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 Malaria (PAN / PF) Test (Cassette) Tests per Package: 30
Whole Blood Code: 15202-1 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 Malaria (PAN / PF) Test is a rapid one step screening test for the qualitative detection of Malaria PAN/P.f. (HRP-II) in human whole blood. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Malaria (PAN / PF) Test is a lateral flow chromatographic immunoassay for the qualitative detection of Malaria P. falciparum specific histidine rich protein - II (Pf HRP-II) and Malaria PANLDH specific lactate in whole blood sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

Malaria PAN / P.f

P.f (HRP-II) + PANLDH

50 parasites/µL

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

 

Malaria is a serious parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P.vivax, P.ovale, and P.malariae. In humans, the parasites migrate to the liver where they mature and release another form, the merozoites.

 

This test is a rapid, qualitative two step immunochromatographic assay. The test employs a combination of monoclonal antibody/colloidal gold dye conjugate and a polyclonal antibody immobilized on the solid phase. This will selectively identify P. f antigen or Pan antigen with a high degree of sensitivity and specificity.

As the specimen flows through the absorbent pad in the sample well and through the antibody/colloidal gold complex any Pan/P.f antigen present in the sample binds to the conjugate forming an antigen/antibody complex. The sample and dye complex continue to migrate along the membrane to the immobilized polyclonal antibody. In the presence of the P.v/P.f antigen the antibody captures the complex. This forms a visible pink/purple band in the (Pan or P.f) region. If no antigen present, there is no band formation in the Pan or P.f region. The remaining complex continues to migrate to another immobilized antibody on the membrane in the (C) region of the cassette, and was captured which forms a band indicating the proper performance of the test.

The kit contains reagents for 30 tests in cassette (code 15202-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15202-1

The EASY Line Malaria (PAN / PF) Test (Whole Blood) contains a membrane strip, which is pre-coated with two monoclonal antibodies as two separate lines across a test strip. One monoclonal antibody (test line 1) is specific to the P.falciparum histidine rich protein-II (Pf HRP-II) and another monoclonal antibody (test line 2) is specific to the lactate dehydrogenase of Plasmodium species (P.falciparum, vivax, malariae, ovale). Conjugate pad is pre-coated with monoclonal antibodies conjugated to colloidal gold,which are specific to P.falcparum histidine rich protein-II (Pf HRP-II) and pan specific to the lactate dehydrogenase of Plasmodium species.

  • Specimen collection container

  • Disposable gloves

  • Timer

Table 1 - The comparison results ofMalaria PAN rapid diagnostic test (RDT) with microscopy examination

 

Microscopy Examination

Total

Positive

Negative

RDT

Positive

375

2

377

Negative

2

205

207

Total

377

207

584

*Sensitivity=375/377x100= 99.5%

*Specificity=205/207= 99.0%

*Accuracy =580/584x100= 99.3%

Table 2 - The comparison results of Malaria P.f rapid diagnostic test (RDT) with microscopy examination

 

Microscopy Examination

Total

Positive

Negative

RDT

Positive

270

7

277

Negative

3

304

307

Total

273

311

584

*Sensitivity=270/273x100=98.9%

*Specificity=304/311x100=97.7%

*Accuracy =574/584x100=98.3%

 

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