Development and evaluation of time‐resolved fluorescent immunochromatographic assay for quantitative detection of SARS‐CoV‐2 spike antigen

BackgroundThe spread of COVID‐19 worldwide caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has necessitated efficient, sensitive diagnostic methods to identify infected people. We report on the development of a rapid 15‐minute time‐resolved fluorescent (TRF) lateral flow immunochromatographic assay for the quantitative detection of the SARS‐CoV‐2 spike protein receptor‐binding domain (S1‐RBD).ObjectivesOur objective was to develop an efficient method of detecting SARS‐CoV‐2 within 15 min of sample collection.MethodsWe constructed and evaluated a portable, disposable lateral flow device, which detected the S1‐RBD protein directly in nasopharyngeal swab samples. The device emits a fluorescent signal in the presence of S1‐RBD, which can be captured by an automated TRF instrument.ResultsThe TRF lateral flow assay signal was linear from 0 to 20 ng/ml and demonstrated high accuracy and reproducibility. When evaluated with clinical nasopharyngeal swabs, the assay was performed at >80% sensitivity, >84% specificity, and > 82% accuracy for detection of the S1‐RBD antigen.ConclusionThe new S1‐RBD antigen test is a rapid (15 min), sensitive, and specific assay that requires minimal sample preparation. Critically, the assay correlated closely with PCR‐based methodology in nasopharyngeal swab samples, showing that the detected S1‐RBD antigen levels correlate with SARS‐CoV‐2 virus load. Therefore, the new TRF lateral flow test for S1‐RBD has potential application in point‐of‐care settings.     

Immunogenicity and Reactogenicity of Ad26.COV2.S in Korean Adults: A Prospective Cohort Study

BackgroundAs the coronavirus disease 2019 (COVID-19) pandemic continues, there are concerns regarding waning immunity and the emergence of viral variants. The immunogenicity of Ad26.COV2.S against wild-type (WT) and variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) needs to be evaluated.MethodThis prospective cohort study was conducted between June 2021 and January 2022 at two university hospitals in South Korea. Healthy adults who were scheduled to be vaccinated with Ad26.COV2.S were enrolled in this study. The main outcomes included anti-spike (S) IgG antibody and neutralizing antibody responses, S-specific T-cell responses (interferon-γ enzyme-linked immunospot assay), solicited adverse events (AEs), and serious AEs.ResultsFifty participants aged ≥ 19 years were included in the study. Geometric mean titers (GMTs) of anti-S IgG were 0.4 U/mL at baseline, 5.2 ± 3.0 U/mL at 3–4 weeks, 55.7 ± 2.4 U/mL at 5–8 weeks, and 81.3 ± 2.5 U/mL at 10–12 weeks after vaccination. GMTs of 50% neutralizing dilution (ND50) against WT SARS-CoV-2 were 164.6 ± 4.6 at 3-4 weeks, 313.9 ± 3.6 at 5–8 weeks, and 124.4 ± 2.6 at 10–12 weeks after vaccination. As for the S-specific T-cell responses, the median number of spot-forming units/10⁶ peripheral blood mononuclear cell was 25.0 (5.0–29.2) at baseline, 60.0 (23.3–178.3) at 5-8 weeks, and 35.0 (13.3–71.7) at 10–12 weeks after vaccination. Compared to WT SARS-CoV-2, ND50 against Delta and Omicron variants was attenuated by 3.6-fold and 8.2-fold, respectively. The most frequent AE was injection site pain (82%), followed by myalgia (80%), fatigue (70%), and fever (50%). Most AEs were grade 1–2, and resolved within two days.ConclusionSingle-dose Ad26.COV2.S was safe and immunogenic. NAb titer and S-specific T-cell immunity peak at 5–8 weeks and rather decrease at 10–12 weeks after vaccination. Cross-reactive neutralizing activity against the Omicron variant was negligible.     

握球运动配合水胶体敷料透明贴在肺癌经外周中心静脉导管置管化疗患者并发症预防中的应用

目的 探讨握球运动配合水胶体敷料透明贴对降低经外周中心静脉导管（PICC）化疗肺癌患者并发症的作用。方法 选取2019年12月至2021年1月九江市第一人民医院呼吸内科收治的96例PICC置管化疗的肺癌患者作为研究对象,按照随机数字表法将其分为对照组与研究组,每组各48例。对照组患者采用50%的硫酸镁温敷,研究组患者采用水胶体敷料透明贴联合握球运动训练干预。比较两组患者置管3个月内的导管相关并发症发生率和置管前及置管后1、2、3个月置管肢体侧腋静脉最大血液流速（Vmax）、单位时间平均血液流速（TMFV）。结果 研究组患者干预后的静脉炎和静脉血栓发生率低于对照组,差异有统计学意义（P<0.05）。两组患者的渗血和导管异位发生率比较,差异无统计学意义（P>0.05）。两组患者置管前的Vmax、TMFV水平比较,差异无统计学意义（P>0.05）;两组患者置管后1、2、3个月的Vmax、TMFV水平低于置管前,差异有统计学意义（P<0.05）;研究组患者置管后1、2、3个月的Vmax、TMFV水平高于对照组,差异有统计学意义（P<0.05）;且组别、交互中差异有...     

不同缝合方法在Sanders Ⅲ型跟骨骨折患者术中的应用比较

目的 比较三层紧密缝合法与Allgower-Donati缝合法在SandersⅢ型跟骨骨折患者术中的应用价值。方法 选取2017年6月至2020年6月东南大学附属中大医院溧水分院的83例SandersⅢ型跟骨骨折患者为研究对象,根据手术缝合方法的不同分为观察组（43例）与对照组（40例）。观察组采用三层紧密缝合法,对照组采用Allgower-Donati缝合法。比较两组的手术疗效、手术相关指标、术后恢复情况及术后切口并发症总发生率,观察两组患者术后的Maryland评分、视觉模拟评分法（VAS）评分及切口皮肤温度变化情况。结果 两组的手术优良率比较,差异无统计学意义（P>0.05）;观察组术后1个月的Maryland评分高于对照组,术后3 d的VAS评分低于对照组,差异有统计学意义（P<0.05）;两组的手术时间及术后引流时间比较,差异无统计学意义（P>0.05）;观察组的皮肤切口缝合时间长于对照组,切口周围皮肤炎症反应面积小于对照组,切口愈合时间短于对照组,差异有统计学意义（P<0.05）;两组的骨折愈合时间比较,差异无统计学意义（P>0.05）;观察组...     

灵芪胶囊对H22荷瘤小鼠p53和bcl-2蛋白表达的影响

目的：探讨灵芪胶囊对H22荷瘤小鼠的抑瘤作用及其抑瘤作用机制。方法：采用体内实验法,于无菌条件下抽取传代7d、生长良好的H22荷瘤小鼠腹水,无菌0．9％氯化钠溶液1：3稀释（约含瘤细胞2×10^6／ml）,按0．2ml／7,接种于消毒后的小鼠右前肢腋部皮下,制成肿瘤模型,灌胃给药灵芪胶囊11d后,称取小鼠体重,脱椎处死小鼠,取脾脏及胸腺称重并计算胸腺指数和脾脏指数。用免疫组化法检测各组凋亡相关基因突变型p53和bcl-2基因的表达。结果：灵芪胶囊在明显抑制肿瘤生长的同时不降低体重,在一定剂量对荷瘤动物的免疫器官指数无明显影响;灵芪胶囊三个剂量组突变型p53基因和bcl-2基N的表达均低于模型组。结论：灵芪胶囊对H22荷瘤小鼠有明显抑瘤作用,其机制可能与抑制突变型p53基N和bcl-2基因表达有关。     

黄芩素制备工艺研究

目的研究由黄芩苷制备黄芩素的最佳工艺。方法采用直接酸水解法和热裂解法相比较，以黄芩素的含量和得率为指标，对其制备工艺进行优化。结果热裂解方法中当温度超过200℃时，可以获得含量为94．47％以上的黄芩素，得率不高于41．64％，而直接酸水解方法获得黄芩素的含量为92．15％以上，且得率为66．03％以上。结论直接酸水解法制备黄芩素工艺简单可行，得率较高，实用性强。     

网片在盆腔脏器脱垂及压力性尿失禁治疗中的应用

目的 探讨网片治疗盆腔脏器脱垂(POP)及压力性尿失禁(SUI)的临床疗效.方法 11例POP和7例SUI患者行网片悬吊带术,同期13例POP和6例SUI患者行传统手术阴道前壁修补或耻骨后膀胱尿道悬吊术.比较手术相关指标和远期疗效.结果 行网片悬吊带术的POP和SUI患者的手术时间、术中出血量、尿管留置时间、住院天数均明显少于传统手术者(P＜0.01或P＜0.05);随访网片悬吊带术患者,未出现膀胱、尿道、直肠损伤和吊带、补片侵蚀及脏器脱垂复发等.结论 与传统手术比较,在女性盆底重建术中应用网片悬吊具有操作简便、效果确切和并发症少的优点.     

盐酸环丙沙星水分的双溶剂费休氏法测定

采用以甲醇为基本溶剂,水为辅助溶剂的双溶剂费休氏法,可准确测定盐酸环丙沙星中分子内和游离状态的全部水分。其平均回收率为１００．０５％,ＲＳＤ为０．２５％,为溶解特性类似的药品提供了可靠的水分测定。     

支持性心理治疗对鼻咽癌患者抑郁情绪的干预研究

目的探讨支持性心理治疗对鼻咽癌患者的抑郁情绪的干预效果及其对生活质量和对同步放化疗依从性的影响。方法将96例鼻咽癌患者随机分为支持性心理治疗组和对照组,评定并比较两组SDS,SF-36生活质量得分,完成同步放化疗的比率。结果支持性心理治疗组SDS评分显著低于对照组（P〈0.01）。生活质量除生理机能外,其他指标支持性心理治疗组均优于对照组（P〈0.05或P〈0.01）。支持性心理治疗组显示良好的对同步放化疗治疗的依从性。结论支持性心理治疗能显著降低鼻咽癌患者抑郁情绪的严重程度,并可提高其生活质量,帮助患者完成同步放化疗治疗。     

胰头肿块型慢性胰腺炎12例诊治分析

目的分析胰头肿块型胰腺炎的诊治方法。方法回顾性分析我院1998年6月至2008年6月间收治的125例慢性胰腺炎病例,总结其中12例因胰头占位而行胰十二指肠切除术患者的病例。结果12例患者术中探查均显示肿块位于胰头,与周围组织有粘连,其中1例与门静脉有粘连,但尚能剥离,术后病理证实均为慢性胰腺炎。结论目前区分慢性胰腺炎与胰腺癌尚无特异性好和敏感性高的鉴别方法,CT结合经内镜逆行胰胆管造影对大部分病例的鉴别诊断具有较高的价值,胰头肿块型胰腺炎行胰头十二指肠切除术治疗效果良好。