Basematrix Negative Diluent is well suited, widely used and readily customizable for assay development and manufacture. The product is formulated from human plasma collected in FDA-licensed facilities and tested in accordance with FDA guidelines for viral markers. The plasma is tested and found non-reactive for HBsAg, anti-HIV1/2, anti-HCV, anti-HBc, anti-HTLVI/II, HIV-1 RNA, HCV RNA and HBV DNA.
Donors are tested and found negative for syphilis per FDA guidelines. The plasma is processed in an FDA-registered, ISO-certified 13485 facility and retains lot-to-lot consistency with total protein (>6.0 g/dL), fibrinogen (<25 mg dl).>25>
Pooling into batches up to 300 Liters
Removal of fibrinogen
0.2 µm filtered and dialyzed to mimic a serum-like state
The processing steps allow for an optically clear matrix suitable for control and calibrator production. Customization available upon request.
For research use only. Not for use in diagnostic procedures.