Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19).
Identifieur interne : 000479 ( an2020/Analysis ); précédent : 000478; suivant : 000480Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19).
Auteurs : Giuseppe Lippi [Italie] ; Ana-Maria Simundic [Croatie] ; Mario Plebani [Italie]Source :
- Clinical chemistry and laboratory medicine [ 1437-4331 ] ; 2020.
Abstract
A novel zoonotic coronavirus outbreak is spreading all over the world. This pandemic disease has now been defined as novel coronavirus disease 2019 (COVID-19), and is sustained by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the current gold standard for the etiological diagnosis of SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for collection, handling, transport and storage of the swabs, collection of inappropriate or inadequate material (for quality or volume), presence of interfering substances, manual errors, as well as specific aspects such as sample contamination and testing patients receiving antiretroviral therapy. Some analytical problems may also contribute to jeopardize the diagnostic accuracy, including testing outside the diagnostic window, active viral recombination, use of inadequately validated assays, insufficient harmonization, instrument malfunctioning, along with other specific technical issues. Some practical indications can hence be identified for minimizing the risk of diagnostic errors, encompassing the improvement of diagnostic accuracy by combining clinical evidence with results of chest computed tomography (CT) and RT-PCR, interpretation of RT-PCR results according to epidemiologic, clinical and radiological factors, recollection and testing of upper (or lower) respiratory specimens in patients with negative RT-PCR test results and high suspicion or probability of infection, dissemination of clear instructions for specimen (especially swab) collection, management and storage, together with refinement of molecular target(s) and thorough compliance with analytical procedures, including quality assurance.
DOI: 10.1515/cclm-2020-0285
PubMed: 32172228
Affiliations:
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pubmed:32172228Le document en format XML
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Croatia.</nlm:affiliation><country xml:lang="fr">Croatie</country><wicri:regionArea>Department of Medical Laboratory Diagnostics, University Hospital Sveti Duh, Zagreb</wicri:regionArea><wicri:noRegion>Zagreb</wicri:noRegion></affiliation></author><author><name sortKey="Plebani, Mario" sort="Plebani, Mario" uniqKey="Plebani M" first="Mario" last="Plebani">Mario Plebani</name><affiliation wicri:level="1"><nlm:affiliation>Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Laboratory Medicine, University Hospital of Padova, Padova</wicri:regionArea><wicri:noRegion>Padova</wicri:noRegion></affiliation></author></analytic><series><title level="j">Clinical chemistry and laboratory medicine</title><idno type="eISSN">1437-4331</idno><imprint><date when="2020" 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This pandemic disease has now been defined as novel coronavirus disease 2019 (COVID-19), and is sustained by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the current gold standard for the etiological diagnosis of SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for collection, handling, transport and storage of the swabs, collection of inappropriate or inadequate material (for quality or volume), presence of interfering substances, manual errors, as well as specific aspects such as sample contamination and testing patients receiving antiretroviral therapy. Some analytical problems may also contribute to jeopardize the diagnostic accuracy, including testing outside the diagnostic window, active viral recombination, use of inadequately validated assays, insufficient harmonization, instrument malfunctioning, along with other specific technical issues. Some practical indications can hence be identified for minimizing the risk of diagnostic errors, encompassing the improvement of diagnostic accuracy by combining clinical evidence with results of chest computed tomography (CT) and RT-PCR, interpretation of RT-PCR results according to epidemiologic, clinical and radiological factors, recollection and testing of upper (or lower) respiratory specimens in patients with negative RT-PCR test results and high suspicion or probability of infection, dissemination of clear instructions for specimen (especially swab) collection, management and storage, together with refinement of molecular target(s) and thorough compliance with analytical procedures, including quality assurance.</div></front></TEI><affiliations><list><country><li>Croatie</li><li>Italie</li></country></list><tree><country name="Italie"><noRegion><name sortKey="Lippi, Giuseppe" sort="Lippi, Giuseppe" uniqKey="Lippi G" first="Giuseppe" last="Lippi">Giuseppe Lippi</name></noRegion><name sortKey="Plebani, Mario" sort="Plebani, Mario" uniqKey="Plebani M" first="Mario" last="Plebani">Mario Plebani</name></country><country name="Croatie"><noRegion><name sortKey="Simundic, Ana Maria" sort="Simundic, Ana Maria" uniqKey="Simundic A" first="Ana-Maria" last="Simundic">Ana-Maria Simundic</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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