100T Urinalysis Test Strip ISO13485 Urine Infection Strips Dry Chemical Method

Urine-H Series, Urinalysis Test Strip (Dry Chemical Method)

1. [Packing Specification]

100 strips / box

2. [Intended Application]

The urinalysis strip is designed for quantitative and semi-quantitative determination of 11 items, including bilirubin, urobilinogen, ketone, ascorbic acid, glucose, protein, occult blood, nitrite, leukocyte, pH value and specific gravity, in human urine. The product can be applied by visual inspection and with a urine analyzer. Routine urinalysis belongs to medical examination. Routine urine test cannot be neglected in clinical conditions, as it reflects severity and progression of kidney and urinary tract diseases. Urine of patients with some early urinary system diseases shows proteinuria or visible components of urinary sediment. Urinalysis shows important referential values for diagnosis of urinary system disease and observation of the curative effect as well as for diagnosis and prognosis of other system diseases. For example, it facilitates diagnosis of urinary system diseases and observation of the curative effect, covering tuberculosis, calculus, vascular or urinary system inflammation, lymphatic lesion, kidney transplant and others, diagnosis of metabolic disorders-induced diseases (such as diabetes, pancreatitis, acute hemolytic disease and others), and auxiliary diagnosis of occupational diseases, including acute mercury poisoning, carbon tetrachloride poisoning, chronic lead, chromium or cadmium poisoning and others.

3. [Test Principles]

1. Bilirubin: Direct bilirubin specifically reacts with dichloroaniline diazonium salt under a strong acid condition to form azo dye.

2. Urobilinogen: According to the principle of azo combination method, urobilinogen couples with diazonium salt under a strong acid condition to form carmine dye.

3. Ketone. According to the principle of sodium nitroprussiate method, sodium nitroprusside interacts with ketone (acetoacetic acid) under an alkaline condition to present purple compound.

4. Ascorbic Acid: Ascorbic acid reverts blue 2,6-dichlorophenol indophenol sodium in oxidation state to colorless compound under an alkaline condition.

5. Glucose: According to the principle of glucose oxidase, glucose oxidase specifically oxidizes glucose to form gluconic acid and hydrogen peroxide. Under the function of peroxidase, hydrogen peroxide oxidizes the indicator to develop a color.

6. Protein: According to the principle of the protein error method for dye combination, protein combines with dye to form compound and show another color.

7. Occult Blood: Peroxide is decomposed under the peroxidase-like catalytic effect of hemoglobin, which oxidizes tetramethyl benzidine to develop a color.

8. Nitrite: Nitrite in urine develops diazo-reaction with sulfanilamide in test paper to form diazonium salt. The diazo compound later combines with naphthyl-ethylenediamine dihydrochloride to show a peach color.

9. Leukocyte: Esterase is contained in neutrophil cytoplasm. It hydrolyzes an indoxyl substrate to release phenol, which reacts with diazonium salt to form purple red compound.

10. pH Value: It is based on acid-alkaline indicator method.

11. Specific Gravity: It is determined with multiple-polyelectrolyte method. Ion exchange occurs between electrolytes in urine and methyl vinyl ether-maleic acid copolymer. Positive ions exchange between electrolyte (in the form of salt) in urine and polymer to release hydrogen ions, which reacts with acid-alkaline indicator, showing a color change.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world