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
Tropical Diseases EASY Line EASY Line Dengue IgG/IgM Test (Cassette) Tests per Package: 30
Serum Code: 15205-1 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.

EASY Line Dengue IgG/IgM Test is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgM and/or IgG antibody in serum or plasma at the sensitivity 1:512 standard product.

This assay provides only a preliminary qualitative test result.

Use a more specific alternate analytical method to obtain a confirmed analytical result. RT-PCR  is the preferred confirmatory method, and can detect a variety of environmental samples and specimens stored longer period of time.

PCR products in terms of quantity and purity can be used in the cloning, sequencing, gene research, rapid diagnosis and molecular biology research such as DN difficult to culture the virus provides a useful mean, but the process cumbersome and complex, technical demanding, is difficult in primary hospital.

Clinical need sensitive, specific and rapid pathogen diagnostic methods. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Dengue IgG/IgM Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-dengue in human serum (or plasma). The kit is a diagnostic device for qualitative detection.

Dengue IgM and IgG antibodies Dengue viruses, transmitted by the mosquito Aedes aegypti and Aedes albopictus mosquitoes. are widely distributed throughout the tropical and Subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2. 3 and 4). In children infection is often subclinical or causes a self-limited febrile disease, However, if the patient  infected second times with a different serotype,  a more severe disease, dengue hemorrhagic fever or dengue shock syndrome is more likely to occur. Usually IgM does not become detectable until 5 to 10 days after the onset of illness in cases of primary dengue infection and until 4 to 5 days after onset of illness in secondary infections. In primary infections, IgG appear the 14th day and persist for life, secondary infections show that IgG rise within 1-2 days alter the onset of symptoms and induce IgM response after 20 days of infection.

When a specimen is added to the test, IgM and IgG antibodies in the specimen sample react with gold particles labeled with dengue envelope proteins. As this specimen/particle mixture migrates along the length of the test, the anti-dengue IgM and/or IgG antibody particle complex is captured by the relevant IgM and IgG test bands located in the test device window causing a pale to dark red band to form at the test region of the cassette window. The intensity of the bands will vary depending upon the amount of antibody present in the sample. The appearance of any colour in test region should be considered as positive for IgM and/or IgG antibody. A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

The kit contains reagents for 30 tests in cassette (code 15205-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15205-1

The test cassette consists of:

  1. a burgundy colored conjugate padcont--aining mouse anti-dengue antigen conjugated with colloid gold (dengue antibody conjugates)

  2. a nitrocellulose membrane strip containing a test line (G line and M line) and a control line (C line). The G line is pre-coated with goat anti-dengue IgG antibody, the M line is pre-coated with goat anti-dengue IgM antibody and the C line is pre-coated with goat anti-mouse IgG antibody.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Dengue IgG/IgM Test and other commercially available rapid  tests. Testing was performed on 200 samples. The comparison results of Dengue lgG/lgM test with Haemagglutination inhibition (HI) test strowed that SD BIOLING.

Dengue lgM/lgG test had good correlation with HI test.

 

Reference assay: HI test

Total

Positive

Negative

lgM/lgG

Positive

156

3

159

Negative

1

40

41

Total

157

43

200

*Sensitivity=156/157x100=99.4%

  Specificity=40/43x100=93%

Technique

used

No. of Samples

teste

lgM

positive

only

lgG

positive

only

lgG+lgM

Both

positive

Total lgM

positive

Total lgG

positive

Negative

MAC-ELISA

200

39

41

70

109

111

50

Commercial Rapid

200

40

78

30

120

158

52

lgM/lgG

200

33

25

98

131

123

44

 

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