Method for producing ELISA Kit to quantify 17-hydroxyprogesterone (17-OHP) hormone used to diagnose adrenal hyperplasia

10/03/2024

Congenital adrenal hyperplasia is a disorder of the synthesis of the adrenal hormone 17-OHP, a substance used by the body to create cortisol. Cortisol production is catalyzed by a number of enzymes; if one or more of these enzymes is deficient or dysfunctional, the result is that the average amount of cortisol produced is reduced and the cortisol precursor 17-OHP accumulates in the blood, causing virilization in women.

Through the newborn screening program, the incidence of this disease in the world is from 1/10,000 to 1/15,000 newborns. Newborns 3-5 days old with significantly increased 17-OHP concentrations (≥10ng/ml plasma) are the gold standard for definitive diagnosis of congenital adrenal hyperplasia. Early detection, diagnosis and treatment of this disease within the first 2 weeks after birth helps children develop normally and healthily. This disease is recommended for screening in all newborns, so the demand at medical facilities for a large number of diagnostic kits for this disease is huge.

ELISA kits to quantify 17-OHP in plasma were released in 1987 by Immunodiagnostic Company, however, the application of these kits in practice in diagnosing adrenal hyperplasia in Vietnam is difficult due to their selling at high prices and not being proactive in kit supply.

Patent for Useful Solutions No. 0003126 was granted by the National Office of Intellectual Property to Associate Professor, Dr. Nguyen Thi Xuan and scientists from the Institute of Genome Research have proposed a method to produce an ELISA kit to quantify the hormone 17-OHP in plasma, used to diagnose adrenal hyperplasia, thereby providing a solution. disease diagnosis kit, serving the huge demand today in the country and around the world. This useful solution belongs to the pilot production project "Research on production of ELISA kits to diagnose G6PD deficiency, congenital hypothyroidism and congenital adrenal hyperplasia", code UDSXTN.04/18 -19 funded by Vietnam Academy of Science and Technology.

The ELISA kit of scientists at the Institute of Genome Research is different from existing kits in the world in terms of detection antibodies. The patented utility solution ELISA kit uses biotin-conjugated detection antibody combined with capture antibody, HRP-conjugated streptavidin and 17-OHP antigen. The capture antibody is a polyclonal antibody produced by inducing a rabbit immune response by injecting 17-OHP protein conjugated with BSA under the skin of the rabbit's abdomen. The biotin-labeled detection antibody is a commercial monoclonal antibody.

Producing this ELISA kit is very necessary because the quality of the kit is equivalent to that of imported kits, but the price is many times lower, and the production time is short, does not require transportation time, and easily meets the requirements. the need for disease screening tests, contributing to improving the quality of Vietnam's population.

Translated by Quoc Khanh
Link to Vietnamese version