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Revista Mexicana de Patología Clínica y Medicina de Laboratorio

ISSN 0185-6014 (Print)
Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio
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2020, Number 2

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Rev Mex Patol Clin Med Lab 2020; 67 (2)

Novel coronavirus: the urgent need to make an adequate selection of laboratory assay

Sierra García-de Quevedo J, Ramos CA, Aguirre-Langle E
Full text How to cite this article 10.35366/95553

DOI

DOI: 10.35366/95553
URL: https://dx.doi.org/10.35366/95553

Language: Spanish
References: 9
Page: 89-92
PDF size: 234.17 Kb.


Key words:

Coronavirus, Sars-Cov-2, clinical trial.

ABSTRACT

The SARS CoV-2 pandemic has flooded the market with serology diagnostic tests, that due to their recent fabrication, have not been tested in multicentric trials, comparative studies, population studies and clinical precision validation studies. Selecting a test that better adapts to the needs of the population health, as well as the resources of every laboratory, has become a primary necessity. Therefore, Immunological Test Evaluating Committee (CEPI) represented by the Mexican Counsel of Diagnostic Enterprises (COMED) has elaborated a guide to facilitate selecting a test by taking into consideration national and international sanitary regulations, type of sample, pre-analytical specifications common to the clinical assays as well as performance and precision evaluations. This algorithm has been evaluated by multiple members of CEPI, assessing at least 12 different inserts concluding that in daily practice, it is a useful tool for the best selection of the immunoassay.


REFERENCES

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  2. Global Preparedness Monitoring Board (GPMB). A world at risk: annual report on global preparedness for health emergencies [Internet]. Geneva: World Health Organization; 2019. Available in: www.apps.who.int/gpmb/assets/pdf/covid_19_press-Realease_cmp-9mar.pdf

  3. Leeflang MMG, Allerberger F. How to: evaluate a diagnostic test. Clin Microbiol Infect. 2019; 25 (1): 54-59. doi: 10.1016/j.cmi.2018.06.011.

  4. Cheng MP, Papenburg J, Desjardins M et al. Diagnostic testing for severe acute respiratory syndrome-related coronavirus 2: a narrative review. Ann Intern Med. 2020; 172 (11): 726-734. doi: 10.7326/M20-1301.

  5. Guo L, Ren L, Yang S et al. Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis. 2020; 71 (15): 778-785. doi: 10.1093/cid/ciaa310.

  6. Sethuraman N, Jeremiah SS, Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA. 2020. doi: 10.1001/jama.2020.8259.

  7. Petherick A. Developing antibody tests for SARS-CoV-2. Lancet. 2020; 395 (10230): 1101-1102.

  8. Okba N, Müler M, Li W, Wnag CH, Geurtsvan Kessel C, Corman V et al. SARS-CoV-2 specific antibody responses in COVID-19 patients. medRxiv. 2020. doi: 10.1101/2020.03.18. 20038059.

  9. https://drive.google.com/drive/folders/1CyVLBQh6BfkTgAn717Fy-5ScNlhRHE7L




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C?MO CITAR (Vancouver)

Rev Mex Patol Clin Med Lab. 2020;67