The 3-Part Hematology Analyzer Control is a tri-level reference material prepared from stabilized blood cell suspensions to evaluate the accuracy and precision of automated hematology counters.
What Are Hematology Controls / Calibrators?
Hematology controls are stabilized cellular suspensions with assigned target values used to monitor routine instrument performance and analytical precision. Unlike calibrators, which adjust instrument settings and baseline calibration factors, controls operate as independent reference samples to detect systemic drift, fluidic errors, and reagent variation without altering internal system coefficients.
Role in Hematology Quality Control
Daily Precision Verification: Monitors counting consistency across fluidic, optical, and impedance channels prior to patient sample testing.
Analytical Error Detection: Assists in identifying signal drift, reagent deterioration, light source decay, and aperture clogging.
Regulatory Compliance: Provides documented quality reference data to support laboratory accreditation protocols.
Lot Transition Validation: Evaluates measurement baseline continuity during reagent batch changes or routine system maintenance.
Control Levels / Application
Low Level: Evaluates measurement accuracy, lower detection limits, and linearity in leukopenic, thrombocytopenic, and anemic ranges.
Normal Level: Monitors instrument performance within standard physiological reference intervals.
High Level: Evaluates upper linearity limits and counting accuracy in leukocytosis, thrombocytosis, and polycythemia ranges.
Control vs. Calibrator
|
Aspect |
Hematology Control |
Hematology Calibrator |
|
Primary Function |
Evaluates ongoing analytical precision |
Sets baseline measurement scale |
|
Execution Frequency |
Daily or each operating shift |
Periodic or post-maintenance |
|
Assigned Target |
Statistical range with upper and lower limits |
Fixed reference value |
|
Material State |
Tri-level stabilized cellular suspension |
Purified single-level reference |
|
System Interaction |
Reports current error without changing settings |
Adjusts internal calibration factors |
Compatible Hematology Analyzers
Formulated for open and closed vial sampling modes across automated three-part differential cell counters using standard isotonic diluent platforms.
Assigned Values / Parameters
|
Parameter |
Unit |
Low Level (Mean ± SD) |
Normal Level (Mean ± SD) |
High Level (Mean ± SD) |
|
WBC |
10^9/L |
2.1 ± 0.4 |
7.2 ± 0.8 |
19.5 ± 1.8 |
|
RBC |
10^12/L |
2.35 ± 0.20 |
4.40 ± 0.30 |
5.50 ± 0.40 |
|
HGB |
g/dL |
6.2 ± 0.4 |
13.5 ± 0.6 |
17.8 ± 0.8 |
|
MCV |
fL |
68.0 ± 4.0 |
88.0 ± 4.0 |
100.0 ± 5.0 |
|
PLT |
10^9/L |
75 ± 15 |
210 ± 30 |
480 ± 50 |
|
LYM% |
% |
15.0 ± 5.0 |
28.0 ± 6.0 |
50.0 ± 8.0 |
|
MID% |
% |
6.0 ± 3.0 |
8.0 ± 3.0 |
12.0 ± 4.0 |
|
GRAN% |
% |
79.0 ± 8.0 |
64.0 ± 7.0 |
38.0 ± 6.0 |
Product Specifications
|
Property |
Technical Specification |
|
Physical Form |
Stabilized liquid suspension of human and mammalian cellular elements |
|
Pack Configuration |
Tri-Level Pack (1 Low, 1 Normal, 1 High) or single level packs |
|
Fill Volume |
3.0 mL per vial |
|
Closed-Vial Shelf Life |
105 days from manufacturing date |
|
Open-Vial Stability |
14 days maintained at 2°C to 8°C |
|
Temperature Range |
Storage and shipment at 2°C to 8°C |
Storage & Stability
Storage Temperature: Keep continuously between 2°C and 8°C. Do not subject to freezing temperatures.
Light Exposure: Store vials inside original outer packaging away from direct light exposure.
Mixing Protocol: Allow vial to reach ambient room temperature (15°C to 30°C) for 15 minutes prior to mixing. Roll the vial horizontally between palms and invert gently until sediment is fully resuspended. Avoid vigorous shaking to prevent mechanical foaming.
Quality Assurance
Safety Testing: Donor blood units test negative for HBsAg, anti-HCV, and anti-HIV antibodies.
Value Assignment: Values established using standard reference methods and calibrated laboratory counters.
Manufacturing System: Formulated and packaged within facilities operating under ISO 13485 quality systems for in vitro diagnostic products.
FAQ
Q: What is the closed-vial shelf life?
A: The material retains target value stability for 105 days from production when maintained between 2°C and 8°C.
Q: How long does the material remain usable after opening?
A: An opened vial maintains target stability for 14 days or 14 sampling entries when recapped immediately and returned to 2°C to 8°C storage.
Q: Can the product be frozen to extend shelf life?
A: Freezing damages cellular structures and causes cell lysis, rendering the material invalid for accurate counts.
Q: What is the correct preparation procedure prior to aspiration?
A: Equilibrate the vial at room temperature for 15 minutes, then roll gently between palms and invert end-over-end until cellular sediment is fully suspended without air bubbles.
Q: Why are target parameters provided as a value range instead of a single digit?
A: Target parameters include an upper and lower limit to account for expected operational variances across different counting channels, optical systems, and ambient measurement environments.
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