An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour
Objectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-10-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971222004362 |
| _version_ | 1818000692494729216 |
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| author | Gonçalo Doria Carla Clemente Eduardo Coelho João Colaço Rui Crespo Andrei Semikhodskii Helder Mansinho Magno Dinis Maria Fernanda Carvalho Manuela Casmarrinha Cátia Samina Ana Cristina Vidal Francisca Delarue Susana Graúdo Ana Catarina Santos David Peças Olga Carreira Raquel Marques Carina Gaspar Orfeu Flores |
| author_facet | Gonçalo Doria Carla Clemente Eduardo Coelho João Colaço Rui Crespo Andrei Semikhodskii Helder Mansinho Magno Dinis Maria Fernanda Carvalho Manuela Casmarrinha Cátia Samina Ana Cristina Vidal Francisca Delarue Susana Graúdo Ana Catarina Santos David Peças Olga Carreira Raquel Marques Carina Gaspar Orfeu Flores |
| author_sort | Gonçalo Doria |
| collection | DOAJ |
| description | Objectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. Results: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. Conclusion: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2’s N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments. |
| first_indexed | 2024-04-14T03:24:56Z |
| format | Article |
| id | doaj.art-f737377930da40c492be6fe5ef1faea5 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-04-14T03:24:56Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-f737377930da40c492be6fe5ef1faea52022-12-22T02:15:12ZengElsevierInternational Journal of Infectious Diseases1201-97122022-10-0112318An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hourGonçalo Doria0Carla Clemente1Eduardo Coelho2João Colaço3Rui Crespo4Andrei Semikhodskii5Helder Mansinho6Magno Dinis7Maria Fernanda Carvalho8Manuela Casmarrinha9Cátia Samina10Ana Cristina Vidal11Francisca Delarue12Susana Graúdo13Ana Catarina Santos14David Peças15Olga Carreira16Raquel Marques17Carina Gaspar18Orfeu Flores19STAB VIDA Lda, Rua dos Inventores, Caparica, Portugal; Correspondence to: Att. Gonçalo Doria, STAB VIDA Lda, Madan Parque - Rua dos Inventores, Sala 2.18, 2825-182 Caparica, Portugal.STAB VIDA Lda, Rua dos Inventores, Caparica, PortugalSTAB VIDA Lda, Rua dos Inventores, Caparica, PortugalSTAB VIDA Lda, Rua dos Inventores, Caparica, PortugalSTAB VIDA Lda, Rua dos Inventores, Caparica, PortugalMedical Genomics Ltd, London, United Kingdom; King Saud Bin Abdulaziz's University for Health Sciences (KSAU-HS), Riyadh, Saudi ArabiaOncology Service, Garcia de Orta Hospital, Almada, PortugalOncology Service, Garcia de Orta Hospital, Almada, PortugalOncology Service, Garcia de Orta Hospital, Almada, PortugalOncology Service, Garcia de Orta Hospital, Almada, PortugalOncology Service, Garcia de Orta Hospital, Almada, PortugalGarcia de Orta Center, Garcia de Orta Hospital, Almada, Portugal; Escola Superior de Saúde Egas Moniz, Caparica, PortugalInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, PortugalInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, PortugalInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, PortugalInternal Medicine Service - Garcia de Orta Center, Garcia de Orta Hospital, Almada, PortugalClinical Pathology Service, Garcia de Orta Hospital, Almada, PortugalClinical Pathology Service, Garcia de Orta Hospital, Almada, PortugalClinical Pathology Service, Garcia de Orta Hospital, Almada, PortugalSTAB VIDA Lda, Rua dos Inventores, Caparica, PortugalObjectives: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase–PCR method. Methods: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. Results: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. Conclusion: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2’s N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments.http://www.sciencedirect.com/science/article/pii/S1201971222004362SARS-CoV-2COVID-19Point-of-care testingNucleic acid amplification techniquesLAMP assayReal-time PCR |
| spellingShingle | Gonçalo Doria Carla Clemente Eduardo Coelho João Colaço Rui Crespo Andrei Semikhodskii Helder Mansinho Magno Dinis Maria Fernanda Carvalho Manuela Casmarrinha Cátia Samina Ana Cristina Vidal Francisca Delarue Susana Graúdo Ana Catarina Santos David Peças Olga Carreira Raquel Marques Carina Gaspar Orfeu Flores An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour International Journal of Infectious Diseases SARS-CoV-2 COVID-19 Point-of-care testing Nucleic acid amplification techniques LAMP assay Real-time PCR |
| title | An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour |
| title_full | An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour |
| title_fullStr | An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour |
| title_full_unstemmed | An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour |
| title_short | An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour |
| title_sort | isothermal lab on phone test for easy molecular diagnosis of sars cov 2 near patients and in less than 1 hour |
| topic | SARS-CoV-2 COVID-19 Point-of-care testing Nucleic acid amplification techniques LAMP assay Real-time PCR |
| url | http://www.sciencedirect.com/science/article/pii/S1201971222004362 |
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