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

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Giang, Do, Duong, Tran, Ha, Dang, Nhan, Ho, Wolbers, Marcel, Nhu, Nguyen, Heemskerk, Dorothee, Quang, Nguyen, Phuong, Doan, Hang, Pham, Loc, Tran, Lan, Nguyen, Dung, Nguyen, Farrar, Jeremy and Caws, Maxine ORCID: https://orcid.org/0000-0002-9109-350X (2015) 'Prospective evaluation of GeneXpert for the diagnosis of HIV- negative pediatric TB cases'. BMC Infectious Diseases, Vol 15, e70.

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Abstract

Background

The GeneXpertMTB/RIF (Xpert) assay is now recommended by WHO for diagnosis of tuberculosis (TB) in children but evaluation data is limited.

Methods

One 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.

Results

The 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).

Conclusions

The 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.

Item Type: Article
Additional Information: The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1471-2334/15/70
Subjects: WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
WF Respiratory System > Tuberculosis > WF 415 Tuberculosis in childhood
WS Pediatrics > Diseases of Children and Adolescents > By System > WS 280 Respiratory system
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1186/s12879-015-0814-2
Depositing User: Lynn Roberts-Maloney
Date Deposited: 27 Oct 2015 09:43
Last Modified: 06 Feb 2018 13:10
URI: https://archive.lstmed.ac.uk/id/eprint/5378

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