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We conducted a systematic review and meta-analysis of studies and reports comparing the performance of antigen rapid diagnostic tests (Ag RDT) for diagnosing Ebola disease (EVD). We searched PubMed, EMBASE, and Web of Science for diagnostic studies published between 1976 and 2023, evaluating them with QUADAS-2. Using a bivariate random-effects model, we estimated the pooled sensitivity and specificity of Ag RDTs. Of 64 eligible full studies and reports, 16 met the inclusion criteria. Pooled sensitivity and specificity were 82.1% (95%CI: 75.2 - 88.0) and 97.0% (95%CI: 95.1-98.2), respectively. We conducted subgroup analysis on 4 Ag RDTs, 3 RT-PCR tests, and 4 sample types, showing varied performance. The high specificity and positive predictive value of Ag RDTs support their use to "rule-in" patients with EVD. However, high-sensitivity RDTs suitable for field settings and capable of detecting multiple ebolavirus species are needed., Competing Interests: Declaration of competing interest That there is no conflict of interest for this paper, (Copyright © 2024. Published by Elsevier Inc.)

We evaluated the diagnostic performance of Rapiim SARS-CoV-2-H (Rapiim-H)-a point-of-care qualitative antigen test-using nasopharyngeal swabs (NPS) and saliva samples and compared its results with those from antigen quantification and nucleic acid amplification tests. NPS and saliva were collected from patients with confirmed and suspected coronavirus disease (COVID-19). In total, 142 NPS and saliva samples were collected. In symptomatic cases, in which the first NPS sample was collected within 10 days of disease onset, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for COVID-19 diagnosis were 91.7 %, 88.6 %, 93.2 %, and 86.1 %, respectively. A similar analysis was performed on saliva samples, and the sensitivity, specificity, PPV, and NPV were 50.8 %, 91.4 %, 91.2 %, and 51.6 %, respectively. The Rapiim-H test using NPS demonstrated approximately 90 % sensitivity and specificity, particularly within the first 10 days after disease onset., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kei Yamamoto reports financial support was provided by Canon Medical Systems Corporation. Hideaki Kato reports a relationship with Shionogi and Co Ltd that includes: funding grants. Hideaki Kato reports a relationship with Asahi Kasei Pharma Corporation that includes: funding grants. Kei Yamamoto reports a relationship with FUJIREBIO Inc that includes: funding grants. Kei Yamamoto reports a relationship with Mizuho Medy Co Ltd that includes: funding grants. Kei Yamamoto reports a relationship with VisGene Co. Ltd. that includes: funding grants. Kei Yamamoto reports a relationship with Sanyo Chemical Industries Ltd that includes: funding grants. Kei Yamamoto reports a relationship with CarbGeM Inc. that includes: funding grants. Kei Yamamoto reports a relationship with Sysmex Corp that includes: funding grants. Kei Yamamoto reports a relationship with Toyobo Co Ltd that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)