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  • PA-21 Accuracy of GeneXpert Ultra for diagnosis of childhood tuberculosis within national public health systems in West Africa – a multicentre pragmatic study

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PA-21 Accuracy of GeneXpert Ultra for diagnosis of childhood tuberculosis within national public health systems in West Africa – a multicentre pragmatic study
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  1. Awa Ba Diallo1,
  2. Victory F Edem2,
  3. Arnauld Fiogbe3,4,
  4. Kwabena A Osman5,
  5. Mohamed Tolofoudie6,
  6. Amadou Somboro6,
  7. Bassirou Diarra6,
  8. Babatunde Ogunbosi7,
  9. Ibrahim I Abok8,
  10. Augustine O Ebonyi8,
  11. Bamenla Goka5,
  12. Dissou Affolabi3,4,
  13. Regina Oladokun7,
  14. Aderemi O Kehinde7,
  15. Nuredin Mohammed2,
  16. Toyin Togun2,9
  1. 1Cheikh Anta Diop University (UCAD), Senegal
  2. 2Medical Research Council Unit The Gambia at the LSHTM (MRCG at LSHTM), The Gambia
  3. 3National Teaching Hospital for Tuberculosis and Respiratory Diseases (CNHU-PPc), Benin
  4. 4National Tuberculosis Program (NTP), Benin
  5. 5Korle Bu Teaching Hospital (KBTH), Ghana
  6. 6University Clinical Research Centre-SEREFO Laboratory, University of Sciences, Techniques and Technologies of Bamako, Mali
  7. 7University College Hospital (UCH), Nigeria
  8. 8Jos University Teaching Hospital (JUTH), Nigeria
  9. 9London School of Hygiene and Tropical Medicine (LSHTM), UK

Abstract

Background We conducted a pragmatic evaluation of GeneXpert Ultra (‘Ultra’) for diagnosis of childhood tuberculosis (TB) within national public health systems in West Africa.

Methods In this cross-sectional study, children (<15 years) with presumed pulmonary TB were consecutively recruited and evaluated at three tertiary hospitals in Benin, Ghana, and Mali. Bivariate random-effects models were used to determine the pooled sensitivity and specificity of Ultra against a microbiological reference standard ([MRS]; liquid culture) and a composite reference standard ([CRS]; culture-confirmed TB and unconfirmed TB).

Results Overall, we enrolled 193 children with a median (IQR) age of 3.2 (1.1 - 8.9) years, 88 (46%) were female, and HIV prevalence was 36/142 (25%). 32 (17%) children had confirmed TB, 39 (20%) had unconfirmed TB, and 122 (63%) had unlikely TB. Using MRS, the pooled sensitivity and specificity of Ultra were 55% (95% CI: 28 - 79%) and 95% (95% CI: 88 - 98%), respectively. Ultra demonstrated sensitivity and specificity of 50% (95% CI: 16 - 84%) and 95% (95% CI: 85 - 99%), respectively, using sputum, as against sensitivity of 46% (95% CI 17 - 77%) and specificity of 93% (95% CI: 87 - 97%) for gastric aspirate. Against the CRS, the pooled sensitivity and specificity of Ultra decreased to 17% (95% CI: 4 - 53%) and 93% (95% CI: 87 - 96%), respectively. Using sputum, sensitivity and specificity of Ultra were 24% (95% CI: 7 - 50%) and 94% (95% CI: 82 - 99%), respectively, compared with sensitivity of 14% (95% CI: 5 - 30%) and specificity of 91% (95% CI: 82 - 96%) using gastric aspirate.

Conclusion The suboptimal sensitivity of Ultra in children with TB investigated routinely within national public health systems in West Africa constitutes a major challenge.

Funding: EDCTP-West African Networks of Excellence for TB, AIDS & Malaria.

https://doi.org/10.1136/bmjgh-2023-EDC.65

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