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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 255.100- Quantitative Testing for Serum Proteins in Plasmapheresis Donors

 

BACKGROUND:

Investigators have reported deviations from Section 640.65(b)(2)(i) of Title 21, Code of Federal Regulations regarding the quantitative testing of serum or plasma by electrophoretic or immunodiffusion techniques to determine protein composition, and the interpretation of the results. To clarify the position of the *Center for Biologics Evaluation and Research (CBER)* and to prevent misinterpretations with respect to Section 640.65(b)(2)(i), the following policy is stated:

POLICY:

1. The normal ranges established by the testing laboratory for protein composition must be expressed with a minimum and maximum value for each protein fraction. A total protein test should also be performed on the same Sample by the laboratory performing quantification tests. The total protein value must be no less than 6.0gm/100ml.

2. A donor may be continued on the program only if the results of the serum protein electrophoresis or the immunoglobulin diffusion test fall within the ranges established by the testing laboratory. If the value of any protein fraction is reported outside this established range, the donor must be removed from the program until another sample is drawn, retested and all values are reported to fall within the established range. If the results are not within the established range, the physician at the plasma center does not have authority to allow a donor to continue on the plasmapheresis program.

*Material between asterisks is new or revised*

Issued: 8/6/76
Revised: 10/1/80, 3/95