YY/T 0616.7-2020 in English

This standard establishes a quantitative detection method for antigenic proteins that induce type I hypersensitivity reactions in medical natural rubber latex gloves. Traditional colorimetric methods (such as the Lowry method) are easily interfered by chemical additives and produce false positives. This immunological method uses an enzyme reader to detect specific antibody binding reactions, with a sensitivity of μg/g level.

Background of technological evolution

The 2008 GB/T 21870 standard has problems such as high detection limit (≥50μg/g) and chemical interference. This method can detect proteins in the concentration range of 0.031-2μg/mL through antigen-antibody specific binding, meeting the needs of low-allergy product research and development.

Key points of quality control

• Edge effect control: The washing solution temperature must be consistent with the incubation temperature (37±1℃)
• Standard curve verification: Each test must include 6 points of standard products (diluted from 2μg/mL)
• Interference elimination: Surfactant-contaminated samples should be verified by gradient dilution ≥3 times

Application scenario expansion

After appropriate adjustment, this method can be applied to: ① interventional products such as natural latex catheters; ② allergenicity evaluation of civilian products such as latex mattresses; ③ protein residue monitoring in production process optimization.