Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies
<h4>Background</h4> RTS,S/AS01 induced anti-circumsporozoite protein (CSP) IgG antibodies are associated with the vaccine efficacy. There is currently no international standardisation of the assays used in the measurement of anti-CSP IgG antibody concentrations for use in evaluations of...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2023-01-01
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| Series: | PLoS ONE |
| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10204981/?tool=EBI |
| _version_ | 1797819795504103424 |
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| author | Robert M. Mugo Benedict Orindi Faiz M. Shee Duncan Bellamy Jedidah Mwacharo Katie J. Ewer Philip Bejon Francis M. Ndungu |
| author_facet | Robert M. Mugo Benedict Orindi Faiz M. Shee Duncan Bellamy Jedidah Mwacharo Katie J. Ewer Philip Bejon Francis M. Ndungu |
| author_sort | Robert M. Mugo |
| collection | DOAJ |
| description | <h4>Background</h4> RTS,S/AS01 induced anti-circumsporozoite protein (CSP) IgG antibodies are associated with the vaccine efficacy. There is currently no international standardisation of the assays used in the measurement of anti-CSP IgG antibody concentrations for use in evaluations of the vaccine’s immunogenicity and/or efficacy. Here, we compared the levels of RTS,S/AS01 induced anti-CSP IgG antibodies measured using three different enzyme-Linked ImmunoSorbent Assays (ELISA). <h4>Methods</h4> 196 plasma samples were randomly selected from the 447 samples collected during the RTS,S/AS01 phase IIb trial in 2007 from Kenyan children aged between 5–17 months. The vaccine-induced anti-CSP IgG antibodies were then measured using two independently developed ELISA protocols (‘Kilifi-RTS,S’ and ‘Oxford-R21’) and compared to the results from the reference ‘Ghent-RTS,S’ protocol for the same participants. For each pair of protocols, a deming regression model was fitted. Linear equations were then derived to aid in conversions into equivalent ELISA units. The agreement was assessed using Bland and Altman method. <h4>Findings</h4> The anti-CSP IgG antibodies measured from the three ELISA protocols were in agreement, and were positively and linearly correlated; ‘Oxford’ and ‘Kilifi’ r = 0.93 (95% CI 0.91–0.95), ‘Oxford’ and ‘Ghent’ r = 0.94 (95% CI: 0.92–0.96), and ‘Kilifi’ and ‘Ghent’ r = 0.97 (95% CI: 0.96–0.98), p<0.0001 for all correlations. <h4>Conclusions</h4> With the linearity, agreement and correlations established between the assays, conversion equations can be applied to convert results into equivalent units, enabling comparisons of immunogenicities across different vaccines of the same CSP antigens. This study highlights the need for the international harmonisation of anti-CSP antibody measurements. |
| first_indexed | 2024-03-13T09:27:52Z |
| format | Article |
| id | doaj.art-12c85a7e4d424b3e846eee3d51bed22a |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-13T09:27:52Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-12c85a7e4d424b3e846eee3d51bed22a2023-05-26T05:30:59ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01185Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodiesRobert M. MugoBenedict OrindiFaiz M. SheeDuncan BellamyJedidah MwacharoKatie J. EwerPhilip BejonFrancis M. Ndungu<h4>Background</h4> RTS,S/AS01 induced anti-circumsporozoite protein (CSP) IgG antibodies are associated with the vaccine efficacy. There is currently no international standardisation of the assays used in the measurement of anti-CSP IgG antibody concentrations for use in evaluations of the vaccine’s immunogenicity and/or efficacy. Here, we compared the levels of RTS,S/AS01 induced anti-CSP IgG antibodies measured using three different enzyme-Linked ImmunoSorbent Assays (ELISA). <h4>Methods</h4> 196 plasma samples were randomly selected from the 447 samples collected during the RTS,S/AS01 phase IIb trial in 2007 from Kenyan children aged between 5–17 months. The vaccine-induced anti-CSP IgG antibodies were then measured using two independently developed ELISA protocols (‘Kilifi-RTS,S’ and ‘Oxford-R21’) and compared to the results from the reference ‘Ghent-RTS,S’ protocol for the same participants. For each pair of protocols, a deming regression model was fitted. Linear equations were then derived to aid in conversions into equivalent ELISA units. The agreement was assessed using Bland and Altman method. <h4>Findings</h4> The anti-CSP IgG antibodies measured from the three ELISA protocols were in agreement, and were positively and linearly correlated; ‘Oxford’ and ‘Kilifi’ r = 0.93 (95% CI 0.91–0.95), ‘Oxford’ and ‘Ghent’ r = 0.94 (95% CI: 0.92–0.96), and ‘Kilifi’ and ‘Ghent’ r = 0.97 (95% CI: 0.96–0.98), p<0.0001 for all correlations. <h4>Conclusions</h4> With the linearity, agreement and correlations established between the assays, conversion equations can be applied to convert results into equivalent units, enabling comparisons of immunogenicities across different vaccines of the same CSP antigens. This study highlights the need for the international harmonisation of anti-CSP antibody measurements.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10204981/?tool=EBI |
| spellingShingle | Robert M. Mugo Benedict Orindi Faiz M. Shee Duncan Bellamy Jedidah Mwacharo Katie J. Ewer Philip Bejon Francis M. Ndungu Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies PLoS ONE |
| title | Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies |
| title_full | Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies |
| title_fullStr | Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies |
| title_full_unstemmed | Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies |
| title_short | Correlations between three ELISA protocols measurements of RTS,S/AS01-induced anti-CSP IgG antibodies |
| title_sort | correlations between three elisa protocols measurements of rts s as01 induced anti csp igg antibodies |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10204981/?tool=EBI |
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