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 Hepatitis A IgM Antibody Test (Cassette) Tests per Package: 30
Serum Code: 15011-1 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 Hepatitis A IgM Antibody Testis a rapid one step screening test for the qualitative detection of Hepatitis A Virus IgM Antibody (HAV-M) in human serum. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Hepatitis A IgM Antibody Test is a lateral flow chromatographic immunoassay for the qualitative detection of HAV in serum or plasma at the following cut-off concentrations:

Test

Calibrator

Cut-off

Hepatitis A IgM virus (HAV-M)

Hepatitis A virus

S3

This assay provides only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to HAV IgM test result, particularly when preliminary positive results are obtained.

In acute infection period, anti-HAV IgM is present of high level in the patient’s sera. The IgM antibody titre is decreased significantly and even disappeared in convalescence period, instead IgG is present. Since cases of hepatitis A are not clinically distinguishable from other types of acute viral hepatitis, a correct diagnosis can be made by blood tests which detect the specific anti-viral antibodies.

Unlike other picornaviruses, however, HAV is not cytolytic and is released by exocytosis. Laboratory isolates of HAV have been adapted to growth in primary and continuous monkey kidney cell lines, but clinical isolates are very difficult to grow in cell culture. HAV Milder disease than Hepatitis B; asymptomatic infections are very common, especially in children. Adults, especially pregnant women, may develop more severe disease no chronic form of the disease. Fulminant hepatitis is rare: 0.1% of cases.

Purified recombinant antigens of HAV are pre-coated onto membrane as a capture reagent on the test band region.

 

If the Anti-HAV IgM is present in the sample and concentration above the cut-off labeled anti-human IgM-dye complex will be formed. This complex is then captured by antigens immobilized in the Test Zone of the membrane, producing a visible pink colour band on the membrane. The colour intensity will depend on the concentration of the anti-HAV IgM present in the sample. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

 

The kit contains reagents for 30 tests in cassette (code 15011-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15011-1

The test contains a membrane strip coated with Anti-human IgM μ chain antibody on 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 mouse monoclonal antigen specific to HAV.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Hepatitis A IgM Antibody Test and other commercially available rapid HEV IgM Test. Testing was performed on 120 samples. All the presumptive positive and negative results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of HAV IgM found in presumptive positive samples tested.

Test

Compounds Contributed to the Totals of GC/MS

HAV IgM Ab

Hepatitis A virus

%Agreement with GC/MS

 

HAV

Positive Agreement

95%

Negative Agreement

100%

Total Results

97.5%

%Agreement with commercial kit

 

HAV IgM Ab

Positive Agreement

99%

Negative Agreement

100%

Total Results

99%

Forty (40) clinical samples for HAV IgM Ab were run using each strip contained within EASY Line Hepatitis A IgM Antibody Test by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

*Note: TCA was based on HPLC data.

Reproducibility

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

HAV IgM conc.(ng/mL)

Total number of Determinations

Result

Precision

No HAV present

40

40 negative

>99%

S1

40

40 positive

>99%

S2

40

40 positive

>99%

S3

40

40 negative

>99%

Analytical Sensitivity

The results are summarized below.

Results of HAV IgM rapid test strip sensitivity

Number

1

2

3

4

5

Concentration

(ng.mL-1)

N1-N15

P1-P15

S1

S2

S3

Test results

-

+

+

+

-/+

Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either HAV-free serum or HAV IgM positive serum. The following compounds show no cross-reactivity when tested with EASY Line Hepatitis A IgM Antibody Test at concentrations.

Non Cross-Reacting Compound

Specificity of HAV IgM rapid test strip

Analyte

Concentration

Lot 1

Result

Lot 2

Result

Lot 3

Result

Rheumatoid Factor

≤ 100 U/mL

-

-

-

hemoglobin

≤ 875 mg/dL

-

-

-

total bilirubin

≤ 169.8 μmol/L

-

-

-

triglycerides

≤ 6.0 mmol/L

-

-

-

Note: - negative result, + positive result.

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