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
Infectious Diseases EASY Line EASY Line Helicobacter Pylori Ag Test (Strip) Tests per Package: 50
Fecal Code: 15501-2 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 Ag Test is a rapid one step screening test for the qualitative detection of Helicobacter Pylori Antigen in stool sample. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Helicobacter Pylori Ag Test is a lateral flow chromatographic immunoassay for the qualitative detection of Helicobacter pylori Antigen in stool sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

One Step Helicobacter pylori Antigen Test (HP-Ag)

Helicobacter pylori Antigen

30 ng/mL

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 Ag Test is a immunoassay utilizing highly specific reactions between double antibody sandwich for the detection of Helicobacter pylori Antigen.

EASY Line Helicobacter Pylori Ag Test is a rapid stool samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Helicobacter pylori Antigen 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 appliedClinical.

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 antigen to the specific Helicobacter pylori antibody, 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 antigen in the sample, the control line will appear.

The kit contains reagents for 50 tests in strip (code 15501-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15501-2

The test contains a membrane strip coated with Helicobacter pylori antibody 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 antibody.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

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

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

Test

Substance

EASY Line Helicobacter Pylori Ag Test

Helicobacter pylori Antigen

%Agreement with results of hospital

 

HP-Ag

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

%Agreement with commercial kit

 

HP-Ag

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

The 1200 clinical samples for Helicobacter pylori Antigen were run using each strip contained within EASY Line Helicobacter Pylori Ag 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

Buffer

40

40 negative

>99%

Positive sample

40

40 positive

>99%

Helicobacter pylori Antigen 30 ng/mL

40

40 positive

>99%

Helicobacter pylori Antigen 60 ng/mL

40

40 positive

>99%

Helicobacter pylori Antigen 120 ng/mL

40

40 positive

>99%

Analytical Sensitivity

Helicobacter pylori antigen was diluted with Normal saline Standard. The results are summarized below.

Antigen concentration Cut-off Range

HP-Ag

-

+

Buffer

10

0

Positive sample

0

10

Helicobacter pylori Antigen 30 ng/mL

0

10

Helicobacter pylori Antigen 60 ng/mL

0

10

Helicobacter pylori Antigen 120 ng/mL

10

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

Ascorbic acid

20 mg/dL

Heme

1000 mg/dL

Bilirubin

60 mg/dL

Triglycerides

500 mg/dL

Cross-Reactivity

A study was conducted to determine the cross-reactivity test, whenother bacteria present in stool specimens.

Non Cross-Reacting Compound

When the sample concentration is below the level of the 107 bacteria/mL, and does not affect the test results.

Name

Name

Staphylococcus aureus

Neisseria gonorrhoeae

Pseudomonas aeruginosa

B streptococcus

Streptococcus C

Proteus vulgaris

Mucositis Brenham cocci

Feces Enterococcus

White rosary

Proteus variation

Neisseria meningitidis

Acinetobacter

Chlamydia trachomatis

Salmonella

Calcium acetate Acinetobacter

Vaginalis

E. coli

Klebsiella pneumoniae

Catarrhal Brenham bacteria

Haemophilus influenzae

Feces Enterococcus

Salmonella choleraesuis

Adenovirus

Rotavirus

The results show that those bacterias in stool specimens above are all negative.

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