3 In 1 Cardiac Blood Tests , MI Heart Related Blood Tests Dilution Tube With Buffer

3 In 1 Cardiac Blood Tests , MI Heart Related Blood Tests Dilution Tube With Buffer

MOQ:5000pcs
PRODUCT DESCRIPTION
High Light:

heart disease blood test

,

heart related blood tests

Brand Name New Life
Certification ISO13485,CE
Delivery Time 20-30days
Minimum Order Quantity 5000pcs
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ABOUT US
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
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3 In 1 Cardiac Blood Tests , MI Heart Related Blood Tests Dilution Tube With Buffer
3 In 1 Cardiac Blood Tests , MI Heart Related Blood Tests Dilution Tube With Buffer
MOQ: 5000pcs
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About Us
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
Company Name Orient New Life Medical Co.,Ltd.
Business Type: Manufacturer,Exporter
Brands: New Life
No. of Employees: 200~300
Year Established: 2009
Annual Sales: 10,000,000-15,000,000
Company Location 12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China
Factory Location No.1369, Chengnan Road, Jiaxing, Zhejiang, China
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

 

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

 

Company's core technical team with more than 35 employees,3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.

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PRODUCT DESCRIPTION
High Light:

heart disease blood test

,

heart related blood tests

Place of Origin China
Brand Name New Life
Certification ISO13485,CE
Model Number cassette
Minimum Order Quantity 5000pcs
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 2000000pcs/month
Category Cardiac
Format cassette multiple
Specimen Whole Blood/Serum/Plasma
Testing time 5-15 minutes
Shelf Life 24 Months
Application myocardial infarction (MI)
Accuracy 98.3%

 

3 In 1 Cardiac Blood Tests , MI Heart Related Blood Tests Dilution Tube With Buffer

Description:

One Step 3 in 1 Cardiac Combo cardiac blood Tests , gold colloidal method,quickly and easily, multiple cassette

 

 

Accessories:

 

Instruction for use, Specimens dilution tube with buffer

 

 

Intended Use:

 

The Cardiac Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin, CK-MB and cardiac Troponin I in whole blood, serum or plasma as an aid in the determination of myocardial infarction (MI).

 

Summary:

 

 

Myoglobin (MYO), Creatine Kinase MB (CK-MB) and cardiac Troponin I (cTnI) are proteins released into the bloodstream after cardiac injury. Myoglobin is a heme-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa. It constitutes about 2 percent of total muscle protein and is responsible for transporting oxygen within muscle cells.1 When muscle cells are damaged, Myoglobin is released into the blood rapidly due to its relatively small size. The level of Myoglobin increases measurably above baseline within 2-4 hours post-infarct, peaking at 9-12 hours, and returning to baseline within 24-36 hours.2,3 CK-MB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.4 Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B”, which combine to form three different isoenzymes, CK-MM, CK-BB and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.5 The release of CK-MB into the blood following an MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours.6 Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.7 Troponin I is part of a three subunit complex comprised of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.8 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of Troponin I is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The Cardiac Combo Rapid Test utilizes a combination of antibody coated particles and capture reagents to qualitatively detect Myoglobin, CK-MB and Troponin I in whole blood, serum or plasma. The minimum detection level is 50 ng/mL Myoglobin, 5 ng/mL CK-MB and 0.5 ng/mL Troponin I.

 

 

Test Principle:

 

 

The One Step Myoglobin/CK-MB/Troponin I Combo Test Single Use Kit (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of Myoglobin, CK-MB and Troponin I in whole blood, serum or plasma. The membrane is precoated with specific capture antibodies in each of the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

TEST PROCEDURE

 

1.  Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2.  Remove the device from the sealed pouch and lay it on a flat and dry surface.

3.  Using the provided pipette, add one drop of fresh specimen to the sample well.

4.  Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5.  Read the result between 15-20minutes. Do not read results after 20 minutes.

 

INTERPRETATION OF RESULTS

 

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

 

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

 

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

 

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

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PERFORMANCE CHARACTERISTICS

 

 

Sensitivity and Specificity

 

 

The Cardiac Combo Rapid Test Card has been evaluated with a leading commercial Myoglobin/CK-MB/Troponin I EIA test using clinical specimens. The results show that relative to leading EIA tests, the Cardiac Combo Rapid Test exhibits 100% sensitivity and 97.7% specificity for Myoglobin, 100% sensitivity and 99.8% specificity for CK-MB, and 98.7% sensitivity and 98.4% specificity for Troponin I.

 

Myoglobin Test vs. EIA

 

 

  Method   EIA Total  
      Results Positive Negative Results  
  MYO Test   Positive 60 9 69  
               
      Negative 0 374 374  
               
  Total Results   60 383 443  
  Relative Sensitivity: 100% (94.0%-100%)*    
  Relative Specificity: 97.7% (95.6%-98.9%)*    
  Accuracy: 98.0% (96.2%-99.1%)*   (* 95% Confidence Interval)
CK-MB Test vs. EIA        
         
  Method   EIA Total  
  CK-MB   Results Positive Negative Results  
    Positive 54 1 55  
  Test    
             
    Negative 0 422 422  
       
               
  Total Results   54 423 477  
           
  Relative Sensitivity: 100% (93.4%-100.0%) *    
  Relative Specificity: 99.8% (98.7%-99.9%)*    
  Accuracy: 99.8% (98.8% to 99.9%)*   (* 95% Confidence Interval)

 

Troponin I Test vs. EIA

 

  Method     EIA Total      
               
            Negativ      
      Results Positive Results      
      e  
  cTnI Test                
                   
    Positive 225   8 233      
             
                     
      Negative 3   505 508      
  Total Results   228   513 741      
                     

 

Relative Sensitivity: 98.7% (96.2%- 99.7%)*

 

Relative Specificity: 98.4% (97.0%-99.3%)*

 

Accuracy: 98.5% (97.4%-99.3%)* (* 95% Confidence Interval)

 

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry
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