Cat.No. SER 101
All individual sera and the serum pool were tested negative for HBsAg and for antibodies against HIV-1, HIV-2 and HCV. Blood from 30 healthy donors was collected in flasks without anticoagulant and allowed to clot. Serum was collected after centrifugation and pooled in a 10-liter flask. After mixing, 1-ml aliquots of the serum were pipetted into 2-ml vials. Each vial was assigned an MBL content of 1000 AU. The material was freeze-dried and the vials closed under vacuum. However, as no test method can offer complete security that infectious agents are absent, the calibrators and patients’ specimens should be handled at Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the CDC/NIH manual “Biosafety In Microbiology and Biomedical Laboratories”, 1999. Solutions containing human serum should be treated as potentially infectious and handled accordingly.
Human MBL1 is an opsonin, which activates the complement system2 on binding to microbial polysaccharides. Plasma concentrations of normally oligomerized MBL range from 0 to 7000 ng/ml and may be below 50 ng/ml in up to 12% of healthy Caucasian blood donors. Low plasma concentrations may be associated with an inherited opsonin defect3. MBL from donors of B/B genotype is poorly oligomerized and gives low readings in MBL assays selective for oligomerized MBL.
Across 3 lots of the MBL Oligomer ELISA Kit (Cat. No. KIT 029); SER 101 was assayed in 3 dilutions, each applied in duplicate. Total CV was 10% and recovery was 103%
|MBL Conc. (ng/mL)||Inter assay CV||Dilution factor||Conc x dil (ng/mL)||Recovery||n total|