Biocell

Custom Calibrators and Controls

$C:\Users\SCooper\Desktop\controls.png$ Biocell is a primary manufacturer of Quality Control materials for Chemistry and Immunology Laboratory Analysis and is widely known as a leader for the stability of its controls and calibrators.
Four decades of continuous experience in the manufacture of liquid and lyophilized calibrators and controls contributes to the exceptional quality of Biocell’s products. Formulation is facilitated by an on-site laboratory capable of continuously monitoring all critical parameters during preparation of the control or calibrator and to perform Quality Control assays.

Numerous studies have demonstrated the equivalence of these controls and calibrators to ensure the monitoring of fully automated and manual methods used in the constituency analysis of sera, urine, and cerebrospinal fluid. Normal and pathological levels of all controls are available, assayed and unassayed.

	AFP, HCG, UE3 Controls (6 vials per box)
4110-12	Control, Maternal, Human, Level 1
4110-13	Control, Maternal, Human, Level 2
4110-15	Control, Maternal, Human, Level 3
4110-33	Control, Maternal, Human, Tri-Level (2 vials each level 1, 2 and 3)

Biocell Biolipid Controls

	Bio-lipid Controls (6 vials per box)
4100-11	Control, Bio-Lipid, Level 1
4100-12	Control, Bio-Lipid, Level 2
4100-13	Control, Bio-Lipid, Level 3
4100-33	Control, Bio-Lipid, Tri-Level (2 vials each level 1, 2 and 3)

Matrix Effect
Biocell has focused on developing a superior human lipid control which can be used with any available methodology in the clinical laboratory. This control exhibits similar behavior to the fresh patient serum/plasma being tested. The key to this product is maximum control of critical processing parameters and minimal processing manipulation. Three components are prepared and combined at different ratios: concentrated LDL, concentrated HDL and a “base matrix”. All three components are stabilized and processed to maintain the native macromolecular lipoprotein complexes, particularly LDL which are susceptible to degradation. Both the apolipoproteins and lipids must remain intact, minimally oxidized, and stabilized in their native lipoprotein structure.

Immunoreactivity
The optimization of our process has been clearly demonstrated in our own and outside studies (available upon request). In a study by Kahn et al. (clin. Chem 40/9, 1722-1729, 1994) evaluating the immunoreactiviy of apolipoproteins in clinical controls, Biocell Biolipid had the immunoreactivity most similar to that of fresh patient sera.

	Lipid Calibrators (6 vials per box)
4122-00	Calibrator, APO A1/ APO B
4123-00	Calibrator, HDL/LDL, Level 1
4124-00	Calibrator, HDL/LDL, Level 2

Integrity
In our laboratory we compared the lipoprotein electrophoresis of ten commercially available controls. The Biocell Biolipid Level 1 exhibited lipoprotein electrophoresis pattern most similar to fresh normal human serum. Other brand controls showed more diffuse bands, undefined HDL peak and/or incomplete separation of the HDL and LDL.

Stability
The Biolipid controls were studied for long term (3 year real time) and open vial stability (both performed at real time). With 90-100% recovery of all assays, the results of this evaluation show the excellent stability of the lyophilized and reconstituted product.

Oxidation
Critical to the integrity and the stability of the lipoproteins in controls is the amount of oxidized LDL. Ten commercial lipid controls were submitted to the University of Southern California for analysis of oxidized lipoproteins. The results showed that the Low Density Lipoproteins in Biolipid were significantly less oxidized compared to other controls.

Conclusions
The Biolipid Evaluation studies have demonstrated that the Biocell BioLipid Controls are the most identical to fresh human serum. The integrity and stability of the lipoproteins in these controls are optimized compared to the other commercially available controls.