Siemens Healthineers launches capillary testing menu for core lab analysers
Siemens Healthineers has introduced capillary blood testing on its Atellica® CH, IM and CI Analysers, following the receipt of CE-mark approval for 24 capillary blood testing claims. The launch extends capillary testing capability into the core laboratory setting, an area in which the collection method has not traditionally been standard practice.
The newly validated menu covers assays that make up the comprehensive metabolic panel, lipid panels, thyroid testing, Vitamin D and HbA1c. Capillary specimens are typically obtained via a finger prick or heel stick, in contrast to venipuncture, which requires a needle inserted directly into a vein.
Rationale for core lab capillary claims
According to the company, capillary claims provide on-label, validated performance data for a collection method that has generally sat outside standard core laboratory practice. Laboratories that have previously used capillary collection have presumably needed to validate their own testing performance separately, since collection method can influence both specimen quality and result accuracy. Many laboratories have consequently continued to rely on venous draws, even as patient access constraints, staffing shortages and pressure for faster turnaround times persist.
Sharon Bracken, head of Diagnostics, Siemens Healthineers, said: “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. Our efforts to expand capillary claims across our assay menu build upon our broader vision to make testing more accessible, efficient, and patient-friendly.”
Clinical rationale for capillary collection
Capillary collection is presented as a suitable option for patients with difficult venous access or low blood volume, for whom repeated venipuncture could pose a risk. It may also benefit patients with trypanophobia (fear of needles) or disabilities that make venipuncture difficult. Siemens Healthineers says that the capability allows laboratories flexibility to diversify their collection approaches, whether extending services to underserved patient groups or broadening existing testing offerings.
Regulatory status
The capillary claims described are CE-marked and validated for use on the Atellica analysers. In the United States, Siemens Healthineers currently offers four assays with capillary claims: total protein (TP_2), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and triiodothyronine (T3). These claims are not available for sale in the U.S. beyond this scope, and the company notes that future availability cannot be guaranteed. Siemens Healthineers is pursuing additional capillary testing claims with the FDA, subject to regulatory review, as part of its broader strategy to support laboratories in expanding patient testing options and simplifying operations.
For more information, visit: https://www.siemens-healthineers.com
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