Fungitell STAT® Assay

Rapid Invasive Fungal Infection Screening

Fungitell STAT^® Assay

Single Sample Format For Rapid Invasive Fungal Infection (IFI) Screening. Fungitell STAT^® is the first and 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.

View a demonstration video here!

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Introducing Fungitell STAT^®

Fungitell^®, The Gold Standard in Rapid Screening for Invasive Fungal Infection (IFI), is now available in a single sample format.

Fungitell^®, the gold standard in (1→3)-β-D-Glucan testing, has been providing reliable laboratory support for IFI diagnosis, or rule-out since 2004.

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
Invasive Fungal Infection is increasing in at-risk populations¹⁰ such as:

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

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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) BG Analytics^® software.

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.

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:

Fungitell STAT^® Index Ranges
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%.²

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Fungitell STAT Box

Fungitell STAT^® Assay

Features & Benefits

Test a single sample at a time – Flexibility of testing when you need it
Rapid in-house results – within 1 hour eliminating the need for expensive send out services
The first and only FDA-Cleared and CE Marked single test (1→3)-β-D-Glucan assay – Reliable cut off values
Detects glucan from most fungi including Candida, Aspergillus and Pneumocystis²
Decreased turn-around-time – no more waiting for large, batched sample runs or send outs

PKF08 with vials

8-well Tube Reader Instrument

Features & Benefits
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.

Incubating absorbance tube reader equipped with 8 wells (1 standard and up to 7 sample positions)
Minimal footprint:
6.87” x 4.65” x 1.5” (W x D x H)
17.45cm X 11.84cm X 3.81cm (W x D x H)
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

BGA Start Screen

BG Analytics^® Software

Features & Benefits
BG Analytics^® is a unique, easy-to-use, intuitive software application that provides a qualitative measurement of (1→3)-β-D-Glucan for use with the Fungitell STAT^® kinetic assay.

BGA Data Collection Screen BGA Test Results Screen BG Analytics^® software collects and processes data from the Lab Kinetics 8-well incubating tube reader, stores the information in a database and produces reports of the test results.

Comes standard with a local SQLite 10 GB database
Allows for backup
Is LIMS compatible
Software System Requirements:
- Operating System:
Microsoft® Windows® 10
64 bit, v1809 or newer
- Physical Memory:
Minimum: 4 GB
Recommended: 8 GB
- Hard Disk Space:
Minimum: 10 GB
Recommended: 15 GB or more
- Communication Ports: at least one free USB port (or two USB ports needed when using barcode scanner)

NOTE: ACC strongly recommends that Microsoft Windows updates are performed on a regular basis to ensure the latest security fixes and critical updates.

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Additional Computer Requirements:

At least one (1) USB port
Connection to a printer
Connection to a barcode scanner

Materials Supplied with the Fungitell STAT^®

Fungitell STAT^® Reagent, a lyophilized (1→3)-β-D-Glucan specific LAL (10 vials)
Fungitell STAT^® Glucan Standard (5 vials), with the (1→3)-β-D-Glucan content stated on the labeling
Instructions for Use
Quick Visual Guide

Reagent Storage
Store all reagents, as supplied, at 2-8°C in the dark. Fungitell STAT^® Reagent and Fungitell STAT^® Standard should be used within 1 hour following reconstitution.

Materials Required
All materials must be free of interfering glucans. Glassware must be dry-heat depyrogenated for at least 7 hours at a minimum of 235°C (or a validated equivalent) to be considered suitable for use.

Ordering Information

Fungitell STAT^®, (10 vials of STAT Reagent and 5 vials of STAT Standard)	#FT007
Lab Kinetics Incubating 8-well Tube Reader with BG Analytics^® Software	#PKF08-PKG
LAL Reagent Water (5.5 mL vial, 10 Pack)³	#W0051-10
Alkaline Pretreatment Solution (2.5 mL vial, 5 Pack)³ IFU Download	#APS51-5
Toxipet Long Pipette tips (20-200 μL, Box of 50)³	#TPT50
Pipette tips (250 μL, 96/Box, 10 Boxes /Pack)	#PPT25
Pipette tips (1000 μL, 96/Box, 8 Boxes/Pack)	#PPT10
Test tubes for patient sample preparation and combining serum pretreatment solution. (12 x 75 mm, 42/Pack, 5 Packs)³	#TB240-5
For product pricing and ordering details, please refer to your local representative.

Additional Items Not Supplied By ACC

Pipettes capable of delivering 20-200 μL and 100-1000 μL volumes Sterile, glucan-free, screw-cap storage tubes for aliquotting samples (most tubes that are certified to be RNAse, DNAse, and pyrogen-free are free of interfering levels of (1→3)-β-D-Glucan).
Parafilm®
BG Analytics^® is designed to be compatible with any barcode scanner configured in USB HID Points of Sale scanner mode. For example, Honeywell healthcare corded barcode scanners Honeywell PN1950HHD and Honeywell 1950HSR are compatible. Refer to the barcode scanner’s user manual for proper scanning technique.

Cryptococcus, Mucorales (such as Absidia, Mucor and Rhizopus) and Blastomyces dermatitidis (infective yeast form) are known to have little or no (1→3)-β-D-Glucan and thus, glucan is not detected during infection with these organisms.
D’Ordine, R.L.; Garcia, K.A.; Roy, J.; Zhang, Y.; Markley, B.; and Finkelman, M.A. Performance Characteristics of Fungitell STAT^®, A Rapid (1→3)-β-D-Glucan Single Patient Sample in vitro Diagnostic Assay. Medical Mycology: In Press.
These products, supplied by Associates of Cape Cod, Inc., are certified free of interfering glucans.

Caution - glass pipettes with cotton plugs and micro-pipette tips with cellulosic filters are potential sources of glucan contamination.

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