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Fungitell STAT® Assay

Comming Soon!

Single Sample Format For Rapid Invasive Fungal Infection Screening

Fungitell®, The Gold Standard in Rapid Screening for Invasive Fungal Infection (IFI), is now available in a single sample format. Fungitell STAT® is the only single sample format FDA-cleared and CE marked rapid in vitro diagnostic screening test for IFI (including Candida, Aspergillus and Pneumocystis) that detects (1→3)-β-D-Glucan in serum.

Introducing Fungitell STAT®

Features & Benefits
  • Test a single sample at a time
  • Rapid in-house results – within 1 hour eliminating the need for expensive send out services
  • CE Marked single test (1→3)-β-D-Glucan assay – Reliable cut off values
  • Detects glucan from most fungi including Candida, Aspergillus and Pneumocystis
  • Decreased turn-around-time – no more waiting for large, batched sample runs or send outs
Why test for (1→3)-β-D-Glucan?
Most pathogenic fungi1 have (1→3)-β-D-Glucan in their cell walls and minute, but detectable quantities are released into the circulation during infection. Detection of elevated levels of (1→3)-β-D-Glucan is an aid to the presumptive diagnosis of IFI in at risk patients.

IFIs cause severe illness in the critically ill and immunocompromised patients and are associated with high morbidity and mortality. More aggressive medical care, including immunosuppressive therapy and ICU care has greatly increased the population of patients at risk of IFI.
Immunocompromised and At-risk Populations
  • Aggressive Care (SICU/MICU/NICU)
  • Mechanical Ventilation
  • Stem Cell and Organ Transplants
  • HIV
  • Cancer Treatment
  • Diabetes
  • Central Venous Catheters
  • Hemodialysis
  • Gastrointestinal Surgery
  • Total Parenteral Nutrition

Fungitell STAT® in a nutshell

Fungitell STAT® presents qualitative information concerning patient serum BG levels, using an index value result format that is both familiar to the infectious disease community and which allows the rapid stratification of patients as diagnostically positive, negative or indeterminate relative to serum BG burden.
The Fungitell STAT® assay is a protease zymogen-based colorimetric assay for the qualitative detection of (1→3)-β-D-Glucan in the serum of patients with symptoms of, or medical conditions predisposing the patient to, IFI. Fungitell STAT® is a design modification to the Fungitell assay format. The Fungitell STAT® assay was developed to answer the need for a single use test format and smaller kit size relative to the 96-well plate format of the Fungitell assay.
Fungitell STAT® offers the convenience of either a single sample or a small number of patient samples test run with a minimal footprint. Test from 1-7 samples in a single run using the Lab Kinetics Incubating 8-well Tube Reader and Beta Glucan BG Analytics™ software.
Fungitell STAT® is designed to provide an easy-to-interpret, computer-generated index result using a reference control provided with the reagent kit. Beta-Glucan Index (BGI) interpretive zones are as follows:
Result Index Value
Negative ≤0.74
Indeterminate 0.75 -1.1
Positive ≥1.2
Fungitell STAT® was developed and tested using the Fungitell® (1→3)-β-D-Glucan Assay predicate device and its results track closely to the familiar pg/mL output of that kit. The concordance testing of Fungitell STAT® BGI results to the original Fungitell pg/ml results provided a Positive Percent Agreement of 99% and a Negative Percent Agreement of 98%

8-well Tube Reader Instrument

Lab Kinetics Incubating 8-well Tube Reader Incubating (37°C) tube reader capable of reading at 405 nm and 495 nm with a range of at least 0 – 1.0 Absorbance Units and accommodates vials of 12 mm diameter.

PKF08 instrument

Features & Benefits
  • Small Incubating absorbance tube reader equipped with 8 wells
  • Solid State Design
  • Low instrument maintenance
  • Each well is individually timed for immediate data collection upon insertion of a reaction tube into the tube reader
  • Uses disposable depyrogenated glass tubes