Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR

Maria Kyritsi, Alexandros Vontas, Ioanna Voulgaridi, Alexia Matziri, Apostolos Komnos, Dimitris Babalis, Antonios Papadogoulas, Aikaterini Oikonomou, Varvara A. Mouchtouri, Matthaios Speletas and Christos Hadjichristodoulou
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Maria Kyritsi: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Alexandros Vontas: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Ioanna Voulgaridi: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Alexia Matziri: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Apostolos Komnos: Intensive Care Unit, General Hospital of Larissa, 41221 Larissa, Greece
Dimitris Babalis: Emergency Department, General Hospital of Larissa, 41221 Larissa, Greece
Antonios Papadogoulas: Intensive Care Unit, General Hospital of Larissa, 41221 Larissa, Greece
Aikaterini Oikonomou: Internal Medicine, First Department of Internal Medicine, General Hospital of Larissa, 41221 Larissa, Greece
Varvara A. Mouchtouri: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Matthaios Speletas: Department of Immunology and Histocompatibility, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece
Christos Hadjichristodoulou: Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, 41500 Larissa, Greece

IJERPH, 2021, vol. 18, issue 17, 1-8

Abstract: Introduction: Rapid antigen tests (RATs) are convenient for SARS-CoV-2 detection because they are simpler and faster than nucleic acid amplification tests (NAATs). This study aimed to assess the accuracy of a locally manufactured test; Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece) in a clinical setting and during mass screening. Methods: Nasopharyngeal samples from 624 individuals were analyzed. The results of the rapid test were compared to real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR). At the end of the test’s procedure, positive test strips were scanned in an S-Flow reader in order to roughly estimate the antigen concentration. Results: The lower limit of detection of the test was 468.75 genome copies/mL. The PROGNOSIS rapid test displayed a sensitivity of 85.5% (141/165) (95%CI: 79.1–90.5) and a specificity of 99.8% (458/459) (95%CI: 98.8–100.0%). The general inter-rater agreement was 0.89 (95%CI: 85.1–93.3). The regression analysis between the S-flow reader measurements (viral antigen) and the viral load of the positive samples demonstrated a weak correlation (R 2 = 0.288, p < 0.001). Conclusion: The Rapid Test Ag 2019-nCoV demonstrated sufficient sensitivity, excellent specificity and could be available to be used with low overall cost. Thus, it could be used as point of care test, but also for mass screening for rapid detection of infected persons (e.g., for travelers).

Keywords: SARS-CoV-2; nucleocapsid protein; rapid antigen test; immunochromatography (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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