Funghi Mailing
Biomedica Fungal Solution

Fungal infections affect approximately one quarter of the global population. They are responsible for at least 1,350,000 deaths worldwide per year, primarily in patients with compromised immune system. An observed increase in incidence of drug resistant and previously rare fungal species is additional public health concern. Awareness of the possibility of fungal co-infection is also essential for reducing delays in diagnosis and treatment, as well as to help prevent severe illness or death. Once diagnosed, early initiation of appropriate antifungal therapy is crucial for reducing morbidity and mortality.

Biomedica has a comprehensive portfolio of state of art diagnostic assays dedicated on rapid detection and differentiation as well as pathogen load quantification.

The ß-Glucan Test is an in vitro diagnostic test for the quantitative determination of (1->3)-ß-D-glucan in serum or plasma. In most pathogenic fungi, (1->3)-ß-D-glucan is an integral component of the cell wall. Small quantities are released into the blood during infection. The Limulus reagent (LAL: Limulus amebocyte lysate), made from the extract of blood cells of horseshoe crabs, has drawn attention as an in vitro diagnostic reagent for mycosis. It reacts with (1->3)-ß-D-glucan as well as with endotoxin. The ß-Glucan Test exclusively measures the (1->3)-ß-D-glucan concentration through a kinetic turbidimetric assay in a sample pretreated with a solution which inactivates endotoxin by the use of a non-ionic detergent and polymyxin B.

ß-Glucan Test with LIMUSAVE MT-7500

ß-Glucan Test with TOXINOMETER MT-6500

Over 30 million people are at risk of invasive aspergillosis each year because of corticosteroid use or other therapies, and over 300,000 patients develop it annually. The disease is common in high-risk patients with:
• Hematological malignancies
• Chemotherapy-induced neutropenia
• Allogeneic HSCT (stem cell transplant)
• Solid organ transplant (primarily lung) Aspergillus as a pathogen plays an important role in terms of post-transplant infections. In solid organ transplantation, invasive aspergillosis occurs mainly from week 2-5 after transplantation, whereas for hematopoietic stem cells transplantation infections with Aspergillus have a broader time-range of 1-6 weeks after transplantation. Reliable and accurate diagnostics for subsequent therapy of invasive aspergillosis (IA) is critical and should aim at differentiation between colonization and infection.

Aspergillus Galactomannan Lateral Flow (IMMY)

Aspergillus Galactomannan Ag VIRCLIA (VIrcell)
Aspergillus spp. fully automated MolDx (Elitech)

Blastomyces dermatitidis is a thermally dimorphic fungus that causes the pulmonary pyogranulomatous disease, blastomycosis. Initial infection is through the lungs and although often subclinical, lymphohematogeneous dissemination may occur, culminating in systemic disease. Clinical disease most often involves the lungs, skin, bones, genitourinary system and central nervous system but dissemination can involve any organ. Blastomycesis endemic in the southern and southeastern states that border the Ohio and Mississippi River valleys as well as Midwestern states and Canadian provinces that border the Great Lakes and the Saint Lawrence Riverway. Additionally, autochthonous cases of blastomycosis have been diagnosed in Africa and India. Serologic testing for blastomycosis should be requested when a patient shows signs of a respiratory infection that progresses gradually, with fever, weight loss, cough with sputum, chest pain, and night sweats. The test should also be performed when there are verrucous or ulcerative lesions on the skin, a common sign of dissemination. Blastomycosis presents a diagnostic challenge as the manifestations of most early infections overlap substantially with those of other respiratory infections or malignancies. In addition, diagnosis by histological or culture studies, though ideal, may take time or reflect false results. Therefore, specific laboratory testing is usually required to establish a diagnosis of blastomycosis.


Latex Agglutination / Immunodiffusion (IMMY)

Invasive candidiasis is a disease of fungal etiology with an increasing incidence, especially in immunosuppressed patients (graft receivers, neutropenic and AIDS patients, etc), long-stay hospitalized and catheterized patients, as well as those subjected to extensive surgery or receiving broad spectrum antibiotic therapy. The diagnosis of invasive candidiasis is especially difficult due to the absence of pathognomonic symptoms specific of the disease and the low recovery of the microorganism in culture. Immediate response and rapid therapy are essential for establishing successful treatment.

Invasive Candidiasis (CAGTA) VIRCLIA

Candida Sepsis Dx from whole blood T2

Cryptococcosis, a fungal disease caused by both species of the Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii). Individuals with impaired cell-mediated immunity are at greatest risk of infection. Cryptococcosis is one of the most common opportunistic infections in AIDS patients. Cryptococcosis is most diagnosed by detection of cryptococcal antigen (CrAg) using one of several methods.

Cryptococcal Antigen Lateral Flow
Latex Agglutination / Immunodiffusion
Enzyme Immuno Assays (EIA)

Coccidioides species are dimorphic fungi that exist as either mycelia (saprobic growth) or spherules (parasitic growth) which cause mainly respiratory diseases. Though endemic in the southwestern United States and Mexico, increased travel to the endemic areas has also increased the incidence in other geographical areas. Coccidioidomycosis should be considered whenever patients have lived or travelled to the endemic areas and display symptoms of pulmonary or meningeal infection. Coccidioidomycosis presents a diagnostic challenge to physicians. The manifestations of most early coccidioidal infections may overlap with those of other respiratory infections. In addition, culturally and histologically, the organisms can be difficult to demonstrate. Therefore, specific laboratory testing is usually required to establish a diagnosis of coccidioidomycosis.

Coccidioides Antigen Lateral Flow (IMMY)

Latex Agglutination / Immunodiffusion
Enzyme Immuno Assays (EIA)

Histoplasma capsulatum (H. capsulatum) is a pathogenic dimorphic fungus found worldwide. It is endemic to the Ohio and Mississippi river valleys in the United States and to certain regions of Central and South Americas. Histoplasmosis is caused by breathing in the fungus. It is typically found in dirt with large amounts of bird or bat droppings. It is one of the most frequent mycoses in the world, with over 100,000 cases of disseminated histoplasmosis occurring in AIDS patients worldwide each year. Signs of infection often resemble flu-like symptoms, including fever, cough, fatigue, chills, headaches, chest pain, and/or body aches. Symptoms can appear anywhere from 3 to 21 days after exposure to the fungus occurs. The detection of antibodies to H. capsulatum by immunodiffusion and complement fixation are serological methods often used to offer rapid alternatives to microbiological techniques. The isolation of H. capsulatum by culture from clinical specimens remains the definitive diagnosis of histoplasmosis. However, culture often requires a two-to-four-week incubation period before the identification of the fungus is possible. A more rational approach to the diagnosis of histoplasmosis and the follow-up of patients may be the rapid detection of H. capsulatum antigen (specifically, galactomannan) in urine.

Histoplasma Galactomannan EIA
Latex Agglutination / Immunodiffusion (IMMY)

Pneumocystis jiroveci is a yeast-like fungus which can be found worldwide. Pneumocystis jiroveci is a distinct species that only infects humans, while the related species P. carinii can be found in rodents and other mammals. Airborne transmission of Pneumocystis from host to host has been demonstrated in rodent models and several observations suggest that interindividual transmission occurs in humans. Both healthy and immunocompromised people can be colonised with P. jiroveci. While it does not affect healthy people, P. jiroveci can cause an interstitial Pneumocystis-pneumonia (PCP) in HIV-patients, persons with primary immune deficiencies, including hypogammaglobulinemia and severe combined immunodeficiency (SCID), patients receiving long-term immunosuppressive regimens for connective-tissue disorders, vasculitides, or solid-organ transplantation, patients with hematologic and nonhematologic malignancies, including solid tumors and lymphomas, and persons with severe malnutrition. Currently the diagnosis of PCP relies on microscopic methods or PCR, as P. jiroveci cannot be cultured in routine microbiology laboratories.

Pneumocystis jirovecii fully automated MolDx (EliTech)

Sporotrichosis is an endemic fungal infection caused by S. schenckii with most case reports coming from the tropical and subtropical regions of the Americas. The LA-Sporothrix test is a sensitive, rapid test that is useful for the presumptive diagnosis of sporotrichosis from patients with localized cutaneous, subcutaneous, disseminated subcutaneous or systemic forms of the disease.

Latex Agglutination / Immunodiffusion (IMMY)