Hematology Control for 3 Part Analyzers

Hematology Control for 3 Part Analyzers is designed to monitor the accuracy and precision of automated and semi-automated impedance type hematology analyzers. D Check D is sampled in the same manner as a patient specimen and supports routine QC workflows for labs using 3-part hematology systems. It is suitable for use as CBC control material 3-part analyzer, blood analyzer control reagent, and quality control for hematology analyzer applications. It is also relevant for laboratories looking for hematology QC control India supply for routine CBC testing.

Pack size: 3 × 2.5 ml

Shelf life: 6 months

Storage: 2° to 8°C

Product Overview

D Check D is a hematology control material for automated and semi-automated impedance type analyzers. According to the IFU, it is composed of human and mammalian erythrocytes, simulated leukocytes, and simulated platelets suspended in a plasma-like fluid with preservatives. It is intended to help laboratories monitor analyzer performance using a stable control material handled in the same way as a patient sample.

If you are also running routine analyzer workflows, this control can be contextually linked to your 3-Part Hematology Analyzer, Diluent for Mindray 3 Part Hematology, and Probe Cleaner for Mindray 3 Part Hematology pages.

Intended Use

D Check D is a control designed to monitor the accuracy and precision of automated and semi-automated impedance type hematology analyzers. Refer to the assay table for specific instrument models.

Summary and Principle

Using a stable control is a standard laboratory practice for monitoring diagnostic test performance. D Check D provides a means of monitoring hematology blood cell counters and is sampled in the same manner as a patient specimen.

Composition

D Check D is an in vitro diagnostic reagent composed of:

• human and mammalian erythrocytes
• simulated leukocytes
• simulated platelets
• a plasma-like fluid with preservatives

Storage and Stability

Store D Check D upright at 2–8°C when not in use. Protect tubes from overheating and freezing. Unopened vials are stable through the expiration date. Opened vials are stable for 30 days, provided they are handled properly.

Signs of Deterioration

After mixing, the product should appear similar to fresh whole blood. In unmixed tubes, the supernatant may appear cloudy and reddish, which is normal and does not indicate deterioration. Other discolouration, very dark red supernatant, or unacceptable results may indicate deterioration. Do not use the product if deterioration is suspected.

Instructions for Use

1. Remove tubes from the refrigerator and allow them to warm to room temperature (15 to 25°C) for 15 minutes before mixing.
2. Hold the tube horizontally between the palms of the hands. Do not pre-mix on a mechanical mixer.
3. Roll the tube back and forth for 20–30 seconds, occasionally inverting the tube. Mix vigorously, but do not shake.
4. Continue mixing until the red cells are completely suspended. Tubes stored for a long time may require extra mixing.
5. Gently invert the tube 8–10 times immediately before sampling.
6. Analyze the sample as instructed in the Quality Control section of the operator’s manual for your instrument.
7. After sampling, clean residual material from the cap and tube rim with a lint-free tissue, replace the cap tightly, and return tubes to the refrigerator within 30 minutes of use.

Expected Results

Check that the lot number on the tube matches the lot number on the table of assay values. Assay values are determined on well-maintained, properly calibrated instruments. Reagent differences, maintenance, operating technique, and calibration may contribute to inter-laboratory variation.

Performance Characteristics

Assigned values are presented as a Mean and Range. The Mean is derived from replicate testing on instruments operated and maintained according to the manufacturer’s instructions. The Range estimates variation between laboratories and also reflects the inherent imprecision of the method.

The IFU also states that:

• a new lot of control should be confirmed before routine use
• the laboratory’s recovered mean should be within the assay range
• each laboratory should establish its own mean and acceptable range and periodically re-evaluate that mean
• Limitations

The performance of this product is assured only if it is properly stored and used as described in the IFU. Incomplete mixing of a tube prior to use invalidates both the sample withdrawn and any remaining material in the tube.

FAQs

What is Hematology Control for 3 Part Analyzers used for?

It is used to monitor the accuracy and precision of automated and semi-automated impedance type hematology analyzers.

Is D Check D suitable as CBC control material for a 3-part analyzer?

Yes. The IFU describes it as a stable control for hematology blood cell counters and states that it is sampled in the same manner as a patient specimen.

What is this blood analyzer control reagent made of?

It is composed of human and mammalian erythrocytes, simulated leukocytes, and simulated platelets suspended in a plasma-like fluid with preservatives.

How should D Check D be stored?

Store it upright at 2–8°C, protect it from overheating and freezing, and return opened tubes to the refrigerator within 30 minutes of use.

How long is an opened vial stable?

Opened vials are stable for 30 days, provided they are handled properly.

What happens if the tube is not mixed properly?

Incomplete mixing invalidates both the sample withdrawn and any remaining material in the tube.