For in vitro diagnostic use.
More than 299,000 new prostate cancer cases will be diagnosed in 2024.1
Prostate cancer is the 4th most common cancer overall.1
About 6 cases in 10 are diagnosed in men who are 65 or older, and it is rare in men under 40.2
Prostate cancer accounts for about 15% of cancers in men worldwide.
It is predicted that the global burden of prostate cancer is set to more than double to almost three million new cases by 2040, compared with the estimated number of cases today.3
= 100,000 cases
= 100,000 new cases
Prostate screening may help identify prostate cancers early, allowing for timely treatment. Survival rates are highest when prostate cancer is caught early.4
Many men have an annual blood test with their primary care provider called a PSA test that stands for “prostate specific antigen” as well as a prostate examination.
Screening: If PSA levels are normal, a clinician will determine screening protocols for each patient.
If the Total PSA test yields abnormal results, subsequent actions may involve repeating the test, conducting secondary tests such as Free PSA, and/or proceeding with imaging before considering a biopsy.
A biopsy is needed to confirm prostate cancer diagnosis.
A clinician will provide treatment plans based on the presence of and stage of cancer.
A PSA test will be used to monitor disease and recurrence.
This webinar showcases two experts who provide a comprehensive understanding of the burden of prostate cancer, highlight the disparities of prostate cancer among different races and ethnicities, and emphasize the pivotal role of biomarkers. Total PSA is a screening test aiding in the diagnosis of prostate cancer. Secondary tests such as Free PSA can aid in discriminating between prostate cancer and benign disease, helping to optimize the patient journey.
INTENDED USE: The Alinity i Total PSA assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of total PSA (both free PSA and PSA complexed to alpha-1-antichymotrypsin) in human serum on the Alinity i analyzer:
INTENDED USE: The Alinity i Free PSA assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of free prostate specific antigen (PSA) in human serum on the Alinity I analyzer. The Alinity i Free PSA assay is intended to be used in conjunction with the Alinity i Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and DRE non-suspicious for cancer to determine the % free PSA value. The Alinity i % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease.
Aid in detection of prostate cancer7
Monitor disease progression and treatment response7
Identify disease recurrence7
Total PSA test
>4 and <10 ng/mL
Free PSA Test
The percent-free PSA (%fPSA) test helps determine the likelihood of prostate cancer by comparing the ratio of free to total PSA, with lower ratios indicating a higher risk and the potential need for a biopsy.
3a. based on
<10% fPSA
3b. based on
10–25% fPSA
3c. based on
>25% fPSA
Authors summarize prostate biomarkers and their clinical performance to aid in the diagnosis and management of prostate cancer.
| PUBLICATION | Description |
| The study discusses the occurrence of the hook effect in immunoassays in total PSA and total hCG with different immunoassay analyzers. The authors also compared the sensitivity of different immunoassay analyzers. | |
| The study aimed to determine if a total PSA combined with percent free PSA (%fPSA) could help risk-stratify men for screening and enhance diagnostic accuracy for clinically significant prostate cancer and fatal prostate cancer using data from the PLCO* Screening trial. |
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CAUTION: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions.
WARNING: The concentration of total PSA in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the total PSA assay used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining total PSA levels serially is changed, additional sequential testing should be carried out. Before changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Note: % free PSA (FPSA) ratios must be calculated using Total PSA and Free PSA results both obtained on the Alinity i analyzer.
CAUTION: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions.
WARNING: The concentration of free PSA (FPSA) in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the free PSA assay used. Values obtained with different assay methods cannot be used interchangeably. Note: % FPSA ratios must be calculated using Total PSA and Free PSA results both obtained on the Alinity i analyzer.
CAUTION: This product requires the handling of human specimens. It is recommended that all human-sourced materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.
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