Patent ID: 8507237

Claim:
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.