ELISA kit for diagnosis of G6PD deficiency, congenital hypothyroidism and congenital adrenal hyperplasia

Congenital hypothyroidism

Congenital hypothyroidism (CH) is an endocrine disease when an infant's thyroid gland does not produce enough hormones to meet the body's metabolic needs and growth. The thyroid is a butterfly-shaped gland located in the front of the neck. This gland uses food iodine introduced into the body every day to synthesize a hormone called T4 (thyroxine). The hormone T4 plays a vital role in a child's development and growth. If the thyroid is not functioning properly, the body will not produce enough T4, affecting the development of the body, especially the brain.

Congenital adrenal hyperplasia

Congenital adrenal hyperplasia (CAH) is an inherited disease that occurs when the hormone production function of the adrenal gland is disturbed. The adrenal gland is a pair of triangular organs located on the kidney, close to the posterior wall of the abdominal cavity. Although it is small, the adrenal gland produces several important hormones that the body cannot lack, including cortisol, the salt-keeping hormone aldosterone and androgens. This is a hormone needed to protect the body against the general effects of illness, diseases or injuries. People with poorly functioning adrenal glands with mild illness can fall into a state of shock with dangerously low blood pressure.

Enzyme-linked immunosorbent assay test technique (ELISA)

The ELISA technique is quite sensitive and simple, allowing the identification of antigens or antibodies at a very low concentration (about ≥ 20 pg/ml). This is a safe, low-cost technique with a high degree of accuracy.

In Vietnam, currently, most laboratories and hospitals use ELISA kits available on the market at very high prices, so the team focuses on creating ELISA kits with quality equivalent to imported ELISA kits at a lower price.

In this project, the research team has fabricated 03 sets of ELISA kits for diagnosis of G6PD enzyme deficiency, congenital hypothyroidism and congenital adrenal hyperplasia with the aim of competing with different types of imported kits, with prices of 1.5-2 times lower and with similar quality, thus being able to proceed to provide a part of the above-mentioned diagnostic kits to meet the huge demand for using a diagnostic kit for these diseases in the domestic and international market.

ELISA Methods

Image simulating a set of diagnostic reagents for congenital hypothyroidism

This kit presents 100% sensitivity and specificity, and there is no cross-reactivity between antigens and antibodies. Compared to the commercial kit, it provides the linearly correlated R-value reaching 0.9962 with the OD values of the standard proteins on the same linear line. Therefore, the team's kit can be further optimized for storage conditions, additive composition, expiry date and some other criteria before applying for a commercial kit license.

The research team has registered two useful solutions for the diagnostic kit of congenital hypothyroidism and congenital adrenal hyperplasia (approved by the Intellectual Property Office of Vietnam). The project is rated excellent.

Translated by Phuong Huyen
Link to Vietnamese version