TY - UNPB
T1 - Stool processing methods for Xpert Ultra testing in childhood tuberculosis
T2 - A prospective, multi-country accuracy study
AU - Jaganath, Devan
AU - Nabeta, Pamela
AU - Nicol, Mark P
AU - Castro, Robert
AU - Wambi, Peter
AU - Zar, Heather J
AU - Workman, Lesley
AU - Lodha, Rakesh
AU - Singh, Urvashi B
AU - Bavdekar, Ashish
AU - Sanghavi, Sonali
AU - Trollip, André
AU - Mace, Aurélien
AU - Bonnet, Maryline
AU - Lounnas, Manon
AU - de Haas, Petra
AU - Tiemersma, Edine
AU - Alland, David
AU - Banada, Padmapriya
AU - Cattamanchi, Adithya
AU - Ruhwald, Morten
AU - Wobudeya, Eric
AU - Denkinger, Claudia M
PY - 2024/12/18
Y1 - 2024/12/18
N2 - BACKGROUND: Centrifuge-free processing methods support stool Xpert Ultra testing for childhood tuberculosis (TB), but there are limited data on their accuracy, acceptability and usability.METHODS: We conducted a prospective evaluation of stool Xpert Ultra in India, South Africa, and Uganda with three methods: Stool Processing Kit (SPK), Simple One-Step (SOS), and Optimized Sucrose Flotation (OSF). Children <15 years old with presumptive TB had respiratory specimen testing with Xpert Ultra and culture. Stool was tested using Xpert Ultra after processing with each method. We compared the accuracy of each method to a microbiological reference standard (MRS) and a composite reference standard (CRS). We surveyed the laboratory staff to assess acceptability and usability of the methods.RESULTS: We included 607 children, of whom the median age was 3.5 years (IQR 1.3-7), 48% were female, and 15.5% were HIV positive. Against the MRS, the sensitivities of SPK, SOS and OSF were 36.9% (95% CI 28.6-45.8), 38.6% (95% CI 17.2-51), and 31.3% (95% CI 20.2-44.1), respectively. The specificities of SPK, SOS and OSF were 98.2% (95% CI 96.4-99.3), 97.3% (95% CI 93.7-99.1) and 97.1% (95% CI 93.3-99), respectively. Laboratory staff reported that the methods were acceptable and usable, but SOS was most feasible to implement in a peripheral facility. Sensitivity increased among children who were culture-positive (55-77.3%) and was low (13-16.7%) against the CRS.CONCLUSIONS: Stool processing methods for Xpert Ultra were acceptable, usable, and performed similarly, with highest sensitivity among children with culture-positive TB.
AB - BACKGROUND: Centrifuge-free processing methods support stool Xpert Ultra testing for childhood tuberculosis (TB), but there are limited data on their accuracy, acceptability and usability.METHODS: We conducted a prospective evaluation of stool Xpert Ultra in India, South Africa, and Uganda with three methods: Stool Processing Kit (SPK), Simple One-Step (SOS), and Optimized Sucrose Flotation (OSF). Children <15 years old with presumptive TB had respiratory specimen testing with Xpert Ultra and culture. Stool was tested using Xpert Ultra after processing with each method. We compared the accuracy of each method to a microbiological reference standard (MRS) and a composite reference standard (CRS). We surveyed the laboratory staff to assess acceptability and usability of the methods.RESULTS: We included 607 children, of whom the median age was 3.5 years (IQR 1.3-7), 48% were female, and 15.5% were HIV positive. Against the MRS, the sensitivities of SPK, SOS and OSF were 36.9% (95% CI 28.6-45.8), 38.6% (95% CI 17.2-51), and 31.3% (95% CI 20.2-44.1), respectively. The specificities of SPK, SOS and OSF were 98.2% (95% CI 96.4-99.3), 97.3% (95% CI 93.7-99.1) and 97.1% (95% CI 93.3-99), respectively. Laboratory staff reported that the methods were acceptable and usable, but SOS was most feasible to implement in a peripheral facility. Sensitivity increased among children who were culture-positive (55-77.3%) and was low (13-16.7%) against the CRS.CONCLUSIONS: Stool processing methods for Xpert Ultra were acceptable, usable, and performed similarly, with highest sensitivity among children with culture-positive TB.
U2 - 10.1101/2024.12.17.24317956
DO - 10.1101/2024.12.17.24317956
M3 - Preprint
C2 - 39763536
T3 - medRxiv : the preprint server for health sciences
BT - Stool processing methods for Xpert Ultra testing in childhood tuberculosis
PB - medRxiv
CY - USA
ER -
