- An in vitro diagnostic quality control material designed to verify the precision, accuracy, and operational performance of multiplex respiratory test devices
Uses
- Quality Assurance Monitoring:
- Serves as the dedicated external quality control set to monitor and validate the performance of the matching OSOM® Flu SARS-CoV-2 Combo Test Kit (PST-GEN-1080)
- Three-Pathogen Verification:
- Confirms the rapid diagnostic test's capability to accurately detect and differentiate antigens for Influenza A, Influenza B, and SARS-CoV-2
- Regulatory Standard Compliance:
- Assists decentralized testing facilities in meeting mandatory clinical laboratory guidelines (such as CLIA and laboratory QA standards) by proving diagnostic accuracy before real patient samples are verified
Features
- 10-Swab Pack Configuration:
- Supplied as a bundled kit containing 5 distinct positive control swabs and 5 distinct negative control swabs
- Combined Antigen Formulation:
- The positive control swabs are pre-coated with non-infectious antigens representing all three targeted respiratory pathways (Flu A, Flu B, and COVID-19), streamlining testing down to a single workflow
- Dry Swab Delivery Format:
- Manufactured in a stable, dry-swab design rather than liquid droplets, allowing technicians to mimic an authentic patient swabbing procedure
- Domestic Quality Standards:
- Formulated, packaged, and manufactured in the USA to meet stringent quality requirements and insulate clinical supply lines
Benefits
- Safeguards Patient Diagnostics:
- Prevents false clinical readings by instantly flagging compromised test strips, bad batches, or user error prior to live diagnostic reporting
- Maximized Workflow Efficiency:
- Eliminates complex manual liquid formulations, reconstitution steps, or dispensing errors
- Establishes Clear-Cut Visual Baselines:
- Yields highly predictable control and target lines on lateral-flow diagnostic sticks, establishing an unambiguous visual benchmark for clinic personnel
- Targeted Diagnostic Security:
- Provides medical teams total operational confidence when utilizing multiplex setups to catch overlapping seasonal viral mutations
