Controls & Calibrators

Controls and Calibrators are essential quality assurance materials used in laboratories to verify the accuracy, precision, and reliability of analytical instruments and test systems. These standardized reference materials ensure that lab results are consistent, traceable, and within regulatory compliance. Whether used with chemistry analyzers, hematology systems, or point-of-care devices, controls and calibrators are fundamental to trustworthy diagnostics and research.

Why Controls and Calibrators Are Essential

Clinical and research laboratories must meet strict accuracy standards, especially when results influence medical decisions. Controls validate that test systems are performing as expected, while calibrators set measurement baselines for analyte detection. Without them, test results could drift, leading to false readings or non-compliance. By incorporating these materials into daily workflows, labs maintain confidence in their data and meet regulatory standards such as CLIA, CAP, ISO, and FDA requirements.

What Are Controls and Calibrators?

Controls are materials with known analyte concentrations used to verify that test systems produce accurate and reproducible results. Calibrators, on the other hand, establish a reference point for quantifying unknown samples. Both are manufactured with high stability, traceability, and compatibility for specific instrument platforms. Controls are typically run with patient samples to detect shifts or errors, while calibrators are used during instrument setup, maintenance, or lot changeovers.

Types of Controls and Calibrators

Multi-Analyte Chemistry Controls

Best for: Routine QC of clinical chemistry panels on automated analyzers.
These controls contain multiple analytes (e.g., glucose, creatinine, ALT, AST) in predefined concentrations.

Key Features:

• Human serum-based or synthetic matrix.
• Low, normal, and high concentration levels.
• Open- or closed-system compatibility.
• Long shelf life and refrigerated storage.
• Traceable to international standards (e.g., NIST).

Applications:

• Routine chemistry panels (CMP, BMP, liver, renal).
• Daily QC in hospital or reference labs.
• Reagent lot-to-lot verification.
• Analyzer performance monitoring.

Immunoassay Controls

Best for: QC of hormone, infectious disease, and biomarker tests.
These controls support ELISA, CLIA, and other immunoassay platforms.

Key Features:

• Includes analytes like TSH, hCG, HIV, or CRP.
• Matrix-matched to actual test samples.
• Compatible with ELISA readers and auto-analyzers.
• Multi-level validation for full reportable range.
• Liquid-stable or lyophilized formats.

Applications:

• Hormone and fertility testing.
• Infectious disease screening.
• Oncology and cardiac biomarker panels.
• Diagnostic kit validation.

Hematology Controls

Best for: Verifying CBC and differential parameters on hematology analyzers.
Used daily to confirm precision of WBC, RBC, HGB, PLT, and other parameters.

Key Features:

• 3-part or 5-part differential controls.
• Mimics whole blood consistency and appearance.
• Multiple concentration levels for full range QC.
• Compatible with major analyzer brands.
• Shelf-stable with extended open-vial stability.

Applications:

• Hospital hematology labs.
• Blood bank QC protocols.
• Instrument performance trend tracking.
• Training and proficiency testing.

Coagulation Controls & Calibrators

Best for: Monitoring PT, aPTT, INR, and D-dimer testing on coagulation analyzers.
These reagents ensure accuracy in clotting time and fibrin marker detection.

Key Features:

• Normal and abnormal plasma levels.
• Lyophilized or liquid-stable plasma-based material.
• Heparin-neutralizing and citrate-matched options.
• FDA-cleared and traceable to WHO/ISTH standards.
• Suitable for open- and closed-system analyzers.

Applications:

• Anticoagulation therapy monitoring.
• Hemostasis lab QC.
• Instrument validation and regulatory compliance.
• Proficiency testing in coagulation labs.

Point-of-Care Controls & Calibrators

Best for: Verifying the accuracy of portable analyzers (glucose, PT/INR, blood gas).
Single-use or multi-use vials ensure reliable results at the point of care.

Key Features:

• Cartridge-, strip-, or vial-based controls.
• Room temperature or refrigerated stability.
• Configured to match POC platform formats.
• Includes control codes or barcodes for tracking.
• Some models CLIA-waived compliant.

Applications:

• Glucometers, PT/INR monitors, and blood gas devices.
• Clinics, urgent care, and home health settings.
• Daily QC in decentralized test sites.
• POC device certification and audit readiness.

When to Use Controls & Calibrators

• During instrument calibration, startup, or reagent changes.
• To meet daily, shift-based, or regulatory QC requirements.
• When validating a new instrument, assay, or method.
• After maintenance or technical issues affecting system accuracy.
• For ongoing performance monitoring or audit documentation.

How to Use Controls and Calibrators

1. Select the control or calibrator that matches your instrument and analyte panel.
2. Prepare according to the manufacturer’s instructions (e.g., reconstitute lyophilized samples if needed).
3. Load into the analyzer and run like a patient sample.
4. Compare results to target ranges or calibration curves.
5. Document performance and investigate out-of-range values as needed.

Key Features of Controls & Calibrators

• Matrix-matched materials ensure realistic performance evaluation.
• Traceability to reference standards guarantees data reliability.
• Multi-level concentrations test the full range of assay sensitivity.
• Instrument-specific compatibility ensures accurate use.
• Regulatory-ready documentation for audits and inspections.

Benefits of Controls & Calibrators

Controls and calibrators provide the foundation for trustworthy lab results. They ensure diagnostic confidence, reduce retesting, and support accreditation from bodies like CLIA, CAP, or ISO. By catching drift or inconsistencies early, they safeguard patient outcomes and uphold your lab’s reputation. With options for virtually every instrument and assay, MedicalEx supports your quality assurance every step of the way.

How to Choose the Right Controls & Calibrators

• Match to your instrument brand and model for compatibility.
• Choose the right analyte panel based on your test menu (chemistry, hematology, coagulation, etc.).
• Select the appropriate levels (low, normal, high) for complete range validation.
• Consider stability and storage needs (refrigerated, lyophilized, open-vial stability).
• Verify regulatory compliance and traceability documentation.

Frequently Asked Questions (FAQs)

Q: What’s the difference between controls and calibrators?
A: Calibrators set the measurement baseline; controls verify that test systems are working properly after calibration.

Q: How often should I run controls?
A: Typically daily or per shift, depending on test complexity and CLIA requirements.

Q: Are controls compatible across different instruments?
A: Not always—choose instrument-specific or third-party validated controls to ensure compatibility.

Q: What does “matrix-matched” mean?
A: It means the control material mimics the actual patient sample type (e.g., serum, plasma, whole blood) for accurate performance.

Q: Do controls expire?
A: Yes. Check expiration dates and open-vial stability per manufacturer instructions to ensure reliable results.

Related Products

• Clinical Chemistry Analyzers: Use with multi-analyte chemistry controls and calibrators.
• Hematology & Coagulation Analyzers: Pair with 3-part, 5-part, PT/INR controls.
• Diagnostic Test Kits: Validate assay kits using appropriate third-party controls.
• Reagent Systems: Calibrators help maintain reagent accuracy over time.

Ensure your lab delivers results you can trust with premium controls and calibrators from MedicalEx. From routine daily QC to complex assay validations, we offer comprehensive solutions for every instrument and regulatory need. Explore our collection today and take control of your lab’s accuracy.