- An in vitro diagnostic quality control material which verifies the precision, accuracy, and overall operational performance of corresponding rapid lateral-flow antigen testing systems
Uses
- Quality Assurance Monitoring:
- Acts as an external, assayed quality control mechanism used to regularly verify the testing accuracy of the matching OSOM® COVID-19 Antigen Rapid Test (PST-GEN-1066-40)
- Antigen Target Verification:
- Confirms the diagnostic assay's ability to qualitatively identify the SARS-CoV-2 nucleocapsid protein antigen from upper respiratory samples
- Regulatory Standard Compliance:
- Assists point-of-care networks and decentralized laboratories in meeting good laboratory practices and mandatory CLIA QA verification guidelines before reporting patient results
Features
- 10-Swab Pack Configuration:
- Packaged as a bundled set consisting of 5 positive control swabs and 5 sterile nasal swabs (negative controls
- Pre-Coated Dry Swab Format:
- Manufactured using a stable, dry-swab delivery design rather than liquid droplets, allowing laboratory staff to accurately mimic an authentic patient collection process
- EUA Authorized Pathway:
- Distributed under an active FDA Emergency Use Authorization (EUA) explicitly for prescription, in vitro diagnostic point-of-care applications
- Targeted Device Compatibility:
- Specifically formatted to complement the extraction solutions, strips, and parameters of the OSOM 1066-40 rapid test kits
Benefits
- Safeguards Against Diagnostic Error:
- Shields clinics from false positive or false negative readings by instantly flagging compromised test batches, reagent expiration, or operator mistakes
- No Fluid Measurement Mistakes:
- The pre-coated dry-swab design eliminates complex liquid pipetting or multi-step volumetric math errors during control formulation
- Establishes Clear Baseline Readouts:
- Provides an unambiguous, contrasting visual reference line for personnel to establish a trusted standard for manual strip readings
- Protects Patient Triage Care:
- Enhances clinical confidence during rapid 15-minute diagnostic routines, ensuring patients are routed to appropriate isolation or antiviral therapies based on true results
