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World’s first lateral flow assay for Histoplasma antigen launched

January 27 2020

In a ground-breaking development for patients with AIDS, the world’s first lateral flow assay able to detect Histoplasma antigen has been launched by MiraVista Diagnostics, based in Indianapolis, USA. The assay detects H. capsulatum galactomannan antigen.

- Read the full paper: Cáceres et al (2019) Evaluation of a Histoplasma antigen lateral flow assay for the rapid diagnosis of progressive disseminated histoplasmosis in Colombian patients with AIDS

- Read more about the assay at the MiraVista website

Diego Cáceres and colleagues at the Centers for Disease Control and Prevention (CDC) independently evaluated the new LFA in serum samples from patients and controls in Medellin, Colombia:

  • There were 24 positives from patients with culture-proven disseminated histoplasmosis in AIDS and 51 controls with other infections diseases complicating AIDS. When the LFA was read manually, sensitivity was 96% and specificity was 90%.
  • Sera were pretreated with EDTA and boiled and analysed with the LFA. The LFA process takes 30 minutes to read.
  • The five false-positive results were from paracoccidioidomycosis, salmonellosis and for uncertain reasons. There was one false negative.

It will be important to assess the LFA in patients’ urine and in patients who are culture negative but have other manifestations of disseminated histoplasmosis. Two other LFA tests for Histoplasma antigen are in development and head to head comparisons will be valuable in the future.

Another reference test is also available as a service for specimens submitted (Miravista Labs) and this assay performs well, with well-characterised specimens. Antigenuria was detected in 92% of those with disseminated histoplasmosis and antigenemia in 100%. Those with severe disease and immunocompromised patients are more often positive. Lower frequencies of positivity are found in those with acute, subacute and chronic pulmonary histoplasmosis. Cross-reactivity was common in patients with blastomycosis.