Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies
Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagn...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Siopi, Maria [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Anmerkung: |
© The Author(s) 2022 |
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| Übergeordnetes Werk: |
Enthalten in: Infectious diseases and therapy - Heidelberg : Springer, 2012, 11(2022), 3 vom: 11. Apr., Seite 1161-1175 |
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| Übergeordnetes Werk: |
volume:11 ; year:2022 ; number:3 ; day:11 ; month:04 ; pages:1161-1175 |
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| DOI / URN: |
10.1007/s40121-022-00627-7 |
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| Katalog-ID: |
SPR047073500 |
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| 100 | 1 | |a Siopi, Maria |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
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| 520 | |a Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. | ||
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| 700 | 1 | |a Karakatsanis, Stamatis |4 aut | |
| 700 | 1 | |a Roumpakis, Christoforos |4 aut | |
| 700 | 1 | |a Korantanis, Konstantinos |4 aut | |
| 700 | 1 | |a Eldeik, Elina |4 aut | |
| 700 | 1 | |a Sambatakou, Helen |4 aut | |
| 700 | 1 | |a Sipsas, Nikolaos V. |4 aut | |
| 700 | 1 | |a Pagoni, Maria |4 aut | |
| 700 | 1 | |a Stamouli, Maria |4 aut | |
| 700 | 1 | |a Tsirigotis, Panagiotis |4 aut | |
| 700 | 1 | |a Meletiadis, Joseph |0 (orcid)0000-0002-8869-1509 |4 aut | |
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10.1007/s40121-022-00627-7 doi (DE-627)SPR047073500 (SPR)s40121-022-00627-7-e DE-627 ger DE-627 rakwb eng Siopi, Maria verfasserin aut Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 Karakatsanis, Stamatis aut Roumpakis, Christoforos aut Korantanis, Konstantinos aut Eldeik, Elina aut Sambatakou, Helen aut Sipsas, Nikolaos V. aut Pagoni, Maria aut Stamouli, Maria aut Tsirigotis, Panagiotis aut Meletiadis, Joseph (orcid)0000-0002-8869-1509 aut Enthalten in Infectious diseases and therapy Heidelberg : Springer, 2012 11(2022), 3 vom: 11. Apr., Seite 1161-1175 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:11 year:2022 number:3 day:11 month:04 pages:1161-1175 https://dx.doi.org/10.1007/s40121-022-00627-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 3 11 04 1161-1175 |
| spelling |
10.1007/s40121-022-00627-7 doi (DE-627)SPR047073500 (SPR)s40121-022-00627-7-e DE-627 ger DE-627 rakwb eng Siopi, Maria verfasserin aut Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 Karakatsanis, Stamatis aut Roumpakis, Christoforos aut Korantanis, Konstantinos aut Eldeik, Elina aut Sambatakou, Helen aut Sipsas, Nikolaos V. aut Pagoni, Maria aut Stamouli, Maria aut Tsirigotis, Panagiotis aut Meletiadis, Joseph (orcid)0000-0002-8869-1509 aut Enthalten in Infectious diseases and therapy Heidelberg : Springer, 2012 11(2022), 3 vom: 11. Apr., Seite 1161-1175 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:11 year:2022 number:3 day:11 month:04 pages:1161-1175 https://dx.doi.org/10.1007/s40121-022-00627-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 3 11 04 1161-1175 |
| allfields_unstemmed |
10.1007/s40121-022-00627-7 doi (DE-627)SPR047073500 (SPR)s40121-022-00627-7-e DE-627 ger DE-627 rakwb eng Siopi, Maria verfasserin aut Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 Karakatsanis, Stamatis aut Roumpakis, Christoforos aut Korantanis, Konstantinos aut Eldeik, Elina aut Sambatakou, Helen aut Sipsas, Nikolaos V. aut Pagoni, Maria aut Stamouli, Maria aut Tsirigotis, Panagiotis aut Meletiadis, Joseph (orcid)0000-0002-8869-1509 aut Enthalten in Infectious diseases and therapy Heidelberg : Springer, 2012 11(2022), 3 vom: 11. Apr., Seite 1161-1175 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:11 year:2022 number:3 day:11 month:04 pages:1161-1175 https://dx.doi.org/10.1007/s40121-022-00627-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 3 11 04 1161-1175 |
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10.1007/s40121-022-00627-7 doi (DE-627)SPR047073500 (SPR)s40121-022-00627-7-e DE-627 ger DE-627 rakwb eng Siopi, Maria verfasserin aut Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 Karakatsanis, Stamatis aut Roumpakis, Christoforos aut Korantanis, Konstantinos aut Eldeik, Elina aut Sambatakou, Helen aut Sipsas, Nikolaos V. aut Pagoni, Maria aut Stamouli, Maria aut Tsirigotis, Panagiotis aut Meletiadis, Joseph (orcid)0000-0002-8869-1509 aut Enthalten in Infectious diseases and therapy Heidelberg : Springer, 2012 11(2022), 3 vom: 11. Apr., Seite 1161-1175 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:11 year:2022 number:3 day:11 month:04 pages:1161-1175 https://dx.doi.org/10.1007/s40121-022-00627-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 3 11 04 1161-1175 |
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10.1007/s40121-022-00627-7 doi (DE-627)SPR047073500 (SPR)s40121-022-00627-7-e DE-627 ger DE-627 rakwb eng Siopi, Maria verfasserin aut Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 Karakatsanis, Stamatis aut Roumpakis, Christoforos aut Korantanis, Konstantinos aut Eldeik, Elina aut Sambatakou, Helen aut Sipsas, Nikolaos V. aut Pagoni, Maria aut Stamouli, Maria aut Tsirigotis, Panagiotis aut Meletiadis, Joseph (orcid)0000-0002-8869-1509 aut Enthalten in Infectious diseases and therapy Heidelberg : Springer, 2012 11(2022), 3 vom: 11. Apr., Seite 1161-1175 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:11 year:2022 number:3 day:11 month:04 pages:1161-1175 https://dx.doi.org/10.1007/s40121-022-00627-7 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2022 3 11 04 1161-1175 |
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(1–3)- - -glucan Diagnosis Dynamiker Fungus assay Invasive aspergillosis Hematology patients |
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Siopi, Maria @@aut@@ Karakatsanis, Stamatis @@aut@@ Roumpakis, Christoforos @@aut@@ Korantanis, Konstantinos @@aut@@ Eldeik, Elina @@aut@@ Sambatakou, Helen @@aut@@ Sipsas, Nikolaos V. @@aut@@ Pagoni, Maria @@aut@@ Stamouli, Maria @@aut@@ Tsirigotis, Panagiotis @@aut@@ Meletiadis, Joseph @@aut@@ |
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Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. 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Siopi, Maria misc (1–3)- misc - misc -glucan misc Diagnosis misc Dynamiker misc Fungus assay misc Invasive aspergillosis misc Hematology patients Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
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Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies (1–3)- (dpeaa)DE-He213 - (dpeaa)DE-He213 -glucan (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Dynamiker (dpeaa)DE-He213 Fungus assay (dpeaa)DE-He213 Invasive aspergillosis (dpeaa)DE-He213 Hematology patients (dpeaa)DE-He213 |
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Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
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Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
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Siopi, Maria Karakatsanis, Stamatis Roumpakis, Christoforos Korantanis, Konstantinos Eldeik, Elina Sambatakou, Helen Sipsas, Nikolaos V. Pagoni, Maria Stamouli, Maria Tsirigotis, Panagiotis Meletiadis, Joseph |
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evaluation of the $ dynamiker^{®} $ fungus (1–3)-β-d-glucan assay for the diagnosis of invasive aspergillosis in high-risk patients with hematologic malignancies |
| title_auth |
Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
| abstract |
Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. © The Author(s) 2022 |
| abstractGer |
Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. © The Author(s) 2022 |
| abstract_unstemmed |
Introduction The $ Dynamiker^{®} $ Fungus (1–3)-β-d-glucan assay (DFA) allows the testing of samples in smaller batches compared to the well-established $ Fungitell^{®} $ assay (FA) making the assay cost-effective in centers with small numbers of samples. Evaluations of its performance for the diagnosis of invasive aspergillosis (IA) are limited. Therefore, we compared the two assays and evaluated their clinical performance in diagnosing IA. Methods A total of 60 adult hematology patients were screened for IA, 13 with probable IA, 19 with possible IA, and 28 with no IA. Serum specimens (n = 166) were collected twice-weekly and tested for (1–3)-β-d-glucan (BDG) using FA and DFA which were compared quantitatively with Spearman rank correlation analysis and qualitatively with the Chi-square test. Agreement and error rates were determined using FA as the reference method. Sensitivity, specificity, and positive predictive and negative predictive values in diagnosing IA were calculated. Results The performance of the DFA was highly consistent with that of the FA, both quantitatively (rs = 0.913) and qualitatively (kappa = 0.725). The agreement was 85% with 8% minor, no major, and 7% very major errors (FA+/DFA−). Using a cut-off value of 20 pg/mL for DFA, very major errors were reduced to 1%, although 5% major errors were detected. BDG levels were lower with DFA than FA (slope 0.653 ± 0.031). Sensitivity, specificity, positive predictive value, and negative predictive value (NPV) was 67%, 53%, 44%, and 74% for FA, and 53%, 67%, 49%, and 71% for DFA, respectively. The optimal BDG positivity threshold calculated did not lead to significant test quality improvement for either assay. However, a higher % of patients with probable IA (62%) had ≥ 2 consecutive positive specimens compared to patients with no IA (FA-BDG 26%, p = 0.10, and DFA-BDG 10%, p = 0.01) leading to improved sensitivity and NPV (71% and 85% for DFA, and 95% and 96% for FA, respectively). Conclusion DFA could be a valuable alternative to the FA, particularly in laboratories with small numbers of samples. The results of the BDG testing should be carefully interpreted in the high-risk setting of patients with hematologic malignancies. Higher NPV was found using as criterion ≥ 2 consecutive positive samples for diagnosing IA. © The Author(s) 2022 |
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Evaluation of the $ Dynamiker^{®} $ Fungus (1–3)-β-d-Glucan Assay for the Diagnosis of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies |
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