STUDYING VALIDATION OF THE PROCEDURE FOR DETERMINING TOTAL PROTEIN CONTENT IN TETANUS ANTITOXIN SERUM (SAT) USING THE MODIFIED LOWRY METHOD

Abstract

The Modified Lowry method is an improved variant of the Lowry protein assay developed by Oliver H. Lowry, designed to overcome several limitations of the classical method in protein quantification. The Modified Lowry method has been adjusted in terms of reagent composition and reaction conditions to improve color stability and reduce the influence of interfering substances, making it more suitable for complex samples such as biologicals, vaccines, or cell extracts. This study was conducted to validate the procedure for "Determining the total protein content in tetanus antitoxin serum (SAT) using the Modified Lowry method". The research employed a descriptive experimental method in the laboratory. The test samples included Tetanus Antitoxin Serum (SAT) produced by the Institute of Vaccines and Medical Biologicals (IVAC) and SAT samples spiked with standard protein at concentrations close to those of the test samples. The validation results met specifications for accuracy, precision (repeatability and intermediate reproducibility), specificity, linearity, and system suitability. The method achieved a limit of quantitation (LOQ) of 8.132 µg and an extended measurement uncertainty of 1.031 mg/ml.