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Time scale performance of rapid antigen testing for SARS-CoV-2: Evaluation of 10 rapid antigen assays.
Abusrewil, Zakarya; Alhudiri, Inas M; Kaal, Hamza H; El Meshri, Salah Eldin; Ebrahim, Fawzi O; Dalyoum, Tarek; Efrefer, Abdussamee A; Ibrahim, Khaled; Elfghi, Mohammed B; Abusrewil, Suleiman; Elzagheid, Adam.
  • Abusrewil Z; Forensic Medicine and Toxicology Department, University of Tripoli, Tripoli, Libya.
  • Alhudiri IM; Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
  • Kaal HH; Hospital Universitario Principe de Asturias, Alcala De Henares, Madrid, Spain.
  • El Meshri SE; Microbiology Department, Biotechnology Research Center, Tripoli, Libya.
  • Ebrahim FO; Cell Biology Department, Biotechnology Research Center, Tripoli, Libya.
  • Dalyoum T; Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
  • Efrefer AA; Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
  • Ibrahim K; Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
  • Elfghi MB; Hospital Universitario Principe de Asturias, Alcala De Henares, Madrid, Spain.
  • Abusrewil S; Pediatric Department, University of Tripoli, Tripoli, Libya.
  • Elzagheid A; Genetic Engineering Department, Biotechnology Research Center, Tripoli, Libya.
J Med Virol ; 93(12): 6512-6518, 2021 12.
Article in English | MEDLINE | ID: covidwho-1544296
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ABSTRACT
There is a great demand for more rapid tests for SARS-CoV-2 detection to reduce waiting time, boost public health strategies for combating disease, decrease costs, and prevent overwhelming laboratory capacities. This study was conducted to assess the performance of 10 lateral flow device viral antigen immunoassays for the detection of SARS-CoV-2 in nasopharyngeal swab specimens. We analyzed 231 nasopharyngeal samples collected from October 2020 to December 2020, from suspected COVID-19 cases and contacts of positive cases at Biotechnology Research Center laboratories, Tripoli, Libya. The performance of 10 COVID-19 Antigen (Ag) rapid test devices for the detection of SARS-CoV-2 antigen was compared to a quantitative reverse transcription-polymerase chain reaction (RT-qPCR). In this study, 161 cases had symptoms consistent with COVID-19. The mean duration from symptom onset was 6.6 ± 4.3 days. The median cycle threshold (Ct ) of positive samples was 25. Among the 108 positive samples detected by RT-qPCR, the COVID-19 antigen (Ag) tests detected 83 cases correctly. All rapid Ag test devices used in this study showed 100% specificity. While tests from six manufacturers had an overall sensitivity range from 75% to 100%, the remaining four tests had a sensitivity of 50%-71.43%. Sensitivity during the first 6 days of symptoms and in samples with high viral loads (Ct < 25), was 100% in all but two of the test platforms. False-negative samples had a median Ct of 34 and an average duration of onset of symptoms of 11.3 days (range = 5-20 days). Antigen test diagnosis has high sensitivity and specificity in early disease when patients present less than 7 days of symptom onset. Patients are encouraged to test as soon as they get COVID-19-related symptoms within 1 week and to seek medical advice within 24 h if they develop disturbed smell/taste. The use of rapid antigen tests is important for controlling the COVID-19 pandemic and reducing the burden on molecular diagnostic laboratories.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / COVID-19 / Antigens, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Female / Humans / Male Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.27186

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / COVID-19 / Antigens, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Female / Humans / Male Language: English Journal: J Med Virol Year: 2021 Document Type: Article Affiliation country: Jmv.27186