The expansion includes 24 assays with CE-mark validation for use on existing Atellica CH, IM, and CI systems.
Siemens Healthineers launched capillary testing on its Atellica CH, IM, and CI Analyzers following the receipt of CE-mark for 24 capillary blood testing claims. The update allows clinical laboratories to run common tests using finger prick or heel stick samples rather than standard venipuncture.
The capillary testing menu supports various laboratory needs, including assays for metabolic panels, lipid panels, thyroid, Vitamin D, and HbA1c. This collection method offers an alternative for patients with difficult veins, low blood volume, or a fear of needles.
“Offering a capillary test menu expands the testing that can be done in the core lab to reach more patients and support more testing needs—all with the same systems they already trust,” says Sharon Bracken, head of diagnostics at Siemens Healthineers, in a release. “Our efforts to expand capillary claims across our assay menu build upon our broader vision to make testing more accessible, efficient, and patient-friendly.”
Validated capillary performance data is not a standard practice for core laboratory analyzers, according to Siemens Healthineers. Laboratories that have previously offered this method often had to perform independent validations to ensure accurate results, as collection methods can influence the quality and accuracy of the data.
The availability of on-label capillary claims provides laboratories with validated performance data to help address patient access challenges and staffing shortages. The system allows core labs to scale their testing offerings using existing infrastructure.
In the US, Siemens Healthineers currently offers four assays with capillary claims: total protein, alanine aminotransferase, aspartate aminotransferase, and triiodothyronine. The company is pursuing additional capillary testing claims with the Food and Drug Administration as part of a strategy to simplify laboratory operations and expand patient testing options.
Photo credit: Siemens Healthineers