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 Carcino-Embryonic Antigen (CEA) Test (Strip) Tests per Package: 50
Serum Code: 15602-2 Package Format: Strip (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 Carcino-Embryonic Antigen (CEA) Test is a rapid, serological, immunochromatographic assay for the detection of CEA in human serum. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Carcino-Embryonic Antigen (CEA)Test is a lateral flow chromatographic immunoassay for the qualitative detection of CEA in serum sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

EASY Line Carcino-Embryonic Antigen (CEA) Test

Carcino-Embryonic Antigen

5 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 CEA test result, particularly when preliminary positive results are obtained.

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

CEA was originally found in colon cancer and  intestinal tissue of fetal, therefore be named carcinoembryonic antigen. Elevated CEA is common in colorectal cancer, pancreatic cancer, gastric cancer, breast cancer, medullary thyroid carcinoma, etc. But smoking, pregnancy and diseases such as cardiovascular disease, diabetes, nonspecific colitis, CEAIn the serum will also rise in 15% ~ 53% of the patients, so the CEA is not a Specific marker of malignant tumour. Only the auxiliary value in diagnosis.In addition,  the level of CEA in the serum has a clear relationship with staging of colorectal cancer , the more advanced lesions, CEA concentration is higher.

EASY Line Carcino-Embryonic Antigen (CEA) Test yields a positive result when the CEAin human serum specimen exceeds 5 ng/mL.

EASY Line Carcino-Embryonic Antigen (CEA) Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of carcino-embryonic antigen(CEA) in human serum specimen. CEA tests are based on the principle of sandwich immunoassay for determination of CEA in human serum specimen. Two monoclonal antibodies are employed to identify CEA specifically. The carcinoembryonic antigen (CEA) is the most commonly tested when antigen rise beyond the normal range, it can be taken as a signal of cancer or other problems. This one step test is very sensitive and only takes about 15 minutes. Test results are read visually without any instrument.

The kit contains reagents for 50 tests in strip (code 15602-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15602-2

The test contains a membrane strip coated with CEA 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 CEA.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Carcino-Embryonic Antigen (CEA) Test and other commercially available rapid CEA 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

CEA

Carcino-Embryonic Antigen

%Agreement with GC/MS

 

CEA

Positive Agreement

95%

Negative Agreement

100%

Total Results

97.5%

%Agreement with commercial kit

 

CEA

Positive Agreement

99%

Negative Agreement

100%

Total Results

99%

 

Forty (40) clinical samples for CEA were run using each strip contained within EASY Line Carcino-Embryonic Antigen (CEA) 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, CEA-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:

Carcino-Embryonic Antigenconc.(ng/mL)

Total number of Determinations

Result

Precision

No CEA 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

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

               Results of CEA rapid test strip sensitivity

Number

1

2

3

4

5

6

7

8

9

Concentration

(ng.mL-1)

0

2

3

4

5

10

20

50

100

Test results

-

-

-

-/+

+

+

+

+

+

Non Cross-Reacting Compound

Specificity of CEA rapid test strip

Compounds

Test results (ng.mL-1)

0

10

50

100

200

CEA

-

+

+

+

+

AFP

-

-

-

-

-

PSA

-

-

-

-

-

CA125

-

-

-

-

-

CA15-3

-

-

-

-

-

Ferritin

-

-

-

-

-

Human Albumin

-

-

-

-

-

Note: - negative result, + positive result.

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