Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay.
COVID-19
SARS-CoV-2 antigen
anterior nasal swab
high-throughput
laboratory-based
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
26 08 2022
26 08 2022
Historique:
received:
13
04
2022
accepted:
31
05
2022
pubmed:
15
6
2022
medline:
5
8
2022
entrez:
14
6
2022
Statut:
epublish
Résumé
Antigen tests are an essential part of SARS-CoV-2 testing strategies. Rapid antigen tests are easy to use but less sensitive compared to nucleic acid amplification tests (NAT) and less suitable for large-scale testing. In contrast, laboratory-based antigen tests are suitable for high-throughput immunoanalyzers. Here we evaluated the diagnostic performance of the laboratory-based Siemens Healthineers SARS-CoV-2 Antigen (CoV2Ag) assay. In a public test center, from 447 individuals anterior nasal swab specimens as well as nasopharyngeal swab specimens were collected. The nasal swab specimens were collected in sample inactivation medium and measured using the CoV2Ag assay. The nasopharyngeal swab specimens were measured by RT-PCR. Additionally, 9,046 swab specimens obtained for screening purposes in a tertiary care hospital were analyzed and positive CoV2Ag results confirmed by NAT. In total, 234/447 (52.3%) participants of the public test center were positive for SARS-CoV-2-RNA. Viral lineage B1.1.529 was dominant during the study. Sensitivity and specificity of the CoV2Ag assay were 88.5% (95%CI: 83.7-91.9%) and 99.5% (97.4-99.9%), respectively. Sensitivity increased to 93.7% (97.4-99.9%) and 98.7% (97.4-99.9%) for swab specimens with cycle threshold values <30 and <25, respectively. Out of 9,046 CoV2Ag screening tests from hospitalized patients, 21 (0.2%) swab specimens were determined as false-positive by confirmatory NAT. Using sample tubes containing inactivation medium the laboratory-based high-throughput CoV2Ag assay is a very specific and highly sensitive assay for detection of SARS-CoV-2 antigen in nasal swab specimens including the B1.1.529 variant. In low prevalence settings confirmation of positive CoV2Ag results by SARS-CoV-2-RNA testing is recommended.
Identifiants
pubmed: 35700973
pii: cclm-2022-0360
doi: 10.1515/cclm-2022-0360
doi:
Substances chimiques
RNA
63231-63-0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1478-1485Informations de copyright
© 2022 Walter de Gruyter GmbH, Berlin/Boston.
Références
Bohn, MK, Lippi, G, Horvath, AR, Erasmus, R, Grimmler, M, Gramegna, M, et al.. IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals. Clin Chem Lab Med 2021;59:1507–15. https://doi.org/10.1515/cclm-2021-0455.
Kruger, LJ, Tanuri, A, Lindner, AK, Gaeddert, M, Koppel, L, Tobian, F, et al.. Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: a multi-centre clinical evaluation. EBioMedicine 2022;75:103774. https://doi.org/10.1016/j.ebiom.2021.103774.
Brummer, LE, Katzenschlager, S, Gaeddert, M, Erdmann, C, Schmitz, S, Bota, M, et al.. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis. PLoS Med 2021;18:e1003735. https://doi.org/10.1371/journal.pmed.1003735.
Khalid, MF, Selvam, K, Jeffry, AJN, Salmi, MF, Najib, MA, Norhayati, MN, et al.. Performance of rapid antigen tests for COVID-19 diagnosis: a systematic review and meta-analysis. Diagnostics (Basel) 2022;12. https://doi.org/10.3390/diagnostics12010110.
Mattiuzzi, C, Henry, BM, Lippi, G. Making sense of rapid antigen testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics. Diagnosis (Berl) 2020;8:27–31. https://doi.org/10.1515/dx-2020-0131.
Lee, RA, Herigon, JC, Benedetti, A, Pollock, NR, Denkinger, CM. Performance of saliva, oropharyngeal swabs, and nasal swabs for SARS-CoV-2 molecular detection: a systematic review and meta-analysis. J Clin Microbiol 2021;59:e02881–20. https://doi.org/10.1128/jcm.02881-20.
Osterman, A, Badell, I, Basara, E, Stern, M, Kriesel, F, Eletreby, M, et al.. Impaired detection of omicron by SARS-CoV-2 rapid antigen tests. Med Microbiol Immunol 2022;211:105–17. https://doi.org/10.1007/s00430-022-00730-z.
Jungnick, S, Hobmaier, B, Mautner, L, Hoyos, M, Haase, M, Baiker, A, et al.. Detection of the new SARS-CoV-2 variants of concern B.1.1.7 and B.1.351 in five SARS-CoV-2 rapid antigen tests (RATs), Germany, March 2021. Euro Surveill 2021;26:2100413. https://doi.org/10.2807/1560-7917.es.2021.26.16.2100413.
Osterman, A, Iglhaut, M, Lehner, A, Spath, P, Stern, M, Autenrieth, H, et al.. Comparison of four commercial, automated antigen tests to detect SARS-CoV-2 variants of concern. Med Microbiol Immunol 2021;210:263–75. https://doi.org/10.1007/s00430-021-00719-0.
Hartard, C, Berger, S, Josse, T, Schvoerer, E, Jeulin, H. Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs. Clin Chem Lab Med 2021;59:2003–9. https://doi.org/10.1515/cclm-2021-0569.
Lippi, G, Henry, BM, Adeli, K. Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis. Clin Chem Lab Med 2022;60:655–61. https://doi.org/10.1515/cclm-2022-0053.
Rambaut, A, Holmes, EC, O’Toole, A, Hill, V, McCrone, JT, Ruis, C, et al.. A dynamic nomenclature proposal for SARS-CoV-2 lineages to assist genomic epidemiology. Nat Microbiol 2020;5:1403–7. https://doi.org/10.1038/s41564-020-0770-5.
Lindner, AK, Nikolai, O, Kausch, F, Wintel, M, Hommes, F, Gertler, M, et al.. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J 2021;57. https://doi.org/10.1183/13993003.03961-2020.
Li, M, Wei, R, Yang, Y, He, T, Shen, Y, Qi, T, et al.. Comparing SARS-CoV-2 testing in anterior nasal vestibular swabs vs. Oropharyngeal swabs. Front Cell Infect Microbiol 2021;11:653794. https://doi.org/10.3389/fcimb.2021.653794.
Tu, YP, Jennings, R, Hart, B, Cangelosi, GA, Wood, RC, Wehber, K, et al.. Swabs collected by patients or health care workers for SARS-CoV-2 testing. N Engl J Med 2020;383:494–6. https://doi.org/10.1056/nejmc2016321.
Polechova, J, Johnson, KD, Payne, P, Crozier, A, Beiglbock, M, Plevka, P, et al.. SARS-CoV-2 rapid antigen tests provide benefits for epidemic control - observations from Austrian schools. J Clin Epidemiol 2022;145:14–9. https://doi.org/10.1016/j.jclinepi.2022.01.002.
Lippi, G, Henry, BM, Montagnana, M, Plebani, M. Diagnostic accuracy of the ultrasensitive S-PLEX SARS-CoV-2 N electrochemiluminescence immunoassay. Clin Chem Lab Med 2022;60:e121–4. https://doi.org/10.1515/cclm-2022-0155.
Hauser, F, Sprinzl, MF, Dreis, KJ, Renzaho, A, Youhanen, S, Kremer, WM, et al.. Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay for non-COVID-19 patient screening at hospital admission. Med Microbiol Immunol 2021;210:165–71. https://doi.org/10.1007/s00430-021-00706-5.
Lefever, S, Indevuyst, C, Cuypers, L, Dewaele, K, Yin, N, Cotton, F, et al.. Comparison of the quantitative DiaSorin liaison antigen test to reverse transcription-PCR for the diagnosis of COVID-19 in symptomatic and asymptomatic outpatients. J Clin Microbiol 2021;59:e0037421. https://doi.org/10.1128/jcm.00374-21.
Landesgesundheitsamt (public health authority) of Baden-Wuerttemberg. Situation reports COVID-19 Baden-Wuerttemberg. Available from: https://www.gesundheitsamt-bw.de/lga/de/fachinformationen/infodienste-newsletter/infektnews/seiten/lagebericht-covid-19/ [Accessed 11 05 2022].
Robert Koch Institute (public health institute). Number and proportion of VOC and VOI in Germany. Available from: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Daten/VOC_VOI_Tabelle.html [Accessed 11 05 2022].