Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i>
Q fever is a zoonosis caused by <i>Coxiella burnetii</i>, a Gram-negative pathogen with a complex life cycle and a high impact on public and animal health all over the world. The symptoms are indistinguishable from those belonging to other diseases, and the disease could be symptomless....
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-12-01
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| Series: | Pathogens |
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| Online Access: | https://www.mdpi.com/2076-0817/9/12/1075 |
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| author | Salvatore Ledda Cinzia Santucciu Valentina Chisu Giovanna Masala |
| author_facet | Salvatore Ledda Cinzia Santucciu Valentina Chisu Giovanna Masala |
| author_sort | Salvatore Ledda |
| collection | DOAJ |
| description | Q fever is a zoonosis caused by <i>Coxiella burnetii</i>, a Gram-negative pathogen with a complex life cycle and a high impact on public and animal health all over the world. The symptoms are indistinguishable from those belonging to other diseases, and the disease could be symptomless. For these reasons, reliable laboratory tests are essential for an accurate diagnosis. The aim of this study was to validate a novel enzyme-linked immunosorbent assay (ELISA) test, named the Chorus Q Fever Phase II IgG and IgM Kit (DIESSE, Diagnostica Senese S.p.A), which is performed by an instrument named Chorus, a new device in medical diagnostics. This diagnostic test is employed for the detection of antibodies against <i>C. burnetii</i> Phase II antigens in acute disease. Our validation protocol was performed according to the Italian Accreditation Body (ACCREDIA) (Regulation UNI CEI EN ISO/IEC 17025:2018 and 17043:2010), OIE (World Organization for Animal Health), and Statement for Reporting Studies of Diagnostic Accuracy (STARD). Operator performance was evaluated along with the analytical specificity and sensitivity (ASp and ASe) and diagnostic accuracy of the kit, with parameters such as diagnostic specificity and sensitivity (DSp and DSe) and positive and negative predictive values (PPV and NPV), in addition to the repeatability. According to the evaluated parameters, the diagnostic ELISA test was shown to be suitable for validation and commercialization as a screening method in human sera and a valid support for clinical diagnostics. |
| first_indexed | 2024-03-10T13:52:42Z |
| format | Article |
| id | doaj.art-d5aa0ffa231e469bab1199878578bc6e |
| institution | Directory Open Access Journal |
| issn | 2076-0817 |
| language | English |
| last_indexed | 2024-03-10T13:52:42Z |
| publishDate | 2020-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pathogens |
| spelling | doaj.art-d5aa0ffa231e469bab1199878578bc6e2023-11-21T01:56:55ZengMDPI AGPathogens2076-08172020-12-01912107510.3390/pathogens9121075Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i>Salvatore Ledda0Cinzia Santucciu1Valentina Chisu2Giovanna Masala3Zoonotic Pathology and OIE Reference Laboratory for Echinococcosis, National Reference Center for Echinococcosis (CeNRE), IZS della Sardegna, 07100 Sassari, ItalyZoonotic Pathology and OIE Reference Laboratory for Echinococcosis, National Reference Center for Echinococcosis (CeNRE), IZS della Sardegna, 07100 Sassari, ItalyZoonotic Pathology and OIE Reference Laboratory for Echinococcosis, National Reference Center for Echinococcosis (CeNRE), IZS della Sardegna, 07100 Sassari, ItalyZoonotic Pathology and OIE Reference Laboratory for Echinococcosis, National Reference Center for Echinococcosis (CeNRE), IZS della Sardegna, 07100 Sassari, ItalyQ fever is a zoonosis caused by <i>Coxiella burnetii</i>, a Gram-negative pathogen with a complex life cycle and a high impact on public and animal health all over the world. The symptoms are indistinguishable from those belonging to other diseases, and the disease could be symptomless. For these reasons, reliable laboratory tests are essential for an accurate diagnosis. The aim of this study was to validate a novel enzyme-linked immunosorbent assay (ELISA) test, named the Chorus Q Fever Phase II IgG and IgM Kit (DIESSE, Diagnostica Senese S.p.A), which is performed by an instrument named Chorus, a new device in medical diagnostics. This diagnostic test is employed for the detection of antibodies against <i>C. burnetii</i> Phase II antigens in acute disease. Our validation protocol was performed according to the Italian Accreditation Body (ACCREDIA) (Regulation UNI CEI EN ISO/IEC 17025:2018 and 17043:2010), OIE (World Organization for Animal Health), and Statement for Reporting Studies of Diagnostic Accuracy (STARD). Operator performance was evaluated along with the analytical specificity and sensitivity (ASp and ASe) and diagnostic accuracy of the kit, with parameters such as diagnostic specificity and sensitivity (DSp and DSe) and positive and negative predictive values (PPV and NPV), in addition to the repeatability. According to the evaluated parameters, the diagnostic ELISA test was shown to be suitable for validation and commercialization as a screening method in human sera and a valid support for clinical diagnostics.https://www.mdpi.com/2076-0817/9/12/1075<i>Coxiella burnetii</i>Q feverimmunological diagnosishuman diagnosisvalidationquality management |
| spellingShingle | Salvatore Ledda Cinzia Santucciu Valentina Chisu Giovanna Masala Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> Pathogens <i>Coxiella burnetii</i> Q fever immunological diagnosis human diagnosis validation quality management |
| title | Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> |
| title_full | Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> |
| title_fullStr | Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> |
| title_full_unstemmed | Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> |
| title_short | Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against <i>Coxiella burnetii</i> |
| title_sort | validation of a novel commercial elisa test for the detection of antibodies against i coxiella burnetii i |
| topic | <i>Coxiella burnetii</i> Q fever immunological diagnosis human diagnosis validation quality management |
| url | https://www.mdpi.com/2076-0817/9/12/1075 |
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