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Clinical Information: Prostate (PSA) Test Service

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Prostate (PSA) Test Service

MyHealthTest’s fingerprick blood test for total Prostate Specific Antigen (PSA) was developed to improve the access and convenience of blood testing.

The test will be of particular use to men who, after consultation with their healthcare provider, have decided that they wish to monitor their PSA level but due to access issues (geographic, physical or time constraints) are finding it difficult to present for blood tests as planned.

The test may also be used to improve the accessibility and convenience of blood testing in an active surveillance program under medical supervision.

This test is not suitable for monitoring for recurrence of prostate problems after treatment via prostatectomy, radiation or chemotherapy.

The MyHealthTest Prostate PSA Test was validated against Australian NATA and NPAAC guidelines to confirm that dried blood spot results obtained are comparable to serum samples collected by traditional venous venepuncture and analysed at an external NATA accredited pathology laboratory.

A reference interval for the MyHealthTest PSA dried blood spot assay was established by comparing results to those from matching serum samples run by an accredited comparator pathology laboratory and adjusting the reference interval based on the resulting regression equation.

Samples are stable for up to 12 days after collection and thermal stability testing confirmed that after holding dried blood spot samples at 46°C for two days there was no significant difference in the PSA values obtained.

Figure 1. Total PSA Bland Altman and Linear Regression analysis of serum vs DBS

Measurement Range:0.5 – 250 µg/L
Limit of Quantitation:0.5 µg/L
Reference Interval:
PSA DBS reference interval (<50 yrs) <1.8 µg/L
PSA DBS reference interval (50 – 60 yrs)   <3.2 µg/L
PSA DBS reference interval (>60 yrs) <5.6 µg/L
Repeatability: ≤14.1%
Reproducibility:12.4% at 2.7 µg/L and 10.1% at 16.7 µg/L
Stability: ≤12 days
Interferences:Human glandular kallikrein (HK2) cross reacts with total PSA.

Heterophilic antibodies in the patient sample may occasionally interfere with the assay.

High or low haematocrit may affect the reported total PSA values.