Background: Prevention against human immunodeficiency virus (HIV) includes natural resistance in the population;mainly frequency of cysteine-cysteine chemokine receptor type-5 (CCR5-delta 32 mutation). By knowing the ...Background: Prevention against human immunodeficiency virus (HIV) includes natural resistance in the population;mainly frequency of cysteine-cysteine chemokine receptor type-5 (CCR5-delta 32 mutation). By knowing the frequency of this resistance in the community, the proportion of the population susceptible to infection can be determined. This study aimed to detect for the first time the rate of CCR5-delta 32 mutation in Sudanese individuals with HIV and sex workers. Methods: Cross-sectional study was followed in the parade from 2019 through 2021, study groups were Sudanese with HIV and sex workers. Sero-negativity of sex workers was confirmed by a rapid immunochromatography test (ICT). A blood sample was targeted for DNA isolation. PCR amplification was accomplished for CCR5 wild type and CCR5-delta 32 mutation genes using specific primers. Result: Among HIV patients, males, basic education level and ages below 60 years were commonly recorded while ages below 40 years, secondary education level and single marital status were predominated in sex workers. All HIV patients were positive for CCR5 wild type and negative for CCR5-delta 32 genotype. The sex workers group showed a frequency of 3.5% (97/200) for homozygous CCR5-delta 32 mutation. Conclusion: The rating of homozygous CCR5-delta 32 genotype in studied Sudanese sex workers was relatively more than other results obtained from African countries, and the mutation was significantly detected among sex workers group (P value = 0.008) when compared to the studied HIV group.展开更多
目的建立重组Omicron BA.4/5-Delta株新冠疫苗体外相对效力的检测方法,并进行验证,以期为替代体内效力检测奠定基础。方法以人源单克隆抗体GH4作为包被抗体,HRP标记的CB6人源单克隆抗体作为酶标抗体的双抗体夹心ELISA法为基础,确定疫苗...目的建立重组Omicron BA.4/5-Delta株新冠疫苗体外相对效力的检测方法,并进行验证,以期为替代体内效力检测奠定基础。方法以人源单克隆抗体GH4作为包被抗体,HRP标记的CB6人源单克隆抗体作为酶标抗体的双抗体夹心ELISA法为基础,确定疫苗解吸附方法;再以该解吸附方法结合双抗体夹心ELISA法建立体外相对效力检测方法。并验证方法的线性范围、专属性、准确性、精密性、耐用性及定量限。采用建立的方法检测3批供试品重组Omicron BA.4/5-Delta株新冠疫苗的体外相对效力。结果确定解吸附方法为:将疫苗与处理液(1.25 mL 20%二乙醇胺,0.20 mL 10%Triton X-100,8.55 mL PBS)按等体积分数混合,于25℃解离30 min,解吸附率可达95%以上。疫苗参考品在1~26 ng/mL浓度范围内,与A_(450)呈良好的线性关系,线性方程为log(y)=1.447 log(x)-1.643,R^(2)为0.998;可特异性检测疫苗参考品的体外相对效力;90000、50000和20000 ng/mL浓度疫苗参比品检测结果的回收率均在80%~120%范围内;重复性及中间精密性验证相对标准偏差(relative standard deviation,RSD)均<20%;解离条件、检测体系孵育时间和显色时间发生微小变动时,检测结果不受影响;定量限为0.2。批号为J202301002、J202301003、J202301004供试品的体外相对效力分别为1.0,1.0和0.8,RSD为11%。结论建立的用于检测体外相对效力的方法具有良好的准确性、精密性、专属性和耐用性,可用于重组Omicron BA.4/5-Delta株新冠疫苗体外相对效力的检测。展开更多
文摘Background: Prevention against human immunodeficiency virus (HIV) includes natural resistance in the population;mainly frequency of cysteine-cysteine chemokine receptor type-5 (CCR5-delta 32 mutation). By knowing the frequency of this resistance in the community, the proportion of the population susceptible to infection can be determined. This study aimed to detect for the first time the rate of CCR5-delta 32 mutation in Sudanese individuals with HIV and sex workers. Methods: Cross-sectional study was followed in the parade from 2019 through 2021, study groups were Sudanese with HIV and sex workers. Sero-negativity of sex workers was confirmed by a rapid immunochromatography test (ICT). A blood sample was targeted for DNA isolation. PCR amplification was accomplished for CCR5 wild type and CCR5-delta 32 mutation genes using specific primers. Result: Among HIV patients, males, basic education level and ages below 60 years were commonly recorded while ages below 40 years, secondary education level and single marital status were predominated in sex workers. All HIV patients were positive for CCR5 wild type and negative for CCR5-delta 32 genotype. The sex workers group showed a frequency of 3.5% (97/200) for homozygous CCR5-delta 32 mutation. Conclusion: The rating of homozygous CCR5-delta 32 genotype in studied Sudanese sex workers was relatively more than other results obtained from African countries, and the mutation was significantly detected among sex workers group (P value = 0.008) when compared to the studied HIV group.
文摘目的建立重组Omicron BA.4/5-Delta株新冠疫苗体外相对效力的检测方法,并进行验证,以期为替代体内效力检测奠定基础。方法以人源单克隆抗体GH4作为包被抗体,HRP标记的CB6人源单克隆抗体作为酶标抗体的双抗体夹心ELISA法为基础,确定疫苗解吸附方法;再以该解吸附方法结合双抗体夹心ELISA法建立体外相对效力检测方法。并验证方法的线性范围、专属性、准确性、精密性、耐用性及定量限。采用建立的方法检测3批供试品重组Omicron BA.4/5-Delta株新冠疫苗的体外相对效力。结果确定解吸附方法为:将疫苗与处理液(1.25 mL 20%二乙醇胺,0.20 mL 10%Triton X-100,8.55 mL PBS)按等体积分数混合,于25℃解离30 min,解吸附率可达95%以上。疫苗参考品在1~26 ng/mL浓度范围内,与A_(450)呈良好的线性关系,线性方程为log(y)=1.447 log(x)-1.643,R^(2)为0.998;可特异性检测疫苗参考品的体外相对效力;90000、50000和20000 ng/mL浓度疫苗参比品检测结果的回收率均在80%~120%范围内;重复性及中间精密性验证相对标准偏差(relative standard deviation,RSD)均<20%;解离条件、检测体系孵育时间和显色时间发生微小变动时,检测结果不受影响;定量限为0.2。批号为J202301002、J202301003、J202301004供试品的体外相对效力分别为1.0,1.0和0.8,RSD为11%。结论建立的用于检测体外相对效力的方法具有良好的准确性、精密性、专属性和耐用性,可用于重组Omicron BA.4/5-Delta株新冠疫苗体外相对效力的检测。
