Comparative Analysis of the Clarus Aspergillus Galactomannan Enzyme Immunoassay Prototype for the Diagnosis of Invasive Pulmonary Aspergillosis in Bronchoalveolar Lavage Fluid.
Humans
Mannans
/ analysis
Galactose
/ analogs & derivatives
Bronchoalveolar Lavage Fluid
/ microbiology
Prospective Studies
Invasive Pulmonary Aspergillosis
/ diagnosis
Immunoenzyme Techniques
/ methods
Cross-Sectional Studies
Middle Aged
Male
Female
Aspergillus
/ isolation & purification
Adult
Sensitivity and Specificity
Aged
ROC Curve
Young Adult
BALF
Diagnostics
Enzyme-linked immunoassay
Galactomannan
Invasive pulmonary aspergillosis
Journal
Mycopathologia
ISSN: 1573-0832
Titre abrégé: Mycopathologia
Pays: Netherlands
ID NLM: 7505689
Informations de publication
Date de publication:
18 Jul 2024
18 Jul 2024
Historique:
received:
18
04
2024
accepted:
04
07
2024
medline:
18
7
2024
pubmed:
18
7
2024
entrez:
18
7
2024
Statut:
epublish
Résumé
Galactomannan (GM) testing using Platelia Aspergillus enzyme immunoassay (Platelia AGM) from bronchoalveolar lavage fluid (BALF) aids in early diagnosis of invasive pulmonary aspergillosis (IPA). Globally, only a minority of laboratories have the capability to perform on-site GM testing, necessitating accessible and affordable alternatives. Hence, we conducted a comparative evaluation of the new clarus Aspergillus GM enzyme immunoassay prototype (clarus AGM prototype) with Platelia AGM using BALF samples. This is a single-center, prospective, cross-sectional study, where Platelia AGM testing was routinely performed followed by clarus AGM prototype testing in those with true positive or true negative AGM test results according to the 2020 EORTC/MSG and the 2024 FUNDICU consensus definitions. Descriptive statistics, ROC curve analysis, and Spearman's correlation analysis were used to evaluate analytical performance of the clarus AGM prototype assay. This study enrolled 259 adult patients, of which 53 (20%) were classified as probable IPA, while 206 did not fulfill IPA-criteria. Spearman's correlation analysis revealed a strong correlation between the two assays (rho = 0.727, p < 0.001). The clarus AGM prototype had a sensitivity of 96% (51/53) and a specificity of 74% (153/206) for differentiating probable versus no IPA when using the manufacturer recommended cut-off. ROC curve analysis showed an AUC of 0.936 (95% CI 0.901-0.971) for the clarus AGM prototype, while the Platelia AGM yielded an AUC of 0.918 (95% CI 0.876-0.959). Clarus AGM prototype demonstrated a strong correlation and promising test performance, comparable to Platelia AGM, rendering it a viable alternative in patients at risk of IPA.
Sections du résumé
BACKGROUND
BACKGROUND
Galactomannan (GM) testing using Platelia Aspergillus enzyme immunoassay (Platelia AGM) from bronchoalveolar lavage fluid (BALF) aids in early diagnosis of invasive pulmonary aspergillosis (IPA). Globally, only a minority of laboratories have the capability to perform on-site GM testing, necessitating accessible and affordable alternatives. Hence, we conducted a comparative evaluation of the new clarus Aspergillus GM enzyme immunoassay prototype (clarus AGM prototype) with Platelia AGM using BALF samples.
METHODS
METHODS
This is a single-center, prospective, cross-sectional study, where Platelia AGM testing was routinely performed followed by clarus AGM prototype testing in those with true positive or true negative AGM test results according to the 2020 EORTC/MSG and the 2024 FUNDICU consensus definitions. Descriptive statistics, ROC curve analysis, and Spearman's correlation analysis were used to evaluate analytical performance of the clarus AGM prototype assay.
RESULTS
RESULTS
This study enrolled 259 adult patients, of which 53 (20%) were classified as probable IPA, while 206 did not fulfill IPA-criteria. Spearman's correlation analysis revealed a strong correlation between the two assays (rho = 0.727, p < 0.001). The clarus AGM prototype had a sensitivity of 96% (51/53) and a specificity of 74% (153/206) for differentiating probable versus no IPA when using the manufacturer recommended cut-off. ROC curve analysis showed an AUC of 0.936 (95% CI 0.901-0.971) for the clarus AGM prototype, while the Platelia AGM yielded an AUC of 0.918 (95% CI 0.876-0.959).
CONCLUSIONS
CONCLUSIONS
Clarus AGM prototype demonstrated a strong correlation and promising test performance, comparable to Platelia AGM, rendering it a viable alternative in patients at risk of IPA.
Identifiants
pubmed: 39023825
doi: 10.1007/s11046-024-00876-9
pii: 10.1007/s11046-024-00876-9
doi:
Substances chimiques
Mannans
0
Galactose
X2RN3Q8DNE
galactomannan
11078-30-1
Types de publication
Journal Article
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
67Informations de copyright
© 2024. The Author(s).
Références
Egger M, Hoenigl M, Thompson GR 3rd, Carvalho A, Jenks JD. Let’s talk about sex characteristics - as a risk factor for invasive fungal diseases. Mycoses. 2022. https://doi.org/10.1111/myc.13449 .
doi: 10.1111/myc.13449
pubmed: 35484713
Denning DW. Global incidence and mortality of severe fungal disease. Lancet Infect Dis. 2024. https://doi.org/10.1016/s1473-3099(23)00692-8 .
doi: 10.1016/s1473-3099(23)00692-8
pubmed: 38395047
Jenks JD, Prattes J, Wurster S, Sprute R, Seidel D, Oliverio M, Egger M, Del Rio C, Sati H, Cornely OA, Thompson GR, 3rd, Kontoyiannis DP, Hoenigl M. 2023. Social determinants of health as drivers of fungal disease. eClinicalMedicine 66. https://doi.org/10.1016/j.eclinm.2023.102325 .
Koehler P, Bassetti M, Chakrabarti A, Chen SCA, Colombo AL, Hoenigl M, Klimko N, Lass-Flörl C, Oladele RO, Vinh DC, Zhu LP, Böll B, Brüggemann R, Gangneux JP, Perfect JR, Patterson TF, Persigehl T, Meis JF, Ostrosky-Zeichner L, White PL, Verweij PE, Cornely OA. Defining and managing COVID-19-associated pulmonary aspergillosis: the 2020 ECMM/ISHAM consensus criteria for research and clinical guidance. Lancet Infect Dis. 2021;21:e149–62.
doi: 10.1016/S1473-3099(20)30847-1
pubmed: 33333012
Latgé JP. Aspergillus fumigatus and aspergillosis. Clin Microbiol Rev. 1999;12:310–50.
doi: 10.1128/CMR.12.2.310
pubmed: 10194462
pmcid: 88920
Kosmidis C, Denning DW. The clinical spectrum of pulmonary aspergillosis. Thorax. 2015;70:270–7.
doi: 10.1136/thoraxjnl-2014-206291
pubmed: 25354514
Marr KA, Patterson T, Denning D. Aspergillosis. Pathogenesis, clinical manifestations, and therapy. Infect Dis Clin North Am. 2002;16:875–94.
doi: 10.1016/S0891-5520(02)00035-1
pubmed: 12512185
Arastehfar A, Carvalho A, Houbraken J, Lombardi L, Garcia-Rubio R, Jenks JD, Rivero-Menendez O, Aljohani R, Jacobsen ID, Berman J, Osherov N, Hedayati MT, Ilkit M, Armstrong-James D, Gabaldón T, Meletiadis J, Kostrzewa M, Pan W, Lass-Flörl C, Perlin DS, Hoenigl M. Aspergillus fumigatus and aspergillosis: from basics to clinics. Stud Mycol. 2021;100:100115–100115.
doi: 10.1016/j.simyco.2021.100115
pubmed: 34035866
pmcid: 8131930
Hashim Z, Nath A, Khan A, Gupta M, Kumar A, Chatterjee R, Dhiman RK, Hoenigl M, Tripathy NK. Effect of glucocorticoids on the development of COVID-19-associated pulmonary aspergillosis: a meta-analysis of 21 studies and 5174 patients. Mycoses. 2023. https://doi.org/10.1111/myc.13637 .
doi: 10.1111/myc.13637
pubmed: 37551043
Prattes J, Koehler P, Hoenigl M. COVID-19 associated pulmonary aspergillosis: regional variation in incidence and diagnostic challenges. Intensive Care Med. 2021;47:1339–40.
doi: 10.1007/s00134-021-06510-2
pubmed: 34468820
pmcid: 8409068
Hoenigl M, Seidel D, Sprute R, Cunha C, Oliverio M, Goldman GH, Ibrahim AS, Carvalho A. COVID-19-associated fungal infections. Nat Microbiol. 2022;7:1127–40.
doi: 10.1038/s41564-022-01172-2
pubmed: 35918423
pmcid: 9362108
Prattes J, Wauters J, Giacobbe DR, Salmanton-García J, Maertens J, Bourgeois M, Reynders M, Rutsaert L, Van Regenmortel N, Lormans P, Feys S, Reisinger AC, Cornely OA, Lahmer T, Valerio M, Delhaes L, Jabeen K, Steinmann J, Chamula M, Bassetti M, Hatzl S, Rautemaa-Richardson R, Koehler P, Lagrou K, Hoenigl M, Debaveye Y, Miceli MH, Tudesq J-J, Paul G, Krause R, Linhofer M, Frost J, Zechner P, Kochanek M, Eller P, Jenks JD, Volpi S, Bellanger A-P, White PL, Goldman GH, Bowyer P, Rokas A, Gago S, Pelosi P, Robba C, Gangneux J-P, Lass-Floerl C, Machado M, Muñoz P. Risk factors and outcome of pulmonary aspergillosis in critically ill coronavirus disease 2019 patients—a multinational observational study by the European Confederation of Medical Mycology. Clin Microbiol Infect. 2022;28:580–7.
doi: 10.1016/j.cmi.2021.08.014
pubmed: 34454093
Hoenigl M, Enoch DA, Wichmann D, Wyncoll D, Cortegiani A. Exploring European consensus about the remaining treatment challenges and subsequent opportunities to improve the management of invasive fungal infection (IFI) in the Intensive Care Unit. Mycopathologia. 2024;189:41.
doi: 10.1007/s11046-024-00852-3
pubmed: 38704761
pmcid: 11070387
Aisner J, Wiernik PH, Schimpff SC. Treatment of invasive aspergillosis: relation of early diagnosis and treatment to response. Ann Intern Med. 1977;86:539–43.
doi: 10.7326/0003-4819-86-5-539
pubmed: 851301
Kriegl L, Egger M, Boyer J, Hoenigl M, Krause R. New treatment options for critically important WHO fungal priority pathogens. Clin Microbiol Infect. 2024. https://doi.org/10.1016/j.cmi.2024.03.006 .
doi: 10.1016/j.cmi.2024.03.006
pubmed: 38461942
Patterson TF, Thompson GR 3rd, Denning DW, Fishman JA, Hadley S, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Nguyen MH, Segal BH, Steinbach WJ, Stevens DA, Walsh TJ, Wingard JR, Young JA, Bennett JE. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the infectious diseases Society of America. Clin Infect Dis. 2016;63:e1–60.
doi: 10.1093/cid/ciw326
pubmed: 27365388
pmcid: 4967602
Ullmann AJ, Aguado JM, Arikan-Akdagli S, Denning DW, Groll AH, Lagrou K, Lass-Flörl C, Lewis RE, Munoz P, Verweij PE, Warris A, Ader F, Akova M, Arendrup MC, Barnes RA, Beigelman-Aubry C, Blot S, Bouza E, Brüggemann RJM, Buchheidt D, Cadranel J, Castagnola E, Chakrabarti A, Cuenca-Estrella M, Dimopoulos G, Fortun J, Gangneux JP, Garbino J, Heinz WJ, Herbrecht R, Heussel CP, Kibbler CC, Klimko N, Kullberg BJ, Lange C, Lehrnbecher T, Löffler J, Lortholary O, Maertens J, Marchetti O, Meis JF, Pagano L, Ribaud P, Richardson M, Roilides E, Ruhnke M, Sanguinetti M, Sheppard DC, Sinkó J, Skiada A, et al. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline. Clin Microbiol Infect. 2018;24(Suppl 1):e1–38.
doi: 10.1016/j.cmi.2018.01.002
pubmed: 29544767
Aerts R, Ricaño-Ponce I, Bruno M, Mercier T, Rosati D, Maertens J, Kumar V, Carvalho A, Netea MG, Hoenigl M. circulatory inflammatory proteins as early diagnostic biomarkers for invasive aspergillosis in patients with hematologic malignancies-an exploratory study. Mycopathologia. 2024;189:24.
doi: 10.1007/s11046-024-00831-8
pubmed: 38407673
pmcid: 10896822
Mercier T, Castagnola E, Marr KA, Wheat LJ, Verweij PE, Maertens JA. Defining galactomannan positivity in the updated EORTC/MSGERC consensus definitions of invasive fungal diseases. Clin Infect Dis. 2021;72:S89–94.
doi: 10.1093/cid/ciaa1786
pubmed: 33709125
Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW Jr, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg B-J, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, et al. Revision and update of the consensus definitions of invasive fungal disease from the European organization for research and treatment of cancer and the mycoses study group education and research consortium. Clin Infect Dis. 2019;71:1367–76.
doi: 10.1093/cid/ciz1008
pmcid: 7486838
Salmanton-García J, Au WY, Hoenigl M, Chai LYA, Badali H, Basher A, Brockhoff RA, Chen SC, Chindamporn A, Chowdhary A, Heath C, Jabeen K, Lee J, Matar M, Taj-Aldeen SJ, Tan BH, Uno K, Wahyuningsih R, Zhu LP, Chakrabarti A, Cornely OA. The current state of laboratory mycology in Asia/Pacific: a survey from the European Confederation of Medical Mycology (ECMM) and International Society for Human and Animal Mycology (ISHAM). Int J Antimicrob Agents. 2023. https://doi.org/10.1016/j.ijantimicag.2023.106718:106718 .
doi: 10.1016/j.ijantimicag.2023.106718:106718
pubmed: 37582478
Salmanton-García J, Hoenigl M, Gangneux JP, Segal E, Alastruey-Izquierdo A, Arikan Akdagli S, Lagrou K, Özenci V, Vena A, Cornely OA. The current state of laboratory mycology and access to antifungal treatment in Europe: a European Confederation of Medical Mycology survey. Lancet Microbe. 2023;4:e47–56.
doi: 10.1016/S2666-5247(22)00261-0
pubmed: 36463916
Lass-Flörl C, Samardzic E, Knoll M. 2021. Serology anno 2021—fungal infections: from invasive to chronic, vol 27, p 1230–1241.
Egger M, Penziner S, Dichtl K, Gornicec M, Kriegl L, Krause R, Khong E, Mehta S, Vargas M, Gianella S, Porrachia M, Jenks JD, Venkataraman I, Hoenigl M. Performance of the euroimmun aspergillus antigen ELISA for the diagnosis of invasive pulmonary aspergillosis in bronchoalveolar lavage fluid. J Clin Microbiol. 2022;60:e0021522.
doi: 10.1128/jcm.00215-22
pubmed: 35350844
Aerts R, Autier B, Gornicec M, Prattes J, Lagrou K, Gangneux JP, Hoenigl M. Point-of-care testing for viral-associated pulmonary aspergillosis. Expert Rev Mol Diagn. 2023. https://doi.org/10.1080/14737159.2023.2257597 .
doi: 10.1080/14737159.2023.2257597
pubmed: 37688631
Jenks JD, Prattes J, Frank J, Spiess B, Mehta SR, Boch T, Buchheidt D, Hoenigl M. Performance of the bronchoalveolar lavage fluid aspergillus galactomannan lateral flow assay with cube reader for diagnosis of invasive pulmonary aspergillosis: a multicenter cohort study. Clin Infect Dis. 2021;73:e1737–44.
doi: 10.1093/cid/ciaa1281
pubmed: 32866234
Autier B, Prattes J, White PL, Valerio M, Machado M, Price J, Egger M, Gangneux JP, Hoenigl M. Aspergillus lateral flow assay with digital reader for the diagnosis of COVID-19-associated pulmonary aspergillosis (CAPA): a multicenter study. J Clin Microbiol. 2022;60:e0168921.
doi: 10.1128/JCM.01689-21
pubmed: 34643415
Bassetti M, Giacobbe DR, Agvald-Ohman C, Akova M, Alastruey-Izquierdo A, Arikan-Akdagli S, Azoulay E, Blot S, Cornely OA, Cuenca-Estrella M, de Lange DW, De Rosa FG, De Waele JJ, Dimopoulos G, Garnacho-Montero J, Hoenigl M, Kanj SS, Koehler P, Kullberg BJ, Lamoth F, Lass-Flörl C, Maertens J, Martin-Loeches I, Muñoz P, Poulakou G, Rello J, Sanguinetti M, Taccone FS, Timsit JF, Torres A, Vazquez JA, Wauters J, Asperges E, Cortegiani A, Grecchi C, Karaiskos I, Le Bihan C, Mercier T, Mortensen KL, Peghin M, Rebuffi C, Tejada S, Vena A, Zuccaro V, Scudeller L, Calandra T. Invasive Fungal Diseases in Adult Patients in Intensive Care Unit (FUNDICU): 2024 consensus definitions from ESGCIP, EFISG, ESICM, ECMM, MSGERC, ISAC, and ISHAM. Intensive Care Med. 2024. https://doi.org/10.1007/s00134-024-07341-7 .
doi: 10.1007/s00134-024-07341-7
pubmed: 38980361
pmcid: 11164757
Anonymous. 2023. clarus ASPERGILLUS GM ENZYME IMMUNOASSAY.
Mercier T, Dunbar A, de Kort E, Schauwvlieghe A, Reynders M, Guldentops E, Blijlevens NMA, Vonk AG, Rijnders B, Verweij PE, Lagrou K, Maertens J. Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: a comparative multicenter study. Med Mycol. 2019. https://doi.org/10.1093/mmy/myz079:myz079 .
doi: 10.1093/mmy/myz079:myz079
pubmed: 31292663
Thornton CR. Development of an Immunochromatographic lateral-flow device for rapid serodiagnosis of invasive aspergillosis. Clin Vaccine Immunol. 2008;15:1095–105.
doi: 10.1128/CVI.00068-08
pubmed: 18463222
pmcid: 2446636
Driemeyer C, Falci DR, Oladele RO, Bongomin F, Ocansey BK, Govender NP, Hoenigl M, Gangneux JP, Lass-Flörl C, Cornely OA, Alanio A, Guinea J, Morrissey CO, Rautemaa-Richardson R, Chakrabarti A, Meis JF, Bruns C, Stemler J, Pasqualotto AC. The current state of clinical mycology in Africa: a European confederation of medical mycology and international society for human and animal mycology survey. Lancet Microbe. 2022;3:e464–70.
doi: 10.1016/S2666-5247(21)00190-7
pubmed: 35659908
Hoenigl M, Arastehfar A, Arendrup MC, Brüggemann R, Carvalho A, Chiller T, Chen S, Egger M, Feys S, Gangneux J-P, Gold JAW, Groll AH, Heylen J, Jenks JD, Krause R, Lagrou K, Lamoth F, Prattes J, Sedik S, Wauters J, Wiederhold NP, Thompson GR. Novel antifungals and treatment approaches to tackle resistance and improve outcomes of invasive fungal disease. Clin Microbiol Rev. 2024;37:e00074-e123.
doi: 10.1128/cmr.00074-23
pubmed: 38602408
Ergün M, Brüggemann RJM, Alanio A, Dellière S, Arkel A, Bentvelsen RG, Rijpstra T, Sar-van der Brugge S, Lagrou K, Janssen NAF, Buil JB, van Dijk K, Melchers WJG, Reijers MHE, Schouten JA, Wauters J, Cordey A, Soni S, White PL, van de Veerdonk FL, Verweij PE. Aspergillus test profiles and mortality in critically-ill COVID-19 patients. J Clin Microbiol. 2021. https://doi.org/10.1128/jcm.01229-21:Jcm0122921 .
doi: 10.1128/jcm.01229-21:Jcm0122921
pubmed: 34495710
pmcid: 8601217
Heng SC, Morrissey O, Chen SC, Thursky K, Manser RL, Nation RL, Kong DC, Slavin M. Utility of bronchoalveolar lavage fluid galactomannan alone or in combination with PCR for the diagnosis of invasive aspergillosis in adult hematology patients: a systematic review and meta-analysis. Crit Rev Microbiol. 2015;41:124–34.
doi: 10.3109/1040841X.2013.804033
pubmed: 23799871
Mercier T, Dunbar A, Veldhuizen V, Holtappels M, Schauwvlieghe A, Maertens J, Rijnders B, Wauters J. Point of care aspergillus testing in intensive care patients. Crit Care. 2020;24:642.
doi: 10.1186/s13054-020-03367-7
pubmed: 33168049
pmcid: 7652676
Jenks JD, Mehta SR, Taplitz R, Aslam S, Reed SL, Hoenigl M. Point-of-care diagnosis of invasive aspergillosis in non-neutropenic patients: aspergillus galactomannan lateral flow assay versus aspergillus-specific lateral flow device test in bronchoalveolar lavage. Mycoses. 2019;62:230–6.
doi: 10.1111/myc.12881
pubmed: 30565352
pmcid: 6380940
Boyer J, Sedik S, Egger M, Dichtl K, Prattes J, Kriegl L, Krause R, Prüller F, Hoenigl M. Performance of the clarus Aspergillus galactomannan enzyme immunoassay prototype for the diagnosis of invasive pulmonary aspergillosis in serum. Mycoses. 2024;67:e13756.
doi: 10.1111/myc.13756
pubmed: 38886163