Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago). The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects. The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
34
Healthy volunteers will have 3 blood samples at M0, M3 and M6.
Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est
Bron, France
Platelets aggregation results for LTA on TA-8V (Stago®)
Normal values for platelets aggregation will be established using various agonists to activate platelets. : • Ristocetin (STAGO®)
Time frame: Month 0
Platelets aggregation results for LTA on TA-8V (Stago®)
Normal values for platelets aggregation will be established using various agonists to activate platelets. : * Collagen (STAGO®) * ADP (adenosine diphosphate) (STAGO®) * Arachidonate (STAGO®) * TRAP (Thrombin Receptor Activating Platelet) (STAGO®)
Time frame: Month 3
Platelets aggregation results for LTA on TA-8V (Stago®)
Normal values for platelets aggregation will be established using various agonists to activate platelets. : * Epinephrine (STAGO®) * PMA (phorbol 12-myristate 13 acetate) (SIGMA®) * PAF (Platelet Activator Factor) (BACHEM®) * Ionophore calcium (SIGMA®) * 11-Epoxy (SIGMA®) * Prostaglandin E1 (SIGMA®)
Time frame: Month 6
LTA intra assay variability
Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
Time frame: Month 0
LTA intra assay variability
Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
Time frame: Month 3
LTA intra assay variability
Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
Time frame: Month 6
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Time frame: Month 0
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Time frame: Month 3
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Time frame: Month 6
Agonist reagents stability duration
Reagents will be reconstituted and stored at -20°C. They will be used for aggregation assay extemporaneously, 1 week, 2 weeks , 1 month and 2 months post reconstitution.
Time frame: up to 2 months post reagents reconstitution and 2 months post reconstitution with the same technician, the same automaton and the same healthy volunteer sample.
Agonist reagents stability duration
Reagents will be reconstituted and stored at -20°C. They will be used for aggregation assay extemporaneously, 1 week, 2 weeks , 1 month and 2 months post reconstitution.
Time frame: up to 2 months post reagents reconstitution
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