Introduction Effective strategies are needed to facilitate early detection and diagnosis of tuberculosis (TB). The over-reliance on passive case detection, symptom screening, and collection of sputum, results in delayed or undiagnosed TB, which directly contributes to on-going TB transmission. We assessed the acceptability and feasibility of in-home, Targeted Universal TB Testing (TUTT) of household contacts using GeneXpert MTB/RIF Ultra at point-of-care (POC) during household contact investigations (HCIs) and compared the feasibility of using sputum vs. tongue swab specimens. Methods Household contacts (HHCs) receiving in-home POC TUTT as part of the TB Home Study were asked to complete a post-test acceptability survey. The survey explored HHCs level of comfort, confidence in the test results, and the perceived appropriateness of in-home POC TUTT. We used the Metrics to Assess the Feasibility of Rapid Point-of-Care Technologies framework to assess the feasibility of using sputum and tongue swab specimens for in-home POC TUTT. Descriptive statistics were used to report participant responses and feasibility metrics. Results Of 313 eligible HHCs, 267/313 (85.3%) consented to in-home POC TUTT. Of those, 267/267 (100%) provided a tongue swab and 46/267 (17.2%) could expectorate sputum. All specimens were successfully prepared for immediate, in-home testing with Xpert Ultra on GeneXpert Edge. Of 164 tongue swab tests conducted, 160/164 (97.6%) generated a valid test result compared to 44/46 (95.7%) sputum-based tests. An immediate test result was available for 262/267 (98.1%) individuals based on in-home swab testing, and 44/46 (95.7%) based on in-home sputum testing. The mean in-home POC TUTT acceptability score (5=highly acceptable) was 4.5/5 (SD= 0.2). Conclusion In-home, POC TUTT using either sputum or tongue swab specimens was highly acceptable and feasible. Tongue swab specimens greatly increase the proportion of HHCs tested compared to sputum. In-home POC TUTT using a combination of sputum and tongue swabs can mitigate shortcomings to case detection.

LL was supported by the National Institute of Mental Health of the National Institutes of Health under grant number K01MH119923. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

NCT04973371

Funding was provided by the United States National Institutes of Health (Grant # R01AI150485 and R21EB023679) and FIND.

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This study was conducted according to the ethical principles set forth in the Declaration of Helsinki, ICH-GCP, European Directive 2001/20/EC, US Code of Federal Regulations Title 21, South African Good Clinical Practice Guidelines, and other local regulatory requirements. The study protocol was approved by the University of Pretoria Human Research Ethics Committee (HREC 391/2021) and by Boston University Institutional Review Board (H-44118).

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