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 II Test (cassette) Tests per Package: 25
Serum,Whole Blood,Plasma Code: 15600T-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 PSA II Test is a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma. Test results are read visually without any instrument.

This kits are intended for In vitro diagnostic use only, must not be sold to the general public and the test has to be carried out  by a health-care professional person.

Prostate specific antigen (PSA) is the best serum marker currently available for the detection of prostate cancer and is the forensic marker of choice for determining the presence of azoospermic semen in some sexual assault cases.

Prostate cancer is a common malignancy in Western populations and a growing public health problem globally. Although the prevalence of prostate tumors becomes very high with age, only a small proportion of tumors are potentially lethal (aggressive) and their identification is an enduring challenge. Established risk factors include age, family history, and race, but, until the causes are better understood, prevention is impossible. In some populations, the widespread use of prostate-specific antigen (PSA) tests to increase early detection has inflated incidence, often by more than twofold, and shifted the disease spectrum toward less aggressive forms, that is, small tumors of low to moderate grade. Given the virtually ubiquitous presence of small low-grade tumors in the prostates of older men, the principal research question now is to identify factors that cause progression to advanced disease.

The human kallikrein (hk) family, located on chromosome 19, encodes prostate-specific antigen (PSA [or hK3]), hK2, hK4, and hK15 (prostin), as well as other serine proteases. Although PSA has been used in the detection of prostate cancer for several years, much remains unknown about its function and forms. The regulatory mechanisms of PSA are vital to its understanding.

Testing for prostate-specific antigen (PSA) has profoundly affected the diagnosis and treatment of prostate cancer. PSA testing has enabled physicians to detect prostate tumours while they are still small, low-grade and localized. This very ability has, however, created controversy over whether we are now diagnosing and treating insignificant cancers. PSA testing has also transformed the monitoring of treatment response and detection of disease recurrence. Much current research is directed at establishing the most appropriate uses of PSA testing and at developing methods to improve on the conventional PSA test.

The EASY Line PSA II Test uses solid-phase immunochromatographic technology for the semi-quantitative detection of prostate specific antigen in whole blood / serum / plasma. The test is a two-site immunometric assay in which a combination of monoclonal PSA antibodies and PSA monoclonal antibody coated particles are used to selectively detect prostate specific antigen in samples with a high degree of sensitivity.

Monoclonal PSA antibodies were immobilized on the test area “T” of the nitrocellulose membrane. PSA monoclonal antibody coated particles were dried on a conjugate pad. Sample is introduced from sampling pad. If there is PSA in the sample, PSA binds to the mobile PSA monoclonal antibody coated particles. Together they move to the test area “T”. PSA molecules bind to the immobilized Monoclonal PSA antibodies and as a result of this, PSA molecules that have already bound to PSA monoclonal antibody coated particles become immobilized in the test area “T” thus creating a visible colored signal indicating positive test result.

Test area “T” intensity weaker than the reference line “R” indicates that the PSA level in the specimen is between 4-10 ng/ml. Test area “T” intensity equal or close to the reference line “R” indicates that the PSA level in the specimen is approximately 10 ng/ml. Test area “T” intensity stronger than the reference line “R” indicates that the PSA level in the specimen is above 10 ng/ml. If there is no PSA in the sample then sample moves to the test area “T” together with free PSA monoclonal antibody coated particles. Immobilized Monoclonal PSA antibodies cannot bind to mobilized PSA monoclonal antibody coated particles, therefore no visible colored signal in test area “T” (no colored test line) can be obtained, indicating negative test result. Regardless of PSA content of the liquid sample, a visible colored signal is produced in the control area “C” (a colored control line), indicating a valid test result. Colored line should be visible in the control area “C” in every case; if no visible colored line in control area “C”, test result should be indicated as invalid.

The EASY Line PSA II Test (cassette) contains sufficient reagent for 25 tests.

The kit contains reagents for 25 tests in cassette (code 15600T-1) with droppers and diluents.

Individually packed test devices with disposable pipettes and silica gel

25

PSA Diluent (3 mL)

1

Number of tests

25

Code

15600T-1

  • Sample collection tube
  • Centrifuge
  • Timer
  • Lancet (for only fingerstick whole blood)
  • Heparinized dispensing bulbs and capillary tubes (for only fingerstick whole blood).

EASY Line PSA II Test has been performed using below samples. Results were shown at below table and evaluated by Tietz Method.

300 PSA positive samples

300 PSA negative samples

100 clinical PSA negative samples

30 potentially interfering PSA negative samples (Ascorbic acid)

30 potentially interfering PSA negative samples (Bilirubin)

30 potentially interfering PSA negative samples (Hemoglobin)

30 potentially interfering PSA negative samples (Triglycerides)

30 potentially interfering PSA negative samples (Uric acid)

30 cross-reactivity samples (hK2)

120 PSA positive calibrated samples

50 PSA positive samples (hook effect)

Tietz method

Reference

Total

+

-

EASY Line PSA II Test

+

470

0

470

-

0

580

580

Total

470

580

1050

Sensitivity:       100 %                                     

Specificity:       100 %

+ Predictive V:  100 %             

- Predictive V:   100 %

 

Cut-off value:

6 different PSA concentrations (2 ng/mL, 4 ng/mL, 10 ng/mL, 20 ng/mL, 40 ng/mL and 100 ng/mL) were tested with EASY Line PSA II Test and cut-off value was observed 4 ng/mL according to performed study by Adaltis.

Cross reactivity:

Cross reactivity has been tested with hK2 positive samples, no cross-reactivity was found with EASY Line PSA II Test.

Interferences:

Potentially interfering substances; Ascorbic acid, bilirubin, hemoglobin, triglycerides, uric acid were tested with EASY Line PSA II Test. In each case, no interference with the expected PSA test results was observed.

Hook effect:

No significant hook effect was detected when samples containing 30.000 ng/mL of PSA were assayed.

Haemolytic samples can interfere and can cause to invalid or false test results.

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