If the validation is completed properly, no additional steps are necessary
Validation of the method should be repeated by an outside lab
The medical director of the blood bank must approve the validation
The FDA must grant a variance to allow the use of this antisera at immediate spin phase
Systemic sclerosis
Inflammatory myositis
SLE
Inflammatory bowel disease
Primary biliary cirrhosis
Reference: http://www.ncbi.nlm.nih.gov/pubmed/15804708
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