Data Collection
The registry involves the collection of both data and _______ specimens.
Blood
Blood specimens will be collected for surveillance of blood-borne agents and this.
Inhibitors
Serum and plasma specimens will be processed in a ___________ certified laboratory.
CLIA
Used to collect participant data at enrollment into the project
Initial Visit Form
When a participant enrolls, this form will be completed.
Initial Visit Form
Serum will be collected to test for blood-borne agents while citrated plasma will be collected to test for inhibitors. These are the two blood-borne agents being tested for.
HCV and HIV
Specimen results are expected to be available within ____ weeks of shipment.
two
Used to collect participant data at episodes of participation other than upon enrollment.
Subsequent Visit Form
Participants of all ages will be asked to contribute data at this frequency.
Annually
Children younger than this age will NOT be asked to contribute serum to test for blood-borne agents. They may be asked to contribute a plasma specimen if indicated by their diagnosis and treatment product use.
Two years old
Should a seroconversion (viral or inhibitor) be detected, CDC will request that a new specimen be collected and submitted for confirmatory testing. Likewise, should a seroconversion be detected by testing at your HTC between episodes of Registry testing, CDC asks that a specimen also be submitted to this location for central testing.
CDC lab
These forms are used when a seroconversion is confirmed to collect additional information on clinical events and treatment product use preceding detection of the seroconversion.
Seroconversion Incident Case Form
At visits following the enrollment visit this form will be completed.
Subsequent Visit Form
Participants with one of these three diagnoses will be tested for inhibitors IF they have used clotting factor concentrate, any blood bank products, or if you do not know what treatment products they have used.
Factor VIII or Factor IX deficiency or Type 3 VWD
CDC will pay for specimen shipment via _____ and provide shipping materials for shipment of specimens on cold packs.
FedEx
These are the three types of Seroconversion Incident Case Forms:
Inhibitor Incident Case Form, Hepatitis C Incident Case Form, and HIV Incident Case Form
Data collection will take place during this type of clinic visit.
Routine clinic visit
The requested blood collection volumes are: serum ____ mL (3.5mL where specimen volume is limited by patient weight or age); plasma ____ mL (2.7mL where specimen volume is limited by patient weight or age).
Serum: 5.0
Plasma: 4.5
Sites are requested to ship refrigerated specimens on cold packs within _______ of collection. Specimens held longer at the site should befrozen and shipped on dry ice.
72 Hours
Completed each time a specimen is submitted for a participant.
Specimen Form