Streck Blood Collection Tube Cleared By FDA
Omaha, NE - Streck, Inc. has received FDA clearance for Cyto-Chex® BCT, the company's blood collection tube that preserves peripheral blood for up to 14 days at room temperature, including HIV-infected patient samples, for immunophenotyping by flow cytometry.
Collection of whole blood is the first step in assessment of HIV patient status by flow cytometry. The Center for Disease Control guidelines for CD4+ T-cell analysis require that blood specimens collected in a standard K2EDTA tube must be analyzed within 48-72 hours of collection. Previous studies have demonstrated that whole blood samples collected in Cyto-Chex BCT are stabilized, yielding reliable and accurate CD3+, CD4+ and CD8+ counts and percent recoveries for seven days at room temperature. Streck has extended the stability claim for the HIV panel of markers CD3, CD4, CD8, CD16+56, CD19 and CD45 in terms of absolute cell counts and percent recovery to 14 days at 18-22ºC for samples collected in Cyto-Chex BCT.
"The extended stability of 14 days allows for the collection of accurate and reliable data from patient samples despite the additional time required for transport from the site of blood draw to specialized, central laboratories for analysis," said Streck President Connie Ryan. "This addresses a major obstacle encountered during large, global clinical trial studies."
The BCT tube is available in 5 ml draw tubes, packaged in six, 25-tube and 100-tube configurations, which will allow both small and large facilities to order appropriate amounts of tubes for their needs.
Additional Streck products for flow cytometry include cellular controls. CD-Chex® Plus is a positive procedure control manufactured from normal human peripheral blood leukocytes and erythrocytes. Unlike a fresh whole blood sample, CD-Chex Plus provides reproducible data when used for daily quality control of immunophenotyping procedures. CD-Chex® CD34 is a whole blood process control manufactured from CD34 positive cells. Both products are available in two levels and offer 30-day open- and 90-day closed-vial stability.
Streck is a leading independent developer and manufacturer of flow cytometry and hematology controls for the clinical laboratory. Over the past 35 years, Streck has developed a reputation for excellence that includes consistent, high quality controls, responsive customer service and technical service teams, and a free interlaboratory quality control program that offers customers easy and quick access to monthly reports.
SOURCE: Streck, Inc.