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Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2022

Evaluation of the performance of multiple immunoassay diagnostic platforms on the National Microbiology Laboratory SARS-CoV-2 National Serology Panel.

СтатьяНазвание и аннотация: Перевод в очереди
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Dibernardo Antonia, Toledo Nikki Pl, Robinson Alyssia, Osiowy Carla, Giles Elizabeth, Day Jacqueline, Robbin Lindsay L, Drebot Michael A, Booth Timothy F, Pidduck Tamara, Baily Ashley, Charlton Carmen L, Tipples Graham, Kanji Jamil N, Brochu Gino, Lang Amanda, Therrien Christian, Bélanger-Collard Mélina, Beaulac Sylvie-Nancy, Gilfix Brian M, Boivin Guy, Hamelin Marie-Ève, Carbonneau Julie, Lévesque Simon, Martin Philippe, Finzi Andrés, Gendron-Lepage Gabrielle, Goyette Guillaume, Benlarbi Mehdi, Gasser Romain, Fortin Claude, Martel-Lafferrière Valérie, Lavoie Myriam, Guérin Renée, Haraoui Louis-Patrick, Renaud Christian, Jenkins Craig, O'Brien Sheila F, Drews Steven J, Conrod Valerie, Tran Vanessa, Awrey Bill, Scheuermann Robert, DuPuis Alan, Payne Anne, Warszycki Casey, Girardin Roxie, Lee William, Zahariadis George, Jiao Lei, Needle Robert, Cordenbach James, Zaharatos Jerry, Taylor Kellee, Teltscher Marty, Miller Matthew, Elsherif May, Robertson Peter, Robinson Jason L

Аннотация

BACKGROUND: Serological assays designed to detect SARS-CoV-2 antibodies are being used in serological surveys and other specialized applications. As a result, and to ensure that the outcomes of serological testing meet high quality standards, evaluations are required to assess the performance of these assays and the proficiency of laboratories performing them.

METHODS: A panel of 60 plasma/serum samples from blood donors who had reverse transcriptase-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 infections and 21 SARS-CoV-2 negative samples were secured and distributed to interested laboratories within Canada (n = 30) and the United States (n = 1). Participating laboratories were asked to provide details on the diagnostic assays used, the platforms the assays were performed on, and the results obtained for each panel sample. Laboratories were blinded with respect to the expected outcomes.

RESULTS: The performance of the different assays evaluated was excellent, with the high-throughput platforms of Roche, Ortho, and Siemens demonstrating 100% sensitivity. Most other high-throughput platforms had sensitivities of >93%, with the exception of the IgG assay using the Abbott ARCHITECT which had an average sensitivity of only 87%. The majority of the high-throughput platforms also demonstrated very good specificities (>97%).

CONCLUSION: This proficiency study demonstrates that most of the SARS-CoV-2 serological assays utilized by provincial public health or hospital laboratories in Canada have acceptable sensitivity and excellent specificity.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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