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Detection of Invasive Pulmonary Aspergillosis in Haematological Malignancy Patients by using Lateral-flow Technology
Published on: March 22, 2012
Aspergillus Lateral Flow Assay with Digital Reader for the Diagnosis of COVID-19-Associated Pulmonary Aspergillosis
Brice Autier1, Juergen Prattes2, P Lewis White3
1Université de Rennes, CHU Rennes, INSERM, EHESP, Irset (Institut de recherche en santé, environnement et travail), Rennes, France.
Abstract:
This multicenter study evaluated the IMMY Aspergillus Galactomannan Lateral Flow Assay (LFA) with automated reader for diagnosis of pulmonary aspergillosis in patients with COVID-19-associated acute respiratory failure (ARF) requiring intensive care unit (ICU) admission between 03/2020 and 04/2021. A total of 196 respiratory samples and 148 serum samples (n = 344) from 238 patients were retrospectively included, with a maximum of one of each sample type per patient. Cases were retrospectively classified for COVID-19-associated pulmonary aspergillosis (CAPA) status following the 2020 consensus criteria, with the exclusion of LFA results as a mycological criterion. At the 1.0 cutoff, sensitivity of LFA for CAPA (proven/probable/possible) was 52%, 80% and 81%, and specificity was 98%, 88% and 67%, for bronchoalveolar lavage fluid (BALF), nondirected bronchoalveolar lavage (NBL), and tracheal aspiration (TA), respectively. At the 0.5 manufacturer's cutoff, sensitivity was 72%, 90% and 100%, and specificity was 79%, 83% and 44%, for BALF, NBL and TA, respectively. When combining all respiratory samples, the receiver operating characteristic (ROC) area under the curve (AUC) was 0.823, versus 0.754, 0.890 and 0.814 for BALF, NBL and TA, respectively. Sensitivity and specificity of serum LFA were 20% and 93%, respectively, at the 0.5 ODI cutoff. Overall, the Aspergillus Galactomannan LFA showed good performances for CAPA diagnosis, when used from respiratory samples at the 1.0 cutoff, while sensitivity from serum was limited, linked to weak invasiveness during CAPA. As some false-positive results can occur, isolated results slightly above the recommended cutoff should lead to further mycological investigations.
Insights
The Aspergillus Galactomannan Lateral Flow Assay (LFA) shows good performance for diagnosing pulmonary aspergillosis in COVID-19 patients using respiratory samples. However, serum LFA sensitivity was limited, suggesting further investigation for positive results.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Critical Care Medicine
Background:
- Pulmonary aspergillosis is a severe complication in critically ill COVID-19 patients.
- Accurate and rapid diagnosis is crucial for effective treatment.
- The Aspergillus Galactomannan Lateral Flow Assay (LFA) offers a potential diagnostic tool.
Purpose of the Study:
- To evaluate the diagnostic performance of the IMMY Aspergillus Galactomannan LFA for pulmonary aspergillosis in COVID-19 patients with acute respiratory failure.
- To compare the assay's accuracy using respiratory samples (BALF, NBL, TA) and serum samples.
- To assess the assay's utility in intensive care unit (ICU) settings.
Main Methods:
- A multicenter retrospective study included 238 patients with COVID-19-associated acute respiratory failure.
- 196 respiratory samples and 148 serum samples were tested using the Aspergillus Galactomannan LFA.
- COVID-19-associated pulmonary aspergillosis (CAPA) status was determined using 2020 consensus criteria, excluding LFA results.
Main Results:
- Respiratory LFA demonstrated good performance, with sensitivity ranging from 52% to 81% and specificity from 67% to 98% at the 1.0 cutoff, depending on sample type.
- At the 0.5 cutoff, sensitivity increased (72%-100%) but specificity decreased (44%-83%) for respiratory samples.
- Serum LFA showed limited sensitivity (20%) but high specificity (93%) at the 0.5 cutoff.
Conclusions:
- The Aspergillus Galactomannan LFA is a valuable tool for diagnosing CAPA when using respiratory samples, particularly at the 1.0 cutoff.
- Serum LFA performance was suboptimal, likely due to low fungal burden or invasiveness in CAPA.
- Positive LFA results, especially those near the cutoff, warrant further mycological investigation to confirm diagnosis.
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