Tóm tắt

Objective: To build a procedure for production of samples for specific serodiagnosis of anti-Fasciola giganticaantibodies via an external quality assessment scheme, and to evaluate the homogeneity and stability of the trialsamples.

Methods: In this experimental study, samples contained an anti-Fasciola gigantica antibody according toscreening by ELISA, followed by confirmation by Western blotting were collected. All samples were tested and foundnegative for other helminth, especially of trematode antibodies. The samples were also negative for anti-HIV-1 and-2 antibodies, anti-HCV antibodies, and HBs antigen. The samples were prepared by freeze-drying and freezingmethods, the stability and homogeneity were evaluated each 2, 4, 8, 12 and up to 24 weeks.

Results: We produced three lots of serum samples containing anti-Fasciola gigantica antibodies at three levels.Lot DK1 had optical density, OD=0.350 ± 0.037; Lots DK3 and DL3 had O=0.653 ± 0.046, and Lot DL1 hadOD=0.850 ± 0.047 with the wavelength of 450 nm. The specific IgG antibodies against Fasciola gigantica antigenswere found to be positive for all three proteins, 8–9 kDa protein (P 8-9), 28 kDa (P 28), and 42 kDa (P 42) by theWestern blot technique. The trial samples were confirmed to be homogeneous by Fisher’s test (F statistics<Fdistribution and sig value>0.05) as well as to be stable during 24 weeks (with t statistics<t distribution and sig [2-tailed]>0.05).

Conclusion: Trial samples for specific serodiagnosis of anti-Fasciola gigantica antibodies via external qualityassessment can be produced with homogeneity and stability lasting for 24 weeks by freeze-drying and freezingmethods.