS (AFB-RTS), and Mycobacterium tuberculosis (Mtb) culture on RTS (Culture-RTS). The results were compared with a composite reference standard. RESULTS: A total of 126 cases with paired results were analysed. Against a composite reference standard, Ultra-RTS demonstrated the highest sensitivity (52%) and specificity (100%). Ultra-Stool showed 84.1% concordance with Ultra-RTS, demonstrating 45.5% sensitivity and 94.7% specificity (kappa = 0.65, 95% CI= 0.51-0.79). The sensitivity of Ultra-Stool was similar to Mtb culture (45.5%, p = 1.000) and higher than AFB-RTS (27.3%, p < 0.05). Assay positivity was associated with age and infiltration range in chest imaging. CONCLUSIONS: When RTS is difficult to obtain, stool sample-based Ultra is a comparable alternative.
OBJECTIVES: To evaluate the diagnostic efficacy of stool-based Xpert MTB/RIF Ultra assay versus other assays for the detection of paediatric pulmonary tuberculosis (PTB). METHODS: A prospective head-to-head comparative study was conducted from Dec 2017 to May 2019 in Shanghai Public Health Clinical Centre. Samples were collected from children (< 15 years) with abnormal chest imaging (X-ray or CT scan) results for the following tests: Ultra on stool sample (Ultra-Stool), Ultra on respiratory tract sample (Ultra-RTS), Xpert MTB/RIF assay (Xpert) on RTS (Xpert-RTS), acid-fast bacilli smear on RTS (AFB-RTS), and Mycobacterium tuberculosis (Mtb) culture on RTS (Culture-RTS). The results were compared with a composite reference standard. RESULTS: A total of 126 cases with paired results were analysed. Against a composite reference standard, Ultra-RTS demonstrated the highest sensitivity (52%) and specificity (100%). Ultra-Stool showed 84.1% concordance with Ultra-RTS, demonstrating 45.5% sensitivity and 94.7% specificity (kappa = 0.65, 95% CI= 0.51-0.79). The sensitivity of Ultra-Stool was similar to Mtb culture (45.5%, p = 1.000) and higher than AFB-RTS (27.3%, p < 0.05). Assay positivity was associated with age and infiltration range in chest imaging. CONCLUSIONS: When RTS is difficult to obtain, stool sample-based Ultra is a comparable alternative.
Authors: Alexander W Kay; Tara Ness; Sabine E Verkuijl; Kerri Viney; Annemieke Brands; Tiziana Masini; Lucia González Fernández; Michael Eisenhut; Anne K Detjen; Anna M Mandalakas; Karen R Steingart; Yemisi Takwoingi Journal: Cochrane Database Syst Rev Date: 2022-09-06
Authors: Claudia Signorino; Martina Votto; Maria De Filippo; Gian Luigi Marseglia; Luisa Galli; Elena Chiappini Journal: Pediatr Allergy Immunol Date: 2022-01 Impact factor: 5.464