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2021, Number 1

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Rev CONAMED 2021; 26 (1)

Quality of the SARS-CoV-2 molecular detection report: the need for standardization

Mucito-Varela E

Language: Spanish
References: 20
Page: 3-16
PDF size: 177.05 Kb.


ABSTRACT

The laboratory report is a communication mechanism between the clinical laboratory and the physicians, so its content must comply with international quality criteria. In the context of the COVID-19 pandemic, the molecular diagnosis carried out in 163 laboratories in Mexico has increased the diagnostic capacity and epidemiological monitoring. Despite having national and international guidelines for the interpretation of this test, the content of the report has not been standardized, increasing the risk of errors that affect patient safety. This study proposes a list of standardized requirements based on the ISO 1589:2012 standard, which was used to evaluate the content of 13 laboratory reports. Some requirements should be improved and others implemented, in order to guarantee the appropriate use of the molecular detection of the SARS-CoV-2 virus, the correct interpretation and the quality assurance of the post-examination phase of the clinical laboratories. A more detailed consensus is needed where participation of societies of clinical laboratory professionals and physicians is needed to generate a report that adds value to patient care.


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