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Protein nitrogen unit precipitation procedure for allergenic extracts: collaborative study

J C May, J T Sih, J Best

    Journal - Association of Official Analytical Chemists
    |November 1, 1981
    PubMed
    Summary
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    Protein nitrogen unit (PNU) determination is a standardized method for quantifying allergenic extract concentration. This method, using phosphotungstic acid precipitation and Kjeldahl analysis, ensures accurate protein content measurement for labeling.

    Area of Science:

    • Allergy and Immunology
    • Analytical Chemistry

    Background:

    • Accurate quantification of allergenic extracts is crucial for effective allergy diagnosis and treatment.
    • Existing methods for protein determination in allergenic extracts required standardization for universal applicability.

    Purpose of the Study:

    • To standardize and validate a method for determining protein nitrogen unit (PNU) concentration in allergenic extracts.
    • To establish PNU as a reliable unit for labeling allergenic extract potency.

    Main Methods:

    • Utilized phosphotungstic acid (PTA) precipitation to isolate proteins from allergenic extracts.
    • Quantified nitrogen content in precipitated proteins using the Kjeldahl method for accuracy and precision.
    • Conducted a collaborative study involving six laboratories analyzing six samples in duplicate.

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    Main Results:

    • The optimized PNU precipitation method demonstrated good repeatability (CV 5.23%) and reproducibility (CV 13.84%).
    • Mean nitrogen content was determined to be 0.1358 mg N/mL across participating laboratories.
    • The method was validated for its accuracy and precision in determining protein nitrogen.

    Conclusions:

    • The protein nitrogen unit (PNU) determination method is a standardized and reliable approach for quantifying allergenic extract concentration.
    • This validated method is applicable to all allergenic extracts, facilitating consistent and accurate labeling.
    • The adoption of this method as official first action supports its widespread use in the field.