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Increasing test specificity without impairing sensitivity: lessons learned from SARS-CoV-2 serology.
Perkmann, Thomas; Koller, Thomas; Perkmann-Nagele, Nicole; Ozsvar-Kozma, Maria; Eyre, David; Matthews, Philippa; Bown, Abbie; Stoesser, Nicole; Breyer, Marie-Kathrin; Breyer-Kohansal, Robab; Burghuber, Otto C; Hartl, Slyvia; Aletaha, Daniel; Sieghart, Daniela; Quehenberger, Peter; Marculescu, Rodrig; Mucher, Patrick; Radakovics, Astrid; Klausberger, Miriam; Duerkop, Mark; Holzer, Barba; Hartmann, Boris; Strassl, Robert; Leitner, Gerda; Grebien, Florian; Gerner, Wilhelm; Grabherr, Reingard; Wagner, Oswald F; Binder, Christoph J; Haslacher, Helmuth.
  • Perkmann T; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Koller T; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Perkmann-Nagele N; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Ozsvar-Kozma M; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Eyre D; Big Data Institute, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Matthews P; Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Bown A; Public Health England Porton Down, Salisbury, UK.
  • Stoesser N; Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Breyer MK; Department of Respiratory and Critical Care Medicine, Clinic Penzing, Vienna, Austria.
  • Breyer-Kohansal R; Ludwig Boltzmann Institute for Lung Health, Vienna, Austria.
  • Burghuber OC; Department of Respiratory and Critical Care Medicine, Clinic Penzing, Vienna, Austria.
  • Hartl S; Ludwig Boltzmann Institute for Lung Health, Vienna, Austria.
  • Aletaha D; Ludwig Boltzmann Institute for Lung Health, Vienna, Austria.
  • Sieghart D; Sigmund Freud Private University Vienna, Vienna, Austria.
  • Quehenberger P; Department of Respiratory and Critical Care Medicine, Clinic Penzing, Vienna, Austria.
  • Marculescu R; Ludwig Boltzmann Institute for Lung Health, Vienna, Austria.
  • Mucher P; Sigmund Freud Private University Vienna, Vienna, Austria.
  • Radakovics A; Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
  • Klausberger M; Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
  • Duerkop M; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Holzer B; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Hartmann B; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Strassl R; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Leitner G; Institute of Molecular Biotechnology, Department of Biotechnology, University of Natural Resources and Life Sciences (BOKU) Vienna, Vienna, Austria.
  • Grebien F; Institute of Bioprocess Science and Engineering, Department of Biotechnology, University of Natural Resources and Life Sciences (BOKU) Vienna, Vienna, Austria.
  • Gerner W; Institute for Veterinary Disease Control, Austrian Agency for Health and Food Safety (AGES), Moedling, Austria.
  • Grabherr R; Institute for Veterinary Disease Control, Austrian Agency for Health and Food Safety (AGES), Moedling, Austria.
  • Wagner OF; Department of Laboratory Medicine, Medical University of Vienna, Wien, Austria.
  • Binder CJ; Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria.
  • Haslacher H; Institute for Medical Biochemistry, University of Veterinary Medicine Vienna, Vienna, Austria.
J Clin Pathol ; 2022 Aug 30.
Article in English | MEDLINE | ID: covidwho-2020140
ABSTRACT

BACKGROUND:

Serological tests are widely used in various medical disciplines for diagnostic and monitoring purposes. Unfortunately, the sensitivity and specificity of test systems are often poor, leaving room for false-positive and false-negative results. However, conventional methods were used to increase specificity and decrease sensitivity and vice versa. Using SARS-CoV-2 serology as an example, we propose here a novel testing strategy the 'sensitivity improved two-test' or 'SIT²' algorithm.

METHODS:

SIT² involves confirmatory retesting of samples with results falling in a predefined retesting zone of an initial screening test, with adjusted cut-offs to increase sensitivity. We verified and compared the performance of SIT² to single tests and orthogonal testing (OTA) in an Austrian cohort (1117 negative, 64 post-COVID-positive samples) and validated the algorithm in an independent British cohort (976 negatives and 536 positives).

RESULTS:

The specificity of SIT² was superior to single tests and non-inferior to OTA. The sensitivity was maintained or even improved using SIT² when compared with single tests or OTA. SIT² allowed correct identification of infected individuals even when a live virus neutralisation assay could not detect antibodies. Compared with single testing or OTA, SIT² significantly reduced total test errors to 0.46% (0.24-0.65) or 1.60% (0.94-2.38) at both 5% or 20% seroprevalence.

CONCLUSION:

For SARS-CoV-2 serology, SIT² proved to be the best diagnostic choice at both 5% and 20% seroprevalence in all tested scenarios. It is an easy to apply algorithm and can potentially be helpful for the serology of other infectious diseases.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Topics: Long Covid Language: English Year: 2022 Document Type: Article Affiliation country: Jcp-2022-208171

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Topics: Long Covid Language: English Year: 2022 Document Type: Article Affiliation country: Jcp-2022-208171