6100 Aspergillus fumigatus

#ASPE-096 FungaDia-Aspergillus Antigen ELISA
ELISA kit for the diagnosis of human invasive aspergillosis

Aspergillus fumigatus is one of the most ubiquitous of the airborne saprophytic fungi. Humans and animals constantly inhale numerous conidia of this fungus. It is responsible from Invasive Aspergillosis (IA) occuring mainly in neutropenic patients (anticancer treatment), in patients treated with immunosuppressants and corticosteroids (following bone marrow transplantation) and in patients hospitalized in intensive care for severe respiratory disease (influenza, COVID-19). Due to the lack of typical clinical manifestations The detection of galactomannan in serum or BAL is the recommended diagnostic method.

Test-Kit

96 determinations of Aspergillus galactomannan antigen in adult and pediatric serum samples and bronchoalveolar lavage (BAL) fluid samples using standard methodologies.

Wells sensitized with mouse monoclonal antibody against galactomanann antigens from Aspergillus fumigatus.

8-wells polystyrene breakable strips: useful and economic format for laboratories with a small workload.

CE registration: CH-202202-0039

Sensitivity and specificity

A sensitivity of 98% was found with 50 sera positive with the Aspergillus Ag ELISA Assay Platelia (BioRad).

A sensitivity of 100% was found with 5 BAL positive with the Aspergillus Ag ELISA Assay Platelia (BioRad).

A specificity of 99% was found with 153 sera negative with the Aspergillus Ag ELISA Assay Platelia (BioRad).

A specificity of 100% was found with 28 BAL negative with the Aspergillus Ag ELISA Assay Platelia (BioRad).

Contents

1x R1 : ELISA Microplate (12x8 microwell plate coated with anti-galactomanann antibody)

1x25ml R2 : Concentrated washing solution (20x, PBST buffer)

1x2ml R3 : Negative control (PBST buffer)

1x2ml R4 : Cut-off control (PBST buffer, galactomanann)

1x2ml R5 : Positive control (PBST buffer, galactomanann)

1x7ml R6 : Antibody conjugated with HRP (anti-galactomanann antibody conjugated with HRP)

1x12ml R7 : Sample Treatment Solution (EDTA solution)

1x25ml R8 : Chromogen TMB Solution (Tetramethyl benzidine (TMB))

1x12ml R9 : Stop Solution (H₂SO₄)

5x M1 : Plate Sealer (Microwell plate adhesive film)

1x IFU : Instruction For Use

Ordering information

#ASPE-096 FungaDia-Aspergillus Antigen ELISA (96 assays)

References

D'Haese et al. Detection of galactomannan in bronchoalveolar lavage fluid samples of patients at risk for invasive pulmonary aspergillosis: analytical and clinical validity. Journal of clinical microbiology, 50,4 (2012)

Pfeiffer et al. Diagnosis of Invasive Aspergillosis Using a Galactomannan Assay: A Meta-Analysis, Clinical Infectious Diseases, 42(10) (2006)

Sehgal al. Utility of Serum and Bronchoalveolar Lavage Fluid Galactomannan in Diagnosis of Chronic Pulmonary Aspergillosis. Journal of clinical microbiology, 57,3 (2019)

Ullmann et al. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline, Clin Microbiol Infect. 24 (2018)

Mercier et al. Point of care aspergillus testing in intensive care patients. Crit Care 24, 642 (2020)

Jenks et al. Invasive aspergillosis in critically ill patients: Review of definitions and diagnostic approaches, Mycoses. 64(9):1002-1014 (2021)

Fekkar et al. Occurrence of Invasive Pulmonary Fungal Infections in Patients with Severe COVID-19 Admitted to the ICU, Am J Respir Crit Care Med. 203(3):307-317 (2021)

Ducrest et al. Performance evaluation of the new FungaDia ELISA kit for the detection of Aspergillus Galactomannan, SFMM, Rouen, France (2022)

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Phone: + 41 21 633 31 67. Fax: + 41 21 633 31 78. Email: cb(at)bordier.ch