Just Blood · The Nanotainer
BLOOD IS
BLOOD.
FINGER. HAND. ARM. FOOT.
Where you collect blood can matter. How you collect it can matter. And different specimen types are not automatically interchangeable for every assay.
BUT BLOOD FROM A FINGER
IS STILL BLOOD.
The laboratory question is: can you collect it reliably, control the variables, validate the method and produce reliable results?
PART 01 / 07
MEET THE NANOTAINER.
0.508 INCHES.
SMALLER THAN A DIME.
Theranos wasn't simply trying to make a smaller blood tube.
It was building a laboratory-testing workflow around a much smaller starting sample.
START WITH
LESS BLOOD.
ONE TESTING WORKFLOW.
PART 02 / 07
THE NANOTAINER
WASN'T THE TEST.
It wasn't the Edison.
It wasn't the chemistry.
IT HELD THE SAMPLE.
But when you're building testing around tiny amounts of blood, that small collection device sits at the beginning of everything downstream.
LESS SAMPLE
Microsampling changes how much specimen is available for the analytical workflow.
SMALLER REACTION VOLUMES
The testing architecture has to work with the volume actually collected.
PRECISE HANDLING
Collection, transfer, anticoagulant and sample integrity all matter.
SENSITIVE DETECTION
The complete analytical method must still meet its required performance specifications.
PART 03 / 07
BUT DOES FINGERSTICK
BLOOD WORK?
That's too simple a question.
THE LABORATORY QUESTION IS:
WAS THE METHOD VALIDATED?
VALIDATE THE
WHOLE PROCESS.
PART 04 / 07
HERE'S HOW I LOOK AT IT
AS A LAB OPERATOR.
“I can validate a test in any tube of my choice—or better yet, a non-FDA-cleared tube that I made myself. If I can demonstrate that the complete method produces reliable, reproducible results, that's what matters analytically.”
THE TUBE DOESN'T
VALIDATE THE TEST.
THE PERFORMANCE DATA
VALIDATES THE METHOD.
PART 05 / 07
NOW HERE'S WHERE
IT GETS INTERESTING.
In July 2015, FDA cleared Theranos' HSV-1 IgG assay.
FDA's clearance documentation describes fingerstick whole blood collected using Theranos Capillary Tubes and Nanotainer Tubes, with testing performed using the Theranos System.
Primary source: FDA — Theranos HSV-1 IgG 510(k) clearance →
PART 06 / 07
THEN FDA
CAME BACK.
During its 2015 inspection, FDA separately scrutinized the Nanotainer as a blood-specimen collection device and raised device-regulatory objections concerning it.
SAME WORKFLOW.
A DIFFERENT REGULATORY QUESTION.
THE LABORATORY QUESTION
Was the complete testing method properly validated and operated?
THE FDA QUESTION
Was the Nanotainer itself independently subject to medical-device requirements?
Primary source: FDA — Theranos 2015 Form 483 →
PART 07 / 07
ONE SYSTEM.
TWO REGULATORY QUESTIONS.
Theranos' microsample workflow connected multiple components: