Quote:
Originally Posted by Natalie8
Can you explain how they can determine the accuracy of the assay after testing 1,000 people? Don't you have to follow the people you test to see if those who test positive for JC virus get PML? Urine, blood, and spinal fluid may not show evidence of JC virus but it could be there, right? That's why we need the assay?
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The 1000 patient trial is to determine the accuracy of whether someone is JC Virus antibody positive or not - the blood test JC Virus Antibody assay result will be compared to the JC Virus PCR Test Result from the same patients urine to detemine proper correlation - should be positive or negative on both - otherwise false positive or false negative.
The 800 patient study will determine the rate of PML in patients who test negative for the JC Virus Antibody.
The premise of the JC Virus Antibody Assay is that if you've been exposed to the JC Virus you'll have JC Virus Antibodies in your system. 11 of 11 patients who developed PML and had earlier blood samples stored tested positive for JC Virus Antibodies.