24/09/2025 — Hallbergmoos, Germany
Xpedite Diagnostics GmbH, a pioneer in rapid nucleic acid extraction technologies, today announced the CE-IVD certification and launch of SwiftX™ Virus — a breakthrough one-step DNA/RNA extraction kit for human serum and plasma.
With precision, simplicity, and speed at its core, SwiftX™ Virus delivers PCR-ready viral RNA and bacterial DNA in just six minutes. The kit uses Xpedite’s proprietary reverse purification technology, eliminating the need for centrifuges, spin columns, or hazardous solvents. Designed for professional diagnostics, SwiftX™ Virus empowers laboratories, hospitals, and field settings with a fast, reliable, and contamination-minimized workflow ideal for point-of-care testing.
Validated Performance Across Major Tropical Pathogens
SwiftX™ Virus has been validated in paired extraction studies against routine reference methods, followed by pathogen-specific (RT-)qPCR. Across 175 clinical and spiked samples, the kit demonstrated outstanding diagnostic performance for six arboviruses and one bacterial pathogen:
- Crimean-Congo Hemorrhagic Fever Virus (CCHFV)
- Chikungunya Virus (CHIKV)
- Dengue Virus (DENV)
- Yellow Fever Virus (YFV)
- West Nile Virus (WNV)
- Usutu Virus (USUV)
- Leptospira (bacterial rule-out for dengue-like fevers)
Diagnostic accuracy:
- Sensitivity: 98% (95% CI: 93.1–99.8%)
- Specificity: 100% (95% CI: 95.1–100%)
- Accuracy: 99.6%
This broad-panel validation highlights the kit’s ability to streamline differential diagnosis of tropical fevers and support rapid outbreak response.
Executive Perspective
“SwiftX™ Virus, now CE-IVD, empowers researchers and clinicians with a fast, precise viral DNA/RNA extraction platform in real-time,” said Dr. Andy Wende, CEO and Head of R&D at Xpedite Diagnostics GmbH. “Its simplicity and robustness make it especially impactful for point-of-care use in resource-limited settings and during emerging outbreaks.”
Key Advantages
- One-step, six-minute workflow with minimal handling
- Compatible with RT-qPCR, multiplex PCR, and isothermal methods
- Requires only 20 µL of serum or plasma
- Reduces environmental impact to <2 g of waste per extraction
- Manufactured under an ISO 13485–compliant quality system
Availability
SwiftX™ Virus is available in both Research Use Only (RUO) and CE-IVD certified configurations:
- SXV-50 (RUO): 50 extractions – 149.50 €
- SXV-50-IVD (CE-IVD): 50 extractions – 149.50 €
- MAG-12: Magnetic separation rack – 149.00 €
All prices exclude shipping and handling. For product specifications, data, and ordering information, contact out team or visit the product page.
Collaboration Opportunities
Xpedite Diagnostics actively partners with hospitals, research institutes, and NGOs on clinical studies, grant programs, and field validation pilots. The company provides SOPs, QC materials, training, and co-authorship opportunities to accelerate deployment in low- and middle-income countries (LMICs) and support global health initiatives.
About Xpedite Diagnostics GmbH
Xpedite Diagnostics GmbH is a fast-growing German biotechnology company specializing in nucleic acid extraction solutions for diagnostics, environmental monitoring, food and water testing, and life science research. With a strong track record in CE-IVD product development and custom workflow integration, Xpedite supports scientists and healthcare professionals worldwide with rapid, reliable, and sustainable molecular tools.
SwiftX™ is a trademark of Xpedite Diagnostics GmbH. All other trademarks are the property of their respective owners.