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      Comparison of the Diagnostic Performance of a Rapid Antigen Test with Real-Time Polymerase Chain Reaction for Detection of SARS-CoV-2 Among Patients Diagnosed with COVID-19 at Selected Hospitals in Addis Ababa, Ethiopia

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          Abstract

          Background

          When faced with a public health problem such as the COVID-19 pandemic, devising a test with an accurate and rapid diagnostic capacity is critical to contain the disease. We compared the diagnostic performance of a rapid antigen test in comparison with a reference method, namely a real-time polymerase chain reaction (RT-PCR) assay.

          Methods

          We enrolled patients with confirmed COVID-19 from two selected hospital in Addis Ababa, Ethiopia, between January and November 2021. We assessed the performance of the Standard Q COVID-19 Ag Kit (SD Biosensor, Republic of Korea) in 200 nasopharyngeal and nasal swab samples.

          Results

          Out of the 200 samples utilized for the diagnostic performance evaluation, equal proportion of the samples were confirmed positive and negative for SARS-CoV-2 based on RT-PCR. Of the 100 confirmed positive cases, 95 showed positive results with the rapid antigen test, yielding a sensitivity of 95% (95% confidence interval [CI] 88.7–98.4%). Of the 100 confirmed negative cases, there were three false-positive results, yielding a specificity of 97% (95% CI 91.5–99.4%). The sensitivity of the rapid antigen test was higher for samples with an RT-PCR cycle threshold (Ct) value ≤25 compared with samples with a higher Ct value.

          Conclusion

          The finding demonstrated that the detection capacity of the Standard Q COVID-19 Ag Test meets the requirements set by the Ministry of Health Ethiopia. The high sensitivity and specificity of the test device indicate the possibility of using it for diagnostic and clinical purposes in resource-constrained settings such as Ethiopia.

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          Most cited references15

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          SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients

          To the Editor: The 2019 novel coronavirus (SARS-CoV-2) epidemic, which was first reported in December 2019 in Wuhan, China, and has been declared a public health emergency of international concern by the World Health Organization, may progress to a pandemic associated with substantial morbidity and mortality. SARS-CoV-2 is genetically related to SARS-CoV, which caused a global epidemic with 8096 confirmed cases in more than 25 countries in 2002–2003. 1 The epidemic of SARS-CoV was successfully contained through public health interventions, including case detection and isolation. Transmission of SARS-CoV occurred mainly after days of illness 2 and was associated with modest viral loads in the respiratory tract early in the illness, with viral loads peaking approximately 10 days after symptom onset. 3 We monitored SARS-CoV-2 viral loads in upper respiratory specimens obtained from 18 patients (9 men and 9 women; median age, 59 years; range, 26 to 76) in Zhuhai, Guangdong, China, including 4 patients with secondary infections (1 of whom never had symptoms) within two family clusters (Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org). The patient who never had symptoms was a close contact of a patient with a known case and was therefore monitored. A total of 72 nasal swabs (sampled from the mid-turbinate and nasopharynx) (Figure 1A) and 72 throat swabs (Figure 1B) were analyzed, with 1 to 9 sequential samples obtained from each patient. Polyester flock swabs were used for all the patients. From January 7 through January 26, 2020, a total of 14 patients who had recently returned from Wuhan and had fever (≥37.3°C) received a diagnosis of Covid-19 (the illness caused by SARS-CoV-2) by means of reverse-transcriptase–polymerase-chain-reaction assay with primers and probes targeting the N and Orf1b genes of SARS-CoV-2; the assay was developed by the Chinese Center for Disease Control and Prevention. Samples were tested at the Guangdong Provincial Center for Disease Control and Prevention. Thirteen of 14 patients with imported cases had evidence of pneumonia on computed tomography (CT). None of them had visited the Huanan Seafood Wholesale Market in Wuhan within 14 days before symptom onset. Patients E, I, and P required admission to intensive care units, whereas the others had mild-to-moderate illness. Secondary infections were detected in close contacts of Patients E, I, and P. Patient E worked in Wuhan and visited his wife (Patient L), mother (Patient D), and a friend (Patient Z) in Zhuhai on January 17. Symptoms developed in Patients L and D on January 20 and January 22, respectively, with viral RNA detected in their nasal and throat swabs soon after symptom onset. Patient Z reported no clinical symptoms, but his nasal swabs (cycle threshold [Ct] values, 22 to 28) and throat swabs (Ct values, 30 to 32) tested positive on days 7, 10, and 11 after contact. A CT scan of Patient Z that was obtained on February 6 was unremarkable. Patients I and P lived in Wuhan and visited their daughter (Patient H) in Zhuhai on January 11 when their symptoms first developed. Fever developed in Patient H on January 17, with viral RNA detected in nasal and throat swabs on day 1 after symptom onset. We analyzed the viral load in nasal and throat swabs obtained from the 17 symptomatic patients in relation to day of onset of any symptoms (Figure 1C). Higher viral loads (inversely related to Ct value) were detected soon after symptom onset, with higher viral loads detected in the nose than in the throat. Our analysis suggests that the viral nucleic acid shedding pattern of patients infected with SARS-CoV-2 resembles that of patients with influenza 4 and appears different from that seen in patients infected with SARS-CoV. 3 The viral load that was detected in the asymptomatic patient was similar to that in the symptomatic patients, which suggests the transmission potential of asymptomatic or minimally symptomatic patients. These findings are in concordance with reports that transmission may occur early in the course of infection 5 and suggest that case detection and isolation may require strategies different from those required for the control of SARS-CoV. How SARS-CoV-2 viral load correlates with culturable virus needs to be determined. Identification of patients with few or no symptoms and with modest levels of detectable viral RNA in the oropharynx for at least 5 days suggests that we need better data to determine transmission dynamics and inform our screening practices.
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            Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study

            Background Antigen point-of-care tests (AgPOCTs) can accelerate SARS-CoV-2 testing. As some AgPOCTs have become available, interest is growing in their utility and performance. Here we aimed to compare the analytical sensitivity and specificity of seven commercially available AgPOCT devices. Methods In a single-centre, laboratory evaluation study, we compared AgPOCT products from seven suppliers: the Abbott Panbio COVID-19 Ag Rapid Test, the RapiGEN BIOCREDIT COVID-19 Ag, the Healgen Coronavirus Ag Rapid Test Cassette (Swab), the Coris BioConcept COVID-19 Ag Respi-Strip, the R-Biopharm RIDA QUICK SARS-CoV-2 Antigen, the nal von minden NADAL COVID-19 Ag Test, and the Roche-SD Biosensor SARS-CoV Rapid Antigen Test. Tests were evaluated on recombinant SARS-CoV-2 nucleoprotein, cultured endemic and emerging coronaviruses, stored respiratory samples with known SARS-CoV-2 viral loads, stored samples from patients with respiratory pathogens other than SARS-CoV-2, and self-sampled swabs from healthy volunteers. We estimated analytical sensitivity in terms of approximate viral concentrations (quantified by real-time RT-PCR) that yielded positive AgPOCT results, and specificity in terms of propensity to generate false-positive results. Findings In 138 clinical samples with quantified SARS-CoV-2 viral load, the 95% limit of detection (concentration at which 95% of test results were positive) in six of seven AgPOCT products ranged between 2·07 × 106 and 2·86 × 107 copies per swab, with an outlier (RapiGEN) at 1·57 × 1010 copies per swab. The assays showed no cross-reactivity towards cell culture or tissue culture supernatants containing any of the four endemic human coronaviruses (HCoV‑229E, HCoV‑NL63, HCoV‑OC43, or HCoV‑HKU1) or MERS-CoV, with the exception of the Healgen assay in one repeat test on HCoV-HKU1 supernatant. SARS-CoV was cross-detected by all assays. Cumulative specificities among stored clinical samples with non-SARS-CoV-2 infections (n=100) and self-samples from healthy volunteers (n=35; cumulative sample n=135) ranged between 98·5% (95% CI 94·2–99·7) and 100·0% (97·2–100·0) in five products, with two outliers at 94·8% (89·2–97·7; R-Biopharm) and 88·9% (82·1–93·4; Healgen). False-positive results did not appear to be associated with any specific respiratory pathogen. Interpretation The sensitivity range of most AgPOCTs overlaps with SARS-CoV-2 viral loads typically observed in the first week of symptoms, which marks the infectious period in most patients. The AgPOCTs with limit of detections that approximate virus concentrations at which patients are infectious might enable shortcuts in decision making in various areas of health care and public health. Funding EU's Horizon 2020 research and innovation programme, German Ministry of Research, German Federal Ministry for Economic Affairs and Energy, German Ministry of Health, and Bill & Melinda Gates Foundation.
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              Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand

              Background The Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. Hence, there is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases. Methods The rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), was compared with the real-time RT-PCR test, Allplex™ 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (mainly nasopharyngeal and throat swabs) were obtained from COVID-19 suspected cases and contact individuals, including pre-operative patients at Siriraj Hospital, Bangkok, Thailand during March–May 2020. Results Of 454 respiratory samples, 60 (13.2%) were positive, and 394 (86.8%) were negative for SARS-CoV-2 RNA by real-time RT-PCR assay. The duration from onset to laboratory test in COVID-19 suspected cases and contact individuals ranged from 0 to 14 days with a median of 3 days. The rapid SARS-CoV-2 antigen detection test’s sensitivity and specificity were 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false negative test result was from a sample with a high real-time RT-PCR cycle threshold (Ct), while five false positive test results were from specimens of pre-operative patients. Conclusions The rapid assay for SARS-CoV-2 antigen detection showed comparable sensitivity and specificity with the real-time RT-PCR assay. Thus, there is a potential use of this rapid and simple SARS-CoV-2 antigen detection test as a screening assay.
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                Author and article information

                Journal
                Infect Drug Resist
                Infect Drug Resist
                idr
                Infection and Drug Resistance
                Dove
                1178-6973
                06 August 2022
                2022
                : 15
                : 4299-4305
                Affiliations
                [1 ]Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University , Addis Ababa, Ethiopia
                [2 ]Department of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa University , Addis Ababa, Ethiopia
                [3 ]Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University , Addis Ababa, Ethiopia
                [4 ]Department of Internal Medicine, College of Health Sciences, School of Medicine, Addis Ababa University , Addis Ababa, Ethiopia
                [5 ]School of Public Health, College of Health Sciences, Addis Ababa University , Addis Ababa, Ethiopia
                [6 ]Institute of Medical Epidemiology, Biostatistics and Informatics, Martin-Luther-University , Halle, Germany
                [7 ]Department of Obstetrics and Gynecology, College of Health Sciences, School of Medicine, Addis Ababa University , Addis Ababa, Ethiopia
                Author notes
                Correspondence: Zelalem Desalegn, Department of Microbiology, Immunology and Parasitology, College of Health Sciences, Addis Ababa University , P.O. Box: 9086, Addis Ababa, Ethiopia, Email zelalem.desalegn@aau.edu.et; tzollove@gmail.com
                [*]

                These authors contributed equally to this work

                Author information
                http://orcid.org/0000-0001-9643-8661
                http://orcid.org/0000-0003-1394-3510
                http://orcid.org/0000-0001-7003-0721
                http://orcid.org/0000-0002-0306-5083
                http://orcid.org/0000-0002-1914-1992
                http://orcid.org/0000-0002-6357-2044
                http://orcid.org/0000-0002-0124-6008
                http://orcid.org/0000-0002-3334-522X
                http://orcid.org/0000-0002-4950-3966
                http://orcid.org/0000-0001-7935-719X
                Article
                353844
                10.2147/IDR.S353844
                9365320
                35965848
                db96e6e1-43c2-4497-9043-6464a4422620
                © 2022 Desalegn et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 15 January 2022
                : 02 July 2022
                Page count
                Figures: 0, Tables: 2, References: 16, Pages: 7
                Funding
                Funded by: Addis Ababa University, SD Biosensor® (Republic of Korea) and Martin Luther University (Halle, Germany);
                This study was partially financed by Addis Ababa University, SD Biosensor ® (Republic of Korea) and Martin Luther University (Halle, Germany).
                Categories
                Original Research

                Infectious disease & Microbiology
                sars-cov-2,covid-19,antigen test
                Infectious disease & Microbiology
                sars-cov-2, covid-19, antigen test

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