A, General objective
- Create a diagnostic kit for G6PD enzyme deficiency, congenital hypothyroidism and congenital adrenal hyperplasia;
- Develop basic standards for each of the above disease detection procedures.

B, Specific Objectives
- Determining the optimal chemical composition for the 3 types of ELISA kits created above including the G6PD enzyme deficiency disease diagnostic kits, congenital hypothyroidism and congenital adrenal hyperplasia;
- Determine the quality of the 3 types of ELISA kits created equivalent to that of imported kits;
- Develop a process to create the above 3 types of ELISA kits.

-    Theoretical results:

• Create 5 kits (each set of 192 tests/2 plates) meeting the basic standards for each type of G6PD deficiency, congenital hypothyroidism and congenital adrenal hyperplasia (the basic standard of ELISA kit: Sensitivity ≥ 95%, specificity ≥ 95%, limit of detection ≤ 100 µg/ml and no cross-reactivity between antigens and antibodies)
• 03 ELISA diagnostic procedures for G6PD enzyme deficiency, congenital hypothyroidism and congenital adrenal hyperplasia
• Report the results according to standard ELISA kits for the 03 diseases mentioned above

-    Applied results:

• Transfer results to businesses
• Create new products for the ELISA bucket market to detect G6PD deficiency, congenital hypothyroidism and congenital adrenal hyperplasia in Vietnam.
• Contribute to improving economic efficiency, improving quality and competitiveness of imported products, meeting domestic consumption demand, reducing imports.
• The enterprise actively produces the above ELISA buckets with cheaper prices and good quality for the Vietnamese market. Thus, contributing to economic development for domestic enterprises and bringing economic benefits to consumers, especially the poor.

Our 03 types of ELISA kit can replace imported kits on the market with 2-3 times cheaper prices, creating opportunities for low-income people to also be able to screen 03 this disease for your child.

-    Scientific papers in referred journals (list):
-    Patents (list):
02 utility solutions to accept applications (NOIP)

• ELISA kit to quantify hormone 17-Hydroxyprogesterone (17-OHP) used to diagnose adrenal hyperplasia (Application number: 2-2020-00413)
• ELISA kit for quantifying thyroid-stimulating hormone (TSH) for diagnosis of congenital hypothyroidism (Application number: 2-2020-00414)

-    Technological products (describe in details: technical characteristics, place):

• Manufacturing 5 kits (each set of 192 test/2 plates) meeting the basic standards for each type of G6PD deficiency, congenital hypothyroidism and congenital adrenal hyperplasia (Basic standard of ELISA kit: Sensitivity ≥ 95%, specificity ≥ 95%, detection limit ≤ 100 µg/ml and no cross-reactivity between antigens and antibodies)
• 03 ELISA diagnostic procedures for G6PD enzyme deficiency, congenital hypothyroidism and congenital adrenal hyperplasia
• Report the results according to standard ELISA kits for the 03 diseases mentioned above

A, TSH antigen detection kit
The kit includes:

• ELISA 96-well plate: 01 plate (12 strips with 8 wells/strip)
• Anti-TSH capture antibody: 1 vial (1 mg/mL) (Goat anti-Human TSH antibody)
• Standard TSH protein: 1 vial (0.1 IU/mL)
• Mouse HRP-conjugated anti-Human TSH monoclonal antibody: 1 vial (0.5 mg/mL)
• Coating buffer solution: 1 vial (15 ml), pH 6.5
• Concentrated blocking buffer solution: 1 vial (30 ml, 2X)
• Concentrated washing buffer solution: 1 vial (60 ml, 10X)
• TMB substrate solution: 1 vial (12 ml)
• H2SO4 2N solution: 1 vial (10 ml)

Place of storage: Institute of Genome Research

B, 17-OHP antigen detection kit
The kit includes:

• ELISA 96-well plate: 01 plate (12 strips with 8 wells/strip)
• Rabbit anti-17-OHP antibody: 1 vial (0.5 mg/mL)
• Standard 17-OHP protein: 1 vial (20 µg/mL)
• Mouse anti-17-OHP antibody: 1 vial (0.5 mg/mL)
• Streptavidin-HRP: 1 vial (0.25 mg/mL)
• Coating buffer solution: 1 vial (15 ml), pH 6.5
• Concentrated blocking buffer solution: 1 vial (30 ml, 2X)
• Concentrated washing buffer solution: 1 vial (60 ml, 10X)
• TMB substrate solution: 1 vial (12 ml)
• H2SO4 2N solution: 1 vial (10 ml)

Place of storage: Institute of Genome Research

C, The G6PD antigen detection kit
The kit includes:

• ELISA 96-well plate: 01 plate (12 strips with 8 wells/strip)
• Rabbit anti-Human G6PD antibody: 1 vial (0.5 mg/mL)
• Standard G6PD protein: 1 vial (40 µg/mL)
• Mouse anti-Human G6PD antibody: 1 vial (0.5 mg/mL)
• Streptavidin-HRP: 1 vial (0.25 mg/mL)
• Coating buffer solution: 1 vial (15 ml), pH 6.5
• Concentrated blocking buffer solution: 1 vial (30 ml, 2X)
• Concentrated washing buffer solution: 1 vial (60 ml, 10X)
• TMB substrate solution: 1 vial (12 ml)
• H2SO4 2N solution: 1 vial (10 ml)

Place of storage: Institute of Genome Research