Generic name: Lyse reagent for hematology analyzer  Brand name: Tangent Lyse 3-Part 

REF: 70603

Package Specification Specification: 500 mL

Intended Use:

For in vitro diagnostic use by professionals. Dissolving red blood cells to release hemoglobin, maintaining the cell structure to be analyzed, for the purpose of cell count and quantitative determination of hemoglobin.

Test Principle:

Determination of hemoglobin: This reagent dissolves red blood cells to release hemoglobin, which then reacts with specific substance in the reagent and forms a stable brown compound. The number of hemoglobin is determined via the absorbance of this compound at 540nm. White blood cell (WBC) count: In addition to dissolving red blood cells, this reagent modifies WBCs without changing their structure. When WBCs pass through the hole in ruby in sequence, they are classified as large, medium, and small via the impedance which varies depending on cell size.

Main Composition

Sodium sulfate, surfactant, triethanolamine.

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:

Lyse 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. WBC membrane is compressed by the reagent and the cell size reduces. The number of WBC is then determined via the pulse rate. In addition, red blood cells are dissolved by the reagent to release hemoglobin, which then reacts with the reagent and determined by colorimetry. 

Reference Range Not applicable.

Quality Indicators:

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

Blank count: WBC ≤ 0.3×109/L,  HGB ≤ 2g/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.