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Disease/health condition - HIV infection
Histoplasma capsulatum antigen
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory
Assay format
Immunoassay
Information History
First added in 2019
Changed in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of disseminated histoplasmosis.
Specimen types
Urine
WHO prequalified or recommended products
N/A
GMDN

52085

Histoplasma capsulatum antigen 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 antigens from the fungus Histoplasma capsulatum 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 2005-2024
EMDN

W0105060399

MYCOLOGY IMMUNOASSAYS - OTHER

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/emdn
WHO supporting publications
Diagnosing and Managing Disseminated Histoplasmosis among People Living with HIV. Washington, D.C.: Pan American Health Organization and World Health Organization; 2020. https://iris.paho.org/handle/10665.2/52304 ; The Spanish version is available at https://iris.paho.org/handle/10665.2/52419
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended conditional inclusion in the EDL of the histoplasma antigen EIA, pending submission within 1 year of more evidence on the performance of the test. The Group requested the WHO technical department on HIV infection to include advice on use of the test in their guidelines. In 2020 SAGE IVD accepted the additional evidence provided and recommended reversing the conditional listing on the Histoplasma antigen test in EDL 3 in favor of a full listing.
Histoplasma antigen has been detected in the urine of 95–100% and in the serum of 80% of patients with disseminated AIDS. The availability of a simple, rapid method to detect H. capsulatum infection in LMICs would dramatically decrease the time to diagnosis and treatment and the number of deaths among patients with AIDS-related disseminated histoplasmosis. In immunocompromised people, tests for detecting histoplasma polysaccharide antigen in urine, serum, bronchoalveolar lavage and cerebrospinal fluid samples allow rapid diagnosis of disseminated histoplasmosis before positive cultures can be identified. The concentration of antigen is highest in urine, which can be used to monitor the response to antifungal therapy and to identify relapses. Lack of availability of the test is a major contributor to deaths from AIDS in endemic areas. In 2020 additional evidence was revised by SAGE IVD, this evidence is available at https://iris.who.int/handle/10665/339064
The evidence for the accuracy of the test is poorly presented in the systematic review. A few reasonable studies may exist, and some show good diagnostic accuracy, but there appears to be unexplained variation in the accuracy of the test. Further detailed analysis of the evidence is needed to evaluate the quality of the studies and their findings. In 2020 SAGE IVD requested the WHO technical department on HIV infection to include advice on use of the Histoplasma antigen test in their guidelines. A 2019 systematic review by Caceres et al. (1) and two primary studies by Caceres et al. (2, 3) were provided as evidence for test performance. The PAHO/WHO guidelines on histoplasmosis have been published (4).
World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527 ; 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