ASPERGILLUS GALF ANTIGEN EIA TEST

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Invasive aspergillosis (IA) is a serious fungal infection caused by inhaled Aspergillus spores and primarily affects individuals with weakened immune systems. This includes individuals with prolonged neutropenia from chemotherapy for hematologic malignancies or recipients of blood or bone marrow transplants, as well as patients with impaired cellular immunity from solid organ transplants, autoimmune disease treatments, or severe viral lung injury such as influenza or COVID-19.

Since cultures from respiratory samples infrequently yield Aspergillus, diagnosis often relies on radiologic findings and the detection of fungal nucleic acids or antigens. Galactofuranose-containing antigens are secreted during IA and can be found in the urine of infected animals and people, forming the basis of the MycoMEIA® Aspergillus Assay (MycoMEIA). MycoMEIA® is an enzyme immunoassay (EIA) for the in vitro qualitative measurement of Aspergillus antigens in human urine.

MycoMEIA® can be used as an aid in the diagnosis of IA when clinically suspected in people with immunosuppression. It can also be used to screen for IA in people at high risk, such as in the setting of prolonged neutropenia.

Qualitative Enzyme Immunoassay (EIA)

Tests should be interpreted in the context of clinical risk and other indicators of infection. Testing in patients without risks for IA may increase the likelihood of false results.

If used for screening, urine should be tested twice weekly and interpreted in context.

Contamination of urine can occur if samples are stored for over 8 hours at room temperature, causing interference with the assay.

The MycoMEIA® Aspergillus assay has not been validated to aid the diagnosis of non-invasive pulmonary disease, such as allergic bronchopulmonary aspergillosis or sinus infection.

Significant hematuria may interfere with results.

Cross-reactivity was detected from samples collected from people with histoplasmosis, cryptococcosis, blastomycosis, candidemia, and Serratia spp. causing bacteremia.

Collect urine samples aseptically in a sterile container. Specimens in transit between laboratories should be maintained at 2-8°C to minimize microbial overgrowth. Specimens should not remain at room temperature for longer than 8 hours. If a delay in specimen processing occurs, specimens can be stored at 2-8°C for up to 5 days, or stored indefinitely at -80°C.

Urine: 0.15 mL

Room Temperature: 8 hours
Refrigerated: 5 days
Frozen: Indefinitely

>8 hours at room temperature

>5 days of refrigeration

Grossly bloody specimens.

Two unique patient identifiers are required on the specimen container.

Any specimen type other than urine.

For specimen submissions that do not meet these criteria, please call Customer Service.

Refrigerated/Frozen

Ship to arrive Monday‐Friday using a next-day delivery service. Samples may be shipped on dry ice or on frozen ice packs.

Testing is performed Monday through Friday and reported the by the next day.

Negative

Urine is the only specimen type cleared by the FDA for the MycoMEIA® assay.

MycoMEIA® Aspergillus Galf Antigen EIA

Aspergillus galactofuranose Ag EIA