- A dedicated external quality control set designed exclusively to verify the performance, accuracy, and technical execution of the OSOM® iFOB Test system
Uses
- System Validation:
- Serves as a reliable, external checkpoint to confirm that the immunochemical fecal occult blood test (iFOBT) strips and extraction reagents are reacting correctly prior to patient sample testing
- Proficiency Auditing:
- Utilized by medical directors and laboratory supervisors to assess, train, and validate the testing techniques of point-of-care clinical staff
- Regulatory Compliance:
- Run periodically to fulfill routine quality assurance protocols required for internal audits and external inspection validations
Features
- Dual-Level Controls:
- Packaged as a matching set containing 1 Positive Control vial and 1 Negative Control vial per box
- Target Specificity:
- Formulated to specifically match the analytical sensitivity profile of the assay (50ng hHb/mL buffer), ensuring the positive control triggers a accurate visual line without over-saturating the strip
- Matrix Verification:
- Replicates the liquid consistency of a processed fecal extraction sample to ensure the lateral flow membrane wicks the fluid at the correct rate
- Streamlined Formulation:
- Composed of stable components that eliminate the complex preparation steps associated with raw biological control matrices
Benefits
- Eliminates False Assurance:
- Verifies that a negative patient result is genuinely negative and not a byproduct of damaged or expired lateral flow test components
- Saves Patient Samples:
- Running external controls prevents the wastage of actual, patient-collected stool specimens on potentially compromised test batches
- Affordable Lab Compliance:
- Offers a low-cost, dedicated restocking mechanism for clinics that exhaust their "QC Inside" built-in sticks before finishing their full diagnostic cassette inventory
- Minimizes Reporting Errors:
- Instills absolute confidence in diagnostic readouts for colorectal cancer screenings, diverticulitis, polyps, or general gastrointestinal bleeding
