Generic name: Diluent reagent for hematology analyzer Brand name: Tangent Diluent 3-Part  REF: 70601

Package Specification Specification: 20 L

Intended Use:

For in vitro diagnostic use by professionals. This product is used for dilution of blood samples and preparation of cell suspensions prior to cell analysis by automated hematology analyzers.

Test Principle:

This reagent provides specific osmotic pressure and pH to control the form of red blood cells and platelets. Together with cell lysis solution, it enables white blood cell measurement against cell size and further blood cell count in electrical conductivity.

Main Composition Sodium sulfate, buffer, antimicrobial.

Storage / Stability:

If stored at 2℃-30℃, relative humidity ≤90%, non-corrosive gas, the close vial stability is 2 years. After first opening and storage at 15-30, the open vial stability is 90 days.

Applicable Instrument:

Applicable to 3-part automated hematology analyzer from Genrui Biotech Inc. For further instructions refer to the user manual of the automated hematology analyzer. For RFID Card Use Only.

Preparation:

Diluent 3-Part is ready to use. If the automated hematology analyzer is a closed system bar code reading is applicable.  

Sample Requirements and Preparation:

Blood samples have no coagulation or contamination and are used within 4 hours after sampling. Diluent 3-Part is ready to use.

Test Method:

Electrical impedance measurements are used. This reagent provides specific osmotic pressure, pH, and electrical conductivity, and is used in conjunction with the cell lysis solution for blood cell count in the automated hematology analyzer.

Reference Range Not applicable.

Quality Indicators

Characteristics: Clear liquid, free from precipitates, particulates, or cotton-like substances.

Blank count : WBC ≤ 0.3×109/L, RBC ≤ 0.05×1012/L,  HGB ≤ 2g/L, PLT ≤ 10×109/L

Interpretation of Test Results:

For interpretation of the test results, refer to the user manual of the automated hematology analyzer. Use quality control CBC-3D for verification of results. 

Warning and Precautions:

1.   Avoid cross-contamination of blood samples.

2.   For trained professionals use only.

3.   Do not use after expiration date.

4.   Stop use if any precipitates, particulates, or cotton-like substances are observed.

5.   Dispose of waste, residual reagents, and contaminated packages in accordance with local regulations.

6.  Avoid direct contact with the reagent. If the reagent is splashed on skin or eyes incautiously, rinse immediately with plenty of water and go to a doctor.

7.   All patient specimens, calibrators and controls should be handled as potentially infectious.

8.   Use personal protective equipment as required.