Objective: To confirm the reactive anti-TP ELISA screening results in blood donor samples, and analyze implementaion of re-examination among reactive donors, so as to provide data support for effectively formulating re-examination strategies. Methods: Confirmation tests were performed on 331 samples (including 224 cases with dual-reagent reactivity and 107 cases with single-reagent reactivity) using treponema pallidum particle agglutination assays (TPPA). A total of 136 blood samples were collected from blood donors who have previously tested for anti-TP ELISA with single-reagent reactivity and voluntarily applied for re-examination from 2020 to 2024. Infectious disease indicators were detected in accordance with the "Technical Operating Procedures of Blood Stations (2019 Edition)". Among them, anti-TP screening was performed using ELISA reagents from two different manufacturers, and HBV/HCV/HIV nucleic acid testing was conducted using an individual donation nucleic acid testing (ID-NAT) mode. Supplementary tests (WB or TPPA) were conducted on samples with anti-TP ELISA single-reagent reactivity. A two-sided Pearson's chi-squared test or Fisher's exact test was used to evaluate the differences of the positive rates of anti-TP among different groups or reagents. Results: Among the 331 samples, the confirmed positive rate was 93.75% (210/224) for dual-reagent reactive samples, and 2.8% (3/107) for single-reagent reactive samples. The confirmed positive rates of double reagent reactive samples with different reagent combinations were 91.7% (95% CI: 85.6%-95.5%), 95.6% (95% CI: 85.2%-98.8%), 96.6% (95% CI: 86.2%-97.3%) respectively, with no statistically significant difference (χ =1.597, P=0.463). From 2020 to 2024, 994 donors showed anti-TP ELISA single-reagent reactive results. Among them, 136 (136/994, 13.68%) donors voluntarily applied for re-examination. After the first round of re-examination, 88 (88/136, 64.71%) donors passed the re-examination, and 18 donors were permanently deffered (18/136, 13.24%). Among the permanently quarantined donors, 12 donors remained anti-TP ELISA single-reagent reactive, including 8 confirmed positive for TP-specific antobodies and 4 with indeterminate results. The remaining 6 donors converted to dual-reagent reactive. Conclusion: The dual-reagent reactive results in anti-TP ELISA has a high true positive rate, and the corresponding blood donors can be directly deffered. The majority of single-reagent reactive anti TP-ELISA results are false positives. Timely confirmation or supplementary testing allows prompt notification of evaluation results to blood donors, and reduces unnecessary follow-up examinations. This helps improve the quality of blood donor services and management efficiency, as well as prevent blood donor attrition.

OBJECTIVE:To establish a method for the simultaneous determination of costunolide and dehydrocostus lactone in Haoweilai soft capsule. METHODS:HPLC was performed on the column of Dikma C18 with mobile phase of acetonitrile- water (V/V,55∶45) at a flow rate of 1.0 ml/min,detection wavelength was 225 nm,column temperature was 25 ℃,and the injection volume was 10 μl. RESULTS:The linear range were 24.00-108.00 μg/ml(r=0.999 7) for costunolide and 20.88-93.98 μg/ml for dehydrocostus lactone (r=0.999 8);RSDs of precision,stability and reproducibility tests were lower than 1%;recoveries were 98.71%-100.00%(RSD=0.25%,n=6)and 96.88%-99.18%(RSD=0.40%,n=6). CONCLUSIONS:The method is simple with good stability and reproducibility,and can be used for the simultaneous determination of costunolide and dehydrocostus lactone in Haoweilai soft capsule.