Just Blood · The Validation Files
VALIDATED.
What does that word actually mean? The trial record contains Theranos assay validation reports covering different analytes, different clinical categories and different analytical questions.
DON'T TAKE OUR WORD FOR IT.
OPEN THE TRIAL EVIDENCE.
PART 01 / 06
WHAT DOES VALIDATED MEAN?
Validation is not “the machine produced a number.” It is a structured attempt to establish how an assay performs under defined conditions.
ACCURACY / RECOVERY
Does the method recover the expected concentration?
PRECISION
Can it reproduce results across repeated measurements?
LINEARITY
Does measured response track concentration across the range?
MEASURING RANGE
What concentrations can the method report?
SENSITIVITY
How low can the assay reliably detect or quantify?
METHOD COMPARISON
How does performance compare with another established method?
ONE TEST COULD BE AN EXPERIMENT.
MULTIPLE ASSAYS ACROSS MULTIPLE CLINICAL CATEGORIES IS A TESTING PROGRAM.
PART 02 / 06
THYROID.
TSH.
Trial Exhibit 9368 identifies itself as a “Validation Document” and is titled TSH – ELISA Assay Validation Report on Edison 3.X Theranos System.
Original court exhibit · TSH validation report and approval chain.
The report lays out calibration criteria and repeated testing rules. It also identifies Adam Rosendorff, M.D., as the Laboratory Director approving the validation document.
THIS ISN'T A MARKETING BROCHURE.
IT'S A VALIDATION DOCUMENT.
PART 03 / 06
HORMONES.
TOTAL TESTOSTERONE.
Trial Exhibit 9382 is titled Total Testosterone ELISA Assay Validation Report on Edison 3.5 Theranos System. The report describes reportable range, precision, clinical correlation, method comparison, dilution linearity, analytical sensitivity, interference and analyte stability.
Original court exhibit · Total Testosterone validation report.
The report's calibration analysis compares reported concentrations with Theranos results across calibrators and displays a regression of R² = 0.9994.
R² = 0.9994
PART 04 / 06
RENAL.
CYSTATIN C.
Trial Exhibit 9129 is explicitly labeled Validation Document — Cystatin C Validation Report.
Original court exhibit · Cystatin C Validation Report.
The report describes precision testing under CLSI EP5-A2 using repeated runs over multiple days and multiple concentration levels.
PART 05 / 06
IMMUNOLOGY.
IgA.
Trial Exhibit 9240 is explicitly labeled Validation Document — Immunoglobulin A (IgA) Validation Report.
Original court exhibit · Immunoglobulin A validation report.
The report includes calibration, quality-control, precision, anticoagulant comparison and bias-estimation work comparing Siemens and Theranos methods.
PART 06 / 06
CLINICAL CHEMISTRY.
CALCIUM.
Trial Exhibit 9086 is an LDT Validation Report for a modified Siemens calcium assay in lithium-heparin plasma.
Original court exhibit · Validation of Modified Siemens Calcium Assay.
This report shows another part of Theranos' laboratory architecture: the trial record contains validation work involving both Theranos/Edison assays and modified methods using commercial platforms.
THE VALIDATION FILES ARE IN THE TRIAL RECORD.