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Specifications:
| Application | Quality Control, Chemiluminescent Immunoassay | ||
| Storage Temperature | 2-8°C | ||
| Product Type | Clinical Control | Forms | Liquid |
| Product Brand | Autobio Diagnostics | ||
| Product Grade | Medical grade | ||
The AutoLumo CLIA Quality Controls are multi-level control materials developed to ensure precision, accuracy, and reliability in the performance of AutoLumo Chemiluminescent Immunoassay (CLIA) Analyzers.
Formulated for use with AutoLumo CLIA reagent kits, these controls provide consistent assay verification across endocrine, tumor, and cardiac marker panels.
Each control level is designed to validate analytical performance, monitor day-to-day assay consistency, and support compliance with internal and external quality assurance programs.
All control products are CE marked, traceable to reference materials, and ready to use upon reconstitution—making them essential for high-quality, reliable clinical diagnostics.
Key Features
- Comprehensive Panel Coverage: Includes controls for endocrine, tumor, and cardiac marker assays.
- Multi-Level Validation: Available in Level 1, Level 2, and Level 3 for full linear range assessment.
- High Stability and Precision: Ensures reproducible chemiluminescent assay results.
- Traceable to Reference Standards: Supports laboratory quality assurance programs.
- CE Marked: Certified for diagnostic laboratory use.
- Ready-to-Use: Supplied in easy-to-reconstitute liquid format.
- Long Shelf Life: Formulated for extended stability and consistent performance.
Product Range
| Code | Product Name | Description | Packaging | CE Mark |
|---|---|---|---|---|
| ZKE0101 | Endocrine Control, Level 1 | Control for endocrine hormone assays | 6 × 3 mL | Yes |
| ZKE0102 | Endocrine Control, Level 2 | Mid-range endocrine quality control | 6 × 3 mL | Yes |
| ZKE0103 | Endocrine Control, Level 3 | High-level control for endocrine assays | 6 × 3 mL | Yes |
| ZMK0101 | Tumor Marker Control II, Level 1 | Control for tumor marker assays (low) | 6 × 3 mL | Yes |
| ZMK0102 | Tumor Marker Control II, Level 2 | Tumor marker mid-level quality control | 6 × 3 mL | Yes |
| ZMK0103 | Tumor Marker Control II, Level 3 | High concentration control for tumor assays | 6 × 3 mL | Yes |
| ZKD0103 | Cardiac Marker Control, Level 1 | Control material for cardiac marker assays | 5 × 3 mL | Yes |
| ZKD0203 | Cardiac Marker Control, Level 2 | Mid-range cardiac quality control | 5 × 3 mL | Yes |
| ZKD0303 | Cardiac Marker Control, Level 3 | High-level cardiac control material | 5 × 3 mL | Yes |
Applications
- Internal Quality Control: Monitors instrument precision and assay accuracy for AutoLumo CLIA tests.
- Assay Verification: Ensures calibration consistency and analytical reliability.
- Performance Validation: Confirms linearity across the test range of CLIA reagents.
- Routine Laboratory Use: For endocrine, tumor marker, and cardiac panels.
- External Proficiency Testing: Compatible with international laboratory quality standards (ISO 15189, CLIA).
Performance Characteristics
- Type: Multi-analyte quality control material
- Matrix: Human serum-based formulation
- Levels: Level 1 (Low), Level 2 (Normal), Level 3 (High)
- Compatibility: AutoLumo CLIA Analyzers
- Stability: Long-term stability at 2–8°C (unopened); refer to IFU for post-reconstitution period
- Packaging: 3 mL vials, supplied in sets of 5 or 6 depending on control category
Unique Advantages
- Covers full AutoLumo assay spectrum including endocrine, tumor, and cardiac markers.
- Supports instrument calibration validation and reagent lot verification.
- CE-marked and traceable to international reference standards.
- Ensures day-to-day accuracy and long-term analyzer performance stability.
- Compatible with AutoLumo CLIA reagents and analyzers for seamless workflow integration.
The AutoLumo CLIA Quality Controls ensure consistent analytical performance and result reliability across all AutoLumo CLIA assay panels.
With multi-level validation, CE-marked assurance, and broad marker compatibility, these controls are essential for maintaining diagnostic accuracy and compliance in clinical, hospital, and research laboratories.
A trusted choice for laboratories seeking high-quality internal quality control solutions for chemiluminescent immunoassay systems.
- Type: Endocrine Control, Level 1 (6 × 3 mL) Endocrine Control, Level 2 (6 × 3 mL) Endocrine Control, Level 3 (6 × 3 mL) Tumor Marker Control II, Level 1 (6 × 3 mL) Tumor Marker Control II, Level 2 (6 × 3 mL) Tumor Marker Control II, Level 3 (6 × 3 mL) Cardiac Marker Control, Level 1 (5 × 3 mL) Cardiac Marker Control, Level 2 (5 × 3 mL) Cardiac Marker Control, Level 3 (5 × 3 mL)