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Evaluation of the COVID-19 IgG/IgM Rapid Test from Orient Gene Biotech.
Dellière, Sarah; Salmona, Maud; Minier, Marine; Gabassi, Audrey; Alanio, Alexandre; Le Goff, Jérôme; Delaugerre, Constance; Chaix, Marie-Laure.
  • Dellière S; Université de Paris, Département des Agents Infectieux, Service de Parasitologie-Mycologie, Hôpital Saint-Louis, Paris, France sarah.delliere@aphp.fr.
  • Salmona M; Université de Paris, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.
  • Minier M; INSERM UMR 976, Université de Paris, Paris, France.
  • Gabassi A; Université de Paris, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.
  • Alanio A; Université de Paris, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.
  • Le Goff J; Université de Paris, Département des Agents Infectieux, Service de Parasitologie-Mycologie, Hôpital Saint-Louis, Paris, France.
  • Delaugerre C; Université de Paris, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France.
  • Chaix ML; INSERM UMR 976, Université de Paris, Paris, France.
J Clin Microbiol ; 58(8)2020 07 23.
Article in English | MEDLINE | ID: covidwho-591726
ABSTRACT
While the coronavirus disease 2019 (COVID-19) pandemic has peaked in many countries already, the current challenge is to assess population immunity on a large scale. Many serological tests are available and require urgent independent validation. Here, we report performance characteristics of Orient Gene Biotech COVID-19 IgG/IgM Rapid Test Cassette (OG) and compare it to Abbott SARS-CoV-2 IgG immunoassay (ASIA). Patients (n = 102) with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase PCR (RT-PCR) were tested. The patients were asymptomatic (n = 2) or had mild (n = 37) or severe symptoms requiring hospitalization in a medical unit (n = 35) or intensive care unit (n = 28). Specificity was evaluated for 42 patients with previous viral and parasitic diseases as well as a high level of rheumatic factor. The sensitivity of OG was 95.8% (95% confidence interval [CI95%], 89.6 to 98.8) for samples collected ≥10 days after the onset of symptoms, which was equivalent to the sensitivity of ASIA of 90.5% (CI95%, 82.8 to 95.6). OG uncovered six false-negative results of ASIA, of which two had only IgM with OG. Specificity was 100% (CI95%, 93.4 to 100) with both tests on samples, including patients infected with endemic coronavirus. Overall, OG performance characteristics indicate that the test is suitable for routine use in clinical laboratories, and its performance is equivalent to that of immunoassay. Testing OG on a larger asymptomatic population may be needed to confirm these results.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoglobulin M / Coronavirus Infections / Clinical Laboratory Techniques / Point-of-Care Testing / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: Jcm.01233-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoglobulin M / Coronavirus Infections / Clinical Laboratory Techniques / Point-of-Care Testing / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: Jcm.01233-20