Objective To evaluate the performance of a blood nucleic acid testing kit,construct a consistency assess-ment system,and analyze the influencing factors of the test results.Methods A total of 18 644 samples of voluntary blood donors in our center were collected,and 189 double positive samples of hepatitis B surface antigen(HBsAg)by ELISA were eliminated,and the remaining 18 455 samples were tested for HBV DNA in parallel with the test reagent and the control rea-gent(Roche Company).Samples with inconsistent results were confirmed with third-party reagents(Grifols Company,with the sensitivity of HBV DNA,HCV RNA and HIV RNA of 4.5 IU/mL,2.4 IU/mL and 17.3 IU/mL by single reagent,which were significantly better than other reagents),and the consistency between the two methods was compared.Results No HCV RNA or HIV RNA positive samples were detected in this study.Among the 18 455 samples in initial test,12 were pos-itive with consistent results,18 378 were negative with consistent results,and 65 were with inconsistent results between the test reagent and the control reagent,with positive concordance rate,negative concordance rate and concordance rate of the two reagents at 85.17％,99.66％and 99.65％,respectively.In order to further clarify the infection of 65 inconsistent sam-ples,five qualitative tests of hepatitis B and single NAT were conducted to comprehensively evaluate the infection.The re-sults showed that there were 60 positive samples with consistent results,18 371 negative samples with consistent results,and 24 samples with inconsistent results between the test reagent and the control reagent,with positive concordance rate,nega-tive concordance rate and the concordance rate for the two reagents at 86.96％,99.92％and 99.87％,respectively.The Kappa value was 0.83,and the Youden index was 0.40.The ROC curve was plotted with the false-positive rate(1-specifici-ty)as the horizontal coordinate and the true-positive rate(sensitivity)as the vertical coordinate,and the area under the ROC curve was 0.705.189 double-positive samples were selected for conformance testing,and the Ct values of the test rea-gent and the control reagent were analyzed and fitted linearly,with correlation coefficient r=0.972.A Bland-Altman model was constructed with the mean value of the logarithm of the quantitative values of the test reagent and the control reagent as the horizontal coordinate and the difference as the vertical coordinate,and 96.30％of the difference values of the test rea-gents were within the confidence interval.Conclusion The construction of the consistency evaluation system showed that the test reagent has similar detection efficiency with the control reagent,and is suitable for HBV DNA routine screening,which can effectively ensure the safety and effectiveness of blood screening.

Standardization is the universal language of the world, and standardization of traditional Chinese medicine (TCM) is essential for its communication in China and globally. However, the principles and methods of TCM acupuncture standardization have been unclear and inadequate in the early stages. Based on an investigative approach to understanding the current status, identifying problems, and finding solutions, our team has established basic principles of TCM acupuncture that embody Chinese wisdom, evaluated the international strategic environment systematically, proposed the principle of “importance of harmony and exercise of impartiality”, and established basic working principles. A series of methods for TCM acupuncture standard development and evaluation have been constructed, including general standards for the revision of TCM acupuncture standards, the first TCM acupuncture clinical research management specification, a shared full chain technology platform, a data center, and an evaluation research base for TCM acupuncture clinical research. Evaluation criteria for ancient literature and expert experience, a recommendation method for the “three main and three auxiliaries” TCM guideline for prevention were established, and quantifiable assessment methods of TCM standard applicability were proposed. These findings provide methodological guidance for TCM acupuncture standardization.