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 HBeAb Test (Cassette) Tests per Package: 30
Serum Code: 15005-1 Package Format: Cassette (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 HBeAb Testis a rapid one step screening test for the qualitative detection of HBeAb in serum for detection of hepatitis B. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

 

HBeAb Test is a profession-performing immunoassay designed for the qualitative determination of HBeAb in serum for detection of hepatitis B and HBeAb in serum at the following cut-off concentrations:

Test

Cut-off

HBeAb

4.0 NCU

This assay provides only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Time resolved fluoroimmmunoassay (TRFIA) is the preferred confirmatory method. Apply clinical and professional judgment to HBeAb test result, particularly when preliminary positive results are obtained.

Hepatitis B Virus Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Hepatitis B Virus (HBV) in human serum specimen. Currently our products are in the format of strip and cassette. All formats are packed and sealed in aluminium foil bags to ensure its validity before its expiration.

Hepatitis B 5 items are currently the most commonly used serum marker in hospital hepatitis B virus (HBV) infection test. Immunological markers of hepatitis B virus include three pairs: HBsAg and HBsAb, HBeAg and HBeAb, HBcAg and HBcAb. The significance of Hepatitis B 5 items inspection is, checking whether the infection of hepatitis B and infection in specific circumstances.

The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies/antigens to selectively identify the Hepatitis B 5 item in the test samples with   an extremely high degree of sensitivity. In less than 20 minutes, levels of Hepatitis B 5 items can be detected.

As the test sample flows through the absorbent device, the labeled antibody/antigen-dye   conjugate binds to the Hepatitis B 5 items forming an antibody-antigen complex. If one item of Hepatitis B 5 items is present in the sample, a pink-purple colored band will form on the test band region. On the other hand, a light colour band will always appear at the control region. This indicates the specimen contains detectable amount of this item.

 

 

EASY Line HBeAb is a lateral flow, immune chromatographic screening test for HBeAb of hepatitis B. The test is based on the principle of sandwich immunoassay for determination of HBeAb in serum. Two Monoclonal antibodies are employed to identify HBeAb specifically. This one step test is very sensitive and only takes about 10-15 minutes. Test results are read visually without any instrument.

 

 

The kit contains reagents for 30 tests in cassette (code 15005-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15005-1

 

 

The test contains a membrane strip coated with HBeAb antigen conjugates on the test line, a goat anti rabbit IgG antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antigen specific to HBeAb.

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  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using HBeAb Test and other commercially available test kit.

Testing was performed on 300 samples.

%Agreement with commercial kit

 

HBeAb

Positive Agreement

99.28%

Negative Agreement

99.46%

A: Sensitivity test: 1# ≥1:32, 2# ≥1:64, 3# ≥1:64 (±)

B: Positive samples: P1-P10 (+)

C: Negative samples: N1-N15 (-)

D: Specificity: HAV, HCV, HIV, TP, HEV, HGV (-)

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