Papel de las pruebas rápidas (POCT) en el diagnóstico del SARS-COV-2, agente causal de COVID-19

Role of Rapid Tests (POCT) in the Diagnosis of SARS-VOC-2, Causal Agent of COVID-19

El estándar de oro actual para la detección de SARS-CoV-2, agente causal de la pandemia de neumonía atípica (COVID-19) que apareció por primera vez en la ciudad de Wuhan (provincia de Hubei, China) en diciembre de 2019 (1), es la RT-qPCR. El protocolo estándar implica la transcripción inversa de ARN de SARS-CoV-2 en cadenas de ADN complementarias (ADNc), seguida de la amplificación de regiones específicas del ADNc. Este procedimiento demanda varias horas para ser completado y deriva en que la información final del estado de la infección pueda demorar hasta 24 horas. Ante la necesidad de disminuir el riesgo de una posible propagación viral dentro de la población originada por la rápida transmisión del SARS-CoV-2, se ha buscado prevenir el contagio, la propagación nosocomial y la transmisión comunitaria posterior, a través de la identificación rápida de casos sospechosos, y predecir las posteriores ondas infecciosas de recurrencia viral. Para esto, se vienen desarrollando métodos de laboratorio rápidos o point of care testing (POCT), que disminuyen el tiempo de diagnóstico y minimizan el riesgo de contagio por parte de los operadores.

1. Zhu , N, Zhang D, Wang W , Li X, Yang B, Zhao X, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20; 382(8):727‐733.

2. Younes N, Al-Sadeq D, Al-Jighefee H, Younes S, Al-Jamal O, Daas H, et al. Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2. Viruses. 2020 May 26; 12(6): E582.

3. Amanat F, Stadlbauer D, Strohmeier S, Nguyen T, Chromikova V, McMahon M, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 May 12; 10: 10.1038/s41591-020-0913-5.

4. Udugama B, Kadhiresan P, Kozlowski H, Malekjahani A, Osborne M, Li V, et al. Diagnosing COVID-19: The Disease and Tools for Detection. ACS Nano. 2020 Apr 28; 14(4): 3822‐3835.
5. Mallapaty S. Will antibody tests for the coronavirus really change everything?. Nature. 2020 Apr; 580(7805): 571-572.

6. Onoda M, Martínez Chamorro M. Pruebas diagnósticas de laboratorio de COVID-19. Asociación Española de Pediatría de Atención Primaria, Grupo de Patología Infecciosa; 2020.

7. Long Q, Liu B, Deng H, Gu GC, Deng K, Chen Y, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun; 26(6): 845-848.

8. Riccò M, Ferraro P, Gualerzi G, Ranzieri S, Henry B, Said Y, et al. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. J Clin Med. 2020 May 18; 9(5): 1515.

9. Liu W, Liu L, Kou G, Kou G, Zheng Y, Ding Y, et al. Evaluation of Nucleocapsid and Spike Protein-based ELISAs for detecting antibodies against SARS-CoV-2. J Clin Microbiol. 2020 Mar 30; 58(6): e00461-20.

10. Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Feb 27; 10: 1002/jmv.25727.

11. Lippi G, Mattiuzzi C, Bovo C, Plebani M. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020 May 11; 91(2): 137-145.

12. Lassaunière R, Frische A, Harboe ZB, Nielsen AC, Fomsgaard A, Krogfelt KA, et al. Evaluation of Nine Commercial SARS-CoV-2 Immunoassays. medRxiv. 2020.

13. Adams E, Ainsworth M, Anand R, Andersson M, Auckland K, Baillie K, et al. Evaluation of Antibody Testing for SARS-CoV-2 Using ELISA and Lateral Flow Immunoassays. medRxiv. 2020.

14. Imai K, Tabata S, Ikeda M, Noguchi S, Kitagawa Y, Matsuoka M, et al. Clinical Evaluation of an Immunochromatographic IgM/IgG Antibody Assay and Chest Computed Tomography for the Diagnosis of COVID-19. Journal of clinical virology. 2020 July; 128 : 104393.

15. Pan Y, Li X, Yang G, Fan J, Tang Y, Zhao J, et al. Serological Immunochromatographic Approach in Diagnosis with SARS-CoV-2 Infected COVID-19 Patients. J. Infect. 2020 Jul; 81: e28-e32.

16. Aviles E, Barba C, Calle D, Guamán L, López V, Saenz K, et al. Protocolo de uso de pruebas rápidas para detección de anticuerpos contra SARS-CoV-2/COVID-19. Informe Técnico. Quito: Ministerio de Salud del Ecuador; 2020.

17. Comité Consultivo de Microbiologia Clínica- SOCHINF. Diagnóstico Microbiológico de SARS-CoV-2 (COVID-19) versión 1.0. Documento de revisión. Santiago de Chile : Sociedad Chilena de Infectología (SOCHINF); 2020.

18. Döhla M, Boesecke C, Schulte B, Diegmann C, Sib E, Richter E, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health. 2020 May; 182: 170‐172.

19. Yan Y, Chang L, Wang L. Laboratory testing of SARS-CoV, MERS-CoV, and SARS-CoV-2 (2019-nCoV): Current status, challenges, and countermeasures. Rev Med Virol. 2020 May; 30(3): e2106.

20. Organización Panamericana de la Salud. Directrices de Laboratorio para la Detección y el Diagnóstico de la Infección con el Virus COVID-19. ; 2020.

21. World Health Organization. Advice on the use of point-of-care immunodiagnostic tests for COVID-19. Scientific brief; 2020.

22. Foundation for Innovative New Diagnostics. FIND Evaluation update: SARS-CoV-2 Immunoassays. [Online]. 2020 [cited 2020 Junio 19]. Disponible en: https://www.finddx.org/covid-19/sarscov2-eval-immuno/

23. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28; 395(10229): 1054-1062.

24. Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Mar 21.

25. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. Documento de posicionamiento de la SEIMC sobre el diagnóstico microbiólogo de COVID-19. SIMC; 2020.

26. Wu A, Peng Y, Huang B, Ding X, Wang X, Niu P, et al. Genome Composition and Divergence of the Novel Coronavirus (2019-nCoV) Originating in China. Cell Host Microbe. 2020 Mar 11; 27(3): 325‐328.

27. Diao B, Wen K, Chen J, Liu Y, Yuan Z, Han C. Diagnosis of Acute Respiratory Syndrome Coronavirus 2 Infection by Detection of Nucleocapsid Protein. MedRxiv. 2020 Mar 30.

28. Sandeep K. In Vitro Diagnostic Assay for COVID-19: Recent Advances and Emerging Trends. Diagnostics. 2020 Apr; 10(4): 202.

29. Wrapp D, Wang N, Corbett K, Goldsmith J, Hsieh C, Abiona O, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science. 2020 Mar 13; 367(6483): 1260‐1263.

30. Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, et al. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19; 382(12): 1177-1179.

31. Pan Y, Zhang D, Yang P, Poon L, Wang Q. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis. 2020 Apr; 20(4): 411-412.

32. To K, Tsang O, Leung W, Raymond A, Wu T, Lung D, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May; 20(5): 565-574.

33. Lippi G, Simundic A, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Jun 25; 58(7): 1070-1076.

34. Li W, Liu L, Chen L, Shang S. Evaluation of a Commercial Colloidal Gold Assay for Detection of Influenza A and B Virus in Children's Respiratory Specimens. Fetal Pediatr Pathol. 2020 Apr; 39(2): 93-98.

35. Loeffelholz M, Tang. Laboratory diagnosis of emerging human coronavirus infections - the state of the art. Emerg Microbes Infect. 2020 Dic; 9(1): 747‐756.

36. Blairon L, Wilmet A, Beukinga I, Tré-Hardy M. Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital. Clin Virol. 2020 May 30; 12: 104472.

37. Okba N, Müller , M, Li W, Li W, Wang C, GeurtsvanKessel C, et al. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease 2019 Patients [published online ahead of print, 2020 Apr 8]. Emerg Infect Dis. 2020 Apr; 26(7).

38. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28;: ciaa344.

39. Lira Carmona R, De la Cruz Pérez J, Maldonado Rodríguez, A, Rojas Montes O. Sistemas de amplificación isotérmica para la detección molecular de los virus zika, dengue y chikungunya. Mens. Bioquim. 2018; 42: 92-102.

40. Poon LL, Leung CS, Tashiro M, Chan KH, Wong BW, Yuen KY, et al. Rapid detection of the severe acute respiratory syndrome (SARS) coronavirus by a loop-mediated isothermal amplification assay. Clin Chem. 2004 Jun; 50(6): 1050–1052.

41. Pyrc K, Milewska A, Potempa J. Development of loop-mediated isothermal amplification assay for detection of human coronavirus-NL63. J Virol Methods. 2011 Jul; 175(1): 133–136.

42. Mori Y, Nagamine K, Tomita N, Notomi T. Detection of loop-mediated isothermal amplification reaction by turbidity derived from magnesium pyrophosphate formation. Biochem Biophys Res Commun. 2001 Nov 23; 289(1): 150–154.

43. Shirato K, Yano T, Senba S, Akachi S, Kobayashi T, Nishinaka T, et al. Detection of Middle East respiratory syndrome coronavirus using reverse transcription loop-mediated isothermal amplification (RT-LAMP). Virol J. 2014 Aug; 8(11): 139.

44. Pang J, Wang M, Ang I, Tan S, Lewis R, Chen J, et al. Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic. Review. J Clin Med. 2020 Feb 26; 9(3): 623.

45. Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, et al. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22; 395(10224): 565‐574.

46. Baek Y, Um J, Antigua , Park J, Kim Y, Oh S, et al. Development of a reverse transcription-loop-mediated isothermal amplification as a rapid early-detection method for novel SARS-CoV-2. Emerg Microbes Infect. 2020 Dec; 9(1): 998‐1007.

47. El-Tholoth M, Bau Haim H, Song J. A Single and Two-Stage, Closed-Tube, Molecular Test for the 2019 Novel Coronavirus (COVID-19) at Home, Clinic, and Points of Entry. ChemRxiv. 2020 Feb.

48. Lamb, L, Bartolone S, Ward E, Chancellor M. Rapid Detection of Novel Coronavirus (COVID19) by Reverse Transcription-Loop-Mediated Isothermal Amplification. MedRxiv. 2020 Feb 24.

49. Zhang Y, Odiwuor N, Xiong J, Sun L, Nyarua R, Wei H, et al. Rapid molecular detection of SARS-CoV-2 (COVID-19) virus RNA using colorimetric LAMP. MedRxiv. 2020 Feb 29.

50. Cordero L, Bartolone S, Ward E, Canciller M. Detección rápida de nuevos coronavirus (COVID-19) por amplificación isotérmica mediada por bucle de transcripción inversa. medRxiv. 2020 Feb.

51. Kashir J, Yaqinuddin A. Loop mediated isothermal amplification (LAMP) assays as a rapid diagnostic for COVID-19. Med Hypotheses. 2020 Apr 25; 141: 109786.

52. Gallas-Lindemann C, Sureshkumar P, Noack M, Sotiriadou I. Loop-Mediated Isothermal Amplification: An Advanced Method for the Detection of Giardia. In Rodriguez-Morales A. Current Topics in Giardiasis.; 2017. 109.

53. Mori Y, Tomita, N, Kanda H, Notomi T. Mori, Y., Tomita, N., Kanda, H., & Notomi, T. (2012). Novel MoleculaDiagnostic Platform for Tropical Infectious Diseases. In Rodriguez Morales A. Current Topics in Tropical Medicine.; 2012. 445.

54. Shen M, Zhou Y, Ye J, Abdullah Al-Maskri A, Kang Y Zeng S, Cai S, et al. Recent advances and perspectives of nucleic acid detection for coronavirus. J Pharm Anal. 2020 Mar; 10(2): 97‐101.

55. Shirato K, Semba S, El-Kafrawy S, Hassan A, Tolah A, Takayama I, et al. Development of fluorescent reverse transcription loop-mediated isothermal amplification (RT-LAMP) using quenching probes for the detection of the Middle East respiratory syndrome coronavirus. J Virol Methods. 2018 Aug; 258: 41‐48.

56. Njiru Z. Loop-mediated isothermal amplification technology: towards point of care diagnostics. PLoS Negl Trop Dis. 2012; 6(6): e1572.

57. Huang P, Wang H, Cao Z, Jin H, Chi H, Zhao J, et al. A Rapid and Specific Assay for the Detection of MERS-CoV. Front Microbiol. 2018 May 29; 9: 1101.

58. Lee S, Baek Y, Kim Y, Choi Y, Song M, Ahn J. One-Pot Reverse Transcriptional Loop-Mediated Isothermal Amplification (RT-LAMP) for Detecting MERS-CoV. Front Microbiol. 2017 Jan 9; 7: 2166.

59. Joung J, Ladha A, Saito M, Segel M, Bruneau R, Huang M, et al. Point-of-care testing for COVID-19 using SHERLOCK diagnostics. MedRxiv. 2020 May 8;: 2020.05.04.20091231.

60. Wang X, Zhong M, Liu Y, Ma P, Dang L, Meng Q, et al. Rapid and Sensitive Detection of COVID-19 Using CRISPR/Cas12a-based Detection with Naked Eye Readout, CRISPR/Cas12a-NER. Sci Bull (Beijing). 2020 May 5;: 2020;10.1016/j.scib.2020.04.041.

61. Hou T, Zeng W, Yang M, Chen W, Ren L, Ai J, et al. Development and Evaluation of a CRISPR-Based Diagnostic For 2019-Novel Coronavirus. medRxiv. 2020 Feb 25.

62. Gallegos S, Mojica J, Meza M, Cuellar C. Lineamientos para el uso de pruebas diagnósticas de SARS-COV-2 (COVID-19) en Colombia. Informe técnico. Bogotá D.C: Ministerio de Salud y Protección Social; 2020.