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真菌抗原检测试剂Fungitell试剂盒

发布时间:2013-1-28 17:02:25

 The Fungitell kit:

A new clinical diagnostics division focusing on (1,3)-ß-D-glucan analysis to aid in the diagnosis of Invasive Fungal Infections (IFI).

In 2004, ACC began the manufacture and sale of the Fungitell® assay, a diagnostic kit for the detection of (1,3)-ß-D-glucan in serum. ACC also owns and operates a CLIA-certified reference laboratory called Beacon Diagnostics™ Laboratory that specializes in serum (1,3)-ß-D-glucan testing.

Immune suppressed patients are at high risk for developing invasive fungal infections, which are typically difficult to isolate and diagnose. Affected patient populations include:
1. Cancer patients undergoing chemotherapy
2. Stem Cell and Organ Transplant patients
3. Burn patients
4. HIV patients
5. ICU patients

The Fungitell kit:

  • Is 510(k) cleared by the FDA for diagnostic use
  • Is indicated for use as an aid in the diagnosis of Invasive Fungal Infections (IFI).
  • Is nearly panfungal - the test will detect most medically important fungi including Aspergillus and Candida. The kit does not detect Zygomycetes and has limited detection of Cryptococcus due to the absence or low levels of (1,3)-ß-D-glucan in these fungi.
  • Contains enough reagents to run 24 to 42 patient samples (depends of number of replicates)
  • Requires only an incubating microplate reader and standard software to run
  • Has a run time of 40 minutes
  • Is sensitive to picogram levels

Originally marketed as the Glucatell® kit, the Fungitell kit has its origins in the research product line of the same name.

Beacon Diagnostics Laboratory, our fungal diagnostic testing service, is a CLIA-certified reference laboratory specializing in serum (1,3)-ß-D-glucan analysis. Beacon Diagnostics laboratory serves the clinical community's need for improved methods for the diagnosis of invasive fungal infection.

In the future, ACC will be adding new diagnostic kits and laboratory tests to its line of products and services. These products will be offered through ACC and its services provided through Beacon Diagnostics Laboratory.