目的:对比兔血和人血2种血液的全血计数试验结果,探讨以兔血替代人血进行医疗器械血液学检测的可行性。方法:参考GB/T 16886.4—2022《医疗器械生物学评价第4部分:与血液相互作用试验选择》和ASTM F2888-13 Standard test method for pl...目的:对比兔血和人血2种血液的全血计数试验结果,探讨以兔血替代人血进行医疗器械血液学检测的可行性。方法:参考GB/T 16886.4—2022《医疗器械生物学评价第4部分:与血液相互作用试验选择》和ASTM F2888-13 Standard test method for platelet leukocyte count—an in-vitro measure for hemocompatibility assessment of cardiovascular materials,选择高密度聚乙烯、黑橡胶、玻璃珠、活性炭、天然橡胶、丁腈橡胶、高硼硅纤维滤纸、一次性使用真空瓶、一次性介入导管鞘套件、一次性使用输血器、血液透析器、体外循环血路12种医疗器械或材料,在同一试验条件下,分别以兔血和人血作为浸提介质,采用全自动血细胞分析仪测定WBC计数值和RBC计数值。结果:活性炭的WBC计数值和RBC计数值与空白对照相比的百分数均小于50%,其他医疗器械或材料的WBC计数值和RBC计数值与空白对照相比的百分数均大于50%。兔全血和人全血的全血细胞计数试验结果具有一致性。结论:在人血获取困难时,兔血可作为一种理想的血液来源应用于医疗器械的血液学检测。展开更多
Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and as...Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and assessed the performance of selected clinical presentations,of rapid diagnostic tests(RDT),and of reference laboratory tests on dried blood spots(DBS)for diagnosing HAT in Guinea.Method The study took place in 14 health facilities in Guinea,where 2345 clinical suspects were tested with RDTs(HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT).Seropositives underwent parasitological examination(reference test)to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay(ELISA)/Trypanosoma brucei gambiense,trypanolysis,Loopamp Trypanosoma brucei Detection kit(LAMP)and m18S quantitative PCR(qPCR).Multivariable regression analysis assessed association of clinical presentation with HAT.Sensitivity,specificity,positive and negative predictive values of key clinical presentations,of the RDTs and of the DBS tests for HAT diagnosis were determined.Results The HAT prevalence,as confirmed parasitologically,was 2.0%(48/2345,95%CI:1.5–2.7%).Odds ratios(OR)for HAT were increased for participants with swollen lymph nodes(OR=96.7,95%CI:20.7–452.0),important weight loss(OR=20.4,95%CI:7.05–58.9),severe itching(OR=45.9,95%CI:7.3–288.7)or motor disorders(OR=4.5,95%CI:0.89–22.5).Presence of at least one of these clinical presentations was 75.6%(95%CI:73.8–77.4%)specific and 97.9%(95%CI:88.9–99.9%)sensitive for HAT.HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT were respectively 97.5%(95%CI:96.8–98.1%),99.4%(95%CI:99.0–99.7%)and 97.9%(95%CI:97.2–98.4%)specific,and 100%(95%CI:92.5–100.0%),59.6%(95%CI:44.3–73.3%)and 93.8%(95%CI:82.8–98.7%)sensitive for HAT.The RDT’s positive and negative predictive values ranged from 45.2–66.7%and 99.2–100%respectively.All DBS tests had specificities≥92.9%.While LAMP and m18S qPCR sensitivities were below 50%,trypanolysis and ELISA/T.b.gambiense had sensitivities of 85.3%(95%CI:68.9–95.0%)and 67.6%(95%CI:49.5–82.6%).Conclusions Presence of swollen lymph nodes,important weight loss,severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea.Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy.Trypanolysis on DBS may discriminate HAT patients from false RDT positives.展开更多
目的分析在新生儿溶血病(hemolytic disease of the fetus and newborn,HDFN)中血清学检测结果的应用价值。方法选取2019年1月—2022年12月在龙岩市第二医院新生儿科接受治疗的高胆红素血症患儿100例,对其进行抗体释放试验、游离抗体试...目的分析在新生儿溶血病(hemolytic disease of the fetus and newborn,HDFN)中血清学检测结果的应用价值。方法选取2019年1月—2022年12月在龙岩市第二医院新生儿科接受治疗的高胆红素血症患儿100例,对其进行抗体释放试验、游离抗体试验、直接抗人球蛋白试验、不规则抗体筛查、血型鉴定检测,对比产前母体采血送检结果与产后婴儿采血送检结果差异。结果100例患儿中,58例患儿出现母婴血型不合,其中ABO血型系统50例,Rh血型系统8例。ABO血型系统HDFN发生率显著高于Rh血型系统(P<0.05);50例ABO血型系统母婴不合者中,O-A型HDFN发生率显著高于O-B型(P<0.05)。31例HDFN患儿的血清学检测结果中,单独抗体放散试验为阳性的HDFN患儿占比率显著高于其他类型(P<0.05)。产前检测IgG抗A或抗B效价结果与产后采血对比,产前检测准确率为90.32%。结论血清学检测结果在HDFN诊断中具有一定的辅助价值,在1周内检测阳性率最高。展开更多
文摘目的:对比兔血和人血2种血液的全血计数试验结果,探讨以兔血替代人血进行医疗器械血液学检测的可行性。方法:参考GB/T 16886.4—2022《医疗器械生物学评价第4部分:与血液相互作用试验选择》和ASTM F2888-13 Standard test method for platelet leukocyte count—an in-vitro measure for hemocompatibility assessment of cardiovascular materials,选择高密度聚乙烯、黑橡胶、玻璃珠、活性炭、天然橡胶、丁腈橡胶、高硼硅纤维滤纸、一次性使用真空瓶、一次性介入导管鞘套件、一次性使用输血器、血液透析器、体外循环血路12种医疗器械或材料,在同一试验条件下,分别以兔血和人血作为浸提介质,采用全自动血细胞分析仪测定WBC计数值和RBC计数值。结果:活性炭的WBC计数值和RBC计数值与空白对照相比的百分数均小于50%,其他医疗器械或材料的WBC计数值和RBC计数值与空白对照相比的百分数均大于50%。兔全血和人全血的全血细胞计数试验结果具有一致性。结论:在人血获取困难时,兔血可作为一种理想的血液来源应用于医疗器械的血液学检测。
文摘Background Passive diagnosis of human African trypanosomiasis(HAT)at the health facility level is a major component of HAT control in Guinea.We examined which clinical signs and symptoms are associated with HAT,and assessed the performance of selected clinical presentations,of rapid diagnostic tests(RDT),and of reference laboratory tests on dried blood spots(DBS)for diagnosing HAT in Guinea.Method The study took place in 14 health facilities in Guinea,where 2345 clinical suspects were tested with RDTs(HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT).Seropositives underwent parasitological examination(reference test)to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay(ELISA)/Trypanosoma brucei gambiense,trypanolysis,Loopamp Trypanosoma brucei Detection kit(LAMP)and m18S quantitative PCR(qPCR).Multivariable regression analysis assessed association of clinical presentation with HAT.Sensitivity,specificity,positive and negative predictive values of key clinical presentations,of the RDTs and of the DBS tests for HAT diagnosis were determined.Results The HAT prevalence,as confirmed parasitologically,was 2.0%(48/2345,95%CI:1.5–2.7%).Odds ratios(OR)for HAT were increased for participants with swollen lymph nodes(OR=96.7,95%CI:20.7–452.0),important weight loss(OR=20.4,95%CI:7.05–58.9),severe itching(OR=45.9,95%CI:7.3–288.7)or motor disorders(OR=4.5,95%CI:0.89–22.5).Presence of at least one of these clinical presentations was 75.6%(95%CI:73.8–77.4%)specific and 97.9%(95%CI:88.9–99.9%)sensitive for HAT.HAT Sero-K-Set,rHAT Sero-Strip,and SD Bioline HAT were respectively 97.5%(95%CI:96.8–98.1%),99.4%(95%CI:99.0–99.7%)and 97.9%(95%CI:97.2–98.4%)specific,and 100%(95%CI:92.5–100.0%),59.6%(95%CI:44.3–73.3%)and 93.8%(95%CI:82.8–98.7%)sensitive for HAT.The RDT’s positive and negative predictive values ranged from 45.2–66.7%and 99.2–100%respectively.All DBS tests had specificities≥92.9%.While LAMP and m18S qPCR sensitivities were below 50%,trypanolysis and ELISA/T.b.gambiense had sensitivities of 85.3%(95%CI:68.9–95.0%)and 67.6%(95%CI:49.5–82.6%).Conclusions Presence of swollen lymph nodes,important weight loss,severe itching or motor disorders are simple but accurate clinical criteria for HAT referral in HAT endemic areas in Guinea.Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy.Trypanolysis on DBS may discriminate HAT patients from false RDT positives.
文摘目的分析在新生儿溶血病(hemolytic disease of the fetus and newborn,HDFN)中血清学检测结果的应用价值。方法选取2019年1月—2022年12月在龙岩市第二医院新生儿科接受治疗的高胆红素血症患儿100例,对其进行抗体释放试验、游离抗体试验、直接抗人球蛋白试验、不规则抗体筛查、血型鉴定检测,对比产前母体采血送检结果与产后婴儿采血送检结果差异。结果100例患儿中,58例患儿出现母婴血型不合,其中ABO血型系统50例,Rh血型系统8例。ABO血型系统HDFN发生率显著高于Rh血型系统(P<0.05);50例ABO血型系统母婴不合者中,O-A型HDFN发生率显著高于O-B型(P<0.05)。31例HDFN患儿的血清学检测结果中,单独抗体放散试验为阳性的HDFN患儿占比率显著高于其他类型(P<0.05)。产前检测IgG抗A或抗B效价结果与产后采血对比,产前检测准确率为90.32%。结论血清学检测结果在HDFN诊断中具有一定的辅助价值,在1周内检测阳性率最高。
