Vidan Diagnostics Enhances Hospital Cost-Efficiency and Sepsis Management with U.S. Launch of FDA-Cleared Procalcitonin FS Assay

SAN ANTONIO, Texas – Vidan Diagnostics, LLC has announced the nationwide availability of the Procalcitonin FS (PCT FS) assay following its FDA 510(k) clearance (K242294). Optimized specifically for acute-care hospital networks and Group Purchasing Organizations (GPOs), this fluid-stable, particle-enhanced immunoturbidimetric test provides emergency departments and intensive care units (ICUs) with a highly predictable, capital-efficient tool to evaluate sepsis progression on a patient’s first day of admission.

Driving Supply Chain and Clinical Value for GPOs and IDNs

By serving as the exclusive U.S. distributor for German manufacturer DiaSys Diagnostic Systems GmbH, Vidan Diagnostics introduces a robust clinical chemistry alternative to traditional dedicated immunoassay platforms. This shifts high-volume sepsis screening to open-channel chemistry infrastructure, eliminating specialized equipment footprints, expensive proprietary cartridges, and maintenance overhead.

• Instrument Interoperability: Engineered for seamless integration across existing hospital hardware, including high-throughput clinical chemistry systems like those of Beckman Coulter and Abbott Diagnostics, eliminating capital expenditures for new machinery.
• Significant Reagent Cost Containment: Liquid-stable, ready-to-use reagents lower total cost-per-test metrics, allowing GPOs to deliver immediate cost-reductive purchasing options to member hospitals.
• Superior Operational Waste Reduction: Exceptional on-board and calibration stability minimizes reagent degradation and calibration frequency, maximizing lab efficiency and eliminating product waste.
• Streamlined Core Lab Workflow: Consolidates critical diagnostic ordering onto central chemistry lines, accelerating turnaround times where every minute impacts patient outcomes.

Clinical Excellence and Sepsis Stewardship

Sepsis continues to represent one of the highest clinical and financial burdens in acute care. The Vidan Procalcitonin FS Assay empowers multi-facility health systems to standardize their clinical protocols with rigorous precision:

• Excellent Concordance: Demonstrated a 0.981 Cohen’s kappa score against the industry-standard predicate method, validating accurate risk stratification at critical decision thresholds.
• Definitive Accuracy: Achieved a 100% positive percent agreement (PPA) at the 0.5 ng/mL risk threshold and a 100% negative percent agreement (NPA) at the 2.0 ng/mL severe sepsis threshold.
• Unrivaled Sample Stability: Patient serum and plasma specimens remain fully stable for up to 24 hours at room temperature, 5 days when refrigerated, and 14 days when frozen, accommodating regionalized hub-and-spoke hospital laboratory networks.
• Resilience in Acute Patients: Utilizing a goat-derived polyclonal antibody design, the assay delivers maximum analytical recovery with zero interference from total proteins (up to 139 g/L) or human anti-mouse antibodies (HAMA up to 480 ng/mL).

About Vidan Diagnostics, LLC

Based in San Antonio, Texas, Vidan Diagnostics delivers high-performing clinical diagnostic supplies and liquid-stable reagents across the United States. The company focuses on equipping acute-care systems and hospital laboratories with accurate, cost-effective diagnostics to elevate patient care metrics while reinforcing supply chain stability.

GPO Contracting & Media Contact

Vidan Diagnostics, LLC
Corporate Accounts Team
24123 Boerne Stage Rd, Ste 205, San Antonio, Texas, 78255
Phone: (210) 314-1884
Website: Vidan Diagnostics

Medical Disclaimer: This news release provides general information regarding an FDA-cleared in-vitro diagnostic product for informational purposes only. It does not constitute medical advice, clinical training, or structural guidance for healthcare administration. Value analysis committees, laboratory directors, and clinical professionals must consult the physical product labels and official manufacturer package inserts to verify technical performance specifications, facility requirements, and validation steps prior to contract activation or clinical roll-out. Please double-check physical labels to confirm all dosage or assay metrics.