Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation(MDI)canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness,and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity,oxide film thickness,coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation(MDI)canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness,and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity,oxide film thickness,coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective To analyze hepatitis B virus(HBV) infection stage in single nucleic acid test(NAT)reactive blood donors.Methods Blood donor samples were screened routinely for HBV DNA by using transcription-mediated amplification(TMA) NAT and quantitative polymerase chain reaction(PCR).Then serum markers of HBV were also detected.The HBV infection stage was analyzed.Results Among the 225 single NAT reactive samples,78(34.67%) were identified to be reactive for HBV DNA by TMA NAT discrimination test and/or PCR test,of which 63(82.89%) were occult HBV infection(OBI),13(17.11%) were probably window period infection(pWP),and 2 cases could not be classified for infection stage.Among the OBI samples,49 samples(77.78%) were with HBV DNA concentration less than 20 IU/mL,whereas,there were only 4 samples(30.77%) in pWP samples.The 225 samples were classified into three groups according to the S/CO of NAT, including 1-<6 group,6-<10 group and 10-17 group, the confirmed HBV DNA positive rates of which were 13.11%,13.64% and 47.18%,and the positive rate of 10-17 group was higher than 1-<6 group and 6-<10 group(P<0.05).In all 63 OBI samples,there were 8(12.70%),3(4.76%) and 52(82.54%) samples were classified into S/CO 1-<6,6-<10 and 10-17,respectively.All of the 13 pWP samples were with NAT S/CO of 10-17.Conclusion Part of single NAT reactive blood donors could be with HBV infection,of which OBI might be popular than pWP, with very low concentration of HBV DNA.Deferral of single NAT reactive blood donors could reduce transfusion-transmitted HBV infection.

ObjectiveTo investigate the effect of individual donation-nucleic acid amplification test (ID-NAT) and minipool of 16 donations-NAT (P16-NAT) on the results of NAT of blood donors.Methods From February 2009 to June 2009,samples randomly collected from voluntary blood donors in Beijing were tested individually or in pooling of 16 donations by the PROCLEIX ULTRIO assay.For ID-NAT reactive samples with HBsAg,anti-HCV,or anti-HIV serologically unqualified,ID-NAT repeat reactive samples with serologically qualified,and P16-NAT reactive and followed resolution ID-NAT reactive samples,were performed for further discriminatory assays for HIV-1,samples and followed resolution ID-NAT reactive samples,were performed for further discriminatory assays for HBV,HCV and HIV-1discriminatory reagents.Samples which were HBV NAT + alone with serologically qualified were further quantified and confirmed of HBV DNA by Roche HBV quantitative PCR,analyzed by HBV serology and were diluted to simulate if they could be detected in P16-NAT.Results ( 1 ) Among 7613 samples tested by ID-NAT,26 were NAT positive,i.e.the ID-NAT positive rate was 0.34％ ( 26/7613 ). ( 2 ) Among 1004 P16 samples from 16 064 blood donations,27 were NAT positive,i.e.the P16-NAT positive rate was 0.17％ (27/16 064).(3)In serological qualified donations,ID-NAT yield rate (1 in 826,9/7438 ) was much higher than P16-NAT ( 1 in 7875,2/15 750) (x2 =11.880,P ＜ 0.05 ).All these 9 ID-NAT positive and 2 P16-NAT positive donations were discriminated as HBV NAT positive.There were no HCV NAT yield or HIV NAT yield samples. (4) Dilution assay showed only 2 of the 9 (22.22％ ) ID-NAT HBV yields were detected by P16-NAT.(5)Eight ID-NAT and 2 P16-NAT positive samples were quantified for HBV DNA and confirmed as HBV NAT yield,although the virus loads were very low:2 samples had HBV viral loads of 15 IU/ml and 472 IU/ml,6 samples ＜ 12 IU/ml,and 2 could not be detected in the original samples while had ＜ 12 IU/ml and 14.3 IU/ml in the 10 times concentrated samples.(6)Among 11 HBV NAT yield cases,3 (27.3％ ) were possible HBV window-period donors with all HBV seromarkers negative,the other 8 (72.7％ ) had occult HBV infections with anti-HBc or anti-HBe positive,however anti-HBc IgM negative.(7) The rate of initial P16-NAT reactive pools needed to be further tested by ID-NAT was 2.49％(25/1004).Initial P16-NAT reactive pools which caused by serologically qualified donations was 0.20％(2/1004).ConclusionsHBV NAT yield cases are detected at a higher frequency with ID-NAT than P16-NAT.In order to avoid samples with low viral loads would be undetected,NAT assay with high sensitivity should be selected and tested in minimized minipool donations or even with individual donation.

Objective To analyze the antibiotic resistance of ureaplasma urealyticum(UU) in vitro in Yangjiang,and instruct the clinical treatment for the ureaplasma urealyticum infection.Methods 538 secretion samples of urethra and cervix were collected and cultured ureaplasma urealyticum in vitro,the drug sensitive test of UU from 253 patients was conducted and detected their drug resistance.Results The 253 positives cases were found in 538 samples.The drug sensitive test results were:the highest sensitivity rates were clarithromycin(731%) and roxithromycin(679%).The resistance rates of rest drugs were azithromycin(771%),josamycin(708%),minocycline(664%),ciprofloxacin(538%),sparfloxacin(435%),doxycycline(423%),the total resistance rate was 489%.Conclusion To treat the ureaplasma urealyticum infection,the first choices are clarithromycin and roxithromycin.