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Disease/health condition -
Aspergillosis
Aspergillus IgG antibody
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of chronic pulmonary aspergillosis.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
52002
Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the fungus Aspergillus fumigatus in a clinical specimen, using an enzyme immunoassay (EIA) method.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W010509
INFECTIOUS IMMUNOLOGY - RAPID TESTS & POINT OF CARE
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
N/A
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including the Aspergillus IgG antibody test category in the third EDL:
• as a disease-specific IVD for clinical laboratories (EDL 3, Section II.b, Aspergillosis);
• using an RDT or immunoassay format;
• to aid in the diagnosis of chronic pulmonary aspergillosis; The group highlighted the need for more information on RDTs and other tests that are currently in the pipeline, for which existing data are scarce.
• as a disease-specific IVD for clinical laboratories (EDL 3, Section II.b, Aspergillosis);
• using an RDT or immunoassay format;
• to aid in the diagnosis of chronic pulmonary aspergillosis; The group highlighted the need for more information on RDTs and other tests that are currently in the pipeline, for which existing data are scarce.
There are no systematic reviews on the clinical utility or impact of Aspergillus antibody diagnosis. But the IgG antibody test is already in use and is the subject of several studies. The Aspergillus IgG assay result also forms part of the Global Action Fund for Fungal Infections’ definition of CPA and as such is critical for a CPA diagnosis.
All ICT, plate ELISA, and auto ELISA for Aspergillus-specific IgG have sufficient sensitivity and specificity for a differential diagnosis between CPA and other chronic pulmonary disease (including TB).
The data submitted show it to be a simple, robust and easy-to-use test that is particularly adaptable to LMIC contexts, where there are no realistic diagnostic alternatives.
Diagnosing chronic pulmonary aspergillosis (CPA) requires evidence of infection, and there is evidence that measuring IgG response related to aspergillosis infection provides this in a high proportion of cases.
No evidence was provided to support the suitability of IgG measures for monitoring disease progression and treatment success.
The full evidence review for this test category is available at https://iris.who.int/handle/10665/339064
World Health Organization. (2021). The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/339064