2020Journal of Clinical MicrobiologyOpen access

An Evaluation of the Performance of the IMMY Aspergillus Galactomannan Enzyme-Linked Immunosorbent Assay When Testing Serum To Aid in the Diagnosis of Invasive Aspergillosis

P. Lewis White, Jessica S. Price, Raquel Posso, Lorna Vale, Matthijs Backx

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Abstract

= 100) were 0.61, 0.11, and 0.14, respectively, and were comparable to those of the Bio-Rad GM-EIA (0.70, 0.04, and 0.04, respectively). Overall qualitative observed sample agreement between the IMMY GM-EIA and Bio-Rad GM-EIA was 94.7%, generating a kappa statistic of 0.820. At a GMI positivity threshold of ≥0.5, the IMMY GM-EIA had a sensitivity and specificity of 71% and 98%, respectively. Reducing the threshold to ≥0.27 generated sensitivity and specificity of 90% and 92%, respectively. The IMMY GM-EIA provides a comparable alternative to the Bio-Rad GM-EIA when testing serum samples. Further prospective, multicenter evaluations are required to confirm the optimal threshold and associated clinical performance.

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= 100) were 0.61, 0.11, and 0.14, respectively, and were comparable to those of the Bio-Rad GM-EIA (0.70, 0.04, and 0.04, respectively). Overall qualitative observed sample agreement between the IMMY GM-EIA and Bio-Rad GM-EIA was 94.7%, generating a kappa statistic of 0.820. At a GMI positivity threshold of ≥0.5, the IMMY GM-EIA had a sensitivity and specificity of 71% and 98%, respectively. Reducing the threshold to ≥0.27 generated sensitivity and specificity of 90% and 92%, respectively. The IMMY GM-EIA provides a comparable alternative to the Bio-Rad GM-EIA when testing serum samples. Further prospective, multicenter evaluations are required to confirm the optimal threshold and associated clinical performance.

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Available abstract

= 100) were 0.61, 0.11, and 0.14, respectively, and were comparable to those of the Bio-Rad GM-EIA (0.70, 0.04, and 0.04, respectively). Overall qualitative observed sample agreement between the IMMY GM-EIA and Bio-Rad GM-EIA was 94.7%, generating a kappa statistic of 0.820. At a GMI positivity threshold of ≥0.5, the IMMY GM-EIA had a sensitivity and specificity of 71% and 98%, respectively. Reducing the threshold to ≥0.27 generated sensitivity and specificity of 90% and 92%, respectively. The IMMY GM-EIA provides a comparable alternative to the Bio-Rad GM-EIA when testing serum samples. Further prospective, multicenter evaluations are required to confirm the optimal threshold and associated clinical performance.

Key concepts: Galactomannan, Aspergillosis, Aspergillus, Immunoassay, Concordance, Medicine, Biology, Veterinary medicine

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