Background
Prostate-specific antigen (PSA) is a protein produced by normal prostate cells. This enzyme participates in the dissolution of the seminal fluid coagulum and plays an important role in fertility. The highest amounts of PSA are found in the seminal fluid; some PSA escapes the prostate and can be found in the serum.
Aim
To determine accuracy, sensitivity, specificity of the one-step PSA test (Fortel Test) ‘FDA approved’ for screening for prostate cancer in comparison to a conventional quantitative assay.
Patients and methods
This prospective cohort clinical study was conducted at the tertiary care hospital at the Urology Department, Outpatient Clinic, Faculty of Medicine, Ain Shams University from January 2022 till June 2022 and performed on a total of 150 patients who were over 50 years old or over 40 years old with a family history of prostate cancer.
Results
Our study results revealed that Fortel PSA test had high sensitivity (97.2%), specificity (96.2%), positive predictive value (95.9%), and negative predictive value (97.4%) in the accuracy of screening of prostatic cancer.
Conclusion
The Fortel PSA test is a simple, feasible, and reproducible tool for prostate cancer screening. The lower cost, ease of handling, and rapid procedure could make this test useful in the general practitioner or urologist office setting as well as for mass primary prostate cancer screening.