I think this is:
"The
Access® Hybritech® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum, using the Access® Immunoassay System" .
FDA documentation is
here. Although the equipment may show 0.000, this report says:
"Results
a. In the sample diluent study:
The three calibrations provided no significant difference for analytical sensitivity, LoB, and LoD and all results were below the published Access Hybritech PSA assay analytical sensitivity value of <0.008 ng/mL (which used Access Hybritech PSA Sample Diluent to establish this claim)."
[LoB = Limit of Blank; LoD = Limit of Detection]
See this report for further details. I'm not sure why the lab report states 0.000. IMO it should be <0.008, the Limit of Detection. The document states that the Limit of Blank is
0.0016. If a sample with
no PSA can give you that value with this test, you can't state that a patient's result is 0.000.
Was this done at Labcorp?
Djin