IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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EASY Line

New Line for Rapid Diagnostic Tests

Rapid Test Product Information & Purchase Order

Method & Sample Line Product Package Info
Microbiology EASY Line EASY Line Helicobacter Pylori Ab Test (Strip) Tests per Package: 50
Serum Code: 15500-2 Package Format: Strip (3mm)
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  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

The EASY Line Helicobacter Pylori Ab Test is a rapid one step screening test for the qualitative detection of Helicobacter Pylori Antibody in serum or plasma. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Helicobacter Pylori Ab Test is a lateral flow chromatographic immunoassay for the qualitative detection of Helicobacter pylori Antibody in serum or plasma sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

One Step Helicobacter pylori Antibody Test(HP-Ab)

Helicobacter pylori Antibody

L1&L2 were inspected, L3 was inspected or was not, L4 was not inspected.

Detection of H. pylori is no ideal test methods to establish a rapid, sensitive and specific diagnosis of H. pylori infection before the method is still an important task of testing workers. Real-time fluorescence-PCR is an ideal method, which not only has high sensitivity, but also overcome the problem of false-positive PCR product contamination tradition brings, such as to reduce test costs, will help popularize this technology. Moreover, antigen detection in feces, the specimen having the advantages of easy to obtain, easy screening infection of children.

EASY Line Helicobacter Pylori Ab Testis a immunoassay utilizing highly specific reactions between double antigen sandwich for the detection of Helicobacter pylori Antibody.

EASY Line Helicobacter Pylori Ab Test is a rapid serum or plasma samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Helicobacter pylori Antibody without the of an instrument.

Helicobacter pylori (Helicobacter pylori, H. pylori) is a gram-negative spiral bacteria in gastric epithelial cells settle reproduction. After H. pylori infection can cause gastritis, peptic ulcers, mucosal-related lymphoma, and even lead to gastric cancer. Therefore, the diagnosis of H. pylori infection in the growing attention of many countries and regions. Detection of H. pylori using the traditional method is the direct microscopic examination of pathological specimens, microbial culture and urease test. Modern methods are immunological techniques for detecting antigen or antibody, and detecting the nucleic acid sequences by molecular biology techniques. Depending on the material used for the detection, laboratory diagnosis of H. pylori is divided into two categories: (1) invasive test: it is to get the gastric mucosa through the endoscope as the test material, microbiological culture, histopathology detection, rapid urease test and genetic diagnosis; (2) non-invasive tests: no need to obtain the gastric mucosa, using gastric juice, serum, saliva, feces samples, the method of H. pylori stool antigen test, serum H. pylori tuberculosis antibody test, urea breath test and stool and determination of H. pylori genes other specimens. The author of Helicobacter pylori infection in laboratory diagnostic methods are reviewed in order to fully understand the various detection methods and applied Clinical.

The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the sample passes through membrane contains Helicobacter pylori antibody to the specific Helicobacter pylori antigen, the line turns distinctly red in the test area. The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of Helicobacter pylori antibody in the sample, the control line will appear.

The kit contains reagents for 50 tests in strip (code 15500-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15500-2

The test contains a membrane strip coated with Helicobacter pylori antigen conjugateson the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with Helicobacter pylori antigen.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Helicobacter Pylori Ab Test and other commercially available rapid One Step Helicobacter pylori Antibody Test. Testing was performed on 1200 samples.

All the presumptive positive and negative results were confirmed by the result of hospital.

Test

Substance

EASY Line Helicobacter Pylori Ab Test

Helicobacter pylori Antibody

%Agreement with results of hospital

 

HP-Ab

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

%Agreement with commercial kit

 

HP-Ab

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

The 1200 clinical samples for Helicobacter pylori Antibody were run using each strip contained within EASY Line Helicobacter Pylori Ab Test by an untrained operator at a Professional Point of Care site. The untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, sample to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested eight times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The results are given below:

Sample

Total number of Determinations

Result

Precision

Negative sample

40

40 negative

>99%

Positive sample

40

40 positive

>99%

Precision sample

40

40 positive

>99%

Analytical Sensitivity

The results are summarized below.

Antibody concentration Cut-off Range

HP-Ab

-

+

Negative sample

10

0

L1

0

10

L2

0

10

L3

0

10

L4

10

 

Analytical Specificity

When the sample concentration is below the level of the material shown in the following list, and does not affect the test results.

Name

Concentration

Heme

1000 mg/dL

Bilirubin

1000 mg/dL

Human serum albumin

2000 mg/dL

Cross-Reactivity

A study was conducted to determine the cross-reactivity test, whenother bacteria present in Serum or plasma.

Non Cross-Reacting Compound

The following list of materials does not cause cross-reactivity.

Name

Name

Campylobacter jejuni

Campylobacter fetus

Campylobacter

E. coli

The results show that those bacterias in serum or plasma above are all negative.

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