Hepatitis B e antigen single quality control product and preparation process thereof
A technology of hepatitis B and quality control products, applied in the field of medical inspection quality control, can solve the problems of quality control obstacles in the immune room, few types of quality control products, unstable supply, etc., and achieve low production costs, easy access, and sufficient sources Effect
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Embodiment 1
[0026] Example 1 Hepatitis B e antigen single quality control product
[0027] (1) Hepatitis B e recombinant antigen diluent: dilute hepatitis B e recombinant antigen 2000 times
[0028] (2) Quality control product stabilizer:
[0029] Bovine serum albumin 30g / L
[0030] Fructose 20 g / L
[0031] Dipotassium hydrogen phosphate 20mmol / L
[0032] Calf serum 25 g / L
[0033] Sodium Thimerosal 5 g / L
[0034] Antigen stabilizer PPCD 10 g / L
[0035] Surfactant SDS 15 g / L.
Embodiment 2
[0036] Example 2 Stability
[0037] The quality control product was frozen at -20°C and tested continuously for 24 months. The long-term frozen storage stability is good, and the results are shown in the table below.
[0038]
0 days
6 months
12 months
18 months
24 months
Test result (COI)
15. 37
15. 46
15. 28
15.79
15.43。
[0039] The quality control product was refrigerated at 2-8°C and tested continuously for 60 days. The long-term refrigerated stability was good, and the results are shown in the table below.
[0040]
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