Purpose <p>The purpose of this work is to show the results of automating with AI, the interpretation of human albumin and immunoglobulin identity tests in commercial drugs for intravenous application, and to evaluate its incorporation into routine laboratory analytical activities, in compliance with Mexican health regulations.</p> Research Question <p>Is it possible to apply AI to determine the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application, as a support for issuing analytical certificates, in compliance with Mexican health regulations?</p> Methods <p>In this work we developed an AI method that supports the determination of the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application.</p> <p>The identity of human albumin and immunoglobulin was determined using the validated pharmacopeial method of immunoelectrophoresis on agarose plates. The agarose plates were photographed using a webcam. The photographs were processed by a pre-trained AI algorithm. The data obtained by the AI were compared with the results from the agarose plates.</p> Results <p>The selectivity, sensitivity, specificity and predictive value were determined, as well as the performance evaluation with respect to the results obtained on the agarose plates. In all cases, the parameters evaluated were satisfactory &gt; 95%. The analysts who performed the analytical execution considered it satisfactory to incorporate AI into the identity tests of human immunoglobulin and albumin in commercial drugs for intravenous application.</p> Conclusions <p>The AI method for identifying human immunoglobulin and human albumin in commercial intravenous medications is reliable and will be perfected for submission to Mexican regulatory authorities.</p>

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Application of Artificial Intelligence in Identifying Human Immunoglobulin and Albumin in Commercial Intravenous Drugs

  • Juan Padierna-Olivos,
  • Juan Francisco Sánchez-Ruiz,
  • Gustavo Alonso Martínez-Blanco,
  • Carlos Arturo Medina-García,
  • Brenda Magali Lin-Li Lagunas-Bucio,
  • Ariadna Rosas-Hernández,
  • Cecilia Padierna-Mota,
  • Alberto Padierna-Mota,
  • Carlos Gershenson-García

摘要

Purpose

The purpose of this work is to show the results of automating with AI, the interpretation of human albumin and immunoglobulin identity tests in commercial drugs for intravenous application, and to evaluate its incorporation into routine laboratory analytical activities, in compliance with Mexican health regulations.

Research Question

Is it possible to apply AI to determine the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application, as a support for issuing analytical certificates, in compliance with Mexican health regulations?

Methods

In this work we developed an AI method that supports the determination of the identity of human immunoglobulin and human albumin in commercial drugs for intravenous application.

The identity of human albumin and immunoglobulin was determined using the validated pharmacopeial method of immunoelectrophoresis on agarose plates. The agarose plates were photographed using a webcam. The photographs were processed by a pre-trained AI algorithm. The data obtained by the AI were compared with the results from the agarose plates.

Results

The selectivity, sensitivity, specificity and predictive value were determined, as well as the performance evaluation with respect to the results obtained on the agarose plates. In all cases, the parameters evaluated were satisfactory > 95%. The analysts who performed the analytical execution considered it satisfactory to incorporate AI into the identity tests of human immunoglobulin and albumin in commercial drugs for intravenous application.

Conclusions

The AI method for identifying human immunoglobulin and human albumin in commercial intravenous medications is reliable and will be perfected for submission to Mexican regulatory authorities.