[Expected use]
Used in conjunction with a urine analyzer, it is suitable for medical institutions to perform semi quantitative/qualitative detection of pH, SG, PRO, GLU, KET, BIL, URO, NIT, LEU, BLD, VC, CR, Ca2+, and MA in urine.
This product is a reagent to determine the multi-component of human urine. It is used for the most basic test item (routine urine test) of clinical urine analysis. It is mainly used for the auxiliary diagnosis of kidney disease, diabetes, urinary infection and other diseases (such as liver metabolism). It has no specificity of disease or indication.
Storage conditions and expiration date
1. Storage conditions: Store in a cool, dry place at 2 ℃ to 30 ℃, away from light. The test strip should be used immediately after being taken out of the packaging tube, and the lid should be immediately closed. Do not remove the desiccant from the packaging tube and do not transfer the test strips to other containers. The test strip should be kept away from moisture, high temperature, and direct sunlight.
2. Product shelf life: Store in a cool, dry place away from light at 2 ℃~30 ℃, with a shelf life of 12 months. After opening, the cylinder cover should be sealed and stored in a dry place at 2 ℃~30 ℃ away from light. The shelf life is 3 months.
3. The production date and expiration date can be found on the label.
[Applicable Instruments]
BH-NY01 Urine Analyzer, BH-QNY01 Fully Automatic Urine Analyzer.
Product Performance Indicators
1. Accuracy: The difference between the detection result and the corresponding reference solution labeled value should not exceed one order of magnitude in the same direction, and there should be no reverse difference. Positive reference solutions should not produce negative results, and negative reference solutions should not produce positive results.
2. Repeatability: The consistency of the test results shall not be less than 90%.
3. Detection limit: the first limit for all detection items except for specific gravity and pHA non negative level should be detectable.
4. Anti VC interference: For glucose, bilirubin, occult blood, nitrite, and white blood cell items, adding 2.8mmol/L ascorbic acid does not interfere with the test results.
5. Analysis specificity: The concentration of interfering substances does not interfere with the test results.