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INTRODUCTION

Since 2006, JUSBIO, a subsidiary of Dunwill, has been focusing on independent research, development, production and sales of clinical biochemical reagents, and in the same year, it obtained the license for the production of medical devices. Through continuous innovation and development, the current product lineups on the market include liver function, renal function, blood lipids, glucose metabolism, cardiac enzymes, special proteins, coagulation and rheumatoid, etc., and the brand and quality of the company have gained wide recognition among the users. Over the years, we have participated in the clinical biochemistry testing projects of the Ministry of Health and Shanghai Center For Clinical Laboratory with excellent results in EQA, the company has passed the TÜV ISO 13485 quality management system certification.

Featured Products
Glycated Albumin Assay Kit
  • Glycated Albumin Determination Kit (Enzymatic Method) (Enzymatic Method Modified BCP) (Registration Certificate No.: Shanghai Machinery Registration Standard 20192400466)

  • 1. Glycated Albumin (GA) reflects the average blood glucose level of diabetic patients in the 2~3 weeks prior to the test. It is more sensitive to short-term glucose changes than HemoglobinA1c (HbA1c) and is a good indicator for evaluating patients' short-term glycemic control.


    2. Being used to screen for diabetes and assist in identifying stress hyperglycemia caused by acute stress such as trauma and infection. As well as screening for diabetes, monitoring of glycemic control and evaluation of efficacy, it is particularly suitable for evaluation of efficacy of diabetic patients after adjustment of their treatment program.


    3. GA is now included in several guideline consensus and is a recommended program of the Japanese Society of Diabetes and Pregnancy. For Example:
    Chinese Guidelines for Clinical Application of Glucose Monitoring (2021 Edition)
    Chinese Guidelines for the Prevention and Control of Type 2 Diabetes (2020 edition)
    Expert Consensus on Health Screening Programs (Chinese Journal of Health Management, April 2014)
    Guidelines for the Treatment of Diabetes Mellitus in Hemodialysis Patients 2012 (Japanese Society of Dialysis Medicine)


Product Features
  • High Accuracy
    Test the standard of JCCRM611-1 Glycated Albumin from Japan and get the results with high accuracy and relative deviation within 10%.
    Standard JCCRM611-1-MJCCRM611-1-HJCCRM611-1-HH
    Standard -1.94%-3.77%-3.06%
  • Wide Detection Range
    Glycated protein can be detected up to 3.0 g/dL and albumin reagents can be detected up to 6.0 g/dL.
  • Good Clinical Relevance
    Good correlation with Lucica GA-L kit manufactured by Asahi Kasei Pharmaceutical Co., Ltd. with r-value up to 0.9935 (Statistical data of 100 clinical samples)
    Good-Clinical-Relevance.jpg
  • High Anti-interference Capability
    It has good resistance to interferences such as calcium hydroxybenzenesulfonate, VC, bilirubin, triglycerides, and uric acid.
    Clinical-Chemistry-Kit-2.jpg
    Clinical-Chemistry-Kit-3.jpg

Basic Product Information

Product Specification
Applicable Samples
Methodological
Specification 1 Glycated Albumin Reagent: R1:1x40ml R2:1x10ml
Albumin Assay Reagent: R1:1x40ml R2:1x20ml
Calibrator: 1mlx1 Bottle (Lyophilized)
Quality Control: L、H 1mlx1 Bottle (Lyophilized)
Specification 2 Glycated Albumin Reagent: R1:1x40ml R2:1x10ml
Albumin Assay Reagent: R1:1x40ml R2:1x20ml
Specification 3 Glycated Albumin Reagent: R1:2x40ml R2:1x20ml
Albumin Assay Reagent: R1:2x40ml R2:1x40ml
Specification 4 Glycated Albumin Reagent : R1:3x60ml R2:1x45ml
Albumin Assay Reagent: R1:3x60ml R2:2x45ml
Plasma
GA: Enzymatic Method 
ALB: Modified BCP Method
Accuracy
Repeatable
Measurement Range
Anti-interference Capability
Relative Deviation Within ±10%
Glycated Albumin CV <5%;
Albumin CV<2%
Glycated Albumin 0.38~2.90g/dL
Albumin 1.0~6.0g/dL
Glycated Albumin （%）:
3.2%~68.1%
Hemoglobin 200mg/dL
Bilirubin 30mg/dL
Milky 2000mg/dL
VitC 100mg/dL
Calcium Hydroxybenzenesulfonate 50 ug/mL

Clinical Significance and Applicable Population

  • Obstetrics - Screening and Management of Gestational Diabetes Mellitus

    Detection and management of gestational diabetes and monitoring of neonatal complications. Glycated albumin (GA) reflects blood glucose levels and glycemic control over the past 2-3 weeks and is not affected by iron deficiency anemia. Monitoring both GA and glycosylated hemoglobin A1c (HbA1c) levels during pregnancy can help to detect and control gestational diabetes in a timely manner; help to better assess glycemic control and guide treatment plans; and help to detect and monitor related neonatal complications to protect the health of mother and baby.

  • Nephrology/Dialysis Unit/General Internal Medicine - Diabetic Patients with Impaired Renal Function

    People with impaired renal function, diabetic patients with impaired renal function and people with certain diseases (e.g. hyperthyroidism, heart failure, etc.) requiring regular testing. For example, patients with liver disease, nephrotic syndrome, diabetes mellitus combined with impaired renal function, dialysis, etc. Due to the decrease in glomerular filtration rate after impaired renal function, the traditional HbA1c level may be inaccurate, and GA can reflect more objectively the blood glucose level and glycemic control of this group of patients, and provide references for timely adjustment of the treatment program.

  • Endocrinology - Diabetes

    Glucose management and dynamic monitoring in diabetic patients. Compared with long-term glycemic control indicators such as HbA1c, GA reflects more recent blood glucose levels and is more sensitive. Regular monitoring of GA levels can help patients better understand the effect of their own glycemic control and short-term fluctuations in blood glucose, which helps to assess the effectiveness of the condition and treatment program, and provides a basis for the selection and adjustment of the subsequent glucose-lowering treatment and nutritional intervention program. Regular monitoring and timely intervention can help reduce the risk of complications such as diabetic nephropathy, retinopathy and related atherosclerosis and improve the quality of life.

  • Health Management Center - Diabetes at Risk

    GA can more accurately assess blood glucose levels and glycemic control in high-risk groups such as those with abnormal glucose tolerance, the elderly, the obese, the malnourished, and those with other chronic diseases (e.g., hypertension, hyperlipidemia, etc.).Abnormal GA is an important indication that suggests that an Oral Glucose Tolerance Test (OGTT) is needed for people at high risk of diabetes; GA (≥17.1%) in conjunction with fasting blood glucose ( FPG) for diabetes screening can help in early detection of the disease and management of potential risks.

  • Surgery - Perioperative Glycemic Control

    Perioperative glycemic control and differential diagnosis of unspecified etiologies. Short and medium-term changes in perioperative glycemic control are usually not reflected by HbA1c. To assess perioperative glycemic control, GA is more useful than HbA1c. The combined detection of GA and HbA1c can assist in determining perioperative hyperglycemic status and differentiating stress hyperglycemia, especially if the patient has renal insufficiency. For comatose patients of unknown etiology or resuscitated patients undergoing glucose infusion, urgent checking of GA and HbA1c is of differential diagnostic value.
Products
Liver Function Series
Name Of Kit Detection Methods Registration Number
1 Alkaline Phosphatase Assay Kit AMP buffer method Shanghai Machinery Registration Standard 20192400215
2 Aspartate Aminotransferase Assay Kit IFCC Recommended Methods Shanghai Machinery Registration Standard 20192400208
3 Alanine Aminotransferase Assay Kit IFCC Recommended Methods Shanghai Machinery Registration Standard 20192400182
4 Gamma-glutamyl Transferase Assay Kit IFCC Recommended Methods Shanghai Machinery Registration Standard 20192400219
5 Total Bilirubin Assay Kit Chemical oxidation method Shanghai Machinery Registration Standard 20192400207
6 Direct Bilirubin Assay Kit Chemical oxidation method Shanghai Machinery Registration Standard 20192400207
7 α-L-Fucosidase Assay Kit CNPF substrate method National Machinery Registration Standard20153400547
8 Total Bile Acid Assay Kit Cyclic Enzyme Rate Method Shanghai Machinery Registration Standard 20192400218
9 Cholinesterase Assay Kit Butyrylthiocholine method Shanghai Machinery Registration Standard 20192400170
10 Total Protein Assay Kit Carbamide Shanghai Machinery Registration Standard 20192400185
11 Albumin Assay Kit Bromocresol green method Shanghai Machinery Registration Standard 20192400203
12 Adenosine Deaminase Assay Kit Colorimetric enzyme assay Shanghai Machinery Registration Standard 20192400222
13 Pre-Albumin Assay Kit Immunoturbidimetric Method Shanghai Machinery Registration Standard 20192400211
14 Aspartate Aminotransferase Isoenzyme Assay Kit Immunosuppression Shanghai Machinery Registration Standard 20202400330
15 Sialic Acid Assay Kit Eenzyme method Shanghai Machinery Registration Standard 20202400331
16 Glycocholic Acid Assay Kit Latex immunoturbidimetric method Shanghai Machinery Registration Standard 20202400534
17 Glutathione Reductase Assay Kit Glutathione substrate method Shanghai Machinery Registration Standard 20212400590
18 Apolipoprotein E Assay Kit Immunoturbidimetric Method National Machinery Registration Standard20182400062
Renal Function Series
Name Of Kit Detection Methods Registration Number
1 Uric Acid Measurement Kit Uric Acidase-POD Method Shanghai Machinery Registration Standard 20192400206
2 Urea Nitrogen Measurement Kit AGLDH coupling method Shanghai Machinery Registration Standard 20192400172
3 Creatinine Assay Kit Creatine oxidase method Shanghai Machinery Registration Standard 20192400165
4 α1-Microglobulin Assay Kit Latex-enhanced immunoturbidimetric assay Shanghai Machinery Registration Standard 20182400060
5 β2-mIcroglobulin Assay Kit Latex-enhanced immunoturbidimetric assay Shanghai Machinery Registration Standard 20192400209
6 Retinol Binding Protein Assay Kit Latex Enhanced Immunoturbidimetric Method Shanghai Machinery Registration Standard 20182400085
7 Urine Microalbumin Assay Kit Latex-enhanced immunoturbidimetric method Shanghai Machinery Registration Standard 20182400084
8 Cystatin C Assay Kit Latex-enhanced immunoturbidimetric assay Shanghai Machinery Registration Standard 20182400063
9 β2-mIcroglobulin Assay Kit Immunoturbidimetric method Shanghai Machinery Registration Standard 20232400051
Cardiac Myosin Series
Name Of Kit Detection Methods Registration Number
1 Creatine Kinase Assay Kit IFCC recommended method Shanghai Machinery Registration Standard 20142400089
2 Creatine Kinase Isoenzyme Assay Kit Immunosuppression Shanghai Machinery Registration Standard 20192400168
3 α-Hydroxybutyrate Dehydrogenase Assay Kit DGKC recommended method Shanghai Machinery Registration Standard 20192400186
4 Lactate Dehydrogenase Assay Kit Lactate substrate method Shanghai Machinery Registration Standard 20192400173
5 Homocysteine Assay Kit Cyclase Shanghai Machinery Registration Standard 20182400036
Lipid Metabolism Series
Name Of Kit Detection Methods Registration Number
1 Triglyceride Assay Kit GPO-PAP method Shanghai Machinery Registration Standard 20192400167
2 Total Cholesterol Measurement Kit CHOD-PAP Method Shanghai Machinery Registration Standard 20192400184
3 HDL Cholesterol Assay Kit Direct method Shanghai Machinery Registration Standard 20192400183
4 LDL Cholesterol Assay Kit Direct method Shanghai Machinery Registration Standard 20192400169
5 Lipoprotein A Assay Kit Immunoturbidimetric method Shanghai Machinery Registration Standard 20192400210
6 Apolipoprotein A1 Assay Kit Immunoturbidimetric method Shanghai Machinery Registration Standard 20192400212
7 Apolipoprotein B Assay Kit Immunoturbidimetric method Shanghai Machinery Registration Standard 准20192400213
Glucose Metabolism Series
Name Of Kit Detection Methods Registration Number
1 Glucose Assay Kit HK method Shanghai Machinery Registration Standard 20192400181
2 Glucose Assay Kit GOD-PAP method Shanghai Machinery Registration Standard 20142400090
3 Glycated Hemoglobin Assay Kit Latex agglutination turbidimetric method Shanghai Machinery Registration Standard 20192400232
4 Free Fatty Acid Assay Kit Enzyme method Shanghai Machinery Registration Standard 20182400061
5 Glycosylated Serum Protein Assay Kit Fructosamine method Shanghai Machinery Registration Standard 20192400171
6 Glycated Albumin Assay Kit Enzymatic Shanghai Machinery Registration Standard 20192400466
Ion Series
Name Of Kit Detection Methods Registration Number
1 Calcium DetermInation Kit Azoarsenic III Method Shanghai Machinery Registration Standard 20192400166
2 Magnesium Assay Kit Colorimetric method with dimethylaniline blue Shanghai Machinery Registration Standard 20192400204
3 Phosphorus Determination Kit Molybdate method Shanghai Machinery Registration Standard 20192400205
Pancreas Series
Name Of Kit Detection Methods Registration Number
1 α-Amylase Assay Kit EPS-G7 method Shanghai Machinery Registration Standard 20142400092
Rheumatoid Series
Name Of Kit Detection Methods Registration Number
1 Antistreptococcal Hemolysin "O" Kit Latex-enhanced immunoturbidimetric assay Shanghai Machinery Registration Standard 20182400087
2 Rheumatoid Factor Kit Latex-enhanced immunoturbidimetric assay Shanghai Machinery Registration Standard 20182400086
Specific Protein Series
Name Of Kit Detection Methods Registration Number
1 Ultrasensitive C-Reactive Protein Assay Kit Latex Turbidimetric Method Shanghai Machinery Registration Standard 20142400091
Coagulation Series
Name Of Kit Detection Methods Registration Number
1 D-dimer Assay Kit Latex-enhanced immunoturbidimetric assa Shanghai Machinery Registration Standard 20182400088
2 Fibrin (Plasma) Degradation Product Measurement Kit Latex Enhanced Immunoturbidimetric Method Shanghai Machinery Registration Standard 20182400059
Applicable Instrument Models
Widely adapted to domestic and foreign mainstream automatic biochemical analyzers

  • Hitachi Series

    7080 / 7100 / 7170 / 7180 / 7600P / 008

  • Toshiba Series

    TBA- 40RF / TBA-120FR / TBA-2000RF / Accute

  • Beckman Series

    AU480 / AU680 / AU2700 / AU5400 / AU5800 / DxC600 / DxC800 / LX4201

  • Abbott Series

    Aeroset 2000 / Aeroset C8000 / Aeroset C16000

  • Roche Series

    Cobas c501 / Cobas c701 / Cobas c702 / Cobas Mira / Cobas Mira S

  • Roche Series

    BS-120 / BS-200 / BS-300 / BS-400 / BS-800 / BS-2000M

  • Siemens Series

    Advia 1200 / Advia 1800 / Advia 2400 / Vista 1500 / Vista 3000 / Xpand Plus

  • Kehua Series

    ZY 1200 / 1280 / ZY 400 / 450 / ZY 350 / 360 / ZY 220 / 230

Alkaline Phosphatase Assay Kit
Clinical measurement of alkaline phosphatase (ALP) is mainly used in the diagnosis and differential diagnosis of diseases of the skeletal and hepatobiliary systems, especially in the differential diagnosis of jaundice.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.04 at 200U/L

2. Accuracy: Relative deviation within ± 10%

3. within-run precision CV ≤4.0%

4. Between run precision：R≤5.0%: Relative extreme difference R≤5.0%

5. Linear range: (0~750) U/L, r≥0.990

6. On-board in use on the analyzer : 14days

7. Expiry date at 2-8℃：12 months

Aspartate Aminotransferase Assay Kit
AST is an important liver function test to check whether the liver tissue is damaged. Serum aspartate aminotransferase is significantly elevated in acute jaundiced hepatitis, chronic active hepatitis, severe hepatitis, cirrhosis, and hepatocellular carcinoma.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.020 at 95U/L
2. Accuracy: Relative deviation within ±10%.
3.Within-run precision: CV ≤4.0%
4.Precision between batches: Relative extreme difference R≤5.0%
5. Linear range: (0~1000) U/L, r≥0.990
6.On-board in use on the analyzer : 30 days
7.Expiry date at 2-8℃：12 months

Alanine Aminotransferase Assay Kit
The clinical significance of elevated ALT lies in the diagnosis and analysis of a range of viral hepatitis such as acute hepatitis B, chronic hepatitis, HBV carriers, severe hepatitis, as well as cirrhosis and hepatocellular carcinoma, etc. Elevated ALT only indicates that the liver may be damaged.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.020 at 95U/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Precision between batches: Relative extreme difference R≤5.0%

5. Linear range: (0~1000) U/L, r≥0.990

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Gamma-glutamyl Transferase Assay Kit
Detects liver disease. Acute hepatitis GGT is moderately elevated; in the inactive stage of chronic hepatitis and cirrhosis, GGT activity is normal; if GGT is persistently elevated, it suggests lesion activity or deterioration. In liver cancer, it can reach more than 10 times of the upper limit of reference value; if combined with AFP, it can improve the correct diagnosis rate of liver cancer. In acute or chronic alcoholic hepatitis or drug hepatitis, GGT can be obviously or moderately elevated (300-1000U/L), while ALT and AST are only mildly elevated or even normal. GGT may also be mildly elevated in fatty liver.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.025 at 130U/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~450) U/L, r≥0.990

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Total Bilirubin Assay Kit
Determination of serum total bilirubin TBiL is an important test in liver and biliary function tests. It can accurately reflect the degree of jaundice and is important for clinical diagnosis of occult jaundice.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.08 at 75U/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~684) U/L, r≥0.990

6. On-board in use on the analyzer:30 days

7. Expiry date at 2-8℃：12 months


Direct Bilirubin Assay Kit
Increased direct bilirubin DBiL: mainly seen in obstructive jaundice, hepatocellular jaundice, hepatocellular carcinoma, pancreatic head carcinoma, cholelithiasis, cholangiocarcinoma.
Product Features

1.Analytical sensitivity: the change in absorbance should be greater than 0.03 at 45μmol/L.
2.Accuracy: Relative deviation within ±10%.
3.Within-run precision: CV ≤4.0%
4.Between run precision: Relative extreme difference R≤5.0%
5.Linear range: (0~430) U/L, r≥0.990
6.On-board in use on the analyzer:30 days
7.Expiry date at 2-8℃：12 months

α-L-Fucosidase Assay Kit
Serum AFU levels were increased in 81.2% of primary liver cancer patients, and combined detection with AFP can improve the positive rate of primary liver cancer diagnosis up to 93.1%. Dynamic observation is important for judging the efficacy, prognosis and recurrence of liver cancer. Serum AFU can also be increased in metastatic liver cancer, lung cancer, breast cancer, ovarian cancer, uterine cancer; and mildly increased in liver cirrhosis, chronic hepatitis, digestive bleeding.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.015 at 25U/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~300) U/L, r≥0.990

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Total Bile Acid Assay Kit
Increased serum total bile acids: can be seen in all kinds of acute and chronic hepatitis, hepatitis B carriers or alcoholic hepatitis (the sensitivity of TBA in detecting mild liver disease is better than that of all other liver function tests), but also can be seen in the vast majority of extrahepatic bile duct obstruction and intrahepatic cholestatic disease, cirrhosis, obstructive jaundice, and so on.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 30 μmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~200) U/L, r≥0.990

6. On-board in use on the analyzer:30 days

7. Expiry date at 2-8℃：12 months


Cholinesterase Assay Kit
Since serum cholinesterase is synthesized by the liver, decreased enzyme activity often reflects liver damage. Increased: seen in neurological disorders, hyperthyroidism, diabetes mellitus, hypertension, bronchial asthma, type IV hyperlipoproteinemia, renal failure. Decreased: seen in organophosphorus poisoning, hepatitis, cirrhosis, malnutrition, pernicious anemia, acute infections, myocardial infarction, pulmonary infarction, muscle injury, chronic nephritis, dermatitis, and late pregnancy, as well as ingestion of drugs such as estrogen, cortisol, quinine, morphine, codeine, theobromine, aminophylline, and barbiturates.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.25 at 5000 U/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (20~15000) U/L, r≥0.990.

6. On-board in use on the analyzer:14 days

7. Expiry date at 2-8℃：12 months


Total Protein Assay Kit
Increased: hemoconcentration due to water loss from various causes (e.g., vomiting, diarrhea, high fever, shock); monoclonal immunoglobulinopathies such as multiple myeloma, macroglobulinemia, and cryoglobulinemia; and a number of chronic illnesses caused by systemic lupus erythematosus, multiple sclerosis, and certain chronic infections resulting in elevated globulins (polyclonal). Decreased: malignant tumors, severe tuberculosis, hyperthyroidism, water and sodium retention, late pregnancy, nephrotic syndrome, chronic gastrointestinal disorders, ulcerative colitis, cirrhosis of the liver, burns, protein-losing enteropathies, malnutrition and increased depletion, disorders of protein synthesis, e.g., hepatocellular lesions, impaired liver function.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 50g/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~120) g/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Albumin Assay Kit
Increased: hemoconcentration due to water loss from various causes (e.g., vomiting, diarrhea, high fever, shock); monoclonal immunoglobulinopathies such as multiple myeloma, macroglobulinemia, and cryoglobulinemia; and a number of chronic illnesses caused by systemic lupus erythematosus, multiple sclerosis, and certain chronic infections resulting in elevated globulins (polyclonal). Decreased: malignant tumors, severe tuberculosis, malnutrition, acute major blood loss, severe burns, hepatic synthetic dysfunction, pleural and abdominal fluid, renal disease, late pregnancy, edema is often seen when ALB is less than 20 g/L, and congenital albumin deficiency (where there is virtually no ALB in the blood, but edema does not occur).
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.40 at 36g/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~60) g/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Adenosine Deaminase Assay Kit
Adenosine deaminase is a nucleic acid metabolizing enzyme that has an important relationship with the cellular immune activity of the body. Determination of ADA and its isoenzyme levels in blood and body fluids is increasingly receiving clinical attention for the diagnosis, differential diagnosis, treatment and study of immune function of certain diseases. For example, liver injury, chronic liver disease, liver fibrosis, jaundice, blood disease, tumor, meningitis, meningeal effusion and so on have certain clinical significance.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.010 at 35 U/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~100) U/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Pre-Albumin Assay Kit
Prealbumin, a sensitive indicator of nutritional proteins, has a decreased blood concentration in acute inflammation, malignancy, cirrhosis, or nephritis.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.08 at 118mg/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~800) g/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Aspartate Aminotransferase Isoenzyme Assay Kit
Elevated: viral hepatitis, chronic hepatitis, active cirrhosis, myocardial infarction, cardiomyopathy.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.015 at 100U/L.

2. Accuracy: Recovery in the range of 85%~115%

3. Within-run precision: CV ≤ 8.0%.

4. Between run precision: Relative extreme difference R≤10.0%

5. Linear range: [5.0~300.0]U/L, r≥0.990

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Sialic Acid Assay Kit
Sialic acid is a derivative of N-acetylneuraminic acid or any of its esters or its alcoholic hydroxyl group; located at the end of the side chain of cell membrane glycoproteins, it is an important component of cell membrane surface receptors; it is increased in the occurrence of a variety of inflammatory diseases and malignant neoplastic disease, such as lung cancer, gastric cancer, intestinal cancer, hepatocellular carcinoma, and ovarian cancer.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.010 at 80mg/dL.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤5.0%

4. Between run precision: Relative extreme difference R≤10.0%

5. Linear range: [1.0~200.0] mg/dL, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Glycocholic Acid Assay Kit
Blood CG in patients with acute hepatitis, chronic active hepatitis, primary hepatocellular carcinoma, cirrhosis, and chronic migratory liver was significantly higher than that of normal people, and increased progressively. Bile duct and gallbladder excretory dysfunction in patients with cholelithiasis with jaundice caused significant elevation of serum CG. Serum CG levels were higher than normal in cirrhosis, obstructive liver disease, and intestinal-hepatic circulation disorders.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.010 at 3.0 mg/L.

2. Accuracy: Recovery in the range of 85%~115%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: [0.5~80.0] mg/L, r≥0.990

6. On-board in use on the analyzer: 30 days.

7. Expiry date at 2-8℃：12 months

Glutathione Reductase Assay Kit
Liver diseases: acute hepatitis, drug-induced liver damage, toxic hepatitis, chronic hepatitis, hepatocellular carcinoma, early cirrhosis, etc. have significant concomitant elevations
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.015 at 100U/L.

2. Accuracy: Recovery in the range of 85%~115%

3. Within-run precision: CV ≤ 5.0%.

4. Between run precision: Relative extreme difference R≤10.0%

5. Linear range: [10.0~300.0]U/L, r≥0.990.

6. On-board in use on the analyzer:30 days .

7. Expiry date at 2-8℃：12 months


Apolipoprotein E Assay Kit
Increased: Type I, III, V hyperlipoproteinemia, obstructive jaundice, nephrotic syndrome, acute hepatitis, etc. Reduced: ApoE deficiency, etc.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 50mg/L.

2. Accuracy: Relative deviation within ±15%.

3. Within-run precision: CV ≤10%.

4. Between run precision: relative extreme difference R≤15%.

5. Linear range: (0.0~100.0) mg/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Uric Acid Measurement Kit
Increased blood uric acid is mainly seen in gout, but a few gout patients have normal blood uric acid measurements during a gouty attack. Increased blood uric acid without gouty attack is hyperuricemia. In renal hypoplasia, it is often accompanied by increased serum uric acid. It can be seen in renal diseases such as acute and chronic nephritis, and in advanced stages of other renal diseases such as renal tuberculosis, pyelonephritis, and hydronephrosis.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 357 μmol/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme difference R≤5.0%.

5. Linear range: (0~1190) μmol/L, r≥0.990

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Urea Nitrogen Measurement Kit
Elevated urea nitrogen is common in renal diseases and is an important indicator of changes in renal function. For example, chronic glomerulonephritis, renal arteriosclerosis, severe pyelonephritis, advanced renal tuberculosis, polycystic kidney and so on caused by renal insufficiency. Blood urea nitrogen increases when renal blood flow decreases due to dehydration, edema, acidosis, circulatory insufficiency and shock. Urinary retention caused by urinary stones and prostate hypertrophy can also increase urea nitrogen. Mild increase in urea nitrogen can be seen when protein breakdown in the body is too vigorous (e.g. hyperthyroidism) and after a high protein diet.
Product Features

1. 分析灵敏度：16.9mmol/L时，吸光度差值（ΔA）≥0.1。

2. 准确度：相对偏差不超过±10%。

3. 批内精密度：CV≤4.0%，

4. 批间精密度：相对极差R≤5.0%。

5. 线性范围：（0.0~35.7）mmol/L，r≥0.990。

6. 开瓶稳定性：试剂瓶首次开启后，避免污染2~8℃可稳定30天。

7. 有效期：试剂在2-8℃避光保存可稳定12个月。


Creatinine Assay Kit
Blood creatinine may be elevated when glomerular filtration is reduced by acute or chronic glomerulonephritis. At the same time, it should be interspersed with the determination of blood creatinine value as a tracking observation indicator on the basis of the known endogenous creatinine clearance rate. Measurement of urea nitrogen and creatinine value at the same time is more meaningful, if both are elevated at the same time, it indicates that there is serious damage to the kidneys.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 442 μmol/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme difference R≤5.0%.

5. Linear range: (0~8840) μmol/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


α1-Microglobulin Assay Kit
Elevated: (1) Renal insufficiency caused by various renal diseases, such as early glomerular injury, primary glomerulonephritis, interstitial nephritis, diabetic nephropathy, lupus nephritis, acute and chronic renal failure, etc.), and the test is an indicator for evaluating renal function. (2) Also seen in IgA myeloma, hepatocellular carcinoma, etc. Decreased: suggests severe liver function impairment, seen in patients with liver disease.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.10 at 75mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (10.0~150.0) mg/L, r≥0.990

6. Expiry date at 2-8℃：12 months.


β2-mIcroglobulin Assay Kit
Detection of β2-MG concentration in blood or urine provides an early, reliable and sensitive indicator for clinical renal function measurement, kidney transplantation survival, diabetic nephropathy, heavy metal cadmium, mercury poisoning, certain malignant tumors, viral infections, autoimmune diseases, and also provides a basis for identifying the nature of proteinuria, glomerular or tubular pathology, and the site of urinary tract infection.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.05 at 5.0mg/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤ 5.0%.

4. Between run precision: relative extreme deviation R≤10.0%.

5. Linear range: (0.4~18.0) mg/L, r≥0.990.

6. Expiry date at 2-8℃：18 months。


Retinol Binding Protein Assay Kit
Reduced: vitamin A deficiency, hypoproteinemia, malabsorption syndrome, liver disease (except for hypernourished fatty liver), obstructive jaundice, hyperthyroidism, infectious diseases, trauma. Elevated: renal insufficiency, over-nutritional fatty liver. Urine RBP↑: acute and chronic nephritis, diabetic nephropathy; chronic renal failure Serum RBP↓: acute and chronic hepatitis; cirrhosis;
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.10 at 50mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (10.0~100.0) mg/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Urine Microalbumin Assay Kit
Urine microalbumin measurement reflects early renal disease and renal injury. Pathologic increases are seen in diabetic nephropathy, hypertension, and preeclampsia in pregnancy. Urine microalbumin test can be used as an indicator of renal function in systemic or local inflammatory reactions, such as early renal lesions caused by urinary tract infections; predictor of complications in acute pancreatitis.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.25 at 56.8 mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (0.0~130.0) mg/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Cystatin C Assay Kit
When renal function is impaired, the concentration of CysC in the blood varies with the glomerular filtration rate. In renal failure, the glomerular filtration rate decreases, and the concentration of CysC in the blood can increase by more than 10 times; if the glomerular filtration rate is normal and the tubular function is abnormal, it will prevent CysC from being absorbed in the tubules and broken down rapidly, so that the concentration in the urine will increase by more than 100 times.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.15 at 4.4 mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (0.0~8.8) mg/L, r≥0.990.

6. On-board in use on the analyzer: 28 days

7. Expiry date at 2-8℃：12 months


β2-mIcroglobulin Assay Kit
Detection of β2-MG concentration in blood or urine provides an early, reliable and sensitive indicator for clinical renal function measurement, kidney transplantation survival, diabetic nephropathy, heavy metal cadmium, mercury poisoning, certain malignant tumors, viral infections, autoimmune diseases, and also provides a basis for identifying the nature of proteinuria, glomerular or tubular pathology, and the site of urinary tract infection.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 10.5mg/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤6.0%.

5. Linear range: (0.0~18.0) mg/L, r≥0.990.

6. Expiry date at 2-8℃：12 months.


Creatine Kinase Assay Kit
Increase: (1) physiological increase: ① after exercise can lead to a significant increase in creatine kinase, and the more intense and longer the exercise, the more obvious creatine kinase elevation. ② Serum creatine kinase activity is higher than normal in parturients and newborns. ③ Some therapeutic and diagnostic measures, such as installation of artificial pacemaker, electroconvulsive shock, radiation therapy, cardiac compression, cardiac catheterization, and urological examination, can increase serum creatine kinase activity. ④ Men with large muscle volume have higher serum creatine kinase activity than women. ⑤ Intramuscular injection of certain drugs (e.g., anesthetics, analgesics, antibiotics, dexamethasone, etc.) can lead to increased serum creatine kinase activity. (6) Oral administration of certain drugs, such as clofibrate, can increase serum creatine kinase activity. (2) Pathological increase: myocardial infarction, viral myocarditis, dermatomyositis, myotonic dystrophy, pericarditis, cerebrovascular accident, etc. Decreased: hyperthyroidism.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.06 at 346 U/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~1000) U/L, r≥0.990.

6. On-board in use on the analyzer:30 days

7. Expiry date at 2-8℃：12 months


Creatine Kinase Isoenzyme Assay Kit
The isoenzymes of creatine kinase are of great importance in clinical diagnosis. The level of creatine kinase in human serum increases rapidly in various pathologies, including muscular dystrophy and myocardial infarction, and it is believed that the measurement of creatine kinase activity is more reliable than electrocardiography in the diagnosis of myocardial infarction. In myocardial infarction, creatine kinase is elevated within 6 hours of the onset of the disease, peaks at 24 hours, and returns to normal within 3-4 days. The highest diagnostic specificity is achieved by the isoenzyme of creatine kinase, CK-MB.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.008 at 155 U/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~1000) U/L, r≥0.990.

6. On-board in use on the analyzer:30 days

7. Expiry date at 2-8℃：12 months


α-Hydroxybutyrate Dehydrogenase Assay Kit
Alpha-hydroxybutyrate dehydrogenase (α-HBDH), together with lactate dehydrogenase (LDH), creatine kinase (CK), and aspartate aminotransferase (AST), make up the cardiac enzyme profile, which is important for the diagnosis of myocardial infarction. Increased serum alpha-hydroxybutyrate dehydrogenase is mainly seen in: myocardial infarction, active rheumatic myocarditis, acute viral myocarditis, hemolytic anemia.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.045 at 300 U/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0~1000) U/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Lactate Dehydrogenase Assay Kit
Increased lactate dehydrogenase activity is mainly seen in myocardial infarction, acute or chronic hepatitis, and hepatocellular carcinoma (especially metastatic hepatocellular carcinoma), while others can be seen in skeletal muscle disorders, hematologic disorders, pulmonary infarcts, hypothyroidism, nephrotic syndrome, and advanced malignancies.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.02 at 271 U/L.

2. Accuracy: Relative deviation within ±15%.

3. Within-run precision: CV ≤10.0%

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (0~1000) U/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Homocysteine Assay Kit
Increased: seen in atherosclerotic vascular disease, stroke, rheumatoid arthritis, many types of cancer. Increased levels of homocysteine, which produces superoxide and peroxide, can lead to vascular endothelial cell damage and low-density lipoprotein oxidation, resulting in persistent contraction of vascular smooth muscle as well as hypoxia, thus accelerating the process of atherosclerosis. It can also disrupt the normal clotting mechanism and increase the chance of thrombosis. If the increase of homocysteine is caused by insufficient intake of vitamin B6, vitamin B12 and folic acid, the plasma homocysteine level can be reduced through diet or increased intake of B vitamins and folic acid, thus reducing the risk of cardiovascular and cerebrovascular diseases.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.03 at 28.0 μmol/L.

2. Accuracy: Relative deviation within ±15%.

3. Within-run precision: CV ≤ 10%

4. Between run precision: Relative extreme deviation R ≤ 15%

5. Linear range: (0.0~50.0) μmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Triglyceride Assay Kit
Increased: Triglycerides are a risk factor for cardiovascular disease. Serum triglyceride levels are influenced by age, gender and diet. Increased serum triglycerides can be seen in familial hypertriglyceridemia secondary to certain diseases such as diabetes mellitus, hypothyroidism, nephrotic syndrome and pancreatitis, atherosclerosis, and glycogen storage disease. Decreased: seen in hyperthyroidism, decreased adrenocortical function, severely depressed liver function, chronic obstructive pulmonary disease, cerebral infarction, malnutrition, congenital alpha-beta lipoproteinemia.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.15 at 1.5mmol/L

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0.0~11.3) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Total Cholesterol Measurement Kit
Pathologically elevated. Hyperlipoproteinemia, atherosclerosis, diabetes, hypothyroidism, obstructive jaundice, nephrotic syndrome. Pathologically lowered. Hyperthyroidism, severe anemia, acute infection, wasting disease, liver disease.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.5 at 4.0 mmol/L

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0.0~19.3) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


HDL Cholesterol Assay Kit
The most important clinical value of increased HDL cholesterol is the ability to transfer foam cells of atherosclerotic plaques to the liver to be excreted from the body, which can be seen in primary hyper-HDLemia, and found that there are more longevity in this group of families. Lower HDL cholesterol is commonly seen in cerebrovascular disease, coronary heart disease, hypertriglyceridemia, liver function damage such as acute and chronic hepatitis, cirrhosis, liver cancer, diabetes mellitus, smoking, lack of physical activity, etc., and its reduction can be used as a risk indicator for coronary heart disease.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.08 at 2.0 mmol/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤4.0%

4. Between run precision: Relative extreme difference R≤5.0%

5. Linear range: (0.0~3.90) mmol/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


LDL Cholesterol Assay Kit
Pathologically elevated: abnormal liver function, hepatitis, atherosclerosis, hypertension, cardiovascular disease, hyperlipoproteinemia, acute myocardial infarction, coronary artery disease, nephrotic syndrome, chronic renal failure, liver disease, and diabetes mellitus, but also in anorexia nervosa and pregnant women. Pathologic Decrease: Lower LDL cholesterol is common in malnutrition, chronic anemia, myeloma, trauma and severe liver disease
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.30 at 5.0 mmol/L.

2. Accuracy: Relative deviation within ± 10%

3. Within-run precision: CV ≤10.0%

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: (0.0~25.8) mmol/L, r≥0.990.

6. On-board in use on the analyzer:30 days

7. Expiry date at 2-8℃：12 months


Lipoprotein A Assay Kit
Increased: seen in atherosclerotic cardiovascular disease, acute myocardial infarction, familial hypercholesterolemia, congenital hyperlipoproteinemia, diabetes mellitus, aortic aneurysms, and certain cancers. Decreased: seen in congenital lipoprotein A deficiency, after liver disease, alcoholism, ingestion of drugs such as neomycin.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.2 at 480mg/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme deviation R≤6.0%.

5. Linear range: (0~1000) mg/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Apolipoprotein A1 Assay Kit
The measured value of ApoAⅠ reflects the amount of HDL. Decreased ApoAⅠ is considered a risk factor for cardiovascular disease. Increased: seen in alcoholic hepatitis, hyperalpha lipoproteinemia, etc. Decreased: seen in coronary heart disease, arteriosclerotic disease, uncontrolled diabetes, nephrotic syndrome, malnutrition, active or acute hepatitis, chronic hepatitis, cirrhosis, extrahepatic biliary obstruction, artificial dialysis, etc.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.8 at 1.0g/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~2.5) g/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date at 2-8℃：12 months


Apolipoprotein B Assay Kit
Increase is common in type II hyperlipidemia, cholestasis, coronary artery disease, nephropathy, cerebrovascular disease, hypothyroidism, psoriasis. Decrease: Commonly seen in substantial hepatic impairment, hyperthyroidism, low beta-lipoproteinemia.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.35 at 1.40g/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~2.5) g/L, r≥0.990.

6. On-board in use on the analyzer: 30 days

7. Expiry date: the reagent can be stabilized for 18 months when stored in 2-8℃ and protected from light.


Glucose Assay Kit
Among the two commonly used methods for glucose determination, the hexokinase method is the reference method recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and its results are not interfered by mild hemolysis, jaundice, heparin, and other factors, and it can be used for quantitative testing of urinary glucose. Glucose measurement of different samples can provide reference for the diagnosis of related diseases, disease conditions and evaluation of treatment effects. Long-term glucose monitoring can assess the control of blood glucose in diabetes treatment and can adjust the treatment program accordingly.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.35 at 5.55 mmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~50.0) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Glucose Assay Kit
Among the two commonly used methods for glucose determination, glucose oxidase method, with accuracy and precision in line with clinical requirements and easy operation, is a routine test method for blood glucose determination, and it can also be used for the determination of cerebrospinal fluid glucose concentration; glucose determination of different samples can provide references for the diagnosis of related diseases, disease conditions and evaluation of treatment effects, and long-term glucose monitoring can assess the control of glucose in diabetic treatment and adjust the treatment program accordingly.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.20 at 5.55 mmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤4.0%

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~50.0) mmol/L, r≥0.990.

6. xpiry date at 2-8℃：12 months


Glycated Hemoglobin Assay Kit
Glycated hemoglobin can be used not only as an indicator for monitoring the condition of diabetes, but also as an indicator for early diagnosis of mild, type 2, and "hidden" diabetes. Blood glucose and urine glucose can only reflect the glucose level at the time of measurement, while the measurement of glycated hemoglobin can reflect the average level of blood glucose over a longer period of time (2 to 3 months), especially in the last 1 to 2 months of blood glucose correlation degree is the best. The purpose of its measurement is to eliminate the influence of blood glucose fluctuation on the control of the disease, in order to make up for the shortcomings of blood glucose and urine glucose measurement.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.035 at 5.1%.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤5.0%

4. Between run precision: relative extreme deviation R≤6.0%.

5. Linear range: (2.0~14.0)%, r≥0.990.

6. R1 On-board in use on the analyzer: 30 days; R2 On-board in use on the analyzer: 14 days.

7. Expiry date at 2-8℃：12 months


Free Fatty Acid Assay Kit
Elevated: diabetes mellitus, glycogen accumulation disease, hyperthyroidism, brown cell tumor, acromegaly, gigantism, Cushing's syndrome, severe liver damage, myocardial infarction, late pregnancy, obstructive jaundice, hepatitis, cirrhosis, hemochromatosis, etc. Lowering: hypothyroidism, Addison's disease, islet cell tumors, hypopituitarism, hypoglycemic or insulin overdose.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.05 at 1000 μmol/L.

2. Accuracy: Relative deviation within ±15%.

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: relative extreme deviation R≤15.0%.

5. Linear range: (0~3000) μmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Glycosylated Serum Protein Assay Kit
Glycosylated serum protein, due to its shorter half-life than glycated hemoglobin, the longest of which is 19 days, has a level that reflects the average blood glucose level in the 1 to 3 weeks prior to measurement. In addition, this test is unaffected by fluctuations in temporary blood glucose concentrations, providing a good indicator for the diagnosis of clinical diabetes patients and the study of blood glucose control levels over a longer period of time.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.025 at 2.3 mmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~6.0) mmol/L, r≥0.990

6. Expiry date at 2-8℃：12 months


Glycated Albumin Assay Kit
Reflects blood glucose control over the past 2 weeks to 1 month from the date of blood collection. It can be used as a reference to determine whether diabetes mellitus is likely to be present and whether to seek medical attention.
Product Features

1. Analytical sensitivity: the change in absorbance should be ranged from 0.02 to 0.20 at GA 1.5g/dL; absorbance difference (ΔA) >0.110 at ALB 4.0g/dL.

2. Accuracy: GA relative deviation within ±10%, ALB relative deviation within ±6%.

3. Within-run precision: GA CV ≤ 5.0%, ALB CV ≤ 2.0%.

4. Between run precision: GA Relative Extremity R≤10.0%, ALB Relative Extremity R≤5.0

5. Linear range: GA [0.38, 2.90] g/dL, ALB [1.00, 6.00], r ≥ 0.990.

6. On-board in use on the analyzer: 28 days

7. Expiry date at 2-8℃：12 months


Calcium DetermInation Kit
Increased: hyperparathyroidism, hypervitaminosis D, multiple myeloma, tuberculosis, etc. Decreased: tetany, hypoparathyroidism, rickets, chronic nephritis, uremia, achondroplasia, malabsorptive hypocalcemia, after massive input of citrate anticoagulation, etc.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.60 at 2.74 mmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (1.0~4.0) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Magnesium Assay Kit
Elevated: can be seen in renal insufficiency, especially in the period of oliguria, anuria, due to the reduced renal clearance function, plasma and red blood cell enzyme content are increased, can appear hypermagnesemia. Decreased: compared with high blood magnesium, low blood magnesium is more common. It is often associated with sexual electrolyte disorders. Decreased blood magnesium can be seen in insufficient magnesium intake, such as fasting, vomiting, chronic diarrhea, poor digestion and absorption, but also can be seen in excessive urinary excretion of magnesium, such as renal insufficiency polyuria, taking diuretics and other conditions.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.20 at 1.05mmol/L

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~2.0) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


Phosphorus Determination Kit
Increased: hypoparathyroidism, renal insufficiency, uremia, myeloma, hypervitaminosis D, healing fractures. Decreased: hyperparathyroidism, renal tubular degenerative lesions, chronic diarrhea, rickets and achondroplasia with secondary parathyroid hyperplasia, continuous intravenous glucose and insulin and insulinoma, Fanconi's syndrome. In addition, inorganic phosphorus may be reduced in normal pregnant women.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.40 at 1.69 mmol/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0.0~2.0) mmol/L, r≥0.990.

6. Expiry date at 2-8℃：12 months


α-Amylase Assay Kit
Increased: acute pancreatitis, pancreatic tumor, mumps, salivary gland suppuration, acute peritonitis, appendicitis, etc. Decreased: cirrhosis, liver failure, etc.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.00005 at 1 U/L.

2. Accuracy: Relative deviation within ±10%.

3. Within-run precision: CV ≤ 4.0%.

4. Between run precision: relative extreme deviation R≤5.0%.

5. Linear range: (0~2000) U/L, r≥0.990.

6. On-board in use on the analyzer: 28 days

7. Expiry date at 2-8℃：12 months


Antistreptococcal Hemolysin "O" Kit
ASO is significantly elevated in rheumatic fever, acute glomerulonephritis, erythema nodosum, scarlet fever and acute tonsillitis. A few patients with hepatitis, connective tissue disease, tuberculosis and multiple myeloma may also have increased ASO. Because people are often in contact with group A streptococci, low-potency antibodies are also present in normal people and are usually considered diagnostic when the potency is >200 IU/ml.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.15 at 230 IU/mL.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: (0~600) IU/mL, r≥0.990.

6. Expiry date at 2-8℃：12 months


Rheumatoid Factor Kit
Positive rheumatoid factor is one of the important serum markers for the diagnosis of rheumatoid arthritis. Rheumatoid factor can also be seen in a variety of other diseases, such as autoimmune diseases, infectious diseases and non-infectious diseases.The level of IgM rheumatoid factor is not closely related to the activity of rheumatoid arthritis, while the IgG rheumatoid factor is closely related to synovitis, vasculitis, and extra-articular symptoms in rheumatoid arthritis patients; the IgA rheumatoid factor is seen in rheumatoid arthritis, scleroderma, and so on.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.18 at 75 IU/mL.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: (0~150) IU/mL, r≥0.990.

6. Expiry date at 2-8℃：12 months


Ultrasensitive C-Reactive Protein Assay Kit
Serum CRP levels are a strong, independent, predictive risk factor for myocardial infarction, stroke, peripheral arterial disease, no apparent cardiovascular disease, patients with acute coronary syndromes, and patients with stable coronary artery disease (CAD).
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.20% at 25mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤20.0%

5. Linear range: (0.0~50.0) mg/L, r≥0.990.

6. On-board in use on the analyzer: 14 days

7. Expiry date at 2-8℃：12 months


D-dimer Assay Kit
Increased: seen secondary to hyperfibrinolytic function, such as hypercoagulable states, disseminated intravascular coagulation, renal disease, organ transplant rejection, and thrombolytic therapy. Myocardial infarction, cerebral infarction, pulmonary embolism, venous thrombosis, surgery, tumors, disseminated intravascular coagulation, infections, and tissue necrosis can also lead to elevated D-dimer.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.10 at 5.2 mg/L.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: (0.0~20.8) mg/L, r≥0.990

6. Expiry date at 2-8℃：12 months


Fibrin (Plasma) Degradation Product Measurement Kit
Fibrin (pro)degradation products primarily reflect fibrinolytic function. Measured simultaneously with other indicators, it can identify primary or secondary hyperfibrinolysis. Clinically, FDP is used as a reference index for a variety of thrombotic diseases and is listed as one of the routine indexes for laboratory diagnosis of disseminated intravascular coagulation.
Product Features

1. Analytical sensitivity: the change in absorbance should be greater than 0.08 at 20.5 μg/mL.

2. Accuracy: relative deviation within ±15%

3. Within-run precision: CV ≤ 10.0%.

4. Between run precision: Relative extreme difference R≤15.0%

5. Linear range: (0.0~82.0) μg/mL, r≥0.990.

6. Expiry date at 2-8℃：12 months


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