Siemens Adds CE-Marked Capillary Claims for 24 Assays on Atellica Analyzers

Core laboratories also face pressure to expand access and maintain throughput using existing analyzers. Capillary collection offers a patient-friendly alternative but lacks on‑label validation across many routine assays in centralized labs. Siemens Healthineers now introduces CE‑marked capillary testing claims for 24 assays on its Atellica analyzers.

Siemens Healthineers has launched capillary testing on the Atellica CH, IM, and CI Analyzers after receiving CE‑mark for 24 capillary blood testing claims, an advancement intended to provide greater confidence in results and higher throughput. The CE‑marked capillary claims are validated to run on the Atellica analyzers. The offering is designed to help core laboratories scale testing using existing infrastructure.

Capillary blood testing is collected via finger prick or heel stick instead of venipuncture. The Atellica menu supports common laboratory testing needs, including assays that comprise the comprehensive metabolic panel, lipid panels, thyroid function, Vitamin D, and HbA1c. This approach is positioned to offer flexibility for diverse patient testing needs.

According to the company, capillary claims provide on‑label, validated performance data that has not been standard practice on core laboratory analyzers. Laboratories previously offering capillary testing have typically undertaken additional steps to validate performance because collection methods can influence quality and accuracy. Many labs have therefore remained dependent on venous draws even as patient access challenges, staffing shortages, and the demand for faster turnaround times have grown.

In the United States, Siemens Healthineers offers four assays with capillary claims: total protein (TP_2), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and triiodothyronine (T3). The company is pursuing additional capillary testing claims with the U.S. Food and Drug Administration (FDA), subject to regulatory review. The broader set of 24 CE‑marked capillary claims is not available for sale in the United States, and future availability cannot be guaranteed.

“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,” said Sharon Bracken, head of Diagnostics, Siemens Healthineers. “Our efforts to expand capillary claims across our assay menu build upon our broader vision to make testing more accessible, efficient, and patient-friendly.”