sōna

ASPERGILLUS GM

LATERAL FLOW ASSAY

It's About

TIME

Over 30 million people are at risk of invasive aspergillosis each year due to use of corticosteroids, chemotherapy or other immunosuppressive agents, and over 300,000 patients develop it annually. 1

Timely diagnosis and initiation of therapy strongly influence outcome. IMMY’s lateral flow assay can detect Aspergillus biomarkers in under an hour.

1) Invasive Aspergillosis. Leading International Fungal Education. https://www.life-worldwide.org/fungal-diseases/invasive-aspergillosis

: Serum & BAL
Results in just

45 MINUTES

Accuracy
Highly

SENSITIVE & SPECIFIC

Test

MORE OFTEN

Clinical Relevancy2,3

Asp LFA Publication Findings

The clinical performance of the IMMY sona Aspergillus Lateral Flow Assay in serum samples from cases classified as proven/probable/chronic IA/IFD (n=32) using EORTC/MSG criteria and control patients with no evidence of IFD (n=100).

Sensitivity Specificity PPV NPV
97% 98% 94% 99%
2) Lewis W., et al. An evaluation of the performance of the IMMY sōna Aspergillus GM LFA when testing serum to aid in the diagnosis of IA. J Clin Micro. 2020; 00053-20.

In serum samples, the AGM LFA will correctly generate a positive result for 97% of patients with IA, and a negative result for 98% of patients without IA. The PPV shows that among patients with a positive AGM LFA result, the probability that they truly have IA is 94%. NPV shows that among patients with a negative AGM LFA result, the probability that they do not have IA is 99%. 2

Asp LFA Publication Findings

The diagnostic performance of the IMMY sona Aspergillus Lateral Flow Assay in BAL samples from hematology patients classified as proven IPA (n=11) using EORTC/MSG criteria and control patients with no evidence of IPA (n=117).

Sensitivity Specificity NPV
91% 92% 99%
3) Mercier T, et al. Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: A comparative multicenter study. Med Mycol. 2019.

In BAL samples, the AGM LFA will correctly generate a positive result for 91% of patients with IA, and a negative result for 92% of patients without IA. The NPV shows that among patients with a negative AGM LFA result, the probability that they do not have IA is 99%. 3

Procedure
Bronchoalveolar lavage Aspergillus Galactomannan lateral flow assay versus Aspergillus-specific lateral flow device test for diagnosis of invasive pulmonary Aspergillosis in patients with hematological malignancies
Jenks JD, Mehta SR, Taplitz R, Law N, Reed SL, Hoenigl M. Bronchoalveolar lavage Aspergillus Galactomannan lateral flow assay versus Aspergillus-specific lateral flow device test for diagnosis of invasive pulmonary Aspergillosis in patients with hematological malignancies. J Infect. 2019 Mar;78(3):249-259.
Respiratory specimens and the diagnostic accuracy of Aspergillus lateral flow assays (LFA-IMMY™): real-life data from a multicentre study.
Lass-Flörl C, Lo Cascio G, Nucci M, Camargo Dos Santos M, Colombo AL, Vossen M, Willinger B. Respiratory specimens and the diagnostic accuracy of Aspergillus lateral flow assays (LFA-IMMY™): real-life data from a multicentre study. Clin Microbiol Infect. 2019 Dec;25(12):1563.e1-1563.e3.
Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: A comparative multicenter study
Mercier T, Dunbar A, de Kort E, et al. Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: A comparative multicenter study. Med Mycol. 2020;58(4):444-452.
The Aspergillus Lateral Flow Assay for the diagnosis of Invasive Aspergillosis: an Update
Jenks JD, Miceli MH, Prattes J, Mercier T, Hoenigl M. The Aspergillus Lateral Flow Assay for the Diagnosis of Invasive Aspergillosis: an Update [published online ahead of print, 2020 Dec 4]. Curr Fungal Infect Rep. 2020;1-6.
Evaluation of the Performance of the IMMY sōna Aspergillus Galactomannan Lateral Flow Assay When Testing Serum to Aid in Diagnosis of Invasive Aspergillosis
White PL, Price JS, Posso R, Cutlan-Vaughan M, Vale L, Backx M. Evaluation of the Performance of the IMMY sona Aspergillus Galactomannan Lateral Flow Assay When Testing Serum to Aid in Diagnosis of Invasive Aspergillosis. J Clin Microbiol. 2020;58(6):e00053-20.
Accuracy of galactomannan testing on tracheal aspirates in COVID-19-associated pulmonary aspergillosis
Roman-Montes ACM, Martinez-Gamboa A, Diaz-Lomelí P, et al. Accuracy of galactomannan testing on tracheal aspirates in COVID-19-associated pulmonary aspergillosis [published online ahead of print, 2020 Nov 20]. Mycoses. 2020;10.1111/myc.13216.
Aspergillus Galactomannan LFA 50 tests AF2003