Diagnostic accuracy of Xpert MTB/RIF Ultra for childhood tuberculosis in West Africa - a multicenter pragmatic study

Awa Ba Diallo; Victory F Edem; Arnauld Fiogbe; Kwabena A Osman; Mohamed Tolofoudie; Amadou Somboro; Bassirou Diarra; Babatunde Ogunbosi; Ibrahim Abok; Augustine O Ebonyi; Bamenla Goka; Dissou Affolabi; Regina Oladokun; Aderemi O Kehinde; Nuredin Mohammed; Toyin Togun

doi:10.1016/j.ijid.2024.01.003

Diagnostic accuracy of Xpert MTB/RIF Ultra for childhood tuberculosis in West Africa - a multicenter pragmatic study

Int J Infect Dis. 2024 Mar:140:86-91. doi: 10.1016/j.ijid.2024.01.003. Epub 2024 Jan 19.

Authors

Awa Ba Diallo¹, Victory F Edem², Arnauld Fiogbe³, Kwabena A Osman⁴, Mohamed Tolofoudie⁵, Amadou Somboro⁵, Bassirou Diarra⁵, Babatunde Ogunbosi⁶, Ibrahim Abok⁷, Augustine O Ebonyi⁷, Bamenla Goka⁴, Dissou Affolabi³, Regina Oladokun⁶, Aderemi O Kehinde⁸, Nuredin Mohammed⁹, Toyin Togun¹⁰

Affiliations

¹ Department of Biological Sciences, Faculty of Pharmacy, Cheikh Anta Diop University, Dakar, Senegal.
² Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, The Gambia; Department of Immunology, College of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria.
³ National Teaching Hospital for Tuberculosis and Respiratory Diseases, Cotonou, Republic of Benin; National Tuberculosis Program, Republic of Benin.
⁴ Department of Paediatrics and Child Health, Korle Bu Teaching Hospital and University of Ghana Medical School, Accra, Ghana.
⁵ University Clinical Research Centre-SEREFO Laboratory, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali.
⁶ Department of Paediatrics, College of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria.
⁷ Department of Paediatrics, Jos University Teaching Hospital and University of Jos, Plateau State, Nigeria.
⁸ Department of Medical Microbiology and Parasitology, College of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria.
⁹ Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, The Gambia.
¹⁰ Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, The Gambia; Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; TB Centre, London School of Hygiene and Tropical Medicine, London, United Kingdom. Electronic address: Toyin.Togun@lshtm.ac.uk.

PMID: 38244884
DOI: 10.1016/j.ijid.2024.01.003

Abstract

Objective: To evaluate the performance of Xpert Mycobacterium Tuberculosis/rifampicin (MTB/RIF) Ultra (Ultra) for diagnosis of childhood tuberculosis (TB) within public health systems.

Methods: In this cross-sectional study, children aged <15 years with presumptive pulmonary TB were consecutively recruited and evaluated for TB at tertiary-level hospitals in Benin, Mali, and Ghana. Bivariate random-effects models were used to determine the pooled sensitivity and specificity of Ultra against culture. We also estimated its diagnostic yield against a composite microbiological reference standard (cMRS) of positive culture or Ultra.

Results: Overall, 193 children were included in the analyses with a median (interquartile range) age of 4.0 (1.1-9.2) years, 88 (45.6%) were female, and 36 (18.7%) were HIV-positive. Thirty-one (16.1%) children had confirmed TB, 39 (20.2%) had unconfirmed TB, and 123 (63.7%) had unlikely TB. The pooled sensitivity and specificity of Ultra verified by culture were 55.0% (95% confidence interval [CI]: 28.0-79.0%) and 95.0% (95% CI: 88.0-98.0%), respectively. Against the cMRS, the diagnostic yield of Ultra and culture were 67.7% (95% CI: 48.6-83.3%) and 70.9% (95% CI: 51.9-85.8%), respectively.

Conclusion: Ultra has suboptimal sensitivity in children with TB that were investigated under routine conditions in tertiary-level hospitals in three West African countries.

Keywords: Children; Diagnostic accuracy; GeneXpert; Tuberculosis.

Publication types

Multicenter Study
Pragmatic Clinical Trial

MeSH terms

Antibiotics, Antitubercular* / pharmacology
Antibiotics, Antitubercular* / therapeutic use
Child
Cross-Sectional Studies
Female
Ghana / epidemiology
Humans
Male
Mycobacterium tuberculosis* / genetics
Rifampin / pharmacology
Rifampin / therapeutic use
Sensitivity and Specificity
Sputum / microbiology
Tuberculosis* / diagnosis
Tuberculosis* / drug therapy
Tuberculosis* / epidemiology

Substances

Antibiotics, Antitubercular
Rifampin