Our current products

NEW! HISTOPLASMA URINARY ANTIGENT EIA KIT

INTENDED USE

The Gotham Biotech Histoplasma Urinary Antigen EIA is an enzyme immunoassay (EIA) intended to qualitatively detect the presence of Histoplasma capsulatum galactomannan antigen in human urine specimens. This kit, when used in conjunction with other diagnostic measures, can be used as an aid in the diagnosis of histoplasmosis.

INTRODUCTION

Histoplasmosis is a systemic disease caused by the thermally dimorphic fungus Histoplasma capsulatum . H. capsulatum is distributed worldwide and endemic to the Ohio and Mississippi River Valleys in the United States, where the CDC estimates 60% to 90% of people who live in the region have been exposed to the fungus at some point during their lifetime, and to certain regions of Central and South America . Histoplasmosis is most common among patients positive for HIV or otherwise have a compromised immune system. It is especially a problem in regions of the world where antiretroviral therapy (ART) is not widely available, as ART prevents HIV- infected people from reaching the stage where they are especially vulnerable to histoplasmosis and other opportunistic infections. In Latin America, histoplasmosis is one of the most common opportunistic infections among people living with HIV. There is a 30% mortality rate among HIV/AIDS patients also diagnosed with Histoplasmosis.

H. capsulatum is typically transmitted by the inhalation of microconidia by the host, deposition in the alveoli, and rapid conversion to a parasitic yeast form in host tissues. Infection is typically asymptomatic. Among immunocompetent hosts in endemic areas, 95-99% of the primary infections are not recognized or detected . Because the symptoms of histoplasmosis have significant clinical overlap with other diseases, the definitive diagnosis of histoplasmosis requires either isolation of H. capsulatum from a clinical specimen or direct visualization of the yeast form in clinical specimens. These procedures may require invasive measures to obtain tissues and cultures may take up to six weeks to reveal fungal growth. In contrast, enzyme immunoassays (EIAs) detect H. capsulatum polysaccharide antigen in bodily fluids including urine and blood. Such tests provide rapid results and reasonable specificity and sensitivity and may be used to supplement culture and microscopic examination to diagnose histoplasmosis.

PRINCIPLE OF THE ASSAY

The Gotham Biotech Histoplasma Urinary Antigen EIA incorporates the principle of a solid phase enzyme-linked immunosorbent assay. The assay system utilizes a unique pair of monoclonal antibodies that are specific to distinct epitopes of intact galactomannan molecule antigen. spectrophotometrically at 450nm and 630nm. Time to result is approximately 1.5 hours.

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ELISA BLASTOMYCES DERMATITIDIS ANTIGEN URINE TEST

Gotham Biotech has developed strong collaborative associations with ARUP Laboratories and the Mayo Clinic in an effort to evaluate a new ELISA for detection of Blastomyces dermatitidis antigen in urine.

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Blastomyces dermatitidis is the causative agent for blastomycosis, an endemic fungal infection prevalent in the Ohio and Mississippi River Valleys, Great Lakes Region, and the Southeastern United States. It causes acute and chronic pneumonia, as well as disseminated extrapulmonary disease.

INTENDED USE

This kit is for the quantitative determination of Blastomyces dermatitidis urinary antigen in a human urine specimen. The Gotham Biotechnology Blastomyces dermatitidis Urinary Antigen Detection Kit (Blasto urine test) is a Research Use Only device for the determination of Blastomycosis in human patients as well as for monitoring of the efficacy of treatment.

SUMMARY AND EXPLANATION

Blastomycosis is a fungal infection in humans.  The infection results in the release of antigen that can be detected in human urine. This assay employs antibodies specific to the Blastomyces dermatitidis urinary antigen for the capture and detection of its presence in a human urine specimen.  The detection method involves an enzyme/substrate system with the level of antigen in the urine proportional to the assay signal.  The patient specimen result is compared to a standard curve of a series of assay calibrators to determine if the patient is positive or negative for Blastomycosis, and if positive, to determine the level of Blastomyces dermatitidis urinary antigen in the specimen.

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BLASTOMYCES DERMATITIDIS SERUM ANTIGEN DETECTION KIT

INTENDED USE

This kit is for the quantitative determination of Blastomyces dermatitidis serum antigen in a human serum  specimen. The Gotham Biotechnology Blastomyces dermatitidis Serum Antigen Detection Kit (Blasto Serum test) is a Research Use Only device for the determination of Blastomycosis in human patients as well as for monitoring of the efficacy of treatment.

SUMMARY AND EXPLANATION

Blastomycosis is a fungal infection in humans.  The infection results in the release of antigen that may be detected in human serum. This assay employs antibodies specific to the Blastomyces dermatitidis  antigen for the capture and detection of its presence in a human serum specimen.  The detection method involves an enzyme/substrate system with the level of antigen in the serum proportional to the assay signal.  The patient specimen result is compared to a standard curve of a series of assay calibrators to determine if the patient is positive or negative for Blastomycosis, and if positive, to determine the level of Blastomyces dermatitidis serum antigen in the specimen.

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Products in the works

LYME DISEASE URINE TEST

We are currently working on promising preliminary research for the direct detection of Lyme Disease and associated Borrelia burgdorferi urinary antigen.

The diagnosis of Lyme disease is at best mediocre and currently suffers from sensitivity as well as specificity issues. We are in the process of developing a rapid urine based, non-invasive, early diagnostic for Lyme disease. Our hope is that it revolutionizes testing for this and other endemic disease.