Krebs von den Lungen-6 as Disease Severity Marker for COVID-19 Patients: Analytical Verification and Quality Assessment of the Tosoh AIA-360 Compared to Lumipulse G600II

Miriana d’Alessandro, Laura Bergantini, Dalila Cavallaro, Sara Gangi, Paolo Cameli, Edoardo Conticini, Siena COVID Unit, Bruno Frediani, Francesco Dotta and Elena Bargagli
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Miriana d’Alessandro: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy
Laura Bergantini: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy
Dalila Cavallaro: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy
Sara Gangi: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy
Paolo Cameli: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy
Edoardo Conticini: Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy
Siena COVID Unit: Collaborators/Membership of the Siena COVID Unit Name is provided in the Acknowledgments Section.
Bruno Frediani: Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy
Francesco Dotta: Diabetes Unit, Department of Medicine, Surgery and Neurosciences, University of Siena and Fondazione Umberto Di Mario ONLUS-Toscana Life Science Park, 53100 Siena, Italy
Elena Bargagli: Respiratory Diseases and Lung Transplantation Unit, Department of Medical and Surgical Sciences & Neurosciences, University of Siena, 53100 Siena, Italy

IJERPH, 2022, vol. 19, issue 4, 1-10

Abstract: Background: Krebs von den Lungen-6 (KL-6) has been proposed as a disease severity marker of COVID-19. All research articles reported the KL-6 assay detected through Fujirebio reagents by Lumipulse G600/G1200 instrument. In the present study, KL-6 assay was analysed through Tosoh AIA-360 and compared with analytical results by Lumipulse G600 in a population of COVID-19 patients. Materials and methods: Sixty-four patients (median age, IQR 67 (58–76) years), all hospitalized for COVID-19 interstitial pneumonia at Siena COVID Unit. KL-6 was measured by two methods, chemiluminescence enzyme immunoassay (CLEIA) and fluorescent enzyme immunoassay (FEIA) method by Lumipulse G600 II and AIA 360 systems, respectively. Results: KL-6 concentrations evaluated by Lumipulse G600II were significantly higher in severe than those in non-severe patients ( p < 0.0001) as well as evaluating by AIA360 ( p < 0.0001). Receiver operating curve (ROC) curve analysis showed that KL-6 concentrations, by Lumipuse G600II, distinguished severe from non-severe COVID-19 patients with an area under the curve (AUC) of 99.8% and the best cut-off value was 448 U/mL. AUROC between severe and non-severe COVID-19 patients using T0 KL-6 concentrations by AIA360 was 97.4% and the best cut-off value was 398 U/mL. According to T0 KL-6 concentrations in COVID-19 patients, Bland–Altman difference analysis revealed a mean bias of 78 ± 174.8; while using T1 KL-6 concentrations in COVID-19 patients, Bland–Altman difference analysis revealed a mean bias of 48 ± 126 (95% limits of agreement −199–295) between the Lumipulse G600 II and the AIA360 systems. Conclusions: In conclusion, our study demonstrated that CLEIA and FEIA methods for serum KL-6 detection are comparable and reliable. KL-6 was confirmed as an easily detectable and effective biomarker to identify severe COVID-19 patients.

Keywords: Krebs von den Lungen-6; COVID-19; analytical validation (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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