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
Tumour Markers EASY Line EASY Line Alpha-Fetoprotein (AFP) Test (Cassette) Tests per Package: 30
Serum Code: 15601-1 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 Alpha-Fetoprotein (AFP) Test is a rapid, serological, immunochromatographic assay for the detection of AFP in human serum. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Alpha-Fetoprotein (AFP) Test is a lateral flow chromatographic immunoassay for the qualitative detection of AFP in serum sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

EASY Line Alpha-Fetoprotein (AFP) Test

Alpha-Fetoprotein (AFP)

20 ng/mL

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 AFP test result, particularly when preliminary positive results are obtained.

EASY Line Alpha-Fetoprotein (AFP) Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Alpha-Fetoprotein (AFP) tumour markers in human serum specimen. AFP tumour marker tests are based on the principle of sandwich immunoassay for determination of AFP in human serum specimen. Two monoclonal antibodies are employed to identify AFP specifically.

As early as 1944, the presence of AFP has been studied. It was not until 1965, serum in 2 cases of primary liver cancer patientscan react with the unit priceantiserum against fetal serum, suggests that serum of patients with primary liver cancer has a common special element with serum of the human fetal, and this kind of special protein content was known as alpha-fetoprotein. It has been determined that this kind of protein the cross-reaction exits  this kind of protein and 18 species of mammals.

EASY Line Alpha-Fetoprotein (AFP) Test yields a positive result when the AFPin human serum specimen exceeds 20 ng/mL.

The Alpha-Fetoprotein (AFP) is the most commonly tested Tumour marker for the liver disease diagnosis. AFP tumour marker is normally present in low levels in the blood. In human blood, the normal concentration range of this biomarker is 0.0 to 20.0 ng/mL, which are variable among different human races (refer to the table at the end of this page). But when Alpha-Fetoprotein rise beyond the normal range, it can be taken as a signal of liver cancer or other problems. That is why AFP becomes the subject of AFP serum detection devices.

This product is composed of the glass fibre strips of monoclonal antibody against Alpha-Fetoprotein (AFP), anti-mouse IgG solid cellulose nitrate (mixing) membrane and the bonders of absorptive colloidal gold - monoclonal  antibody against AFP. It  adopts  the  principles  of  double  antibody  sandwich  method  and immunochromatography to test the AFP in the serum.

 

The kit contains reagents for 30 tests in cassette (code 15601-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15601-1

The test contains a membrane strip coated with AFP conjugates (purified bovine serum) 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 antibody specific to AFP.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Alpha-Fetoprotein (AFP) Test and other commercially available rapid AFP 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 drugs found in presumptive positive samples tested.

Test

Compounds Contributed to the Totals of GC/MS

AFP

Alpha-Fetoprotein

%Agreement with GC/MS

 

AFP

Positive Agreement

95%

Negative Agreement

100%

Total Results

97.5%

%Agreement with commercial kit

 

AFP

Positive Agreement

99%

Negative Agreement

100%

Total Results

99%

Forty (40) clinical samples for AFP were run using each strip contained within AFP Rapid 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, AFP-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:

Alpha-Fetoprotein

conc.(ng/mL)

Total number of Determinations

Result

Precision

No AFP present

40

40 negative

>99%

5

40

40 negative

>99%

10

40

40 negative

>99%

20

40

40 positive

>99%

40

40

40 positive

>99%

Analytical Sensitivity

The results are summarized below.

Cross-Reactivity

               Results of AFP rapid test strip sensitivity

Number

1

2

3

4

5

6

7

8

9

Concentration

(ng.mL-1)

0

5

10

15

20

50

100

200

500

Test results

-

-

-

-/+

+

+

+

+

+

A study was conducted to determine the cross-reactivity of the test with compounds in either AFP-free serum or AFP positive serum. The following compounds show no cross-reactivity when tested with AFPRapid Test at concentrations.

Non Cross-Reacting Compound

Specificity of AFP rapid test strip

Compounds

Test results (ng.mL-1)

0

10

50

100

200

AFP

-

-

+

+

+

CEA

-

-

-

-

-

PSA

-

-

-

-

-

CA125

-

-

-

-

-

CA15-3

-

-

-

-

-

Ferritin

-

-

-

-

-

Human Albumin

-

-

-

-

-

Note: - negative result, + positive result.

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