Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis
Abstract The causal protein of amyloid light‐chain (AL) amyloidosis is a monoclonal immunoglobulin free light chain (mFLC), which must be quantified in the serum for patient diagnosis and monitoring. Several manufacturers commercialize immunoassays that quantify total kappa (κ) and lambda (λ) FLC, b...
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| Format: | Article |
| Language: | English |
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Wiley
2022-08-01
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| Series: | eJHaem |
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| Online Access: | https://doi.org/10.1002/jha2.516 |
| _version_ | 1828716031105826816 |
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| author | Hajer Abroud Asma Beldi‐Ferchiou Vincent Audard François Lemonnier Fabien Le Bras Karim Belhadj Anissa Moktefi Elsa Poullot Khalil El Karoui Jehan Dupuis Alizée Maarek Louise Roulin Marie‐Hélène Delfau‐Larue Silvia Oghina Mounira Kharoubi Mélanie Bézard Amira Zaroui Thibaud Damy Valérie Molinier‐Frenkel |
| author_facet | Hajer Abroud Asma Beldi‐Ferchiou Vincent Audard François Lemonnier Fabien Le Bras Karim Belhadj Anissa Moktefi Elsa Poullot Khalil El Karoui Jehan Dupuis Alizée Maarek Louise Roulin Marie‐Hélène Delfau‐Larue Silvia Oghina Mounira Kharoubi Mélanie Bézard Amira Zaroui Thibaud Damy Valérie Molinier‐Frenkel |
| author_sort | Hajer Abroud |
| collection | DOAJ |
| description | Abstract The causal protein of amyloid light‐chain (AL) amyloidosis is a monoclonal immunoglobulin free light chain (mFLC), which must be quantified in the serum for patient diagnosis and monitoring. Several manufacturers commercialize immunoassays that quantify total kappa (κ) and lambda (λ) FLC, but results can differ greatly between these tests. Here, we compared a recently developed enzyme‐linked immunosorbent assay (ELISA) (Sebia) with N‐Latex immunonephelometry (Siemens) in 96 patients diagnosed with AL amyloidosis (histologically confirmed) and 48 non‐AL patients sent to our referral center for suspicion of cardiac amyloidosis. ELISA free‐light chain difference (dFLC) were lower than N‐Latex values, and agreement between methods was reduced in the case of involved λ FLC. Diagnosis sensitivity and specificity were >85% with both assays. A receiver operating characteristic analysis indicated that ELISA performances could be improved by using a higher value for the lower limit of the κ/λ ratio. We also assessed Freelite (The Binding Site) in a subgroup of these same AL patients, including 18 cases with normal κ/λ ratio by at least one assay. Only two patients had normal κ/λ ratio with all three assays. Overall, ELISA demonstrated slightly lower sensitivity than N‐Latex but may be an alternative to nephelometry/turbidimetry in certain difficult cases. |
| first_indexed | 2024-03-12T14:06:29Z |
| format | Article |
| id | doaj.art-37bd029390be4c56b0408595bd4a2fe3 |
| institution | Directory Open Access Journal |
| issn | 2688-6146 |
| language | English |
| last_indexed | 2024-03-12T14:06:29Z |
| publishDate | 2022-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | eJHaem |
| spelling | doaj.art-37bd029390be4c56b0408595bd4a2fe32023-08-21T14:06:34ZengWileyeJHaem2688-61462022-08-013382883710.1002/jha2.516Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosisHajer Abroud0Asma Beldi‐Ferchiou1Vincent Audard2François Lemonnier3Fabien Le Bras4Karim Belhadj5Anissa Moktefi6Elsa Poullot7Khalil El Karoui8Jehan Dupuis9Alizée Maarek10Louise Roulin11Marie‐Hélène Delfau‐Larue12Silvia Oghina13Mounira Kharoubi14Mélanie Bézard15Amira Zaroui16Thibaud Damy17Valérie Molinier‐Frenkel18Département d'Hématologie‐Immunologie AP‐HP, Hopital Henri Mondor Creteil FranceDépartement d'Hématologie‐Immunologie AP‐HP, Hopital Henri Mondor Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceDépartement d'Hématologie‐Immunologie AP‐HP, Hopital Henri Mondor Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceFrench Referral Centre for Cardiac Amyloidosis Cardiogen Network GRC Amyloid Research Institute Henri Mondor Hospital Creteil FranceDépartement d'Hématologie‐Immunologie AP‐HP, Hopital Henri Mondor Creteil FranceAbstract The causal protein of amyloid light‐chain (AL) amyloidosis is a monoclonal immunoglobulin free light chain (mFLC), which must be quantified in the serum for patient diagnosis and monitoring. Several manufacturers commercialize immunoassays that quantify total kappa (κ) and lambda (λ) FLC, but results can differ greatly between these tests. Here, we compared a recently developed enzyme‐linked immunosorbent assay (ELISA) (Sebia) with N‐Latex immunonephelometry (Siemens) in 96 patients diagnosed with AL amyloidosis (histologically confirmed) and 48 non‐AL patients sent to our referral center for suspicion of cardiac amyloidosis. ELISA free‐light chain difference (dFLC) were lower than N‐Latex values, and agreement between methods was reduced in the case of involved λ FLC. Diagnosis sensitivity and specificity were >85% with both assays. A receiver operating characteristic analysis indicated that ELISA performances could be improved by using a higher value for the lower limit of the κ/λ ratio. We also assessed Freelite (The Binding Site) in a subgroup of these same AL patients, including 18 cases with normal κ/λ ratio by at least one assay. Only two patients had normal κ/λ ratio with all three assays. Overall, ELISA demonstrated slightly lower sensitivity than N‐Latex but may be an alternative to nephelometry/turbidimetry in certain difficult cases.https://doi.org/10.1002/jha2.516AL amyloidosiscardiac amyloidosisELISAfree‐light chainmonoclonal gammopathy |
| spellingShingle | Hajer Abroud Asma Beldi‐Ferchiou Vincent Audard François Lemonnier Fabien Le Bras Karim Belhadj Anissa Moktefi Elsa Poullot Khalil El Karoui Jehan Dupuis Alizée Maarek Louise Roulin Marie‐Hélène Delfau‐Larue Silvia Oghina Mounira Kharoubi Mélanie Bézard Amira Zaroui Thibaud Damy Valérie Molinier‐Frenkel Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis eJHaem AL amyloidosis cardiac amyloidosis ELISA free‐light chain monoclonal gammopathy |
| title | Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis |
| title_full | Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis |
| title_fullStr | Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis |
| title_full_unstemmed | Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis |
| title_short | Evaluation of a new ELISA assay for monoclonal free‐light chain detection in patients with cardiac amyloidosis |
| title_sort | evaluation of a new elisa assay for monoclonal free light chain detection in patients with cardiac amyloidosis |
| topic | AL amyloidosis cardiac amyloidosis ELISA free‐light chain monoclonal gammopathy |
| url | https://doi.org/10.1002/jha2.516 |
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