A preoperative chymopapain sensitivity test for chemonucleolysis candidates

Area of Science:

• Immunology
• Allergy and Immunology
• Clinical Chemistry

Background:

• Anaphylactic reactions are serious allergic responses mediated by immunoglobulin E (IgE) antibodies.
• Chymopapain, an enzyme used in chemonucleolysis, can trigger anaphylaxis in sensitized individuals.
• Accurate identification of patients with chymopapain-specific IgE is crucial for preventing adverse events.

Purpose of the Study:

• To describe a novel fluorescence enzyme immunoassay for quantifying chymopapain-specific IgE antibody levels in human serum.
• To evaluate the utility of this assay as a screening tool for identifying patients at risk of chymopapain-induced anaphylaxis.

Main Methods:

• Development and validation of the ChymoFAST fluorescence enzyme immunoassay.
• Testing of preoperative serum samples from 11,658 patients undergoing chemonucleolysis.
• Analysis of postmarketing surveillance data from 4776 procedures to assess predictive values.

Main Results:

• The ChymoFAST test quantifies chymopapain-specific IgE antibody concentrations.
• A prevalence of 0.94% (110/11,658) positive IgE results was observed in the study population.
• The assay demonstrated good predictive values for both positive and negative test results, confirmed by postmarketing surveillance.

Conclusions:

• The ChymoFAST test provides an objective method for screening chymopapain-specific IgE.
• This assay can help identify patients likely to tolerate chymopapain, thereby reducing the risk of anaphylactic reactions.
• The test aids in improving patient safety during chemonucleolysis procedures.