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Quality Control Specifications
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Sterility tests are performed on each lot of fetal bovine serum using current USP and EP methods. Specific tests for contaminants are listed below in the Specification Certificate. ATCC also checks each lot for its ability to support the growth of several different cell lines. Additionally, this lot of serum is tested for its ability to support the growth and differentiation of embryonic stem (ES) cells. Plating efficiency, colony morphology, and the expression of at least five markers of differentiation are determined for undifferentiated cells and cells induced to form embryoid bodies (EB) through full differentiation. The results are compared with cells grown with a control lot of serum.
Origin
This fetal bovine serum is manufactured from fetal bovine blood collected in USDA-inspected abattoirs located in the United States.
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Test*
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Specification
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Sterility Testing (Current USP)
Bacteria and Fungi
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No growth
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Virus Testing (9 CFR 113.53)
Fluorescent antibody
Bluetongue
Bovine Adenovirus
Bovine Parvovirus
Bovine Respiratory Syncytial Virus
Bovine Diarrhea Virus
Rabies
Reovirus
Cytopathogenic Agents (e.g. IBR)
Hemadsorbing Agents (e.g., PI3)
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Not detected
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Mycoplasma Testing
Large volume, direct culture Hoechst DNA stain
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Pass
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Endotoxin (Limulus Amebocyte Lysate -Gel Clot)
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≤ 10 EU/mL
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Hemoglobin (Spectrophotometric)
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Report result
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Growth Promotion
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Pass
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*Please consult the Certificate of Analysis for lot-specific test results.
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