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Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody

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Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody

China Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody supplier
Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody supplier Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody supplier Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody supplier

Large Image :  Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,

Payment & Shipping Terms:

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
Detailed Product Description
Category: Test Home Kit Format: H.Pylori Kit
Specimen: Whole Blood/Serum/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: H.Pylori Antibody Home Use
Accuracy: 89.50%

Blood test H.Pylori Ab Home Testing kits, individual package, high accuracy, Gold colloidal method, rapidly and easily

 

 

 

 

INTENDED USE:

 

The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood.

 

 

INTRODUCTION

 

H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimendependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining. Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods. Individuals infected with H. pylori develop antibodies which correlate strongly with histologically confirmed H. pylori infection. The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of H. Pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H. pylori antibodies in whole blood, serum, or plasma in just minutes.

 

 

TEST PRINCIPLE

 

The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of H. pylori antibodies in whole blood, serum, or plasma. In this test procedure, anti-human IgG is immobilized in the test line region of the test. After specimen is added to the specimen well of the device, it reacts with H. pylori antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized anti-human IgG. If the specimen contains H. pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H. pylori antibodies, a colored line will not appear in this region indicating 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.

 

 

Rapid Diagnostic Home Health Test Kits Serum Specimen For H.Pylori Antibody

 

 

 

 

INTERPRETATION OF RESULTS

 

 

Positive:

Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of H. Pylori antibody.

 

Negative:

Only one pink line appears in the control region (C). This indicates that there is no detectable H. Pylori antibody in specimen.

 

Invalid:

No colored line appears in the control region regardless of the presence or absence of the test line.

 

 

PERFORMANCE STUDY

 

The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals who presented for endoscopic examination. Culture and/or Histology of biopsy specimens served as the reference method. Of the 321 fresh clinical samples collected, 136 were considered biopsy positive and 185 clinical specimens were considered biopsy negative. Biopsy “positive” was defined as either or both culture and histology are positive and biopsy “negative” was defined as both culture and histology negative. The results for each sample matrix are summarized below.

 

 

    Method   Biopsy/Histology
  H. pylori   Results   Positive Negative
    Positive   121 21
  Test Device    
    Negative   15 164
       
  Sensitivity = 121/136 = 89% (82%-94%)*   Specificity = 164/185 = 89% (83%-93%)*
Accuracy = 285/321 = 89% (85%-92%)*    
      PLASMA    
    Method   Biopsy/Histology
  H. pylori   Results   Positive Negative
    Positive   120 21
  Test Device    
    Negative   16 164
       
  Sensitivity = 120/136 = 88% (81%-93%)*   Specificity = 164/185 = 89% (83%-93%)*
Accuracy = 284/321 = 88% (84%-92%)*    
      FINGERSTICK    
    Method   Biopsy/Histology
  H. pylori   Results   Positive Negative
    Positive   54 12
  Test Device    
    Negative   8 76
       
  Sensitivity = 54/62 = 87% (76% -94%)*   Specificity = 76/88 = 86% (77%-93%)*
Accuracy = 130/150 = 87% (80%-92%)*    
      VENOUS WHOLE BLOOD  
    Method   Biopsy/Histology
  H. pylori   Results   Positive Negative
    Positive   119 22
  Test Device    
    Negative   17 163
       
  Sensitivity = 119/136 = 88% (81%-93%)*   Specificity = 163/185 = 88% (83%-92%)*
Accuracy = 282/321 = 88% (84%-91%)* *Denotes 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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