Fortel® – Prostate (PSA) Screening Test

Laboratory accuracy in the comfort of your home, with results in 10 minutes.

The Fortel® Prostate (PSA) Screening Test is a simple at-home visual test. Using a finger prick blood sample, it detects elevated levels of Prostate Specific Antigen (PSA). Elevated levels of PSA may be an important sign of possible prostate disease and useful for early detection.

 

The Fortel® Prostate (PSA) Screening test from Biomerica is a simple at-home visual test to detect elevated levels of Prostate Specific Antigen (PSA) using a finger prick blood sample.

The test is CE marked and is intended for self-testing or over-the-counter (OTC) use for screening elevated levels of PSA in males.

Fortel Prostate Screening Test brings laboratory accuracy in the comfort of your home. Its performance versus laboratory reference method is: Accuracy: 97.5%; Sensitivity: 100%; Specificity: 95%

The Fortel Prostate (PSA) Screening Test is available for online purchase for home use from Una Health Consumers shop: www.una-athome.co.uk

 

Early Detection is the Best Protection and Can Save Lives

 

The Prostate (PSA) Screening Test is also available for professional use, in primary care settings, as EZ-PSA™. For further information, please contact us at enquiries@unahealth.co.uk

Easy to read results
Quick, simple to use, results in 10 minutes
Laboratory accuracy, CE marked for at-home use

Fortel® Prostate (PSA) Screening Test is a rapid lateral flow test to detect human Prostate Specific Antigen (PSA) using a finger prick whole blood sample.

PSA is produced by the prostate gland and released in very small amounts into the bloodstream. The test is designed to detect PSA levels above the expected normal range. The cut-off mevel is 4ng/ml which equals a normal level.

Elevated PSA levels may be a sign of possible prostate disease (enlarged prostate, prostate cancer). Screening based on PSA can facilitate early detection of Prostate Cancer, reducing mortality in long term.

Note: As with all self-testing devices, a definitive diagnosis should not be made on the basis of a single test. The diagnosis should be made by a physician after all clinical and laboratory findings have been evaluated.

Prostate Cancer is the most common cancer in men¹.

Across the UK, more than 52,000 men are diagnosed with prostate cancer every year on average – that’s 143 men every day.

1 in 8 men will be diagnosed with prostate cancer in their lifetime.

More than 12,000 men die from prostate cancer every year.

 

Screening based on PSA allows for the detection of Prostate Cancer at an early stage, reducing cancer-specific mortality at long-term follow-up.²

 

[1] Prostate Cancer UK – https://prostatecanceruk.org/prostate-information/about-prostate-cancer

[2] European Association of Urology – Policy Paper on PSA screening for prostate cancer

The full instructions are available as per the IFU.

PSA Test Instructions for use

PSA Test Instructions for use

PSA Test Instructions for use

PSA Test Instructions for use

Note: If the test result is positive, see your physician to confirm the result and to possibly obtain treatment. If the test result is negative, but you are not feeling well or if you are concerned about your prostate health, see your physician for further testing and diagnosis.

Fortel® Prostate (PSA) Screening Test – Laboratory Accuracy

 

Clinical Study #1

Performance vs. Reference Method (Immulite 2000/ Abbott Axsym Total PSA/ Roche E170 tests)

  • Clinical studies for PSA were performed using 161 clinically confirmed samples
  • Sensitivity: 100%
  • Specificity: 95%
  • Accuracy: 97.5%

 

Reference Method

Product Description

Code

Size

 

CE Marked

Fortel® PSA (for at-home testing)
1081-1
1 test per pack
 
YES
EZ-PSA™ (for professional use)
1081-15
15 tests per pack
 
YES

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