Test of performance

Structure of Transfusion Medicine ASO SS AntonioeBiagio-Alessandria-Italy

EVALUATION OF PERFORMANCE SYSTEM JOINT PRP KIT

The JOINT PRP Kit (Assembled by the company Joint Biomaterials) is adevice dedicated to the preparation of PRP (Class IIa with CE approval). The system is sterile,dedicated to the preparation of a single dose of Platelet Rich Plasma (PRP); the system is there fo reopened the PRP product,according to the Italian Legislation in force on the blood components(DM2 November 2015)is to be produced and applied to the patient and you cannot proceed to a storage or freezing.

The JOINT PRP system provides the collection/removal of 20mL of autologous anti-coagulated whole blood in thesyringe and the direct and immediate transfer of blood in the dedicated device. The loaded devicei splaced in to the slot of the dedicated centrifuge and centrifuged according to the speed program/preset time of 3200RPM for aduration of 5minutes. The blood transfer(load)and recovery of the separated PRP take place guaranteeing the attack of sterile syringes to a luerlock.

The system is easy to use,fast and suitable in particular to the point of care.The tests carried out showed that the PRP obtained respects the canonsfor the platelet concentration expected in Italian Legislation D.M. November2, 2015 (performance of device 800,000-1.200.000 platelets/ microliter) is met if the final volume of 2mL of PRP, volume through system method. The presence of the WBC may be reduced by slightly reducing the volume (200 microlitres),this variation can, however, affect the number of collected platelets.

Average charateristics of the JOINT PRP Kit

baseline
volume ml
baseline PLT
10³/mm³
baseline WBC
10³/mm³
prp volume
ml
platelets prp
10³/mm³
wbc prp
10³/mm³

20

188

4.8

2

950

8.6
The gelification of the PRP product with the JOINT PRP, occurs easily, simply by adding 0.5 mL of Calcium Gluconate / chloride (final volume 2.5 mL), the average time is 8 / 10minutes.
Gelification
Gelification
Gelification

Evaluation of performance system joint prp kit

Structure of Transfusion Medicine ASO SS Antonio e Biagio - Alessandria- Italy