El diagnóstico rápido de aspergilosis pulmonar invasiva (IPA) es esencial, ya que el tratamiento adecuado temprano mejora la supervivencia. Sin embargo, los métodos microbiológicos actuales adolecen de una baja sensibilidad o un largo tiempo de respuesta, a menudo como resultado del procesamiento por lotes. Recientemente, se han comercializado y marcado con la CE dos ensayos de flujo lateral para diagnosticar IPA. Estos ensayos se pueden utilizar para pruebas rápidas de una sola muestra. Por lo tanto, buscamos evaluar y comparar estos ensayos en pacientes adultos con hematología. Probamos retrospectivamente 235

Muestras de líquido de lavado broncoalveolar (BALf) de pacientes adultos con hematología de cuatro centros utilizando el AspLFD (OLM

Diagnostics) y el Sōna Aspergillus galactomannan LFA (IMMY).

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ASPERGILLUS GM

LATERAL FLOW ASSAY

REF: AF2003

: Serum, BAL

This document contains brief descriptions of the papers and posters related to the Aspergillus Galactomannan Lateral Flow Assay.

PUBLICATIONS

An evaluation of the performance of IMMY sōna Aspergillus Galactomannan Lateral Flow Assay when testing serum to aid in the diagnosis of invasive aspergillosis

White L, et al. An evaluation of the performance of IMMY sōna Aspergillus Galactomannan Lateral Flow Assay when testing serum to aid in the diagnosis of invasive aspergillosis. J Clin Microbio. 2020.

Key Takeaways

This study retrospectively evaluated the performance of IMMY’s sōna Aspergillus Galactomannan (GM) Lateral Flow Assay   (LFA) by testing 179 serum samples from a large cohort of patients at-risk for invasive aspergillosis (IA). Patients were categorized using the 2019 EORTC/MSG criteria. The sōna Aspergillus LFA was compared to Bio-Rad’s Platelia GM Enzyme Immunoassay (EIA) by using IMMY’s digital cube reader to obtain index values.

The sōna Aspergillus LFA had a sensitivity of 97% (95%CI: 94, 99.5) and a specificity of 98% (95% CI: 93, 99.5). The assay could

be confidently used to both confirm (positive likelihood ratio: 48.44) and exclude (negative likelihood ratio: 0.03) a diagnosis of IA. Overall, the qualitative observed agreement between the LFA and GM-EIA was 89% (95% CI: 84, 93). This study found the LFA performance to be excellent, with an ROC analysis confirming the optimal GMI threshold to be 0.5. When used with the cube reader, the sōna Aspergillus LFA provides an alternative to the well-established GM-EIA, particularly for use in resource-limited settings.

Sensitivity	Specificity	NPV	PPV
97%	98%	94%	99%

Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: A comparative multicenter study

Toine Mercier, Albert Dunbar, Elizabeth de Kort, Alexander Schauwvlieghe, Marijke Reynders, Ellen Guldentops, Nicole MA Blijlevens, Alieke G Vonk, Bart Rijnders, Paul E Verweij, Katrien Lagrou, Johan Maertens

Published: Med Mycol. 2019 Jul 9.

Key Takeaways: 

Fast diagnosis of invasive pulmonary aspergillosis (IPA) is essential as early adequate therapy improves survival. However, current

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microbiological methods suffer from a low sensitivity or a long turnaround time, often as a result of batching. Recently, two lateral flow assays for diagnosing IPA have been CE-marked and commercialized. These assays can be used for fast single sample testing. We therefore sought to evaluate and compare these assays in adult hematology patients. We retrospectively tested 235

bronchoalveolar lavage fluid (BALf) samples of adult hematology patients from four centers using the AspLFD (OLM

Diagnostics) and the sōna Aspergillus galactomannan LFA (IMMY). Both tests were read out independently by two researchers and by a digital reader. We included 11 patients with proven IPA, 64 with probable IPA, 43 with possible fungal disease, and 117 controls with

no signs of IPA. In cases of proven IPA, the performance of both assays was similar. In cases of proven and probable IPA, we found an identical specificity for both assays, but a higher sensitivity (0.83 vs 0.69, P = .008) and a better negative

predictive value (0.89 vs 0.82, P = .009) for the LFA. Digital readout improved the diagnostic performance of both tests.

In conclusion, both assays showed a good performance for the diagnosis of IPA in BALf from adult hematology patients. Results were further improved by using a digital reader, especially for weakly positive results.

		Sensitivity	Specificity	Negative Predictive Value
Proven IPA (n=11) vs Controls (n=117)	IMMY LFA	91%	87%	99%
LFD	82%	87%	98%

Prospective evaluation of the turbidimetric B-D-glucan Assay and Two Lateral Flow Assays on Serum in Invasive Aspergillosis.

Mercier T, et al. Prospective evaluation of the turbidimetric BDG assay and two lateral flow assays on serum in IA. Clin Infect Dis. 2020.

Key Takeaways

This study prospectively evaluated the performance of IMMY’s sōna Aspergillus Galactomannan (GM) Lateral Flow Assay (LFA) by testing 229 serum samples from adults with underlying hematological disorders at-risk for developing IA. The sōna

Aspergillus LFA was compared to the OLM Diagnostics LFD, FUJIFILM’s BDG Assay, and Bio-Rad’s Platelia GM Enzyme Immunoassay (EIA) by using IMMY’s digital cube reader to obtain index values. Using 41 proven or probable IA

cases, the LFA was found to be as sensitive as the GM-EIA. The highest NPV was obtained in patients that had a negative BDG combined with either a negative LFA or GM-EIA result. When excluding serum GM from the EORTC classification criteria, the LFA was found to statistically outperform both the LFD and serum GM. The LFA is a fast and effective alternativ to serum galactomannan detection for the diagnosis of IA and is especially useful for centers with low sample throughputs.

Respiratory specimens and the diagnostic accuracy of Aspergillus lateral flow assays (LFA-IMMY™): real-life data from a multicentre study

C. Lass-Flörl, G. Lo Cascio, M. Nucci, M. Camargo dos Santos, A. Lopes Colombo, M. Vossen, B. Willinger Published: Clin Microbiol Infect. 2019 Aug 22.

Key Takeaways

Proper diagnosis of invasive aspergillosis is challenging because conventional methods lack sensitivity and are complicated by time-con- suming incubation processes. To meet the requirement for early diagnosis the new Aspergillus-specific point-of-care test LFA-IMMY™ was evaluated with respect to the ability to accurately detect Aspergillus in bronchoalveolar fluids and sputa, and to clarify the potential of cross-reactivity with other fungal pathogens.

Respiratory specimens (n = 398) from non-selected patients (n = 390) underwent either fungal microscopy, culture or both before

Aspergillus lateral flow assay testing.

For Aspergillus culture- and microscopy-positive samples, sensitivity (48/52) and specificity (44/48) were 92% and 91%, respectively.

IMMY LFA is a reliable diagnostic tool for the detection of Aspergillus in respiratory samples. Based on evidence-based microbiological data, we observed a diagnostic accuracy of 92% (92/100) for the IMMY LFA, suggesting its usefulness in the clinical setting.

PERFORMANCE BASED ON RESPIRATORY SAMPLES WITH CULTURE AND MICROSCOPY PROVEN

ASPERGILLUS  SPECIES

Sensitivity	Specificity	NPV
92%	91%	91%

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

Jeffrey D. Jenks MD, MPH , Sanjay R. Mehta MD, ABMM, Randy Taplitz MD , Nancy Law MD , Sharon L. Reed MD, ABMM , Martin Hoenigl MD, FECMM

Published: J Infect. 2019 Mar

Key Takeaways: 

Early diagnosis and treatment of IPA remains the most important factor to reduce mortality and improve outcome. As an important limitation, GM testing is limited in particular by varying turnaround times (3 days or more in some centers), dependent on the number of specimens to be tested and the distance/duration of transport between the clinical setting and the laboratory where the test is performed. [The IMMY Aspergillus GM LFA] may overcome the limitation of long turnaround time by conventional galactomannan ELISA testing and may further facilitate point-of-care diagnosis of IPA. The objective of this study was to evaluate the new Aspergillus Galactomannan Lateral Flow Assay (LFA) and compare its performance against the Aspergillus specific LFD and other biomarkers for the diagnosis of IPA in patients with hematological malignancies.

A total of 24 BALF samples obtained from 24 patients with underlying hematological malignancies were included in this analysis. IPA was classified according to the revised EORTC/MSG criteria with one modification: exclusion of beta-d-Glucan as mycological criterion. A total of 10/24 (42%) of patients were receiving mold-active antifungal prophylaxis/therapy at the time of the BALF procedure.

We found that both tests were highly sensitive and specific for diagnosing IPA in patients with hematological malignancies. Given the importance of early and reliable diagnosis of IPA for targeted and successful treatment, rapid tests allowing for point-of-care diagnosis of IPA are an extremely attractive tool.

Assessment of a Lateral Flow Assay for Detection of Aspergillus Galactomannan in Serum and Bronchoalveolar Lavage Samples

L. Misner, T. Gniadek, E.S. Theel

Poster presented at ASM Microbe 2019 Key Takeaways:

Prompt diagnosis and initiation of therapy strongly influence outcome. The Platelia™ Aspergillus Ag EIA (Bio-Rad Laboratories) is FDA-cleared for detection of Aspergillus galactomannan (GM) in bronchoalveolar lavage (BAL) and serum specimens, however issues with reproducibility, false positive and false negative results have been reported. Recently, a lateral flow assay (LFA) for detection of Aspergillus GM was developed by IMMY. Here, we compared the performance of the IMMY LFA assay with the Bio-Rad EIA using residual serum and/or BAL clinical samples from patients at risk for invasive aspergillosis (IA).

Residual serum and BAL samples were prospectively collected from 83 patients for which the Bio-Rad EIA assay on serum and/or BAL was ordered as part of routine clinical care. Paired BAL/serum samples were available for 67 patients. All samples were tested by the Bio-Rad EIA and IMMY LFA assays concurrently and the results compared. Clinical records were reviewed and patients were categorized with proven, probable, possible or no IA or invasive fungal infection (IFI) according to the 2008 EORTC/MSG criteria. Both assay results were also compared to IFI categorization.

Compared to the Bio-Rad EIA, the IMMY LFA showed 100% and 95.5% overall agreement in serum and BAL samples, respectively, in patients with suspected IFI. The recently developed Aspergillus GM LFA assay showed similar sensitivity for detection of IA and possibly higher specificity among non-IA IFIs as compared to the Platelia Aspergillus GM EIA.

	Bio-Rad EIA	IMMY LFA
Method	EIA	LFA
Test Time	180 mins.	45 mins.
Antigen Detected	Aspergillus GM	Aspergillus GM
Detection Antibody	1 mAb	2 mAbs
Repeat Testing?	Yes	No

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