First Results of an External Quality Assessment (EQA) Scheme for Molecular, Serological and Antigenic Diagnostic Test for SARS-CoV-2 Detection in Lombardy Region (Northern Italy), 2020-2022
Articolo
Data di Pubblicazione:
2022
Citazione:
First Results of an External Quality Assessment (EQA) Scheme for Molecular, Serological and Antigenic Diagnostic Test for SARS-CoV-2 Detection in Lombardy Region (Northern Italy), 2020-2022 / F. Pasotti, L. Pellegrinelli, G. Liga, M. Rizzetto, G. Azzarà, S. Da Molin, O.L. Lungu, S. Greco, C. Galli, L. Bubba, E. Pariani, M. Corradin, D. Cereda, S. Buoro. - In: DIAGNOSTICS. - ISSN 2075-4418. - 12:6(2022), pp. 1483.1-1483.9. [10.3390/diagnostics12061483]
Abstract:
For diagnosing SARS-CoV-2 infection and for monitoring its spread, the implementation of
external quality assessment (EQA) schemes is mandatory to assess and ensure a standard quality
according to national and international guidelines. Here, we present the results of the 2020, 2021,
2022 EQA schemes in Lombardy region for assessing the quality of the diagnostic laboratories
involved in SARS-CoV-2 diagnosis. In the framework of the Quality Assurance Programs (QAPs),
the routinely EQA schemes are managed by the regional reference centre for diagnostic laboratories
quality (RRC-EQA) of the Lombardy region and are carried out by all the diagnostic laboratories.
Three EQA programs were organized: (1) EQA of SARS-CoV-2 nucleic acid detection; (2) EQA of
anti-SARS-CoV-2-antibody testing; (3) EQA of SARS-CoV-2 direct antigens detection. The percentage
of concordance of 1938 molecular tests carried out within the SARS-CoV-2 nucleic acid detection
EQA was 97.7%. The overall concordance of 1875 tests carried out within the anti-SARS-CoV-2
antibody EQA was 93.9% (79.6% for IgM). The overall concordance of 1495 tests carried out within
the SARS-CoV-2 direct antigens detection EQA was 85% and it was negatively impacted by the results
obtained by the analysis of weak positive samples. In conclusion, the EQA schemes for assessing the
accuracy of SARS-CoV-2 diagnosis in the Lombardy region highlighted a suitable reproducibility
and reliability of diagnostic assays, despite the heterogeneous landscape of SARS-CoV-2 tests and
methods. Laboratory testing based on the detection of viral RNA in respiratory samples can be
considered the gold standard for SARS-CoV-2 diagnosis.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
anti‐SARS‐CoV‐2 antibody test; external quality assessment (EQA); SARS‐CoV‐2; SARS‐CoV‐2 direct antigens detection; SARS‐CoV‐2 nucleic acid detection
Elenco autori:
F. Pasotti, L. Pellegrinelli, G. Liga, M. Rizzetto, G. Azzarà, S. Da Molin, O.L. Lungu, S. Greco, C. Galli, L. Bubba, E. Pariani, M. Corradin, D. Cereda, S. Buoro
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