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
National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
BCCDC Public Health Laboratory, Vancouver, British Columbia, Canada.
J Assoc Med Microbiol Infect Dis Can. 2022 Sep 27;7(3):186-195. doi: 10.3138/jammi-2021-0026. eCollection 2022 Sep.
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.
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 ( = 30) and the United States ( = 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.
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%).
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.
旨在检测新型冠状病毒2（SARS-CoV-2）抗体的血清学检测方法正用于血清学调查及其他特殊应用。因此，为确保血清学检测结果符合高质量标准，需要进行评估以测定这些检测方法的性能以及进行检测的实验室的熟练度。
获取一组60份来自逆转录聚合酶链反应（RT-PCR）确诊感染SARS-CoV-2的献血者的血浆/血清样本以及21份SARS-CoV-2阴性样本，并分发给加拿大境内（=30）和美国境内（=1）感兴趣的实验室。要求参与的实验室提供所使用诊断检测方法的详细信息、检测方法所使用的平台以及每个样本组样本的检测结果。实验室对预期结果不知情。
所评估的不同检测方法表现出色，罗氏、奥森多和西门子的高通量平台显示出100%的灵敏度。大多数其他高通量平台的灵敏度>93%，使用雅培ARCHITECT的IgG检测方法除外，其平均灵敏度仅为87%。大多数高通量平台也显示出非常好的特异性（>97%）。
这项熟练度研究表明，加拿大省级公共卫生或医院实验室使用的大多数SARS-CoV-2血清学检测方法具有可接受的灵敏度和出色的特异性。
