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 PSA Test (Strip) Tests per Package: 50
Serum Code: 15600-2 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.

The EASY Line PSA Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Prostate Specific Antigen (PSA) tumor markers in human serum specimen. PSA tumor marker tests are based on the principle of sandwich immunossay for determination of PSA in human serum specimen. Two monoclonal antibodies are employed to identify cancer PSA specifically.

For “in vitro” diagnostic use only.

Prostate cancer is now the most frequently diagnosed cancer in male and considered as the leading cause of mortality due to cancer. Prostate cancer’s incidence increases dramatically in males over 40 years, occurring in 50% of those over 70 years. Compared to other cancers prostate cancer is more successfully treated if diagnosed early. Digital rectal examination has been a useful procedure in early detection of prostate cancer but it has been shown of having limitations. Also the biochemical markers which are available to monitor this disease (i.e. prostatic acid phosphatase, total alkaline phosphatase, carcinoembryonic antigen, creatine kinase isoenzyme BB etc.) are not specific for prostate cancer. Therefore, the management of patients with prostate cancer has been hindered by the lack of a more accurate markers.

Recently, another prostate enzyme has been identified and purified, which is specific for prostate tissue, normal or malignant and also found in periurethral glands. This enzyme is called prostate specific antigen (PSA). Human PSA is a single chain glycoprotein with a molecular weight of approx.30kDa containing 8% of carbohydrate by weight. prostate cancer, benign prostate hyperplasia (BPH) and in some cases of inflammatory disorders of other genitourinary tissues in proximity to the prostate. Increased levels are not observed in healthy men or those with cancers other than the prostate. Females who are healthy or have cancer do not exhibit PSA. Serial testing for elevated levels of PSA in serum can provide an important tool in the monitoring of disease recurrence or in following the effectiveness of a particular treatment.

The prostate specific antigen (PSA) is the most commonly tested Tumour marker for the prostate gland disease diagnosis. PSA tumour marker is normally present in low levels in the blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/mL, which are variable among different human races (refer to the table at the end of this page). But when prostate specific antigen rise beyond the normal range, it can be taken as a signal of prostate gland cancer or other problems. That is why PSA becomes the subject of PSA serum detection devices.

This product is composed of the fiberglass strips of monoclonal antibody against Prostate Specific Antigen (PSA), anti-mouse IgG solid cellulose nitrate (mixing) membrane and the bonders of absorptive colloidal gold - monoclonal  antibody  against  PSA. It adopts the  principles of double antibody sandwich method and immunochromatography to test the PSA in the serum.

The kit contains reagents for 50 tests in strip (code 15600-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15600-2

Test device: Membrane assembly pre-dispensed with monoclonal anti PSA antibody colloidal gold conjugate, rabbit globulin colloidal gold conjugate, monoclonal anti PSA antibody and goat anti rabbit at the respective regions EA.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

In an clinical study a panel 480 samples whose results were earlier confirmed with Hospital ELISA test were tested with EASY Line PSA Test. The results obtained were as follows.

Method

Hospital ELISA

Total Results

EASY Line PSA Test

Results

Positive

Negative

Positive

154

2

156

Negative

3

241

244

Total Results

157

243

400

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