IVD Assay Development

Basematrix Negative Diluent

Material Number 1805-0075
Size 1 L
Inventory Status In Stock
Unit EA
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).>

Processing includes:

  • 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.

Reference number: 501101