medRxiv : the preprint server for health sciences · 2026
In-home molecular testing of tongue swabs and sputum to inform household-level screening with diagnostic escalation strategies for tuberculosis contact investigation: a prospective cohort study in South Africa.
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Medina-Marino Andrew, Olifant Sharon, Pieruccini Maria, Fiphaza Kuhle, Ngcelwane Nondumiso, Ruhwald Morten, Penn-Nicholson Adam, Fourie Bernard
Аннотация
BACKGROUND: Household contact investigation for tuberculosis (TB) is limited by referral for clinic-based testing services. We evaluated the performance of in-home tongue swab (TS) testing among symptom-agnostic household contacts (HHC) to inform HCI screening strategies.
METHODS: We conducted a prospective cohort study among HHC of TB patients in Eastern Cape, South Africa. In-home testing of sputum and TSs, with TSs pooled from up to three HHCs, was performed using Xpert Ultra on portable GeneExpert devices. Outcomes included diagnostic performance of TS testing relative to sputum and linkage-to-care outcomes.
FINDINGS: Between June 2021 and October 2024, 909 HHC were enrolled; 99·1% provided s TS, 31·6% provided sputum. Overall sensitivity and specificity of TS testing was 61·9% (95% CI: 38·4%-81·9%) and 100% (98·9%-100%), respectively; sensitivity was 100% (47·8%-100%) for individually tested swabs. Among two-swab and three-swab pools where ≥1 individual was sputum positive, 55·6% (21·2%-86·3%) and 42·9% (9·9%-81·6%) tested positive, respectively; TS sensitivity declined with decreasing sputum Ultra semi-quantitative category. 27 of 439 (6·2%) households had an indictation of secondary TB; 13 (3·0%) by sputum and TS, 11 (2·5%) by sputum only, 3 (0·7%) by TS only. Sputum testing identified 29 HHC with TB (yield=3·2%); 25/29 (86·2%) linked to care (median 1 day [IQR 1-2]).
INTERPRETATION: While in-home molecular testing of sputum supported rapid linkage-to-care, and TSs enabled near-universal testing of symptom-agnostic HHCs, efficiency gains through pooled TS testing must be balance against sensitivity trade-offs.
FUNDING: U.S. NIH; Australian Department of Foreign Affairs and Trade; UK Foreign, Commonwealth and Development Office.
METHODS: We conducted a prospective cohort study among HHC of TB patients in Eastern Cape, South Africa. In-home testing of sputum and TSs, with TSs pooled from up to three HHCs, was performed using Xpert Ultra on portable GeneExpert devices. Outcomes included diagnostic performance of TS testing relative to sputum and linkage-to-care outcomes.
FINDINGS: Between June 2021 and October 2024, 909 HHC were enrolled; 99·1% provided s TS, 31·6% provided sputum. Overall sensitivity and specificity of TS testing was 61·9% (95% CI: 38·4%-81·9%) and 100% (98·9%-100%), respectively; sensitivity was 100% (47·8%-100%) for individually tested swabs. Among two-swab and three-swab pools where ≥1 individual was sputum positive, 55·6% (21·2%-86·3%) and 42·9% (9·9%-81·6%) tested positive, respectively; TS sensitivity declined with decreasing sputum Ultra semi-quantitative category. 27 of 439 (6·2%) households had an indictation of secondary TB; 13 (3·0%) by sputum and TS, 11 (2·5%) by sputum only, 3 (0·7%) by TS only. Sputum testing identified 29 HHC with TB (yield=3·2%); 25/29 (86·2%) linked to care (median 1 day [IQR 1-2]).
INTERPRETATION: While in-home molecular testing of sputum supported rapid linkage-to-care, and TSs enabled near-universal testing of symptom-agnostic HHCs, efficiency gains through pooled TS testing must be balance against sensitivity trade-offs.
FUNDING: U.S. NIH; Australian Department of Foreign Affairs and Trade; UK Foreign, Commonwealth and Development Office.