tetano
Editor, Senior Moderator
BMC Infect Dis
. 2022 Oct 31;22(1):810.
doi: 10.1186/s12879-022-07786-5.
Evaluation of qualitative and semi-quantitative cut offs for rapid diagnostic lateral flow test in relation to serology for the detection of SARS-CoV-2 antibodies: findings of a prospective study
Maddalena Peghin[SUP] 1 2 3 [/SUP], Giulia Bontempo[SUP] 4 [/SUP], Maria De Martino[SUP] 5 [/SUP], Alvisa Palese[SUP] 6 [/SUP], Valentina Gerussi[SUP] 4 [/SUP], Elena Graziano[SUP] 4 7 [/SUP], Martina Fabris[SUP] 8 [/SUP], Federica D'Aurizio[SUP] 8 [/SUP], Francesco Sbrana[SUP] 9 [/SUP], Andrea Ripoli[SUP] 10 [/SUP], Francesco Curcio[SUP] 8 [/SUP], Miriam Isola[SUP] 5 [/SUP], Carlo Tascini[SUP] 4 [/SUP]
Affiliations
Abstract
Background: There is limited information to compare the qualitative and semi-quantitative performance of rapid diagnostic tests (RDT) and serology for the assessment of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, the objective of the study was (a) to compare the efficacy of SARS-CoV-2 antibody detection between RDT and laboratory serology, trying to identify appropriate semi-quantitative cut-offs for RDT in relation with quantitative serology values and to (b) evaluate diagnostic accuracy of RDT compared to the NAAT gold standard in an unselected adult population.
Methods: SARS-CoV-2 antibodies were simultaneously measured with lateral flow immunochromatographic assays (LFA), the Cellex qSARS-CoV-2 IgG/IgM Rapid Test (by capillary blood), the iFlash-SARS-CoV-2 IgG/IgM chemiluminescent immunoassay (CLIA) (by venous blood) and the nucleic acid amplification test (NAAT) in samples from in- and out-patients with confirmed, suspected and negative diagnosis of coronavirus disease 2019 (COVID-19) attending Udine Hospital (Italy) (March-May 2020). Interpretation of RDT was qualitative (positive/negative) and semi-quantitative based on a chromatographic intensity scale (negative, weak positive, positive).
Results: Overall, 720 paired antibody measures were performed on 858 patients. The qualitative and semiquantitative agreement analysis performed in the whole sample between LFA and CLIA provided a Kendall's tau of 0.578 (p < 0.001) and of 0.623 (p < 0.001), respectively, for IgM and IgG. In patients with a diagnosis of COVID-19, accordance between LFA and CLIA was maintained as a function of time from the onset of COVID-19 disease and the severity of disease both for qualitative and semi-quantitative assessments. RDT compared to the NAAT gold standard in 858 patients showed 78.5% sensitivity (95% CI 75.1%-81.7%) and 94.1% specificity (95% CI 90.4%-96.8%), with variable accordance depending on the timing from symptom onset.
Conclusion: The RDT used in our study can be a non-invasive and reliable alternative to serological tests and facilitate both qualitative and a semi-quantitative antibody detection in COVID-19.
Keywords: Antibodies; CLIA; COVID-19; ELISA; Lateral flow immunoassay; POC; RDT; Rapid diagnostic test; SARS-CoV-2; Serology.
. 2022 Oct 31;22(1):810.
doi: 10.1186/s12879-022-07786-5.
Evaluation of qualitative and semi-quantitative cut offs for rapid diagnostic lateral flow test in relation to serology for the detection of SARS-CoV-2 antibodies: findings of a prospective study
Maddalena Peghin[SUP] 1 2 3 [/SUP], Giulia Bontempo[SUP] 4 [/SUP], Maria De Martino[SUP] 5 [/SUP], Alvisa Palese[SUP] 6 [/SUP], Valentina Gerussi[SUP] 4 [/SUP], Elena Graziano[SUP] 4 7 [/SUP], Martina Fabris[SUP] 8 [/SUP], Federica D'Aurizio[SUP] 8 [/SUP], Francesco Sbrana[SUP] 9 [/SUP], Andrea Ripoli[SUP] 10 [/SUP], Francesco Curcio[SUP] 8 [/SUP], Miriam Isola[SUP] 5 [/SUP], Carlo Tascini[SUP] 4 [/SUP]
Affiliations
- PMID: 36316641
- DOI: 10.1186/s12879-022-07786-5
Abstract
Background: There is limited information to compare the qualitative and semi-quantitative performance of rapid diagnostic tests (RDT) and serology for the assessment of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, the objective of the study was (a) to compare the efficacy of SARS-CoV-2 antibody detection between RDT and laboratory serology, trying to identify appropriate semi-quantitative cut-offs for RDT in relation with quantitative serology values and to (b) evaluate diagnostic accuracy of RDT compared to the NAAT gold standard in an unselected adult population.
Methods: SARS-CoV-2 antibodies were simultaneously measured with lateral flow immunochromatographic assays (LFA), the Cellex qSARS-CoV-2 IgG/IgM Rapid Test (by capillary blood), the iFlash-SARS-CoV-2 IgG/IgM chemiluminescent immunoassay (CLIA) (by venous blood) and the nucleic acid amplification test (NAAT) in samples from in- and out-patients with confirmed, suspected and negative diagnosis of coronavirus disease 2019 (COVID-19) attending Udine Hospital (Italy) (March-May 2020). Interpretation of RDT was qualitative (positive/negative) and semi-quantitative based on a chromatographic intensity scale (negative, weak positive, positive).
Results: Overall, 720 paired antibody measures were performed on 858 patients. The qualitative and semiquantitative agreement analysis performed in the whole sample between LFA and CLIA provided a Kendall's tau of 0.578 (p < 0.001) and of 0.623 (p < 0.001), respectively, for IgM and IgG. In patients with a diagnosis of COVID-19, accordance between LFA and CLIA was maintained as a function of time from the onset of COVID-19 disease and the severity of disease both for qualitative and semi-quantitative assessments. RDT compared to the NAAT gold standard in 858 patients showed 78.5% sensitivity (95% CI 75.1%-81.7%) and 94.1% specificity (95% CI 90.4%-96.8%), with variable accordance depending on the timing from symptom onset.
Conclusion: The RDT used in our study can be a non-invasive and reliable alternative to serological tests and facilitate both qualitative and a semi-quantitative antibody detection in COVID-19.
Keywords: Antibodies; CLIA; COVID-19; ELISA; Lateral flow immunoassay; POC; RDT; Rapid diagnostic test; SARS-CoV-2; Serology.