1. (a) Program content and frequency of challenge. To be approved for proficiency testing for immunology, the annual program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of reactivity from highly reactive to nonreactive. The samples may be provided through mailed shipments.

2. (b) Challenges per testing event. The minimum number of challenges per testing event the program must provide for each analyte or test procedure is five. Analytes or tests for which laboratory performance is to be evaluated include:

   Table 1 to Paragraph (b)—Analyte or Test Procedure

   Alpha-l antitrypsin.

   Alpha-fetoprotein (tumor marker).

   Antinuclear antibody.

   Antistreptolysin O (ASO).

   Anti-human immunodeficiency virus (HIV).

   Complement C3.

   Complement C4.

   C-reactive protein (high sensitivity).

   HBsAg.

   Anti-HBc.

   HBeAg.

   Anti-HBs.

   Anti-HCV.

   IgA.

   IgG.

   IgE.

   IgM.

   Infectious mononucleosis.

   Rheumatoid factor.

   Rubella.

3. (c) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c)(1) through (5) of this section.

   1. (1) To determine the accuracy of a laboratory's response for quantitative and qualitative immunology tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. The proficiency testing program must indicate the minimum concentration that will be considered as indicating a positive response. Both methods must be attempted before the program can choose to not grade a PT sample.

   2. (2) For quantitative immunology analytes or tests, the program must determine the correct response for each analyte by the distance of the response from the target value. After the target value has been established for each response, the appropriateness of the response must be determined by using either fixed criteria or the number of standard deviations (SDs) the response differs from the target value.

      Table 2 to Paragraph (c)(2)—Criteria for Acceptable Performance

      The criteria for acceptable performance are—Analyte or test	Criteria for acceptable performance
      Alpha-1 antitrypsin	Target value ± 20%.
      Alpha-fetoprotein (tumor marker)	Target value ± 20%.
      Antinuclear antibody (ANA)	Target value ±2 dilutions or positive or negative.
      Antistreptolysin O	Target value ±2 dilutions or positive or negative.
      Anti-Human Immunodeficiency virus (HIV)	Reactive (positive) or nonreactive (negative).
      Complement C3	Target value ±15%.
      Complement C4	Target value ±20% or ±5 mg/dL (greater).
      C-reactive protein (HS)	Target value ±30% or ±1 mg/L (greater).
      HBsAg	Reactive (positive) or nonreactive (negative).
      Anti-HBc	Reactive (positive) or nonreactive (negative).
      HBeAg	Reactive (positive) or nonreactive (negative).
      Anti-HBs	Reactive (positive) or nonreactive (negative).
      Anti-HCV	Reactive (positive) or nonreactive (negative).
      IgA	Target value ±20%.
      IgE	Target value ±20%.
      IgG	Target value ±20%.
      IgM	Target value ±20%.
      Infectious mononucleosis	Target value ±2 dilutions or positive or negative.
      Rheumatoid factor	Target value ±2 dilutions or positive or negative.
      Rubella	Target value ±2 dilutions or positive or negative or immune or nonimmune.

   3. (3) The criterion for acceptable performance for qualitative general immunology tests is positive or negative.

   4. (4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:

      

   5. (5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:

      

[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, 2003; 87 FR 41237, July 11, 2022]