Serum: Collect 3-5 mL whole blood in a gel separator tube (SST)

Serum:
Allow specimen to clot and separate from the cells within 2 hours.  Freeze specimen in parent tube. DO NOT POP THE CAP!!! Send frozen serum in primary tube to the sendout department for further transport to testing facility.

Centrifuge specimen within 2 hours of draw to pellet cells below the gel. Minimum volume of 0.5 mL serum for adults and 0.2 mL for infant and pediatric samples folowing centrifugation.

The serum can be decanted into a suitable container that is free of interfering levels of (1-3)-B-D-glucan; however, the use of pour-off tubes is not recommended due to the potential for environmental contamination of the sample that can lead to false positive results. Serum samples which are transferred to sterile, leak-proof containers should be handled in a a sterile cabinet. Interpret results from samples provided in pour-off tubes with caution.

Lipemic, icteric, or hemolyzed specimens. Specimens that have been stored at ambient temperature. Specimens that have been stored at 2 to 8°C for >5days. If storage longer than 5 days is needed, samples should be frozen at -20°C or colder. Unless indicated as stored frozen, the specimen will be rejected if the draw date is >5 days from receipt. Specimens other than serum.

Samples obtained by heel or finger stick methods are unacceptable as the alcohol-soaked gauze used to prepare the site (and potentially the skin surface-pooling of blood) has been shown to contaminate the specimens.

Specimen can be stored refrigerated at 2 to 8°C or preferably stored frozen. Specimen should be shipped on dry ice for overnight delivery

Patients with renal failure on hemodialysis utilizing cellulose membranes may have false positive results.

Patients treated with fractionated blood products such as albumin and immunoglobulin and in specimens and subjects exposed to glucancontaining gauze. Patients require 3 to 4 days for the restoration of baseline levels of serum (1,3)- ß-D-glucan, after surgical exposure to (1,3)-ß-D-glucan containing sponges and gauze.

Same day (within 8 to 12 hours of specimen receipt), Monday through Saturday

Serum reference range:

Negative: Less than 60 pg/mL. Indeterminate: 60 to 79 pg/mL Positive: Greater than or equal to 80 pg/mL

A reference range for specimens other than serum has not be established by the USFDA or Viracor-IBT Laboratories. The Fungitell ß-D Glucan assay is indicated for presumptive diagnosis of fungal infection. It should be used in conjunction with other diagnostic procedures. The Fungitell ß-D Glucan assay does not detect certain fungal species such as the genusCryptococcus, which produces very low levels of (1,3) ß-D-glucan. This assay also does not detect the Zygomycetes, such asAbsidia, Mucor, and Rhizopus, which are not known to produce (1,3) ß-glucan.