FDA Approves New Instrumentation for Latent Tuberculosis Detection
New instrumentation offers clinical labs the option of automating TB tests for faster and more reliable results
The U.S. Food and Drug Administration has approved the use of two additional cell isolation instruments from PerkinElmer’s Oxford Immunotec with the company’s previously approved T-Cell Select™ reagent kit that helps diagnose tuberculosis (TB) in vitro.
“Traditional methods for the detection of latent TB can be both time- and labor-intensive, with cell separation being one of the greatest bottlenecks for laboratories,” said Phill Keefe, chief executive officer of PerkinElmer’s Oxford Immunotec. “This supplement approval creates a wider portfolio of approved instrumentation labs may use to automate a clinically superior assay, ultimately meaning faster and more reliable results for more patients with a potentially life-threatening infection.”
The approved instrumentation offers plate- or strip-based sample preparation to meet variable throughput requirements. This versatility further optimizes workflow efficiency, reduces hands-on time, and minimizes both labor and resource costs.
TB workflow automation also improves blood sample logistics, as samples may be stored at room temperature for up to 54 hours with no complex phlebotomy practices. The extended blood sample stability enables easy centralization of sample processing, giving laboratories more flexibility with the potential for sample batching.
- This press release was originally published on the PerkinElmer Inc. website