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. 2022 Mar 7;12(3):650.
doi: 10.3390/diagnostics12030650.

Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients

Immacolata Polvere  1   2 , Serena Voccola  2 , Silvia D'Andrea  2 , Lucrezia Zerillo  1   2 , Romualdo Varricchio  2 , Jessica Raffaella Madera  1 , Romania Stilo  1 , Pasquale Vito  1   2 , Tiziana Zotti  1   2
Affiliations

Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients

Immacolata Polvere et al. Diagnostics (Basel). .

Abstract

Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42-99.15%) and a recall of 98.26% (95% CI 93.88-99.25%), with a specificity of 99.22% (95% CI 97.74-99.74%), a negative predictive value of 99.48% (95% CI 97.98-99.87%), and an overall accuracy of 99.00% (95% CI 97.69-99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947-0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.

Keywords: Ag-RDT; COVID-19; RT-qPCR; SARS-CoV-2; antigenic test; diagnosis; surveillance.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart summarizing the study design. Over a period of four months, 1012 individuals were tested for SARS-CoV-2 infection. Eligible patients for the comparative study were 501 individuals declaring mild or no COVID-19 related symptoms and not previously diagnosed as COVID-19-cases.
Figure 2
Figure 2
RT-qPCR amplification results of positive samples. Ct values for probe-based RT-qPCR amplification of N, RdRP/Hel and E genes in 115 SARS-CoV-2-positive samples.
Figure 3
Figure 3
Comparison of RT-qPCR and antigenic test results. Graphical distribution of 501 SARS-CoV-2-positive and -negative samples detected through FAST COVID Ag-RDT respect to Ct values for the N gene resulting from RT-qPCR analysis. All colored dots are representative of SARS-CoV-2-positive samples diagnosed as described in the Materials and Methods section. Red dots represent samples with very late or no amplification of N (Ct > 40) but positive for RdRP/Hel gene amplification.
Figure 4
Figure 4
Assessment of limit of detection for the Ag-RDT. Serial dilutions of recombinant SARS-CoV-2 Nucleocapsid (N) protein have been used to assess the lowest concentration detectable in the antigenic test. The time of appearance of the colored band in the window of the test line is also reported. Results on the cassettes have been read within 20 min.
See this image and copyright information in PMC

References

    1. Wang C., Horby P.W., Hayden F.G., Gao G.F. A novel coronavirus outbreak of global health concern. Lancet. 2020;395:470–473. doi: 10.1016/S0140-6736(20)30185-9. - DOI - PMC - PubMed
    1. Huang C., Wang Y., Li X., Ren L., Zhao J., Hu Y., Zhang L., Fan G., Xu J., Gu X., et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497–506. doi: 10.1016/S0140-6736(20)30183-5. - DOI - PMC - PubMed
    1. Chan J.F.-W., Yuan S., Kok K.-H., To K.K.-W., Chu H., Yang J., Xing F., Liu J., Yip C.C.-Y., Poon R.W.-S., et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: A study of a family cluster. Lancet. 2020;395:514–523. doi: 10.1016/S0140-6736(20)30154-9. - DOI - PMC - PubMed
    1. Mardian Y., Kosasih H., Karyana M., Neal A., Lau C.-Y. Review of Current COVID-19 Diagnostics and Opportunities for Further Development. Front. Med. 2021;8:615099. doi: 10.3389/fmed.2021.615099. - DOI - PMC - PubMed
    1. World Health Organization Clinical Management of COVID-19: Interim Guidance. 27 May 2020 (who.int) [(accessed on 30 December 2021)]. Available online: https://apps.who.int/iris/handle/10665/332196.

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