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

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...
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Autor*in:	Fabio Pasotti [verfasserIn] Laura Pellegrinelli [verfasserIn] Giuseppa Liga [verfasserIn] Manuela Rizzetto [verfasserIn] Giovanna Azzarà [verfasserIn] Simona Da Molin [verfasserIn] Oana Livia Lungu [verfasserIn] Silvia Greco [verfasserIn] Cristina Galli [verfasserIn] Laura Bubba [verfasserIn] Elena Pariani [verfasserIn] Matteo Corradin [verfasserIn] Danilo Cereda [verfasserIn] Sabrina Buoro [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection

Übergeordnetes Werk:	In: Diagnostics - MDPI AG, 2012, 12(2022), 6, p 1483
Übergeordnetes Werk:	volume:12 ; year:2022 ; number:6, p 1483

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/diagnostics12061483

Katalog-ID:	DOAJ025541951

Internformat


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allfields	10.3390/diagnostics12061483 doi (DE-627)DOAJ025541951 (DE-599)DOAJ11c96c9009b44c5a838ef474e74f3765 DE-627 ger DE-627 rakwb eng R5-920 Fabio Pasotti verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General) Laura Pellegrinelli verfasserin aut Giuseppa Liga verfasserin aut Manuela Rizzetto verfasserin aut Giovanna Azzarà verfasserin aut Simona Da Molin verfasserin aut Oana Livia Lungu verfasserin aut Silvia Greco verfasserin aut Cristina Galli verfasserin aut Laura Bubba verfasserin aut Elena Pariani verfasserin aut Matteo Corradin verfasserin aut Danilo Cereda verfasserin aut Sabrina Buoro verfasserin aut In Diagnostics MDPI AG, 2012 12(2022), 6, p 1483 (DE-627)718627814 (DE-600)2662336-5 20754418 nnns volume:12 year:2022 number:6, p 1483 https://doi.org/10.3390/diagnostics12061483 kostenfrei https://doaj.org/article/11c96c9009b44c5a838ef474e74f3765 kostenfrei https://www.mdpi.com/2075-4418/12/6/1483 kostenfrei https://doaj.org/toc/2075-4418 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 6, p 1483
spelling	10.3390/diagnostics12061483 doi (DE-627)DOAJ025541951 (DE-599)DOAJ11c96c9009b44c5a838ef474e74f3765 DE-627 ger DE-627 rakwb eng R5-920 Fabio Pasotti verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General) Laura Pellegrinelli verfasserin aut Giuseppa Liga verfasserin aut Manuela Rizzetto verfasserin aut Giovanna Azzarà verfasserin aut Simona Da Molin verfasserin aut Oana Livia Lungu verfasserin aut Silvia Greco verfasserin aut Cristina Galli verfasserin aut Laura Bubba verfasserin aut Elena Pariani verfasserin aut Matteo Corradin verfasserin aut Danilo Cereda verfasserin aut Sabrina Buoro verfasserin aut In Diagnostics MDPI AG, 2012 12(2022), 6, p 1483 (DE-627)718627814 (DE-600)2662336-5 20754418 nnns volume:12 year:2022 number:6, p 1483 https://doi.org/10.3390/diagnostics12061483 kostenfrei https://doaj.org/article/11c96c9009b44c5a838ef474e74f3765 kostenfrei https://www.mdpi.com/2075-4418/12/6/1483 kostenfrei https://doaj.org/toc/2075-4418 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 6, p 1483
allfields_unstemmed	10.3390/diagnostics12061483 doi (DE-627)DOAJ025541951 (DE-599)DOAJ11c96c9009b44c5a838ef474e74f3765 DE-627 ger DE-627 rakwb eng R5-920 Fabio Pasotti verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General) Laura Pellegrinelli verfasserin aut Giuseppa Liga verfasserin aut Manuela Rizzetto verfasserin aut Giovanna Azzarà verfasserin aut Simona Da Molin verfasserin aut Oana Livia Lungu verfasserin aut Silvia Greco verfasserin aut Cristina Galli verfasserin aut Laura Bubba verfasserin aut Elena Pariani verfasserin aut Matteo Corradin verfasserin aut Danilo Cereda verfasserin aut Sabrina Buoro verfasserin aut In Diagnostics MDPI AG, 2012 12(2022), 6, p 1483 (DE-627)718627814 (DE-600)2662336-5 20754418 nnns volume:12 year:2022 number:6, p 1483 https://doi.org/10.3390/diagnostics12061483 kostenfrei https://doaj.org/article/11c96c9009b44c5a838ef474e74f3765 kostenfrei https://www.mdpi.com/2075-4418/12/6/1483 kostenfrei https://doaj.org/toc/2075-4418 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 6, p 1483
allfieldsGer	10.3390/diagnostics12061483 doi (DE-627)DOAJ025541951 (DE-599)DOAJ11c96c9009b44c5a838ef474e74f3765 DE-627 ger DE-627 rakwb eng R5-920 Fabio Pasotti verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General) Laura Pellegrinelli verfasserin aut Giuseppa Liga verfasserin aut Manuela Rizzetto verfasserin aut Giovanna Azzarà verfasserin aut Simona Da Molin verfasserin aut Oana Livia Lungu verfasserin aut Silvia Greco verfasserin aut Cristina Galli verfasserin aut Laura Bubba verfasserin aut Elena Pariani verfasserin aut Matteo Corradin verfasserin aut Danilo Cereda verfasserin aut Sabrina Buoro verfasserin aut In Diagnostics MDPI AG, 2012 12(2022), 6, p 1483 (DE-627)718627814 (DE-600)2662336-5 20754418 nnns volume:12 year:2022 number:6, p 1483 https://doi.org/10.3390/diagnostics12061483 kostenfrei https://doaj.org/article/11c96c9009b44c5a838ef474e74f3765 kostenfrei https://www.mdpi.com/2075-4418/12/6/1483 kostenfrei https://doaj.org/toc/2075-4418 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 6, p 1483
allfieldsSound	10.3390/diagnostics12061483 doi (DE-627)DOAJ025541951 (DE-599)DOAJ11c96c9009b44c5a838ef474e74f3765 DE-627 ger DE-627 rakwb eng R5-920 Fabio Pasotti verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General) Laura Pellegrinelli verfasserin aut Giuseppa Liga verfasserin aut Manuela Rizzetto verfasserin aut Giovanna Azzarà verfasserin aut Simona Da Molin verfasserin aut Oana Livia Lungu verfasserin aut Silvia Greco verfasserin aut Cristina Galli verfasserin aut Laura Bubba verfasserin aut Elena Pariani verfasserin aut Matteo Corradin verfasserin aut Danilo Cereda verfasserin aut Sabrina Buoro verfasserin aut In Diagnostics MDPI AG, 2012 12(2022), 6, p 1483 (DE-627)718627814 (DE-600)2662336-5 20754418 nnns volume:12 year:2022 number:6, p 1483 https://doi.org/10.3390/diagnostics12061483 kostenfrei https://doaj.org/article/11c96c9009b44c5a838ef474e74f3765 kostenfrei https://www.mdpi.com/2075-4418/12/6/1483 kostenfrei https://doaj.org/toc/2075-4418 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 6, p 1483
language	English
source	In Diagnostics 12(2022), 6, p 1483 volume:12 year:2022 number:6, p 1483
sourceStr	In Diagnostics 12(2022), 6, p 1483 volume:12 year:2022 number:6, p 1483
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection Medicine (General)
isfreeaccess_bool	true
container_title	Diagnostics
authorswithroles_txt_mv	Fabio Pasotti @@aut@@ Laura Pellegrinelli @@aut@@ Giuseppa Liga @@aut@@ Manuela Rizzetto @@aut@@ Giovanna Azzarà @@aut@@ Simona Da Molin @@aut@@ Oana Livia Lungu @@aut@@ Silvia Greco @@aut@@ Cristina Galli @@aut@@ Laura Bubba @@aut@@ Elena Pariani @@aut@@ Matteo Corradin @@aut@@ Danilo Cereda @@aut@@ Sabrina Buoro @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	718627814
id	DOAJ025541951
language_de	englisch
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callnumber-first	R - Medicine
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spellingShingle	Fabio Pasotti misc R5-920 misc SARS-CoV-2 misc external quality assessment (EQA) misc SARS-CoV-2 nucleic acid detection misc anti-SARS-CoV-2 antibody test misc SARS-CoV-2 direct antigens detection misc Medicine (General) 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
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topic_title	R5-920 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 SARS-CoV-2 external quality assessment (EQA) SARS-CoV-2 nucleic acid detection anti-SARS-CoV-2 antibody test SARS-CoV-2 direct antigens detection
topic	misc R5-920 misc SARS-CoV-2 misc external quality assessment (EQA) misc SARS-CoV-2 nucleic acid detection misc anti-SARS-CoV-2 antibody test misc SARS-CoV-2 direct antigens detection misc Medicine (General)
topic_unstemmed	misc R5-920 misc SARS-CoV-2 misc external quality assessment (EQA) misc SARS-CoV-2 nucleic acid detection misc anti-SARS-CoV-2 antibody test misc SARS-CoV-2 direct antigens detection misc Medicine (General)
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title	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
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title_full	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
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title_sort	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
callnumber	R5-920
title_auth	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
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.
abstractGer	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.
abstract_unstemmed	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.
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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

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