Announcement

Collapse
No announcement yet.

PLoS One . Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • PLoS One . Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2


    PLoS One


    . 2021 Nov 29;16(11):e0259527.
    doi: 10.1371/journal.pone.0259527. eCollection 2021.
    Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2


    Rainer Thell 1 2 , Verena Kallab 1 2 , Wolfgang Weinhappel 3 , Wolfgang Mueckstein 3 , Lukas Heschl 4 , Martina Heschl 4 , Stefan Korsatko 5 , Franz Toedling 6 , Amelie Blaschke 1 2 , Theresa Herzog 1 2 , Anna Klicpera 1 2 , Clara Koeller 7 8 , Moritz Haugk 1 7 , Anna Kreil 1 9 , Alexander Spiel 1 10 , Philipp Kreuzer 11 , Robert Krause 12 , Christian Sebesta 1 2 , Stefan Winkler 13 , Brenda Laky 14 15 , Marton Szell 1 2



    Affiliations

    Abstract

    Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients.
    Methods: For this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed.
    Results: Differences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%).
    Conclusions: The highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.


Working...
X