The kit allows laboratories to extract DNA and RNA from a range of clinical specimens using a single method.
Xpedite Diagnostics GmbH announced that its ClassiX DNA/RNA universal extraction kit has received CE-IVD marking as a Class A device under the European Union In Vitro Diagnostic Medical Devices Regulation.
The extraction kit uses a single chemistry and protocol across seven clinically relevant sample types, including whole blood, serum, stool, urine, semen, respiratory swabs, urogenital swabs, and rectal swabs. It is designed to cover nine organism classes, spanning Gram-positive and Gram-negative bacteria, RNA and DNA viruses, fungi, and parasites.
DNA and RNA are co-purified from a single input, either manually or fully automated on the SwiftXtractor SL system. The chemistry can also be used on virtually any liquid handling platform featuring built-in magnetic separation capabilities.
“Our objective was a single, universal chemistry that performs consistently across every matrix a laboratory encounters, rather than another kit optimized for one,” says Dr Andy Wende, founder and managing director of Xpedite Diagnostics GmbH, in a release. “With CE-IVD marking, clinical laboratories can now bring that same chemistry into routine diagnostics, instead of maintaining a separate extraction workflow for each specimen type.”
Clinical Performance and Inhibitor Resistance
In a clinical performance evaluation of 123 samples—comprising 110 clinical specimens and 13 spiked specimens across seven human sample types—the kit demonstrated a diagnostic sensitivity of 97.2% and a diagnostic specificity of 100%. Under its CE-IVD intended use, the kit is indicated for professional manual and automated extraction from human specimens.
Engineered to process challenging matrices, the kit delivered lower Cq values than commercial reference kits when testing whole blood and stool, showing no PCR inhibition across a 32-sample fecal panel. In addition, the reagents are stored at room temperature, eliminating the need for cold-chain shipping and storage logistics.
Initially launched for research use only in September 2026, ClassiX DNA/RNA is now commercially available for routine clinical diagnostic use across the EU and in international markets that recognize the CE mark.
Photo credit: Xpedite Diagnostics GmbH
