The 5-Part Hematology Analyzer Control is a tri-level tri-phasic whole-blood reference material engineered to monitor the precision and accuracy of automated differential cell counters. Formulated with stable human and avian cellular components, it mimics fresh blood specimens across white blood cell differentials, red blood cells, hemoglobin, and platelets. Each production lot includes instrument-specific target values to ensure compliant daily laboratory quality control protocols.
What Are Hematology Controls / Calibrators?
Hematology controls and calibrators serve as essential quality management tools in clinical laboratories, distinct from operational consumables such as diluents or lysing reagents.
Hematology Controls: Stable cellular suspensions with pre-determined concentration ranges. They are tested alongside routine clinical samples to evaluate daily measurement precision, identify analytical drift, and verify baseline system performance.
Hematology Calibrators: Highly characterized reference materials with single traceable point values. They are used exclusively to adjust signal gain settings and set physical measurement baselines during system installation or after major maintenance.
Role in Hematology Quality Control
Routine quality control testing ensures system stability and analytical consistency across daily laboratory operations:
Systemic Drift Identification: Detects optical pathway misalignment, fluidic pressure fluctuations, and reagent degradation before patient results are generated.
Precision Verification: Tracks run-to-run and day-to-day reproducibility within established standard deviation boundaries.
Regulatory Recordkeeping: Generates traceable performance records required for laboratory accreditation audits.
Differential Gating Validation: Confirms optical scatter and impedance gating algorithms for accurate identification of leukocyte subpopulations.
Control Levels / Application
This reference material is supplied in three distinct concentration levels to validate instrument response across the complete clinical measurement range:
Low Level
Simulates sub-normal cellular concentrations. Evaluates measurement sensitivity and linearity at lower detection limits, verifying accurate reporting for leukopenia, anemia, and thrombocytopenia.
Normal Level
Represents healthy physiological cell counts. Serves as the primary daily benchmark for routine system performance and optical scatterplot verification.
High Level
Simulates elevated cellular concentrations. Verifies measurement linearity without signal saturation or cell coincidence loss at upper detection limits.
Control vs. Calibrator
Distinguishing between controls and calibrators prevents improper adjustments to factory calibration factors and maintains test integrity:
|
Functional Feature |
Hematology Control |
Hematology Calibrator |
|
Primary Function |
Continuous precision and stability monitoring |
Setting baseline accuracy and gain adjustment |
|
Testing Frequency |
Daily or per shift |
Bi-annually or post-maintenance |
|
Assigned Value Type |
Target mean with defined range (±SD) |
Single fixed reference value |
|
System Impact |
Monitors performance without altering settings |
Directly updates internal calibration constants |
Compatible Hematology Analyzers
Formulated for matrix compatibility across automated 5-part differential platforms utilizing semiconductor laser scatter, flow cytometry, chemical staining, and electrical impedance technologies. Compatible parameter channels include:
- Forward light scatter, side scatter, and fluorescence channels
- Electrical impedance volume gating
- Colorimetric spectrophotometry for hemoglobin concentration
Assigned Values / Parameters
Each lot is assayed on target analytical platforms using reference measurement procedures. Assay sheets provide target means and acceptable ranges for the following 26 parameters:
|
Category |
Abbreviation |
Parameter Name |
Target Range Example (Normal) |
|
Leukocyte Count |
WBC |
White Blood Cells |
6.5 - 8.5 × 10⁹/L |
|
Differential % |
NEU% / LYM% / MON% / EOS% / BAS% |
Leukocyte Subpopulations (%) |
Established per lot |
|
Differential Absolute |
NEU# / LYM# / MON# / EOS# / BAS# |
Leukocyte Subpopulations (Abs) |
Established per lot |
|
Erythrocyte Count |
RBC |
Red Blood Cells |
4.00 - 5.00 × 10¹²/L |
|
Hemoglobin |
HGB |
Hemoglobin Concentration |
135 - 155 g/L |
|
Indices |
HCT / MCV / MCH / MCHC |
Hematocrit & Red Cell Indices |
Standard physiological bounds |
|
Red Cell Width |
RDW-CV / RDW-SD |
Red Cell Distribution Width |
11.5 - 15.0 % |
|
Platelet Count |
PLT |
Platelet Count |
180 - 280 × 10⁹/L |
|
Platelet Indices |
MPV / PDW / PCT |
Platelet Indices |
Standard physiological bounds |
Product Specifications
|
Technical Property |
Specification |
|
Physical Form |
Suspension liquid; dark red when mixed |
|
Matrix Source |
Stabilized human red blood cells and nucleated biological components |
|
Vial Type |
Screw-cap vials with puncture-permeable septa |
|
Volume Options |
2.0 mL / 3.0 mL / 4.0 mL |
|
Packaging Configurations |
Tri-level combination sets or single-level bulk packages |
|
Measurement Traceability |
Reference procedures defined by ICSSH guidelines |
Storage & Stability
|
Operational Parameter |
Guideline |
|
Storage Temperature |
2°C to 8°C (35°F to 46°F). Do not freeze. Protect from light. |
|
Unopened Shelf Life |
90 days from manufacturing date when stored at 2°C–8°C |
|
Open-Vial Stability |
14 days when sampled according to protocol and promptly refrigerated |
|
Thermal Cycle Limit |
Up to 14 thermal cycles within the 14-day open-vial window |
Quality Assurance
Batch Precision: Manufactured under ISO 13485 quality systems to maintain minimal inter-lot variation (CV < 2.5%).
Donor Screening: Source biological materials test negative for HBsAg, anti-HCV, and anti-HIV antibodies using standard screening assays.
Homogeneity Analysis: Random sampling across production runs undergoes statistical evaluation prior to distribution.
Cold Chain Shipping: Insulated shipping containers maintain internal temperatures between 2°C and 8°C during international transit.
FAQ
Q: How should the vial be mixed before sampling?
A: Remove the vial from refrigerated storage and allow it to adjust to room temperature for 15 minutes. Roll the vial horizontally between palms 8 to 10 times, invert gently 8 to 10 times, and confirm the cellular pellet at the bottom is fully resuspended. Avoid mechanical vortexing.
Q: What action is required if control values fall outside expected limits?
A: Inspect the vial visually for hemolysis, clotting, or microbial contamination. Re-mix the vial thoroughly and repeat the assay. If values remain out of range, check reagent fluidics, temperature controls, and background counts before adjusting instrument settings.
Q: Can this product be used to calibrate an analyzer?
A: No. Controls are formulated specifically for precision monitoring and routine stability checks. Calibration requires dedicated calibrator materials with single reference setpoints.
Q: How does room temperature exposure impact open-vial stability?
A: Temperatures exceeding 25°C accelerate cellular degradation. Return vials to 2°C–8°C storage immediately after aspirating the required sampling volume.
Q: Are target values available in digital formats?
A: Yes. Assay values, target means, and ranges are supplied in printed format and as downloadable files compatible with analyzer quality control software modules.
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