Uncomplicated malaria in children: The place of rapid diagnostic test

Background:

Malaria has remained a major cause of morbidity and mortality among the under-five children in Nigeria. Prompt and accurate diagnosis of malaria is necessary in controlling this high burden and preventing unnecessary use of anti-malarial drugs. Malaria rapid diagnostic test (MRDT) offers the hope of achieving this goal. However, the performance of these kits among the most vulnerable age group to malaria is inadequate.

Materials and Methods:

In this cross-sectional study, 433 out-patients, aged <5 years with fever or history of fever were enrolled. Each candidate was tested for malaria parasitaemia using ACON; malaria pf. Thick and thin films were also prepared from the same finger prick blood for each candidate.

Result:

Malaria rapid diagnostic test had sensitivity of 8.3%, specificity of 100%, positive predictive value (PPV) of 100% and negative predictive value (NPV) of 74%. The sensitivity of MRDT increased with increasing age. This effect of age on sensitivity was statistically significant (P = 0.007). Similarly parasite density had significant effect on the sensitivity of MRDT (P = <0.001).

Conclusion:

Histidine-rich protein-2 based MRDT is not a reliable mean of diagnosing malaria in the under-five age children with acute uncomplicated malaria.     

Relation of predictive value to sensitivity and specificity of a diagnostic test

This paper discusses how the positive and negative predictive values vary withcontrary variations of sensitivity and specificity at a certain disease prevalence.Let thesensitiviy be Se and the specificity be Sp at the initial cutoff point,correspondingly Se'and Sp' at a new cutoff point:A=Se'/Se:B-(1-Sp')/(1-Sp):C=Sp'/Sp;D=(I-Se')/(I-Se).Moving the cutoff point from the initial point to the new point,if the contrary variationsof the sensitivity and specificity satisfy the inequality A>B,then the positive predictivevalue increases,otherwise it decreases or remains unchanged.If the variations satisfy theinequality C>D,then the negative prcdictive value increases,otherwise it decreasses or re-mains unchanged.     

A comparative laboratory diagnosis of malaria: microscopy versus rapid diagnostic test kits

Objective

To compare the two methods of rapid diagnostic tests (RDTs) and microscopy in the diagnosis of malaria.

Methods

RDTs and microscopy were carried out to diagnose malaria. Percentage malaria parasitaemia was calculated on thin films and all non-acute cases of plasmodiasis with less than 0.001% malaria parasitaemia were regarded as negative. Results were simply presented as percentage positive of the total number of patients under study. The results of RDTs were compared to those of microscopy while those of RDTs based on antigen were compared to those of RDTs based on antibody. Patients'' follow-up was made for all cases.

Results

All the 200 patients under present study tested positive to RDTs based on malaria antibodies (serum) method (100%). 128 out of 200 tested positive to RDTs based on malaria antigen (whole blood) method (64%), while 118 out of 200 patients under present study tested positive to visual microscopy of Lieshman and diluted Giemsa (59%). All patients that tested positive to microscopy also tested positive to RDTs based on antigen. All patients on the second day of follow-up were non-febrile and had antimalaria drugs.

Conclusions

We conclude based on the present study that the RDTs based on malaria antigen (whole blood) method is as specific as the traditional microscopy and even appears more sensitive than microscopy. The RDTs based on antibody (serum) method is unspecific thus it should not be encouraged. It is most likely that Africa being an endemic region, formation of certain levels of malaria antibody may not be uncommon. The present study also supports the opinion that a good number of febrile cases is not due to malaria. We support WHO''s report on cost effectiveness of RDTs but, recommend that only the antigen based method should possibly, be adopted in Africa and other malaria endemic regions of the world.     

快速检测HIV抗体诊断实验的系统评价

目的系统评价快速检测(R T)试验诊断HIV感染的临床应用价值。方法计算机检索PubMed(1966～2010.12)、EMBASE(1974～2010.12)、中国生物医学文献数据库CBM(1978～2010.12)、中国期刊全文数据库CNK(I1994～2010.12)等,全面收集快速检测HIV抗体的临床诊断试验。按QUADAS条目对纳入研究文献进行质量评价,应用统计软件Meta-DiSc1.4和STATA11.0进行数据分析。结果最终纳入14个研究,结果显示:快速检测诊断试验敏感度、特异度、阳性似然比(+LR)、阴性似然比(-LR)、诊断优势比(DOR)及SR OC曲线下面积分别为:100%(95%CI 99%-100%),99%(95%CI 99%-99%),118.40(95%CI 60.27-232.57),0.01(95%CI 0.00-0.04),16 398.26(95%CI 6 617.73-40 633.71)和0.9991。结论快速检测诊断HIV感染的敏感性和特异性均很高,是临床上快速筛查HIV感染者的有效方法。     

三种代谢综合征定义在中国冠心病患者中的应用比较

目的探讨ATPⅢ(2001)、CDS(2004)、IDF(2005)等三种代谢综合征定义在中国冠心病人群中应用价值。方法于2005年6月1日至2005年9月30日期间在北京、上海、广州等7个城市共52家三级甲等医院心内科所有符合冠心病诊断纳入条件的住院患者连续入选为研究对象,共收集有效病例3 513例。分别应用ATPⅢ、CDS以及IDF的工作定义诊断MS,比较各定义下的MS的患病率以及通过运用ROC曲线来考查这三种工作定义两两间比较的一致性情况。结果ATPⅢ、CDS以及IDF工作定义下冠心病患者MS患病率分别为40.2%、52.8%和53.5%。ROC曲线特征:CDS为参照下,ATPⅢ和IDF的灵敏度、特异度、曲线下面积分别为0.62、0.84、0.73和0.73、0.68、0.70。IDF为参照下,ATPⅢ和CDS的灵敏度、特异度、曲线下面积分别为0.59、0.82、0.70和0.72、0.69、0.70。ATPⅢ为参照下,IDF和CDS的灵敏度、特异度、曲线下面积分别为0.79、0.53、0.71和0.81、0.66、0.74。结论ATPⅢ、CDS、IDF工作定义侧重点不一,IDF定义下的MS患病率最高。     

陕西省2016—2020年结核病快速诊断技术应用效果分析

目的 分析2016—2020年陕西省结核病快速检测技术的应用效果,为进一步优化结核病发现流程,制定防控策略提供依据。方法 在中国疾病预防控制中心《结核病信息管理系统》,按首管理单位导出2016—2020年陕西省登记的104 437例肺结核患者病案,收集痰涂片、痰培养和分子生物学检测的实验室检查结果,对肺结核患者的病原学阳性率、痰涂片、痰培养、分子生物学检测率以及检测阳性率的指标进行统计学分析。结果 陕西省2016—2020肺结核病原学阳性率分别为13.49%（2 664/19 754）、22.68%（5 081/22 401）、35.99%（8 232/22 876）、48.14%（10 438/21 682）、52.65%（9 332/17 724）,呈逐年上升趋势（χ²_趋势=9 473.12,P<0.001）。仅分子生物学阳性构成比分别为0（0/2 664）、0.16%（8/5 081）、15.44%（1 271/8 232）、27.58%（2 879/10 438）、31.52%（2 941/9 332）,呈逐年上升趋势（χ²_趋势=2 971.44,P<0.001）。登记肺结核患者的分子生物学检测率分别为0.01%（2/19 754）、0.38%（85/22 401）、21.11%（4 828/22 876）、52.42%（11 365/21 682）、55.18%（9 780/17 724）,呈逐年上升趋势（χ²_趋势=28 269.23,P<0.001）。涂阴患者分子生物学检测率为22.72%（17 976/79 130）。市级定点医院和县级定点医院仅分子生物学阳性患者构成比分别为33.43%（4 032/ 12 062）和11.99%（2 279/19 014）,差异有统计学意义（χ²=2 096.46,P<0.001）。结论 陕西省2016—2020年分子生物学检测率呈逐年上升趋势。通过应用分子生物学检测技术,肺结核病原学阳性率显著提高,但目前陕西省分子生物学检测率与其他省相比较低,在县级定点医院以及涂阴患者中应用较少,应继续加强推广。     

粉尘螨皮肤点刺诊断试剂盒对粉尘螨引起的过敏性疾病的诊断试验

目的探讨粉尘螨皮肤点刺诊断试剂盒对粉尘螨引起的过敏性哮喘和变应性鼻炎等过敏性疾病的诊断价值。方法按照“阳性金标准”：有过敏性疾病史;血清粉尘螨特异性IgE浓度检测结果≥O．35KU／L,为1级或1级以上;阿罗格点刺试验结果为（＋）及（＋）以上;“阴性金标准”：有过敏性疾病史;血清中粉尘螨特异性IgE浓度检测结果〈0．35KU／L,为0级;阿罗格点刺试验结果为（-）,选择阳性、阴性受试者各150名,用粉尘螨皮肤点刺诊断试剂盒进行点刺,测量各个受试者的丘疹面积,并判断是阴性还是阳性。结果本试剂盒ROC的曲线下面积为0．95（0．92～0．98）,敏感度为93．3％,特异度为96．0％。阳性预测值在80％以上,除个别情况外,阴性预测值也在70％以上。结论该粉尘螨皮肤点刺诊断试剂盒是辅助诊断由粉尘螨引起的过敏性哮喘和变应性鼻炎等过敏性疾病的一种有效手段。     

静脉盐水负荷试验在原发性醛固酮增多症诊断中的应用

目的探讨静脉盐水负荷试验在原发性醛固酮增多症(原醛症)诊断中的应用价值。方法2004~2006年临床确诊原醛症患者65例,其中醛固酮瘤27例,特发性醛固酮增多症(特醛症)26例,原发性肾上腺增生11例,醛固酮癌1例。所有患者检测血电解质,血、尿醛固酮及立位血浆肾素活性等生化指标,同时行静脉盐水负荷试验。以19例原发性高血压患者作为对照组。结果与对照组比较,原醛症组患者的血、尿醛固酮明显升高,而血钾及立位血浆肾素活性则低;原醛症组和对照组静脉盐水负荷后血醛固酮不能抑制者分别为95.4%(62/65)和21.1%(4/19);该试验对原醛症诊断的敏感性和特异性分别为95.4%和93.9%。65例原醛症患者中,醛固酮瘤和原发性肾上腺增生患者的血钾较特醛症患者低,而血、尿醛固酮则高;醛固酮瘤、特醛症、原发性肾上腺增生及醛固酮癌患者的静脉盐水负荷后血醛固酮的抑制率分别为16.1%、28.9%、15.4%和5.2%。结论原发性肾上腺增生患者生化指标改变与醛固酮瘤患者类似,均较特醛症患者更为明显。静脉盐水负荷试验是一项安全且可靠的原醛症确诊方法,其敏感性和特异性均较高。     

Comparison of clinical, microscopic and rapid diagnostic test methods in the diagnosis of Plasmodium falciparum malaria in Enugu, Nigeria

OBJECTIVE: To compare the use of clinical, microscopic and immunochromato-graphic methods in the diagnosis of Plasmodium falciparum malaria. METHODS:Children with history of fever were consecutively recruited. Information on personal characteristics, and clinical features were obtained with the parental consent before enrolment. Malaria parasite density was done with quantitative microscopy, as well as specie identification in both local and reference laboratories. Rapid diagnostic test (RDT) kits were also used for parasite detection. RESULTS: Eighty three children had clinical diagnosis of malaria, while the remaining 6 had other diagnoses. On microscopy 89 and 26 patients had parasitaemia by the local and reference laboratories respectively. With the RDT, 15 patients had parasitaemia with corresponding minimum densities of 1200 and 716 parasites per ul from the local and reference laboratories. The sensitivity and specificity of the RDT to the reference laboratory were 42.31% and 93.65% respectively, while concordance was 57.69% for RDT, 30.49% for clinical diagnosis (all symptoms), 43.75% for clinical diagnosis (fever alone), and 29.21% for local laboratory. CONCLUSION: There was a significant deficiency in malaria diagnosis using any of the methods alone. For reliable diagnosis of malaria a combination of the methods of diagnosis is recommended. Degradation of the RDTs might have contributed to its low sensitivity. Training and better quality assurance should be established for the medical and laboratory workers in order to improve malaria diagnosis.     

探究快速血清学检验和微生物快速培养检测诊断小儿肺炎支原体感染的临床意义

目的：探析比较快速血清学检验和微生物快速培养检测诊断小儿肺炎支原体感染的临床意义。方法：选取2014年1月至2016年1月该院收治的89例肺炎支原体感染患儿,随机分为甲组（n ＝45）、乙组（n ＝44）。甲组给予快速血清学检验,乙组给予微生物快速培养检测,对两组患儿检测结果予以观察比较。结果：甲组、乙组患儿检测阳性率分别为62．2％、88．6％,组间比较差异有统计学意义（P ＜0．05）。结论：在小儿肺炎支原体感染诊断中,微生物快速培养检测更具优势,值得临床推广应用。然而,为了有效提高诊断准确性,可以联用两种检测方式。     

小儿急性阑尾炎脓液细菌培养及药敏试验结果研究

目的：分析小儿急性阑尾炎主要致病细菌及药敏情况,为临床合理应用抗生素提供依据。方法：自2005年8月-2007年7月,在我院行阑尾切除术患儿,术中采集腹腔渗液标本共84例,进行细菌培养及药敏试验。回顾分析培养阳性的65株需氧菌及药敏结果。结果：小儿急性阑尾炎主要致病细菌仍以大肠埃希菌为主,其药物敏感率由高到低依次为亚胺培南、哌拉西林／他唑巴坦、阿米卡星、头孢他啶、头孢匹肟、头孢曲松、头孢唑啉、庆大霉素、氨苄西林／舒巴坦。氨苄西林全部耐药。结论：大肠埃希菌仍为目前小儿急性阑尾炎主要致病细菌,对临床常用的抗生素有较高的耐药性。脓液细菌培养对术前合理用药及术后抗生索的选用有指导意义。     

B超、CT、MRCP及ERCP诊断胆管癌临床价值的Meta分析

目的 系统评价B超、CT、磁共振胰胆管造影(MRCP)及经内镜逆行性胰胆管造影术(ERCP)诊断胆管癌的价值.方法 收集PubMed、Medine、Embase、中国知网(CNKI)、万方5大电子文献数据库中所有关于胆管癌的文献,对B超、CT、MRCP及ERCP怀疑胆管癌的患者进行系统回顾,评价指标包括灵敏度及特异度,采用汇总受试者工作特征(SROC)曲线得出曲线下面积(AUC)及各自的Q值,分析4种检查方法的诊断价值.结果 共纳入44篇文章,总病例数4 364例.B超、CT、MRCP合并灵敏度、特异度分别为0.75、0.72,0.82、0.80,0.85、0.87,ERCP细胞学及ERCP图像灵敏度、特异度分别为0.62、0.98,0.88、0.84),Q值分别为0.690 8、0.787 8、0.841 7(ERCP细胞学及ERCP图像分别为0.846 1、0.833 2).结论 CT、MRCP及ERCP 3者诊断胆管癌的准确性相当,均明显高于B超,是有效的辅助检查方法.ERCP细胞学检查合并特异度明显高于其他检查方法,对高度怀疑胆管恶性肿瘤者具有高度的临床诊断价值.     

虎红平板凝集试验、标准试管凝集试验、酶联免疫吸附方法在布鲁氏菌病中检测的特性及诊断效能

目的 研究虎红平板凝集试验（Rose-Bengal plate agglutination test, RBPT）、标准试管凝集试验（standard tube agglutination test, SAT）、酶联免疫吸附（enzyme-linked immunosorbent assay, ELISA）方法在布鲁氏菌病中检测的特性及诊断效能。方法 选取兴安盟人民医院2020年3月—2021年5月接诊的且有完整记录的489例疑似布鲁氏菌病患者。以接触史+临床症状+血清学检测/布鲁氏菌分离培养为诊断金标准,分析SAT、RBPT和ELISA对布鲁氏菌病的诊断价值。结果 489例疑似患者确诊阳性183例（37.42%）,而RBPT、ELISA、SAT分别检出阳性234例（47.85%）、148例（30.27%）、195例（39.88%）;RBPT诊断布鲁氏菌病的灵敏度、特异度、阳性预测值、阴性预测值、准确度分别为95.08%、80.39%、74.36%、96.47%、85.89%,ELISA诊断布鲁氏菌病的灵敏度、特异度、阳性预测值、阴性预测值、准确度分别为78.69%、98.69%、97...     

离体逼尿肌肌条试验的操作体会

目的 介绍离体逼尿肌肌条试验操作时的一些经验技巧.方法 和结果本文从胶垫、帽头钉、双刃刀的制备和运用;肌条的制备;肌条实验液体的选择与配置;器官槽温度的保持;肌条自发收缩的产生等具体操作方面进行了详细阐述.结论 逼尿肌肌条实验中,应用上述经验技巧能够取得较好的实验效果.     

利用McNemar方案及ROC曲线评价进口品牌甲功检测结果临床诊断价值

目的: 评估不同进口品牌罗氏Cobas E602、西门子Centaur XP及贝克曼DXI800间血清甲状腺功能（甲功）检测项目临床诊断价值及诊断效能是否一致。方法:选择初诊甲状腺功能亢进症（甲亢）患者63例、初诊甲状腺功能减退症（甲减）患者66例及健康体检者70名作为对照组。采集3组未经治疗期血清标本,检测甲功5项（TSH、FT4、FT3、T4、T3）,采用多因素联合诊断受试者工作特征曲线（ROC曲线）及WS/T505-2017《定性测定性能评价指南》提供的McNemar方案评价诊断价值及效能。结果:多因素联合诊断ROC曲线分析,3个品牌5个项目联合检测,甲亢患者的曲线下面积（AUC）在0.98~0.99之间,甲减在0.81~0.84之间,3个品牌比较差异无统计学意义（均P>0.05）;根据McNemar方案,以各品牌既定临界点（参考范围上下限）作为判断点,甲亢患者3个品牌诊断效能基本一致,仅TSH项目西门子具备更好临床敏感性的同时降低了临床特异性,甲减患者3个品牌互有优势,但FT3及FT4无论是甲亢或甲减,3个品牌临床敏感性及临床特异性均较低（13.70%~50.00%）。结论:Cobas E602、Centaur XP及DXI800检测血清甲功项目时,对于甲亢的诊断价值均较高并基本一致,建议使用该3个品牌的检验机构可以开展甲亢检测结果的互信;对于甲减的诊断价值虽然中等并一致,但FT3及FT4 3个品牌临床敏感性均较低。     

液基细胞学检查在宫颈疾病中的诊断价值

目的探讨液基超薄细胞技术（thinprep cytologic test,TCT）和Bethesd系统（TBS）在早期宫颈病变诊断中的临床价值。方法 2 187例患者进行TCT检查和TBS细胞学分类诊断,对TCT检查发现异常者行病理检查。结果 2 187例TCT中检出细胞学异常的139例,其中不典型鳞状细胞（ASC）93例,低度鳞状上皮内病变（LSIL）22例,高度鳞状上皮内病变（HSIL）24例。大于55岁年龄段,细胞学阳性检出率最高,其次是36～45岁年龄段;TCT与病理检查符合率分别为ASCUS 69.64%、LSIL 45.45%、HSIL94.44%。结论 TCT技术结合TBS应用于宫颈细胞学涂片配合阴道镜下活检是筛查和诊断子宫颈癌前病变的有效手段。     

氟康唑纸片扩散法和E-test法检测酵母菌体外药敏试验相关性研究

目的对比研究酵母菌氟康唑纸片扩散法和E-test法的相关性,以期确立一种简便可靠的酵母菌体外药物敏感试验方法。方法分别应用纸片扩散法和E-test法检测151株临床分离的酵母菌对氟康唑的敏感性,采用BOMIC仪自动读取培养板上的抑菌环直径,记录试验结果并对质控数据进行核实,使用WHONET-5.4软件分析结果并进行比较。结果两种体外药敏试验方法的一致率可达84.7%,极重要误差率为0.7%,重大误差率为2.0%,次要误差率为12.6%;对于光滑假丝酵母菌两种方法的检测结果有较大差异。结论应用WHO-NET-5.4软件分析得出氟康唑纸片扩散法和E-test法对于检测大多数酵母菌具有非常好的一致性,但对于部分菌株需要进一步应用常量肉汤法确定其最低抑菌浓度值。     

运动平板试验对诊断冠心病的价值

目的:评价运动平板试验(TET)在冠心病中的诊断价值.方法:选择我院2008年7月～2009年8月行CAG和TET的患者200例,并分析患者年龄、性别对TET结果的影响.结果:通过与冠状动脉造影(CAG)的对比,分析TET检出冠心病的灵敏性为78.6%、特异性为51.5%、准确度为77.5%.结论:TET是近年来诊断评...     

Diagnostic Utility of Interferon-Gamma Release Assay in Tuberculous Lymphadenitis

Objective The aim of this study was to evaluate the diagnostic performance of T-SPOT.TB for tuberculous lymphadenitis. Methods Suspected tuberculous lymphadenitis patients between September 2010 and September 2018 who had both peripheral blood T-SPOT.TB test and lymph node biopsy were retrospectively enrolled in this study. The cutoff value of T-SPOT.TB test for peripheral blood was set as 24 spot forming cell (SFC)/10 ⁶ periphreral blood monocyte cell (PBMC) according to the instruction of testing kits. The gold standard for diagnosis of TBL was the combination of microbiology results, histopathology results and patient's response to anti-TB treatment. Diagnostic efficacy of T-SPOT.TB was evaluated, including sensitivity, specificity, accuracy, predictive values, and likelihood ratio. Results Among 91 patients who met the inclusion criteria, we excluded 8 cases with incomplete clinical information and 6 cases who lost to follow-up. According to the gold standard, there were 37 cases of true TBL (9 confirmed TBL and 28 probable TBL), 30 cases of non-TBL, and 10 cases of clinically indeterminate diagnosis who were excluded from the final analyses. The T-SPOT.TB tests yielded 43 cases of positive response and 24 cases of negative response. The sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of peripheral blood T-SPOT.TB for diagnosing TBL were 89.2%, 66.7%, 79.1%, 76.7%, 83.3%, 2.68 and 0.16, respectively. The number of SFCs of T-SPOT.TB in TBL patients [432(134-1264)/10 ⁶ PBMCs] was higher than that in non-TBL patients [0 (0-30) /10 ⁶PBMCs] with a significant difference (Z=-5.306, P <0.001).Conclusion T-SPOT.TB is a rapid and simple diagnostic test for TBL with a high sensitivity and negative predictive value.