Device and method for concentrating and detecting pathogenic microbes from blood products and/or their derivatives

A method for detecting contaminating microbes possibly present in a blood product comprising blood cells comprising:

• a) providing a sterile device for concentrating microbes possibly present in a blood product containing blood cells comprising:
• a first watertight, sterile tank containing a piston and at least one blood cell aggregation agent and, optionally, at least one marker agent for labeling pathogenic microbes;
• a second watertight, sterile tank containing at least one lysis agent for blood cells and, optionally, at least one marker agent for labeling pathogenic microbes;
• a first filter located between the first tank and the second tank, wherein the size of the pores of the first filter are between about 2 μm and about 20 μm and having pores that allow passage of contaminating microbes, but not cell aggregates;
• a second filter, wherein the size of the pores of the second filter are between about 0.2 μm and about 2 μm is enclosed in a membrane support having two removable, separable parts and located downstream of the second tank and having pores that retain contaminating microbes and allow passage of cellular debris;
• a first watertight, sterile connector joining the first tank and the first filter;
• a second watertight, sterile connector joining the first filter and the second tank;
• a third watertight, sterile connector joining the second tank and the second filter;
• a fourth watertight, sterile connector comprising a reverse lock valve and joining a bag containing a blood product to the first sterile tank,
• b) subjecting a sample of the blood product to an aggregation treatment of the blood cells in the first tank,
• c) substantially eliminating aggregates formed in step (b) by passage of the sample over the first filter to allow passage of contaminating microbes, but not cell aggregates,
• d) selectively lysing residual cells of the filtrate obtained in step (c) in the second tank,
• e) labeling the contaminating microbes with a marker agent either during step (b) or step (d),
• f) recovering the contaminating microbes by passage of the lysate from step (d) over the second filter to retain contaminating microbes and allow passage of cellular debris, and
• g) analyzing material on the second filter to detect labeled contaminating microbes possibly retained by the second filter, said method being performed in the sterile device.