scholarly journals Aspergillus Lateral Flow Assay with Digital Reader for the Diagnosis of COVID-19 Associated Pulmonary Aspergillosis (CAPA): A multicenter study

2021 ◽  
Author(s):  
Brice Autier ◽  
Juergen Prattes ◽  
P. Lewis White ◽  
Maricela Valerio ◽  
Marina Machado ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Multicenter Study ◽  
Area Under The Curve ◽  
Lavage Fluid ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Sample Type ◽  
Serum Samples ◽  
Pulmonary Aspergillosis ◽  
Roc Area

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), non-directed 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.

scholarly journals Performance of the Bronchoalveolar Lavage Fluid Aspergillus Galactomannan Lateral Flow Assay With Cube Reader for Diagnosis of Invasive Pulmonary Aspergillosis: A Multicenter Cohort Study

2020 ◽  
Author(s):  
Jeffrey D Jenks ◽  
Juergen Prattes ◽  
Johanna Frank ◽  
Birgit Spiess ◽  
Sanjay R Mehta ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Multicenter Study ◽  
Diagnostic Performance ◽  
Bronchoalveolar Lavage Fluid ◽  
Invasive Pulmonary Aspergillosis ◽  
Rapid Test ◽  
Lavage Fluid ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
University Hospital

Abstract Background The Aspergillus Galactomannan Lateral Flow Assay (LFA) is a rapid test for the diagnosis of invasive aspergillosis (IA) that has been almost exclusively evaluated in patients with hematologic malignancies. An automated digital cube reader that allows for quantification of results has recently been added to the test kits. Methods We performed a retrospective multicenter study on bronchoalveolar lavage fluid (BALF) samples obtained from 296 patients with various underlying diseases (65% without underlying hematological malignancy) who had BALF galactomannan (GM) ordered between 2013 and 2019 at the University of California, San Diego, the Medical University of Graz, Austria, and the Mannheim University Hospital, Germany. Results Cases were classified as proven (n = 2), probable (n = 56), putative (n = 30), possible (n = 45), and no IA (n = 162). The LFA showed an area under the curve (AUC) of 0.865 (95% confidence interval [CI] .815–.916) for differentiating proven/probable or putative IA versus no IA, with a sensitivity of 74% and a specificity of 83% at an optical density index cutoff of 1.5. After exclusion of GM as mycological criterion for case classification, diagnostic performance of the LFA was highly similar to GM testing (AUC 0.892 vs 0.893, respectively). LFA performance was consistent across different patient cohorts and centers. Conclusions In this multicenter study the LFA assay from BALF demonstrated good diagnostic performance for IA that was consistent across patient cohorts and locations. The LFA may serve a role as a rapid test that may replace conventional GM testing in settings where GM results are not rapidly available.

scholarly journals Performance of Aspergillus Galactomannan Lateral Flow Assay on Bronchoalveolar Lavage Fluid for the Diagnosis of Invasive Pulmonary Aspergillosis

2020 ◽  
Vol 6 (4) ◽  
pp. 297
Author(s):  
Kathleen A. Linder ◽  
Carol A. Kauffman ◽  
Marisa H. Miceli
Keyword(s):  
Bronchoalveolar Lavage ◽  
Predictive Value ◽  
Bronchoalveolar Lavage Fluid ◽  
Invasive Pulmonary Aspergillosis ◽  
Lavage Fluid ◽  
Underlying Disease ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Pulmonary Aspergillosis ◽  
Optical Density Index

Background: Several newly developed biomarker tests for invasive pulmonary aspergillosis (IPA) have been developed, including the IMMY Aspergillus galactomannan lateral flow assay (Aspergillus GM-LFA) evaluated in this study. Methods: Twenty patients with proven/probable IPA (EORTC/MSGERC criteria) were matched by age and underlying disease with 20 patients without IPA. Bronchoalveolar lavage fluid (BALF) was analyzed in duplicate using the Aspergillus GM-LFA. Results were read visually by two blinded observers, and the optical density index (ODI) was obtained digitally with a cube reader. Results: Using a cutoff of ≥0.5 ODI, the Aspergillus GM-LFA had a sensitivity of 40%, specificity of 80%, positive predictive value (PPV) of 67% and negative predictive value (NPV) of 57%. When the cutoff was increased to ≥1.0 ODI, sensitivity remained at 40%, specificity rose to 95%, PPV was 89%, and NPV was 61%. Excellent agreement was found when duplicate samples were read either visually (κ = 1) or with the cube reader (κ = 0.89). Correlation of results obtained by visual inspection and those obtained using the cube reader was excellent (κ = 0.82). Conclusion: The Aspergillus GM-LFA had poor sensitivity but excellent specificity for proven/probable IPA in BALF. The assay was easy to interpret, and there was high concordance between results obtained visually and with a cube reader.

scholarly journals Evaluation of Aspergillus-Specific Lateral-Flow Device Test Using Serum and Bronchoalveolar Lavage Fluid for Diagnosis of Chronic Pulmonary Aspergillosis

2019 ◽  
Vol 57 (5) ◽  
Author(s):  
Takahiro Takazono ◽  
Yuya Ito ◽  
Masato Tashiro ◽  
Keitaro Nishimura ◽  
Tomomi Saijo ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Bronchoalveolar Lavage Fluid ◽  
Point Of Care ◽  
Invasive Pulmonary Aspergillosis ◽  
Antibody Test ◽  
Lavage Fluid ◽  
Serum Samples ◽  
Pulmonary Aspergillosis ◽  
Flow Device ◽  
Chronic Pulmonary Aspergillosis

ABSTRACT The Aspergillus-specific lateral-flow device (AspLFD) test is a newly developed point-of-care diagnostic method for invasive pulmonary aspergillosis. However, evidence of the diagnostic performance of the AspLFD for chronic pulmonary aspergillosis (CPA) is limited. Therefore, we conducted a retrospective study to investigate this in comparison with the galactomannan (GM) β-d-glucan (BDG) test. Fifty patients with chronic pulmonary aspergillosis and 65 patients with respiratory disease, as a control, were enrolled in this study. The majority of the CPA disease entities were chronic pulmonary aspergillosis (64.0%, n = 32), followed by subacute invasive pulmonary aspergillosis (IPA) (20.0%, n = 10) and simple pulmonary aspergilloma (SPA) (16.0%, n = 8). The sensitivity and specificity of the AspLFD test in serum samples were 62.0% and 67.7%, respectively. The GM test (cutoff index, 1.54) showed a sensitivity of 22% and a specificity of 92.3%, while the sensitivity and specificity of the BDG test (cutoff, 19.3 pg/ml) were 48% and 90.8%, respectively. In bronchoalveolar lavage fluid samples, the AspLFD test showed a sensitivity of 66.7% and a specificity of 69.2%, while those of the GM test (cutoff index, 0.6) were 72.7% and 83.1%, respectively. The Aspergillus precipitating antibody test had 70% sensitivity. Unlike the Aspergillus precipitating antibody test, the AspLFD on serum samples showed similar sensitivity to non-fumigatus Aspergillus species. Patients with false-positive results for the AspLFD on serum samples were of a significantly higher age and had a higher prevalence of cavitary lesions in chest computed tomography than patients with negative results in the control group. Given the results in this study, the performance of the AspLFD using serum was acceptable as a point-of-care test for the diagnosis of CPA.

scholarly journals 257. Aspergillus Galactomannan Lateral Flow Assay for Rapid Diagnosis of Invasive Aspergillosis in Bronchoalveolar Lavage

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S143-S143
Author(s):  
Martin Hoenigl ◽  
Sharon L Reed ◽  
Sanjay R Mehta ◽  
Nancy Law ◽  
Saima Aslam ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Hematological Malignancies ◽  
Invasive Pulmonary Aspergillosis ◽  
Rapid Test ◽  
Lavage Fluid ◽  
Rapid Diagnosis ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Lower Specificity ◽  
Neutropenic Patients

Abstract Background Early diagnosis and treatment of invasive pulmonary aspergillosis (IPA) remain the most important factor to reduce mortality. Diagnosis remains a challenge, however, due to unspecific clinical presentation and radiological findings. Only very recently rapid tests for IPA have been developed. The objective of this study was to evaluate the performance of the new CE-marked Aspergillus Galactomannan Lateral Flow Assay (LFA; IMMY, Oklahoma, USA; figure) for IPA in patients with and without hematological malignancies. Methods The Aspergillus Galactomannan LFA was retrospectively performed according to the manufacturer’s instructions in 106 previously frozen bronchoalveolar lavage fluid (BAL) samples from 106 patients at risk for IPA (23% with underlying hematological malignancies). Samples were collected between September 2016 and September 2018 at the University of California, San Diego. Performance of the LFA was compared with Galactomannan, BAL culture and the Aspergillus-specific LFD (another rapid test for IPA). IPA was classified according to revised EORTC/MSG criteria. Results Overall, 22 patients met criteria of probable or proven IPA, 9 possible IPA, while 75 patients did not fulfill criteria of IPA. Sensitivity of the Apergilllus Galactomanann LFA for probable/proven IPA was 77% (17/22). Sensitivity was similar to BAL GM (77% with a cutoff of 1.0 ODI), but higher compared with the Aspergillus-specific LFD (59%), and BAL culture (23%). The LFA resulted negative in 7/9 cases with possible IPA and 47/73 cases without IPA (overall specificity 66%, 54/82). The less than perfect specificity was driven particularly by non-neutropenic patients (specificity 62%, 43/69), while specificity was 85% among patients with underlying hematological malignancies. Lower specificity among non-neutropenic patients was also observed for the BAL GM (overall 77%, non-neutropenic patients 72%), the Aspergillus-specific LFD (overall 70%, non-neutropenic patients 67%) and BAL culture (overall 90%, non-neutropenic 88%). Conclusion Our study indicates that the LFA may be useful for rapid diagnosis of IPA in BALF when IPA is clinically suspected. The lower specificity in non-neutropenic patients may be explained by limited applicability of the EORTC/MSG criteria in those patients. Disclosures All authors: No reported disclosures.

scholarly journals Diagnostic Value of Galactomannan Antigen Test in Serum and Bronchoalveolar Lavage Fluid Samples from Patients with Nonneutropenic Invasive Pulmonary Aspergillosis

2017 ◽  
Vol 55 (7) ◽  
pp. 2153-2161 ◽  
Author(s):  
Wei Zhou ◽  
Hongxing Li ◽  
Yan Zhang ◽  
Mei Huang ◽  
Qian He ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Bronchoalveolar Lavage Fluid ◽  
Invasive Pulmonary Aspergillosis ◽  
Lavage Fluid ◽  
Diagnostic Value ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Pulmonary Aspergillosis ◽  
Cutoff Value ◽  
Gm Detection

ABSTRACT The objective of this study was to compare the diagnostic value of galactomannan (GM) detection in bronchoalveolar lavage fluid (BALF) and serum samples from nonneutropenic patients with invasive pulmonary aspergillosis (IPA) and determine the optimal BALF GM cutoff value for pulmonary aspergillosis. GM detection in BALF and serum samples was performed by enzyme-linked immunosorbent assay (ELISA) in 128 patients with clinically suspected nonneutropenic pulmonary aspergillosis between June 2014 and June 2016. On the basis of the clinical and pathological diagnoses, 8 patients were excluded because their diagnosis was uncertain. The remaining 120 patients were diagnosed with either IPA ( n = 37), community-acquired pneumonia (CAP; n = 59), noninfectious diseases ( n = 19), or tuberculosis ( n = 5). At a cutoff optical density index (ODI) value of ≥0.5, the sensitivity of BALF GM detection was much higher than that of serum GM detection (75.68% versus 37.84%; P = 0.001), but there was no significant difference between their specificities (80.72% versus 87.14%; P = 0.286). At a cutoff value of ≥1.0, the sensitivity of BALF GM detection was still much higher than that of serum GM detection (64.86% versus 24.32%; P < 0.001), and their specificities were similar (90.36% versus 95.71%; P = 0.202). Receiver operating characteristic (ROC) curve analysis showed that when the BALF GM detection cutoff value was 0.7, its diagnostic value for pulmonary aspergillosis was optimized, and the sensitivity and specificity reached 72.97% and 89.16%, respectively. BALF GM detection was valuable for the diagnosis of IPA in nonneutropenic patients, and its diagnostic value was superior to that of serum GM detection. The optimal BALF GM cutoff value was 0.7.

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