#ASP-025 FungaDia-Aspergillus Antigen Rapid Test
Rapid
test kit for the diagnosis of human invasive aspergillosis
Parasitology
and clinical relevance
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 25 determinations of Aspergillus galactomannan antigen in serum and bronchoalveolar lavage (BAL) fluid from patients suspected of Fungal infections using standard methodologies. The antigens in the sample react
with the red-colored nanoparticles and form a complex which is captured by
the anti-Aspergillus antibodies present on the membrane (Test line)
forming a red line. |
Sensitivity and specificity A
sensitivity of 78% was found with 49 sera positive with the
Aspergillus Ag ELISA Assay Platelia (BioRad). A
sensitivity of 100% was found with 2 BAL positive with the
Aspergillus Ag ELISA Assay Platelia (BioRad). A
specificity of 96% was found with 28 BAL negative with
the Aspergillus Ag ELISA Assay Platelia (BioRad). |
|
Contents 1x1ml Positive Control (50ng/ml galactomanann) 1x1ml Negative Control 1x3ml Sample treatment solution 1x Instruction for use
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Ordering
information
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References
Reischies F, Hoenigl M. The role of surgical debridement in different clinical manifestations of invasive aspergillosis. Mycoses 2014; 57 (Suppl 2):1–14. Eigl S. et al. Influence of mould-active antifungal treatment on the performance of the Aspergillus-specific bronchoalveolar lavage fluid lateral-flow device test. Int J Antimicrob Agents. 2015; 46(4):401–5. White PL. et al. Evaluation of real-time PCR, galactomannan enzyme-linked immunosorbent assay (ELISA), and a novel lateral-flow device for diagnosis of invasive aspergillosis. J Clin Microbiol. 2013; 51(5):1510–6. Hoenigl M. et al. Performance of galactomannan, beta-D-glucan, Aspergillus lateral-flow device, conventional culture, and PCR tests with bronchoalveolar lavage fluid for diagnosis of invasive pulmonary aspergillosis. J Clin Microbiol. 2014; 52(6):2039–45. Held J. et al. Comparison of a novel Aspergillus lateral-flow device and the Platelia galactomannan assay for the diagnosis of invasive aspergillosis following hematopoietic stem cell transplantation. Infection. 2013; 41(6):1163–9. Johnson GL. et al.
Aspergillus-specific lateral-flow device and real-time PCR testing of
bronchoalveolar lavage fluid: a combination biomarker approach for
clinical diagnosis of invasive pulmonary aspergillosis. J Clin Microbiol.
2015; 53(7):2103–8. |
European directive 98/79/EC registration
Poster presentation SFMM congress 2023
Instructions For Use: Eng - Fra
Material Safety Data Sheet: Eng - Fra
Bordier Affinity Products SA, Chatanerie 2,
Bâtiment Biokema,
CH-1023 Crissier, Switzerland
Phone: + 41 21 633 31 67. Fax: + 41 21
633
31 78. Email: cb(at)bordier.ch