- An in vitro diagnostic quality control material used in clinical laboratories and healthcare facilities, it verifies the precision and accuracy of rapid immunoassay testing systems
Uses
- Quality Assurance:
- Used as an external quality control to monitor and evaluate the performance of the OSOM® H. pylori Test Kit (PST-GEN-175)
- Accuracy Verification:
- Validates the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori in human serum, plasma, or whole blood
- Regulatory Compliance:
- Helps medical labs meet clinical compliance standards (such as CLIA regulations) by validating testing accuracy before reporting patient results
Features
- Dual-Vial Configuration:
- Packaged as a set containing one vial of positive control and one vial of negative control
- Pre-Rendered Liquid Form:
- Provided ready-to-use in a stable liquid format, eliminating the need for reconstitution or manual mixing
- Human Serum Base:
- Prepared from processed human serum to mimic real patient specimens closely
- Preservative Matrix:
- Formulated with added stabilizers, biochemicals, and preservatives (including sodium azide) to maintain shelf life
- Standard Cold Storage:
- Formulated for prolonged upright storage at standard refrigeration temperatures of 2°C–8°C (36°F–46°F)
Benefits
- In-House Validation:
- Gives laboratory technicians confidence that the diagnostic test strips and reagents are performing as expected
- Saves Laboratory Time:
- Ready-made liquid formula minimizes sample prep error and speeds up everyday laboratory setup procedures
- Reduces Diagnostic Error:
- External controls protect against false positives or false negatives caused by compromised test kits or incorrect storage conditions
- Clear-Cut Visual Results:
- Designed to yield a stark, unambiguous positive or negative reading line, aligning exactly with the corresponding test parameters
