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 (pf+pv) Device (Cassette) Tests per Package: 30
Whole Blood Code: 15200-1 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 pf (HRP-II) / pv (pLDH) Ag (whole blood)is a rapid, serological, immunochromatographic assay for the rapid qualitative determination of Malaria P. falciparum specific histidine rich protein-2 (Pf HRP-2)and malaria P. vivax specific lactate dehydrogenase (pLDH) in human blood as an aid in the diagnosis of Malaria infection. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

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 P.v 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 P.v/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 (P.v or P.f) region. If no antigen present, there is no band formation in the P.v 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 EASY Line Malaria pf (HRP-II) / pv (pLDH) Ag (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-2 (Pf HRP-2) and another monoclonal antibody (test line 2) is pan specific to the lactate dehydrogenase of Plasmodium species (P.falciparum, vivax, malariae, ovale).Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold, which are specific to P.falcparum histidine rich protein-2     (Pf HRP-2)and pan specific to the lactate dehydrogenase of Plasmodium species.

 

 

The kit contains reagents for 30 tests (code 15200-1).

Individually packed test devices (cassette)

30

5 µL Sample Loop

30

Assay Buffer

2

Number of tests

30

Code

15200-1

 

  • Calibrated Pipette
  • Lancet
  • Timer

Accuracy

A side-by-side comparison was conducted using Malaria rapid diagnostic test and microscopy examination. Testing was performed on 331 blood samples.

Table 1:General information of the detected blood samples and the results of blood examination

The type of blood

No.of cases

Male

Female

The mean density of parasite

(µL blood) - (Range)

Malaria

121

109

12

22857.68±48112.62 (73~285440)

 

P.v

69

59

10

7819.22±7963.85 (320~41280)

P.f

48

46

2

48135.09±71659.26 (73~285440)

mix

4

4

0

6779.25±5201.61 (2252~12190)

Negative

210

114

96

-

Total

331

223

108

-

Table 2:The comparison results ofMalariaP.v/P.f rapid diagnostic test (RDT) with microscopy examination

RDT

microscopy examination

Total

P.v

P.f

mix

Negative

P.v

60

0

1

0

61

P.f

0

48

3

3

54

Negative

9

0

0

207

216

Total

69

48

4

210

331

Analytical Sensitivity and Specificity

Table 3: Sensitivity, Specificity and Accuracy rate of RDT

 

Sensitivity (%)

Specificity (%)

Accuracy (%)

Malaria

112/121(92.56)

207/210 (98.57)

319/331 (96.38)

P.v

60/69 (86.96)

210/210 (100)

270/279 (96.77)

P.f

48/48 (100)

207/210 (98.57)

255/258 (98384)

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