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Launching at MMC - Aspergillus Galactomannan EIA - . “Galactomannan Screening for the Early Diagnosis of Invasive Aspergillosis” Dr. Vilma M. Co / Dr. Demetrio Valle Pledge of Support – Pfizer / Lifeline Message of Acceptance – Makati Medical Center Ceremonial MOA Signing

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launching at mmc aspergillus galactomannan eia
Launching at MMC - Aspergillus Galactomannan EIA -

“Galactomannan Screening for the Early Diagnosis of Invasive Aspergillosis”

Dr. Vilma M. Co / Dr. Demetrio Valle

  • Pledge of Support – Pfizer / Lifeline
  • Message of Acceptance – Makati Medical Center
  • Ceremonial MOA Signing

...........................Refreshments……………………….

aspergillus
Aspergillus
  • fungus (or mold) that is common in the environment
    • soil
    • plants and in decaying plant matter
    • household dust
    • building materials
    • spices & some food items.
different types of aspergillus
Different types of Aspergillus
  • Aspergillus fumigatus
  • Aspergillus flavus
  • Aspergillus terreus
  • Aspergillus nidulans
  • Aspergillus niger
aspergillosis
Aspergillosis
  • allergic bronchopulmonary aspergillosis (also called ABPA)

- a condition where the fungus causes allergic respiratory symptoms, such as wheezing and coughing, but does not actually invade and destroy tissue.

aspergillosis1
Aspergillosis
  • Invasive Aspergillosis

- a disease that usually affects people with immune system problems.

- the fungus invades and damages tissues in the body.

- most commonly affects the lungs, but can also cause infection in many other organs & can spread throughout the body.

high risk patients
High-risk Patients
  • Invasive aspergillosis generally affects immunocompromised patients
    • bone marrow transplant or solid organ transplant,
    • people who are taking high doses of corticosteroids,
    • people getting chemotherapy for cancers such as leukemia.
    • persons with advanced HIV infection
mode of transmission
Mode of Transmission
  • Inhalation of Aspergillus spores (i.e., in a very dusty environment) can lead to infection.
  • Studies have shown that invasive aspergillosis can occur during building renovation or construction.
  • Outbreaks of Aspergillus skin infections have been traced to contaminated biomedical devices.
symptoms of aspergillosis
Symptoms of Aspergillosis:
  • respiratory symptoms like wheezing, coughing and even fever
  • allergic sinusitis/bloody sputum
  • aspergilloma, or a “fungus ball” in the lung or other organs.
  • Lung aspergillomas usually occur in people with other forms of lung disease, like emphysema or a history of TB.
invasive aspergillosis
Invasive Aspergillosis
  • fever, chest pain, cough, and shortness of breath.
  • When invasive aspergillosis spreads outside of the lungs, it can affect almost any organ in the body, including the brain.
incubation period
Incubation Period
  • Incubation time varies depending on host factors & exposure characteristics.
diagnosis of aspergillus infection
Diagnosis of Aspergillus infection
  • risk factors, symptoms, & P.E. findings
  • chest x-ray or CT scan of the lungs.
  • fungal culture of samples of respiratory secretions or affected tissues
  • biopsies of affected tissue
  • newer tests that can help monitor for invasive aspergillosis in high-risk persons who are severely immunocompromised
aspergillus galactomannan eia clinical utility
Aspergillus Galactomannan EIA CLINICAL UTILITY
  • used in conjunction with other diagnostic procedures to aid in the diagnosis of Invasive Aspergillosis.
    • microbiological culture
    • histological examination of biopsy specimens
    • radiographic evidence
slide14

Screening & Diagnosing IA in High-Risk Patients

KEY BENEFITS :

Screening high-risk patients with PlateliaTMAspergillus EIA, twice-weekly, provides early diagnosis of IA.

Recent publications:

  • GM Ag was positive 6-10 days before onset of clinical signs
  • GM positivity preceded positivity of CT-Scan or culture by >1 week
  • PlateliaTMAspergillus EIA was most sensitive (compared to RT-PCR and -glucan) at predicting the diagnosis of IA in patients with hematologic disorder.
slide15

Screening and Diagnosing IA in High-Risk patients

Comparison to Other Diagnostic Methods :

J.Maertens JID 2002

treatment of invasive aspergillosis
Treatment of Invasive Aspergillosis
  • Voriconazole is currently first-line treatment for invasive aspergillosis.
  • itraconazole, lipid amphotericin formulations, caspofungin, micafungin, and posaconazole
  • Whenever possible, immunosuppressive medications should be discontinued or decreased.
prevention
Prevention
  • avoidance of dusty environments and activities where dust exposure is likely (such as construction zones)
  • wearing N95 masks in dusty environments
  • avoidance of activities such as gardening
  • air quality improvement measures such as HEPA filtration may be used in healthcare settings
  • prophylactic antifungal medication in some circumstances 
elisa setup
ELISA SETUP

WASHER

INCUBATOR

READER

procedure
PROCEDURE
  • immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen
  • adult and pediatric serum samples
  • uses EBA-2 monoclonal antibodies which detect Aspergillus galactomannan.
slide22

Screening & Diagnosing IA in High-Risk patients

  • For maximum sensitivity, the test should be performedat least twice-weeklyduring hospitalization.For all positive patients, it is recommended that a newaliquot of the same sample be repeated as well ascollection of a new sample from the patient.
  • According to the EORTC/MSG criteria, two consecutivepositive results are required forclassification as truepositive.In daily practice, it is important that physicianssubmit a follow-up specimen upon receipt of the initialpositive result, ideally before initiating antifungal therapyto achieve the highest specificity using the test.
specimen type specimen handling
SPECIMEN TYPE & SPECIMEN HANDLING
  • Serum:
  • Collect 3 to 5 ml blood specimen in a serum separator tube (SST) without anti-coagulants.
  • Allow specimen to clot, then centrifuge specimen within 2 hours of draw to pellet cells below the gel.
  • Minimum volume of 1.0 ml serum following centrifugation is required.
  • Specimen should be stored at 2 to 8°C or frozen in a non-self-defrosting freezer & shipped with frozen gel packs or dry ice for overnight delivery
specimen type specimen handling1
SPECIMEN TYPE & SPECIMEN HANDLING
  • BAL:
  • 1 to 3 ml collected in a sterile, screw-cap tube;
  • specimen should be stored at 2 to 8°C or frozen in a non-self-defrosting freezer
  • shipped with frozen gel packs or dry ice for overnight delivery
causes for rejection of specimen
CAUSES FOR REJECTION of specimen
  • Lipemic, icteric, or hemolyzed specimens.
  • Specimens that have been stored at ambient temperature.
  • Specimens that have been stored at 2 to 8°C for >5 days.
  • If storage longer than 5 days is needed, samples should be frozen at -70°C.
assay range
ASSAY RANGE
  • The reference range is an index of <0.5.
  • Numerical index values will be reported.
  • Patients with an index of >0.5 are considered to be positive for galactomannan antigen.
  • Patients with an index of <0.5 are considered to be negative for galactomannan antigen.
assay limitations
ASSAY LIMITATIONS
  • A negative test result cannot rule out the diagnosis of Invasive Aspergillosis.
  • Patients at risk for Invasive Aspergillosis should be tested twice per week.
  • If a positive result is obtained, a second specimen should be collected and sent for testing immediately.
false positive galactomannan test results
False-positive galactomannan test results
  • patients receiving piperacillin/tazobactam; interpret results in these patients with caution & confirm w/ other diagnostic methods.
  • Patients with intestinal mucositis caused by chemotherapy / irradiation, which allows for extra absorption of dietary galactomannan.
  • patients receiving Plasmalyte for IV hydration or if Plasmalyte is used for BAL collection.
turnaround time
TURNAROUND TIME
  • Same day (within 8 to12 hours of specimen receipt)