OBJECTIVES: We measured the intraindividual variation of prostate-specific antigen (PSA) in the serum of healthy men screened for prostate cancer. METHODS: We used a fully automated PSA assay system (ACS: 180 assay) to evaluate a screening population of 814 men (mean age, 63.3 years; range, 50 to 79 years) without documented prostate cancer or prostate surgery. A second blood sample was drawn 15 to 183 days after the first specimen (mean, 80 days). RESULTS: In the ACS PSA ranges of 0 to 7.2 ng/mL, 7.3 to 17.9 ng/mL, and 18.0 ng/mL or greater (O to 4 ng/mL, 4 to 10 ng/mL, and 10.0 ng/mL or greater by the Tandem-R assay), the mean coefficient of variation of the first and second blood drawn was 20%, 12%, and 10%, respectively. In 435 men whose first blood samples were measured twice for PSA difference (interassay or run-to-run variation), the intraindividual variation in the range of 0 to 7.2 ng/mL was significantly larger than the interassay variation, which was also true the 7.3 to 17.9 ng/mL range. In the range of 0 to 7.2 ng/mL, 251 of 695 (36%) showed a 20% or greater relative increase and 69 of 695 (10%) showed a 1.3 ng/mL (0.75 ng/mL by the Tandem-R assay) or greater absolute increase of PSA at the second blood sample. CONCLUSIONS: We conclude that in the low ranges of PSA concentrations, one should consider the possibility of substantial intraindividual variation when interpreting serial PSA measurements.
OBJECTIVES: We measured the intraindividual variation of prostate-specific antigen (PSA) in the serum of healthy men screened for prostate cancer. METHODS: We used a fully automated PSA assay system (ACS: 180 assay) to evaluate a screening population of 814 men (mean age, 63.3 years; range, 50 to 79 years) without documented prostate cancer or prostate surgery. A second blood sample was drawn 15 to 183 days after the first specimen (mean, 80 days). RESULTS: In the ACS PSA ranges of 0 to 7.2 ng/mL, 7.3 to 17.9 ng/mL, and 18.0 ng/mL or greater (O to 4 ng/mL, 4 to 10 ng/mL, and 10.0 ng/mL or greater by the Tandem-R assay), the mean coefficient of variation of the first and second blood drawn was 20%, 12%, and 10%, respectively. In 435 men whose first blood samples were measured twice for PSA difference (interassay or run-to-run variation), the intraindividual variation in the range of 0 to 7.2 ng/mL was significantly larger than the interassay variation, which was also true the 7.3 to 17.9 ng/mL range. In the range of 0 to 7.2 ng/mL, 251 of 695 (36%) showed a 20% or greater relative increase and 69 of 695 (10%) showed a 1.3 ng/mL (0.75 ng/mL by the Tandem-R assay) or greater absolute increase of PSA at the second blood sample. CONCLUSIONS: We conclude that in the low ranges of PSA concentrations, one should consider the possibility of substantial intraindividual variation when interpreting serial PSA measurements.
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