Evaluation of the Diagnostic Performance of a Rapid Prostate-Specific Antigen Test for Prostate Cancer
Mohammed Elsayed*, Mohamed Mustafa and Ahmed Abdelsalam Saadoun Ismaael
ABSTRACT
Background: Prostate cancer is one of the most common malignancies affecting men worldwide. Early detection through prostate-specific antigen (PSA) testing can improve clinical outcomes; however, conventional laboratory assays may not always be readily available in all healthcare settings. Rapid PSA tests have emerged as a convenient alternative for screening, offering faster results and easier implementation. Assessing the diagnostic performance of these rapid tests is essential before their widespread use in clinical practice.
Objective: This study aimed to evaluate the diagnostic accuracy of the Fortel rapid PSA test for prostate cancer screening by comparing its performance with the standard clinical PSA assay.
Methods: A cross-sectional study was conducted on 150 male participants aged over 50 years, or over 40 years with a family history of prostate cancer. All participants underwent medical history assessment, digital rectal examination, conventional serum PSA measurement, and Fortel rapid PSA testing. Diagnostic indices, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy, were calculated by comparing the rapid test with the clinical PSA results.
Results: The mean age of participants was 57.73 ± 4.90 years. Clinical PSA testing identified 72 (48.0%) positive and 78 (52.0%) negative cases, while the Fortel rapid PSA test showed 73 (48.7%) positive and 77 (51.3%) negative results. No significant association was found between age and Fortel PSA test results (p = 0.975). A highly significant agreement was observed between the rapid test and clinical PSA findings (p < 0.001). The Fortel PSA test demonstrated excellent diagnostic performance, with 97.2% sensitivity, 96.2% specificity, 95.9% PPV, 97.4% NPV, and an overall accuracy of 96.7%.
Conclusions: The Fortel rapid PSA test demonstrated high diagnostic accuracy and strong agreement with conventional serum PSA testing. Its excellent sensitivity and specificity suggest that it is a reliable, rapid, and practical screening tool for prostate cancer, particularly in primary healthcare and resource-limited settings. Further multicenter studies are recommended to validate these findings in larger and more diverse populations.
