SeraCon II CD Hormone Depleted Negative Diluent is well suited and widely used in assay development and manufacture. The diluent 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-HIV 1/2, anti-HCV, HIV-1 RNA, and HCV RNA. 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), and cholesterol triglycerides (><20 mg dl).>
Pooling into batches up to 1,000 Liters
Removal of fibrinogen
Removal of lipids
Charcoal stripped for hormone depletion
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. Reference Number: 22011