Serum

Plasma

Whole blood

Cerebropinal fluid

Urine

Aqueous

Vitreous

Other biodistribution endpoints

Double quality control system

1, QC in Kit

2, Monkey’s plasma (QC high/mid/low)

CriteriaSterilization Device

1, FDA Guideline for Analytical Procedures and Methods Validation

2, Merck Criteria of biomarker measurement

PriMed use automatic instrument Roche cobas 6000 systems C501& E601 to perform clinical chemistry test, including liver function, lipid metabolism, heart function, renal function, glycometabolism and electrolyte. All biomarkers have a double quality control system.

PriMed uses microplate reader Molecular Devices SpectraMax M4 to perform Elisa test and has established complete ELISA validation and test system. The validation includes immunological methods, stability of the plate and samples. We established an internal quality control system by monkey plasma.

Five classifications of hematology instrument Siemens ADVIA 2120i is available. It can test blood cell count, leukocyte differential count, platelet counts and function and reticulocyte.

Hemoglobin A1c analyzer Siemens DCA Vantage is available and has a double quality control system.

PT, aPTT, TT and fibrinogen tests are avaliable.