Prospective evaluation of GeneXpert for the diagnosis of HIV- negative pediatric TB cases

BMC Infectious Diseases

Research Article

Dorothee Heemskerk¹  Ho Thi Nhan¹  Nguyen Thi Quynh Nhu¹  Jeremy Farrar¹  Marcel Wolbers¹  Maxine Caws²  Pham Thu Hang³  Nguyen Thi Ngoc Lan³  Tran Ngoc Duong³  Nguyen Dang Quang³  Dang Thi Minh Ha³  Nguyen Huy Dung³  Tran Huu Loc³  Doan Thanh Phuong³  Do Chau Giang⁴ 

[1] Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam;Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam;Department of Clinical Sciences, Liverpool School of tropical Medicine, L3 5QA, Pembroke Place, UK;Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam;Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam;Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam;

关键词: Tuberculosis;    Pediatric;    Childhood;    Xpert;    Genexpert;    Diagnosis;    MGIT culture;    Smear;   

DOI  :  10.1186/s12879-015-0814-2

 received in 2014-10-13, accepted in 2015-02-09,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe GeneXpertMTB/RIF (Xpert) assay is now recommended by WHO for diagnosis of tuberculosis (TB) in children but evaluation data is limited.MethodsOne hundred and fifty consecutive HIV negative children (<15 years of age) presenting with suspected TB were enrolled at a TB referral hospital in Ho Chi Minh City, Vietnam. 302 samples including sputum (n = 79), gastric fluid (n = 215), CSF (n = 3), pleural fluid (n = 4) and cervical lymphadenopathic pus (n = 1) were tested by smear, automated liquid culture (Bactec MGIT) and Xpert.Patients were classified retrospectively using the standardised case definition into confirmed, probable, possible, TB unlikely or not TB categories. Test accuracy was evaluated against 2 gold standards: [1] clinical (confirmed, probable and possible TB) and [2] ‘confirmed TB’ alone.ResultsThe median age of participants was 18 months [IQR 5–170]. When test results were aggregated by patient, the sensitivity of smear, Xpert and MGIT against clinical diagnosis as the gold standard were 9.2% (n = 12/131) [95%CI 4.2; 14.1], 20.6% (n = 27/131) [95%CI 13.7; 27.5] and 29.0% (n = 38/131) [21.2;36.8], respectively. Specificity 100% (n = 19/19), 94.7% (n = 18/19), 94.7% (n = 18/19), respectively. Xpert was more sensitive than smear (P = <0.001) and less sensitive than MGIT (P = 0.002).ConclusionsThe systematic use of Xpert will increase early TB case confirmation in children and represents a major advance but sensitivity of all tests remains unacceptably low. Improved rapid diagnostic tests and algorithm approaches for pediatric TB are still an urgent research priority.

【 授权许可】

Unknown   
© Giang et al.; licensee BioMed Central. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.