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

Do Chau Giang; Tran Ngoc Duong; Dang Thi Minh Ha; Ho Thi Nhan; Marcel Wolbers; Nguyen Thi Quynh Nhu; Dorothee Heemskerk; Nguyen Dang Quang; Doan Thanh Phuong; Pham Thu Hang; Tran Huu Loc; Nguyen Thi Ngoc Lan; Nguyen Huy Dung; Jeremy Farrar; Maxine Caws

doi:10.1186/s12879-015-0814-2

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

Do Chau Giang, Tran Ngoc Duong, Dang Thi Minh Ha, Ho Thi Nhan, Marcel Wolbers, Nguyen Thi Quynh Nhu, Dorothee Heemskerk, Nguyen Dang Quang, Doan Thanh Phuong, Pham Thu Hang, Tran Huu Loc, Nguyen Thi Ngoc Lan, Nguyen Huy Dung, Jeremy Farrar, Maxine Caws

Clinical Sciences

Research output: Contribution to journal › Article › peer-review

30 Citations (Scopus)

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.

Original language	English
Article number	70
Pages (from-to)	e70
Journal	BMC Infectious Diseases
Volume	15
Issue number	1
DOIs	https://doi.org/10.1186/s12879-015-0814-2
Publication status	Published - 18 Feb 2015

Keywords

Childhood
Diagnosis
Genexpert
MGIT culture
Pediatric
Smear
Tuberculosis
Xpert

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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BMC Infectious Diseases 15 70Final published version, 611 KBLicence: CC BY

Cite this

Giang, D. C., Duong, T. N., Ha, D. T. M., Nhan, H. T., Wolbers, M., Nhu, N. T. Q., Heemskerk, D., Quang, N. D., Phuong, D. T., Hang, P. T., Loc, T. H., Lan, N. T. N., Dung, N. H., Farrar, J., & Caws, M. (2015). Prospective evaluation of GeneXpert for the diagnosis of HIV- negative pediatric TB cases. BMC Infectious Diseases, 15(1), e70. Article 70. https://doi.org/10.1186/s12879-015-0814-2

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abstract = "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] {\textquoteleft}confirmed TB{\textquoteright} 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.",

keywords = "Childhood, Diagnosis, Genexpert, MGIT culture, Pediatric, Smear, Tuberculosis, Xpert",

author = "Giang, {Do Chau} and Duong, {Tran Ngoc} and Ha, {Dang Thi Minh} and Nhan, {Ho Thi} and Marcel Wolbers and Nhu, {Nguyen Thi Quynh} and Dorothee Heemskerk and Quang, {Nguyen Dang} and Phuong, {Doan Thanh} and Hang, {Pham Thu} and Loc, {Tran Huu} and Lan, {Nguyen Thi Ngoc} and Dung, {Nguyen Huy} and Jeremy Farrar and Maxine Caws",

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doi = "10.1186/s12879-015-0814-2",

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TY - JOUR

T1 - Prospective evaluation of GeneXpert for the diagnosis of HIV- negative pediatric TB cases

AU - Giang, Do Chau

AU - Duong, Tran Ngoc

AU - Ha, Dang Thi Minh

AU - Nhan, Ho Thi

AU - Wolbers, Marcel

AU - Nhu, Nguyen Thi Quynh

AU - Heemskerk, Dorothee

AU - Quang, Nguyen Dang

AU - Phuong, Doan Thanh

AU - Hang, Pham Thu

AU - Loc, Tran Huu

AU - Lan, Nguyen Thi Ngoc

AU - Dung, Nguyen Huy

AU - Farrar, Jeremy

AU - Caws, Maxine

PY - 2015/2/18

Y1 - 2015/2/18

N2 - 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.

AB - 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.

KW - Childhood

KW - Diagnosis

KW - Genexpert

KW - MGIT culture

KW - Pediatric

KW - Smear

KW - Tuberculosis

KW - Xpert

U2 - 10.1186/s12879-015-0814-2

DO - 10.1186/s12879-015-0814-2

M3 - Article

SN - 1471-2334

VL - 15

SP - e70

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

IS - 1

M1 - 70

ER -

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

Abstract

Keywords

UN SDGs

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