Establishment of an Experimental Procedure for Preparing Trial Serum Samples for the Specific Serodiagnosis of for External Quality Assessment Schemes.

BACKGROUND

External quality assessment (EQA) provides evidence of reliable, accurate, and precise results for customers using the diagnostic test for . To establish a procedure for producing standard serum samples for serodiagnostic testing in EQA.

METHODS

The collected serum samples to contain anti- serum samples for serodiagnostic testing in EQA. -test and a -test were applied to evaluate their homogeneity and stability.

RESULTS

Among eleven samples positive by ELISA, ten of them were confirmed via Western blotting by positive reaction with 5 specific serum samples for serodiagnostic testing in EQA. serum samples for serodiagnostic testing in EQA. > 0.05). Samples produced by both methods were stable for 7 days at 30°C ( > 0.05). Samples produced by both methods were stable for 7 days at 30°C (.

CONCLUSION

Specific serodiagnosis samples of anti- antibodies for EQA could be produced that possessed homogeneity and stability lasting for 3 months and 6 months by the freeze-drying and freezing methods, respectively. At 30°C, the samples produced by both methods were stable for 7 days, suitable for delivery to remote laboratories. serum samples for serodiagnostic testing in EQA.