Evaluation of the fully automated LIAISON®XL chemiluminescence analyzer for QuantiFERON®-CMV testing in transplant recipients
Copyright © 2023. Published by Elsevier B.V..
BACKGROUND: Monitoring CMV-specific cell-mediated immunity by the QuantiFERON®-CMV (QF-CMV) may be useful in predicting the risk of CMV infection in transplant recipients (TR).
OBJECTIVES: As the QuantiFERON-Tuberculosis (QFT®-Plus) became available on the fully automated LIAISON®XL chemiluminescence (CLIA) analyzer, we evaluated the performance of the QF-CMV on the LIAISON®XL analyzer using the QuantiFERON®-TB Gold Plus reagent.
STUDY DESIGN: Between 2018 and 2022, 81 samples from TR were collected at the Department of Virology of Limoges Hospital, France. Whole blood was collected into each of the three QF-CMV collection tubes: a CMV-antigen tube (QF-Ag), a mitogen tube (QF-Mg) (positive control), and a nil tube (negative control). The QF-CMV was performed on the LIAISON®XL analyzer, and results were compared with those obtained by conventional microplate ELISA.
RESULTS: Intra- and inter-assay coefficients of variation were inferior to 20%. No inter-sample contamination was found (p=0.366). The level of concordance between CLIA and the commonly used ELISA method was 88.9%. Positive and negative percent agreements were 92.3% and 85.7%, respectively, with a very good agreement between assays (κ=0.818). Most discordances were due to indeterminate- or negative-ELISA/positive-CLIA results (most of ELISA results were borderline). Linear regression analyses demonstrated a strong correlation between both assays (QF-Ag Pearson's r=0.978, QF-Mg Pearson's r=0.963). No significant difference was observed in median QF-CMV values between both assays (QF-Ag p=0.776; QF-Mg p=0.853; Mann-Whitney U test). The Bland-Altman plots showed a minor difference in IFN-γ release (QF-Ag -0.069 IU/ml, 95% limits of agreement (LoA): -1.589; 1.451; QF-Mg 0.190 IU/ml, 95% LoA: -2.070; 2.450).
CONCLUSION: Automated QF-CMV with CLIA is comparable to QF-CMV performed by ELISA with a presumably higher sensitivity for IFN-γ detection that may result in the conversion of samples close to the ELISA cut-off into positive results. Moreover, the use of a random-access analyzer allows to optimize the follow-up of TR.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:166 |
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| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 166(2023) vom: 01. Sept., Seite 105550 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mafi, Sarah [VerfasserIn] |
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| Links: |
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| Themen: |
82115-62-6 |
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| Anmerkungen: |
Date Completed 16.08.2023 Date Revised 16.08.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcv.2023.105550 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360273610 |
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| 100 | 1 | |a Mafi, Sarah |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the fully automated LIAISON®XL chemiluminescence analyzer for QuantiFERON®-CMV testing in transplant recipients |
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| 500 | |a Date Revised 16.08.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023. Published by Elsevier B.V. | ||
| 520 | |a BACKGROUND: Monitoring CMV-specific cell-mediated immunity by the QuantiFERON®-CMV (QF-CMV) may be useful in predicting the risk of CMV infection in transplant recipients (TR) | ||
| 520 | |a OBJECTIVES: As the QuantiFERON-Tuberculosis (QFT®-Plus) became available on the fully automated LIAISON®XL chemiluminescence (CLIA) analyzer, we evaluated the performance of the QF-CMV on the LIAISON®XL analyzer using the QuantiFERON®-TB Gold Plus reagent | ||
| 520 | |a STUDY DESIGN: Between 2018 and 2022, 81 samples from TR were collected at the Department of Virology of Limoges Hospital, France. Whole blood was collected into each of the three QF-CMV collection tubes: a CMV-antigen tube (QF-Ag), a mitogen tube (QF-Mg) (positive control), and a nil tube (negative control). The QF-CMV was performed on the LIAISON®XL analyzer, and results were compared with those obtained by conventional microplate ELISA | ||
| 520 | |a RESULTS: Intra- and inter-assay coefficients of variation were inferior to 20%. No inter-sample contamination was found (p=0.366). The level of concordance between CLIA and the commonly used ELISA method was 88.9%. Positive and negative percent agreements were 92.3% and 85.7%, respectively, with a very good agreement between assays (κ=0.818). Most discordances were due to indeterminate- or negative-ELISA/positive-CLIA results (most of ELISA results were borderline). Linear regression analyses demonstrated a strong correlation between both assays (QF-Ag Pearson's r=0.978, QF-Mg Pearson's r=0.963). No significant difference was observed in median QF-CMV values between both assays (QF-Ag p=0.776; QF-Mg p=0.853; Mann-Whitney U test). The Bland-Altman plots showed a minor difference in IFN-γ release (QF-Ag -0.069 IU/ml, 95% limits of agreement (LoA): -1.589; 1.451; QF-Mg 0.190 IU/ml, 95% LoA: -2.070; 2.450) | ||
| 520 | |a CONCLUSION: Automated QF-CMV with CLIA is comparable to QF-CMV performed by ELISA with a presumably higher sensitivity for IFN-γ detection that may result in the conversion of samples close to the ELISA cut-off into positive results. Moreover, the use of a random-access analyzer allows to optimize the follow-up of TR | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a LIAISON®XL | |
| 650 | 4 | |a QuantiFERON®-CMV | |
| 650 | 4 | |a Transplant recipients | |
| 650 | 7 | |a Interferon-gamma |2 NLM | |
| 650 | 7 | |a 82115-62-6 |2 NLM | |
| 700 | 1 | |a Alain, Sophie |e verfasserin |4 aut | |
| 700 | 1 | |a Hantz, Sébastien |e verfasserin |4 aut | |
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