Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom
ABSTRACT The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.)...
| Asıl Yazarlar: | , , , , , , , , , , , , , , , , , |
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| Materyal Türü: | Makale |
| Dil: | English |
| Baskı/Yayın Bilgisi: |
American Society for Microbiology
2022-12-01
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| Seri Bilgileri: | Microbiology Spectrum |
| Konular: | |
| Online Erişim: | https://journals.asm.org/doi/10.1128/spectrum.02012-22 |
| _version_ | 1828263118215577600 |
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| author | Debora S. Faffe Rachel L. Byrne Richard Body Terezinha Marta P. Castiñeiras Anna P. Castiñeiras Lorna S. Finch Konstantina Kontogianni Daisy Bengey Rafael Mello Galliez Orlando C. Ferreira Diana Mariani Bianca Ortiz da Silva Sabrina Santana Ribeiro Margaretha de Vos Camille Escadafal Emily R. Adams Amilcar Tanuri Ana I. Cubas Atienzar |
| author_facet | Debora S. Faffe Rachel L. Byrne Richard Body Terezinha Marta P. Castiñeiras Anna P. Castiñeiras Lorna S. Finch Konstantina Kontogianni Daisy Bengey Rafael Mello Galliez Orlando C. Ferreira Diana Mariani Bianca Ortiz da Silva Sabrina Santana Ribeiro Margaretha de Vos Camille Escadafal Emily R. Adams Amilcar Tanuri Ana I. Cubas Atienzar |
| author_sort | Debora S. Faffe |
| collection | DOAJ |
| description | ABSTRACT The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. The collected samples (446 nasal swabs from Brazil and 246 nasopharyngeal samples from the UK) were analyzed by the Ag-RDT and compared to reverse transcription-quantitative PCR (RT-qPCR). Analytical evaluation of the Ag-RDT was performed using direct culture supernatants of SARS-CoV-2 strains from the wild-type (B.1), Alpha (B.1.1.7), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529) lineages. An overall sensitivity and specificity of 88.2% (95% confidence interval [CI], 81.3 to 93.3) and 100.0% (95% CI, 99.1 to 100.0), respectively, were obtained for the Brazilian and UK cohorts. The analytical limit of detection was determined as 1.0 × 103 PFU/mL (Alpha), 2.5 × 102 PFU/mL (Delta), 2.5 × 103 PFU/mL (Gamma), and 1.0 × 103 PFU/mL (Omicron), giving a viral copy equivalent of approximately 2.1 × 104 copies/mL, 9.0 × 105 copies/mL, 1.7 × 106 copies/mL, and 1.8 × 105 copies/mL for the Ag-RDT, respectively. Overall, while a higher sensitivity was claimed by the manufacturers than that found in this study, this evaluation finds that the Ag-RDT meets the WHO minimum performance requirements for sensitivity and specificity of COVID-19 Ag-RDTs. This study illustrates the comparative performance of the Hotgen Ag-RDT across two global settings and considers the different approaches in evaluation methods. IMPORTANCE Since the beginning of the SARS-CoV-2 pandemic, we have witnessed growing numbers of antigen rapid diagnostic tests (Ag-RDTs) being brought to market. In the United Kingdom, this was somewhat controlled indirectly as the government offered free tests from a small number of companies. However, as this has now ceased, individuals are responsible for their own acquisition of test kits. Similarly in Brazil, as of January 2022, pharmacies and other health care retailers are permitted to sell Ag-RDTs directly to the community. Many of these Ag-RDTs have not been externally evaluated, and results are not readily available to the public. Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. |
| first_indexed | 2024-04-13T04:07:14Z |
| format | Article |
| id | doaj.art-f8ff8f3384514a3db241b9ce1aa00e2c |
| institution | Directory Open Access Journal |
| issn | 2165-0497 |
| language | English |
| last_indexed | 2024-04-13T04:07:14Z |
| publishDate | 2022-12-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | Microbiology Spectrum |
| spelling | doaj.art-f8ff8f3384514a3db241b9ce1aa00e2c2022-12-22T03:03:13ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972022-12-0110610.1128/spectrum.02012-22Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United KingdomDebora S. Faffe0Rachel L. Byrne1Richard Body2Terezinha Marta P. Castiñeiras3Anna P. Castiñeiras4Lorna S. Finch5Konstantina Kontogianni6Daisy Bengey7Rafael Mello Galliez8Orlando C. Ferreira9Diana Mariani10Bianca Ortiz da Silva11Sabrina Santana Ribeiro12Margaretha de Vos13Camille Escadafal14Emily R. Adams15Amilcar Tanuri16Ana I. Cubas Atienzar17Universidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomOxford University, Oxford, United KingdomUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilFIND, Geneva, SwitzerlandFIND, Geneva, SwitzerlandLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomUniversidade Federal do Rio de Janeiro (UFRJ), Núcleo de Enfrentamento e Estudos de Doenças Infecciosas e Emergentes e Reemergentes (NEEDIER), Rio de Janeiro, BrazilLiverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United KingdomABSTRACT The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. The collected samples (446 nasal swabs from Brazil and 246 nasopharyngeal samples from the UK) were analyzed by the Ag-RDT and compared to reverse transcription-quantitative PCR (RT-qPCR). Analytical evaluation of the Ag-RDT was performed using direct culture supernatants of SARS-CoV-2 strains from the wild-type (B.1), Alpha (B.1.1.7), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529) lineages. An overall sensitivity and specificity of 88.2% (95% confidence interval [CI], 81.3 to 93.3) and 100.0% (95% CI, 99.1 to 100.0), respectively, were obtained for the Brazilian and UK cohorts. The analytical limit of detection was determined as 1.0 × 103 PFU/mL (Alpha), 2.5 × 102 PFU/mL (Delta), 2.5 × 103 PFU/mL (Gamma), and 1.0 × 103 PFU/mL (Omicron), giving a viral copy equivalent of approximately 2.1 × 104 copies/mL, 9.0 × 105 copies/mL, 1.7 × 106 copies/mL, and 1.8 × 105 copies/mL for the Ag-RDT, respectively. Overall, while a higher sensitivity was claimed by the manufacturers than that found in this study, this evaluation finds that the Ag-RDT meets the WHO minimum performance requirements for sensitivity and specificity of COVID-19 Ag-RDTs. This study illustrates the comparative performance of the Hotgen Ag-RDT across two global settings and considers the different approaches in evaluation methods. IMPORTANCE Since the beginning of the SARS-CoV-2 pandemic, we have witnessed growing numbers of antigen rapid diagnostic tests (Ag-RDTs) being brought to market. In the United Kingdom, this was somewhat controlled indirectly as the government offered free tests from a small number of companies. However, as this has now ceased, individuals are responsible for their own acquisition of test kits. Similarly in Brazil, as of January 2022, pharmacies and other health care retailers are permitted to sell Ag-RDTs directly to the community. Many of these Ag-RDTs have not been externally evaluated, and results are not readily available to the public. Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom.https://journals.asm.org/doi/10.1128/spectrum.02012-22diagnosticsCOVID-19SARS-CoV-2LFAAg-RDT |
| spellingShingle | Debora S. Faffe Rachel L. Byrne Richard Body Terezinha Marta P. Castiñeiras Anna P. Castiñeiras Lorna S. Finch Konstantina Kontogianni Daisy Bengey Rafael Mello Galliez Orlando C. Ferreira Diana Mariani Bianca Ortiz da Silva Sabrina Santana Ribeiro Margaretha de Vos Camille Escadafal Emily R. Adams Amilcar Tanuri Ana I. Cubas Atienzar Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom Microbiology Spectrum diagnostics COVID-19 SARS-CoV-2 LFA Ag-RDT |
| title | Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom |
| title_full | Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom |
| title_fullStr | Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom |
| title_full_unstemmed | Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom |
| title_short | Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom |
| title_sort | multicenter diagnostic evaluation of a novel coronavirus antigen lateral flow test among symptomatic individuals in brazil and the united kingdom |
| topic | diagnostics COVID-19 SARS-CoV-2 LFA Ag-RDT |
| url | https://journals.asm.org/doi/10.1128/spectrum.02012-22 |
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