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Impaired detection of omicron by SARS-CoV-2 rapid antigen tests.
Osterman, Andreas; Badell, Irina; Basara, Elif; Stern, Marcel; Kriesel, Fabian; Eletreby, Marwa; Öztan, Gamze Naz; Huber, Melanie; Autenrieth, Hanna; Knabe, Ricarda; Späth, Patricia M; Muenchhoff, Maximilian; Graf, Alexander; Krebs, Stefan; Blum, Helmut; Durner, Jürgen; Czibere, Ludwig; Dächert, Christopher; Kaderali, Lars; Baldauf, Hanna-Mari; Keppler, Oliver T.
  • Osterman A; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Badell I; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Basara E; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Stern M; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Kriesel F; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Eletreby M; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Öztan GN; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Huber M; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Autenrieth H; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Knabe R; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Späth PM; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Muenchhoff M; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
  • Graf A; German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
  • Krebs S; COVID-19 Registry of the LMU Munich (CORKUM), University Hospital, LMU Munich, Munich, Germany.
  • Blum H; Laboratory for Functional Genome Analysis, Gene Center, LMU München, Munich, Germany.
  • Durner J; Laboratory for Functional Genome Analysis, Gene Center, LMU München, Munich, Germany.
  • Czibere L; Laboratory for Functional Genome Analysis, Gene Center, LMU München, Munich, Germany.
  • Dächert C; Labor Becker MVZ GbR, Munich, Germany.
  • Kaderali L; Department of Conservative Dentistry and Periodontology, University Hospital, LMU München, Goethestr. 70, 80336, Munich, Germany.
  • Baldauf HM; Labor Becker MVZ GbR, Munich, Germany.
  • Keppler OT; Max Von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU München, Feodor-Lynen-Str. 23, 81377, Munich, Germany.
Med Microbiol Immunol ; 211(2-3): 105-117, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1702741
ABSTRACT
Since autumn 2020, rapid antigen tests (RATs) have been implemented in several countries as an important pillar of the national testing strategy to rapidly screen for infections on site during the SARS-CoV-2 pandemic. The current surge in infection rates around the globe is driven by the variant of concern (VoC) omicron (B.1.1.529). Here, we evaluated the performance of nine SARS-CoV-2 RATs in a single-centre laboratory study. We examined a total of 115 SARS-CoV-2 PCR-negative and 166 SARS-CoV-2 PCR-positive respiratory swab samples (101 omicron, 65 delta (B.1.617.2)) collected from October 2021 until January 2022 as well as cell culture-expanded clinical isolates of both VoCs. In an assessment of the analytical sensitivity in clinical specimen, the 50% limit of detection (LoD50) ranged from 1.77 × 106 to 7.03 × 107 RNA copies subjected to the RAT for omicron compared to 1.32 × 105 to 2.05 × 106 for delta. To score positive in these point-of-care tests, up to 10-fold (LoD50) or 101-fold (LoD95) higher virus loads were required for omicron- compared to delta-containing samples. The rates of true positive test results for omicron samples in the highest virus load category (Ct values < 25) ranged between 31.4 and 77.8%, while they dropped to 0-8.3% for samples with intermediate Ct values (25-30). Of note, testing of expanded virus stocks suggested a comparable RAT sensitivity of both VoCs, questioning the predictive value of this type of in vitro-studies for clinical performance. Given their importance for national test strategies in the current omicron wave, awareness must be increased for the reduced detection rate of omicron infections by RATs and a short list of suitable RATs that fulfill the minimal requirements of performance should be rapidly disclosed.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: Med Microbiol Immunol Year: 2022 Document Type: Article Affiliation country: S00430-022-00730-Z

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: Med Microbiol Immunol Year: 2022 Document Type: Article Affiliation country: S00430-022-00730-Z