Nsawotebba, AndrewIbanda, IvanSsentalo Bagaya, BernardNyombi, AbdunoorKagirita, AtekTugumisirize, DidasMujuni, DennisMajwala, Robert KaosOcen, FrancisKabugo, JoelAdam, IsaWekiya, EnockMunduku, BenoniLinda, LillianKalyesubula-Kibuuka, SimonOkiira, ChristopherKigozi, EdgarOgwok, PatrickLutakoome Joloba, MosesNabadda, SusanSsengooba, Willy2022-06-062022-06-062021Nsawotebba, A., Ibanda, I., Ssewanyana, I., Bagaya, B. S., Nyombi, A., Kagirita, A., ... & Ssengooba, W. (2021). Operationalization of COVID-19 Rapid Diagnosis Using Xpert® Xpress SARS CoV-2 Assay in Resource-Limited Settings: Early Implementation Lessons From Uganda. https://doi.org/10.21203/rs.3.rs-154102/v1https://doi.org/10.21203/rs.3.rs-154102/v1https://nru.uncst.go.ug/handle/123456789/3782The novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease is a global challenge. Several countries have adopted testing, isolation, and tracing strategy towards the control of the COVID-19 pandemic, but access to rapid and accurate testing is still a global challenge. The conventional PCR – based assay is the most commonly used test yet it has huge costs, infrastructural, and procurement logistical challenges. The Xpert® Xpress SARS-CoV-2 test is an automated in – vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 within a turnaround time of 60 minutes on the widely used GeneXpert Dx Instrument Systems. Here we document the best practices and challenges encountered with the operationalization of Xpert® Xpress SARS-CoV-2 testing in a resource-limited setting. Materials and Methods: The Xpert® Xpress SARS-CoV-2 implementation followed an operational work plan that included; Laboratory COVID-19 policy and planning, situational analysis of the Laboratory network, country Xpert® Xpress SARS-CoV-2 assay verification, and rollout at Mutukula Port Health Laboratory. The Laboratory strategy was based on a set of six objectives; conducting infrastructural modifications, building a strong COVID-19 testing capacity, developing robust Laboratory Quality and Information Management Systems, establishing a Bio-risk management and Bio-banking capacity.enCOVID-19Xpert® Xpress SARS CoV-2Rapid diagnosisResource-Limited SettingsImplementationArticle