Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2
| العنوان: | Evaluation of a novel, rapid antigen detection test for the diagnosis of SARS-CoV-2 |
|---|---|
| المؤلفون: | Verena Kallab, Marton Szell, Amelie Blaschke, Lukas Heschl, Rainer Thell, Anna Klicpera, Alexander O. Spiel, Moritz Haugk, Stefan Winkler, Stefan Korsatko, Wolfgang Mueckstein, Franz Toedling, Philipp Kreuzer, Martina Heschl, Theresa Herzog, Brenda Laky, Christian Sebesta, Anna Kreil, Robert Krause, Wolfgang Weinhappel, Clara Koeller |
| المصدر: | PLoS ONE PLoS ONE, Vol 16, Iss 11, p e0259527 (2021) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, RNA viruses, Viral Diseases, Critical Care and Emergency Medicine, Coronaviruses, Epidemiology, Prevalence, Artificial Gene Amplification and Extension, medicine.disease_cause, Polymerase Chain Reaction, Medical Conditions, Medicine and Health Sciences, Medicine, Prospective cohort study, Antigens, Viral, Pathology and laboratory medicine, Coronavirus, Virus Testing, Aged, 80 and over, Multidisciplinary, Middle Aged, Medical microbiology, medicine.anatomical_structure, Infectious Diseases, Rapid antigen test, Viruses, Female, SARS CoV 2, Pathogens, Emergency Service, Hospital, Viral load, Research Article, Adult, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), SARS coronavirus, Science, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Research and Analysis Methods, Sensitivity and Specificity, Microbiology, COVID-19 Serological Testing, Young Adult, Antigen, Diagnostic Medicine, Throat, Internal medicine, Confidence Intervals, Humans, Molecular Biology Techniques, Molecular Biology, Aged, Cycle threshold, business.industry, SARS-CoV-2, Organisms, Viral pathogens, COVID-19, Biology and Life Sciences, Covid 19, Reverse Transcriptase-Polymerase Chain Reaction, Microbial pathogens, Health Facilities, business |
| الوصف: | BackgroundSevere 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.MethodsFor 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.ResultsDifferences 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%).ConclusionsThe 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.SUMMARYThe rapid SARS-Cov-2 antigen test (SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics), was compared in symptomatic patients with PCR testing both in emergency departments and primary health care centres. It showed an overall sensitivity of 80.3% and specificity of 99.1%; these were higher with lower PCR cycle threshold numbers and with a shorter onset of symptoms. |
| تدمد: | 1932-6203 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::661b3afdb7b0078d11c3939d59eb5ef9 https://pubmed.ncbi.nlm.nih.gov/34843505 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....661b3afdb7b0078d11c3939d59eb5ef9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19326203 |
|---|