1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is...1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.展开更多
Reports manifest a continuing need for the development of rapid and on-site (point of care) assays. Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations. Scien...Reports manifest a continuing need for the development of rapid and on-site (point of care) assays. Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations. Scientists at Micro Detect, Inc. have developed an innovative diagnostic device (method) that can be utilized broadly for antibody/antigen interactions including diagnostic assays in the medical, veterinary and food industries. The developed device can be utilized for the detection of antibodies against a single antigen or vice versa. It can also be tailored for specific panels that detect antigens or antibodies for diverse infectious agents, proteins, hormones, tumor markers, autoimmune markers, and allergens. Additionally, it can also be used for detection of toxins, antitoxins, nucleic acids, enzymes, drugs, etc. in both humans and animals. Specimens used in different formats of the device can be tears, saliva, whole blood, serum, plasma, urine, stool, and other bodily discharges. The good intra and inter precisions and acceptable linearity of the device support reliable use of the device. The CV of the device is 1.9% - 2.2%. Likewise, the performance of the device using 92 confirmed negative and positive specimens via a typical assay showed 100% sensitivity, 80% specificity, 96.8% efficacy, 80% positive predictive value, and 100% negative predictive value. The results of our feasibility study suggest reliable utility of a device for rapid, easy-to-use, inexpensive, and on-site (point of care) diagnostic assays. This presents a potential breakthrough in diagnostic methodologies that can be integrated into modern medicine and food industries.展开更多
The comparative studies of diagnostic efficiency of excretory-secretory antigens of Trichinella spiralis and Trichinella nativa were performed using blood sera of rats from Wistar line experimentally infected with Arc...The comparative studies of diagnostic efficiency of excretory-secretory antigens of Trichinella spiralis and Trichinella nativa were performed using blood sera of rats from Wistar line experimentally infected with Arctic trichinellae. For animal infection and antigen preparation Trichinella from muscles of wild carnivorous mammals from Arctic regions of Russia were used. When antigen from T. nativa larvae was used to analyze titers of sera of rats experimentally infected with Arctic Trichinella, a significant increase in efficacy ofELISAwas detected. E.g., sera of rats infected with trichinellae from ringed seals retained in ELISA with T. nativa antigen values higher than diagnostic level at titers of 1:6400 - 1:12800, while titer of those same sera when using T. spiralis antigen was no higher than 1:200 - 1:400.展开更多
Serum pancreatic tissue carcinoma antigen (PCA) was measured by ELISA in 396 patients with pancreatic carcinoma (PC) and other diseases diagnosed by clinical examination, histopathology and operation. Serum PCA more t...Serum pancreatic tissue carcinoma antigen (PCA) was measured by ELISA in 396 patients with pancreatic carcinoma (PC) and other diseases diagnosed by clinical examination, histopathology and operation. Serum PCA more than 300 U/ml was considered as diagnostic value for PC and 30-299 U/ml as probable index for PC. The sensitivity of PCA for PC was 78.2% (43/55), and the specifity 94.6%. The positive rate of PCA in other diseases were 0-13.3%. Combining the determination of PCA with B-mode ultrasonic scanning (BU). CT and/or ERCP (endos-copic retrograde cholangiopancreatography) may increase the diagnostic rate of PC to 89-91%, and with the "cocktail" of CA19-9, CEA (carcino-embryonic antigen) and RNase-C, PC be diagnosed in 88.9%. Therefore, it is suggest that PCA si a promising tumor market of PC with high sensitivity and relative specificity.展开更多
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 calc...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.展开更多
BACKGROUND Pancreaticobiliary cancer(PB Ca)is a lethal disease,and a useful diagnostic marker is urgently needed.A correlation between the human microbiota and malignant gastrointestinal diseases was recently reported...BACKGROUND Pancreaticobiliary cancer(PB Ca)is a lethal disease,and a useful diagnostic marker is urgently needed.A correlation between the human microbiota and malignant gastrointestinal diseases was recently reported.AIM To investigate the efficacy of the duodenal microbiota for diagnosing PB Ca.METHODS We recruited 22 patients with benign pancreaticobiliary diseases(benign group)and 12 patients with PB Ca(malignant group).The duodenal microbiota of each patient was analyzed by the 16S rDNA terminal restriction fragment length polymorphism method.Patient characteristics,tumor markers,and relative abundances of the duodenal microbiota were compared between the benign and malignant groups.RESULTS Cancer antigen 19-9(CA19-9),Bifidobacterium,Clostridium cluster XVIII,and Prevotella levels differed significantly between the benign and malignant groups.Clostridium cluster XVIII had the greatest area under the receiver operating characteristic curve(AUC)among the four factors with respect to diagnosing PB Ca(cutoff value:3.038%;sensitivity:58.3%;specificity:95.2%;AUC:0.81).The combination of Clostridium cluster XVIII(cutoff value:3.038%)and CA19-9 Levels(cutoff value:18.8 U/mL)showed 91.7%sensitivity and 71.4%specificity for diagnosing PB Ca.CONCLUSION The duodenal microbiota may be useful for PB Ca screening.展开更多
While hepatitis B virus(HBV)screening relies on hepatitis B surface antigen to confirm HBV infection since the early days of hepatitis B disease management,hepatitis C virus(HCV)infection screening is based on anti-HC...While hepatitis B virus(HBV)screening relies on hepatitis B surface antigen to confirm HBV infection since the early days of hepatitis B disease management,hepatitis C virus(HCV)infection screening is based on anti-HCV testing which does not discriminate active from past infection.Thus to confirm infection HCV RNA testing has been required;recently a HCV core antigen assay became widely commercially available which could serve to confirm infection.That assay is less sensitive than current HCV RNA assays,but as more than 50%of anti-HCV positive persons will be HCV core antigen positive,HCV core antigen testing can be a cost effective and reflex test to confirm HCV infection in anti-HCV positive individuals and will be easier as it can be applied on the same platform.For treatment monitoring,more data need to be generated,but the early data available at present suggest that HCV core antigen may be an alternative to HCV RNA monitoring.With direct antivirals,HCV core antigen could even be superior to HCV RNA testing,as direct antivirals might already prevent virus formation when HCV core antigen is still produced and thereby correlates better with eventual viral clearance.展开更多
BACKGROUND Current diagnosis of hepatitis C virus(HCV)infection requires two sequential steps:testing for anti-HCV followed by HCV RNA PCR to confirm viremia.We have developed a highly sensitive and specific HCV-antig...BACKGROUND Current diagnosis of hepatitis C virus(HCV)infection requires two sequential steps:testing for anti-HCV followed by HCV RNA PCR to confirm viremia.We have developed a highly sensitive and specific HCV-antigens enzyme immunoassay(HCV-Ags EIA)for one-step diagnosis of viremic HCV infection.AIM To assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in human immunodeficiency virus(HIV)-coinfected individuals.METHODS The study blindly tested HCV-Ags EIA for its performance in one-step diagnosing viremic HCV infection in 147 sera:10 without HCV or HIV infection;54 with viremic HCV monoinfection;38 with viremic HCV/HIV coinfection;and 45 with viremic HCV and non-viremic HIV coinfection.RESULTS Upon decoding,it was 100%accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR test.In five sera with HCV infection,HCV RNA was as low as 50-59 IU/mL,and four out of five tested positive for HCV-Ags EIA.Likewise,it was also 100%accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR in 83 sera with HCV and HIV coinfection,regardless if HIV infection was active or not.CONCLUSION The modified HCV-Ags EIA has a lower detection limit equivalent to serum HCV RNA levels of approximately 100 IU/mL.It is highly sensitive and specific in the setting of HIV coinfection,regardless of HIV infection status and CD4 count.These data support the clinical application of the HCV-Ags EIA in one-step diagnosis of HCV infection in HIV-infected individuals.展开更多
Prostate cancer is one of the most common cancers in men. Traditional screening and diagnostic methods include digital rectal examinations （DREs）, biopsies and serum prostate-specific antigen （PSA） tests, with the...Prostate cancer is one of the most common cancers in men. Traditional screening and diagnostic methods include digital rectal examinations （DREs）, biopsies and serum prostate-specific antigen （PSA） tests, with the latter being the more popular. PSA is a biomarker for prostate cancer; however, it is highly sensitive to external factors as well as other prostate diseases. As such, the reliability of of the serum PSA level as a sole screening and diagnostic tool for prostate cancer is controversial. Recently, it has been shown that fasting extremes can affect concentrations of serum chemistry analytes, thus raising the question of whether or not fasting has an effect on the highly sensitive PSA biomarker. Patients testing for serum PSA levels are often concomitantly submitting to other tests that require fasting, subjecting certain patients to a fasting PSA level while others not. The objective of this study was to investigate whether this discrepancy in fasting state translates into an effect on serum PSA levels. Serum PSA levels and fasting time records for 157 276 men who underwent testing at Calgary Laboratory Services （CLS; Calgary, Alberta, Canada） between 01 January 2010 and 31 March 2013 were accessed. Linear regression models of mean PSA levels and fasting times revealed a statistically important relationship at certain fasting times. Applying a dynamic mathematical model to explore the clinical effect of fasting suggests minimal impact on serum PSA result interpretation. Thus, patients can be tested for serum PSA levels regardless of their fasting state.展开更多
Background: A new rapid Immunochromatographic test (ICT) kit (MPT64 TB Ag Kit) for detection of MPT64 Antigen in M. tuberculosis (MTB) isolates used for rapid identification of MTB isolates developed by SD (Standard D...Background: A new rapid Immunochromatographic test (ICT) kit (MPT64 TB Ag Kit) for detection of MPT64 Antigen in M. tuberculosis (MTB) isolates used for rapid identification of MTB isolates developed by SD (Standard Diagnostics) Bio line, South Korea was evaluated. The ICT is a rapid, reliable and cheaper method that can be used instead of conventional biochemical tests for confirming MTB in culture isolates in resource limited laboratories. The study also evaluated the ability of ICT to detect MPT64-Antigen before the micro MGIT could signal positive. Material/Methods: A total of 450 sputum samples of individual patients were used for the study. 152 isolates of Mycobacteria were recovered from solid and liquid media. These strains were tested for the detection of MPT64-antigen. H37Rv strain was served as the positive reference control and also used for early detection of Antigen experiment. Findings: The development of bands on both test and sample region when H37Rv strain was tested were seen (MPT64 antigen positive). When 138 MTB isolates were tested, it showed a similar banding pattern indicating 100% sensitivity. MPT64 band formation was not detected in any of the 14 isolates indicating 100% specificity. Both PPV & NPV were 100%. All the isolates negative for MPT64 Ag were confirmed as MOTT by conventional bio-chemical PNBA. The H37Rv strain showed a faint band from the 2nd day onwards from inoculation till 3rd day in the earlier Antigen detection experiment. Conclusion: Rapid identification of MTB culture isolate is a pressing need for diagnosis and proceeding to perform drug susceptibility testing. MPT64 TB Ag detection ICT kit is a rapid, reliable method, good substitute for molecular identification methods, and conventional biochemical test which is time-consuming and technically demanding. The early detection of Antigen can be used as an effective tool in diagnosis.展开更多
目的:血清游离轻链(free light chain,FLC)在多种疾病中表达异常,但其在肺癌中的表达尚不清楚,本研究旨在探讨血清FLC在肺癌中的表达及诊断价值。方法:选取2021年1至12月湖南师范大学附属湘东医院收治的80例肺癌患者作为肺癌组,另选取...目的:血清游离轻链(free light chain,FLC)在多种疾病中表达异常,但其在肺癌中的表达尚不清楚,本研究旨在探讨血清FLC在肺癌中的表达及诊断价值。方法:选取2021年1至12月湖南师范大学附属湘东医院收治的80例肺癌患者作为肺癌组,另选取同时期的80例健康体检人员作为对照组。收集所有参与者的一般资料、血清κFLC和λFLC水平;收集肺癌组患者住院期间的相关临床指标[血清癌胚抗原(carcinoembryonic antigen,CEA)、细胞角蛋白-19片段抗原(cytokeratin fragment antigen 21-1,CYFRA21-1)水平,以及肿瘤直径、组织学分型、TNM分期、是否有淋巴结转移]。比较肺癌组和对照组血清FLC[κFLC、λFLC、FLC(κ+λ)]的表达水平。将80例肺癌患者按性别、年龄、吸烟史、肿瘤直径、TNM分期、组织学分型、淋巴结转移进行分组,比较组间血清κFLC、λFLC表达水平的差异。采用受试者操作特征(receiver operating characteristic,ROC)曲线评价血清FLC水平单独及联合其他指标在肺癌中的诊断价值。结果:肺癌组血清FLC(κ+λ)、κFLC表达水平均显著高于对照组,差异均有统计学意义(均P<0.001);而2组间血清λFLC表达水平的差异无统计学意义(P>0.05)。不同肿瘤直径、组织学分型、TNM分期的肺癌血清κFLC表达水平差异均无统计学意义(均P>0.05);但是,有淋巴结转移的肺癌患者血清κFLC水平高于无淋巴结转移的肺癌患者,且差异有统计学意义(P=0.033)。不同肿瘤直径、组织学分型肺癌患者的血清λFLC表达水平差异均无统计学意义(均P>0.05);但是,TNM分期III期+IV期、有淋巴结转移的肺癌患者血清λFLC表达水平分别高于TNM分期I期+II期、无淋巴结转移的肺癌患者,差异均有统计学意义(分别P=0.033,P=0.019)。κFLC、CEA诊断肺癌的曲线下面积(area under the curve,AUC)差异无统计学意义(P=0.333)。在2项联合诊断肺癌的指标中,κFLC+CYFRA21-1的诊断效能(AUC=0.875)及敏感性(71.3%)最高。κFLC+λFLC+CEA+CYFRA21-1联合诊断肺癌的AUC为0.915(95%CI 0.860~0.953,P<0.001)。结论:血清FLC在肺癌中高表达,并且与肺癌的浸润和转移有关。血清FLC尤其是κFLC对肺癌的诊断具有价值,FLC、CEA、CYFRA21-1联合检测的诊断效能最佳。展开更多
目的探讨甲状腺癌患者血清糖类抗原242(CA242)在甲状腺癌中的临床应用价值,为甲状腺癌的诊疗提供参考。方法筛选141例分化型甲状腺癌患者(甲状腺癌组)、82例甲状腺结节患者(甲状腺结节组)作为研究对象,24例健康查体者作为对照组,应用康...目的探讨甲状腺癌患者血清糖类抗原242(CA242)在甲状腺癌中的临床应用价值,为甲状腺癌的诊疗提供参考。方法筛选141例分化型甲状腺癌患者(甲状腺癌组)、82例甲状腺结节患者(甲状腺结节组)作为研究对象,24例健康查体者作为对照组,应用康乃格试剂采用ELISA方法检测各组CA242,比较各组受试者间的血清CA242水平,分析血清CA242对甲状腺癌诊断的特异性、灵敏度、阳性预测值、阴性预测值,并绘制受试者工作特征曲线(receiver operating characteristic curve,ROC),分析CA242的临床价值。结果甲状腺癌组血清CA242水平高于甲状腺结节组和健康对照组,差异具有统计学意义(P<0.05)。CA242对甲状腺癌诊断的灵敏度为29.8%、特异性为92.7%、阳性预测值87.5%、阴性预测值为43.4%,ROC曲线结果显示,曲线下面积(area under the curve,AUC)为0.626,差异具有统计学意义(P<0.05)。随访中,2例CA242升高的甲状腺结节患者经组织细胞学检查确诊为甲状腺癌。结论对于甲状腺结节患者,B超检查为主要手段,同时结合血CA242检测作为补充,可助于甲状腺癌的诊断。展开更多
文摘1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.
文摘Reports manifest a continuing need for the development of rapid and on-site (point of care) assays. Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations. Scientists at Micro Detect, Inc. have developed an innovative diagnostic device (method) that can be utilized broadly for antibody/antigen interactions including diagnostic assays in the medical, veterinary and food industries. The developed device can be utilized for the detection of antibodies against a single antigen or vice versa. It can also be tailored for specific panels that detect antigens or antibodies for diverse infectious agents, proteins, hormones, tumor markers, autoimmune markers, and allergens. Additionally, it can also be used for detection of toxins, antitoxins, nucleic acids, enzymes, drugs, etc. in both humans and animals. Specimens used in different formats of the device can be tears, saliva, whole blood, serum, plasma, urine, stool, and other bodily discharges. The good intra and inter precisions and acceptable linearity of the device support reliable use of the device. The CV of the device is 1.9% - 2.2%. Likewise, the performance of the device using 92 confirmed negative and positive specimens via a typical assay showed 100% sensitivity, 80% specificity, 96.8% efficacy, 80% positive predictive value, and 100% negative predictive value. The results of our feasibility study suggest reliable utility of a device for rapid, easy-to-use, inexpensive, and on-site (point of care) diagnostic assays. This presents a potential breakthrough in diagnostic methodologies that can be integrated into modern medicine and food industries.
文摘The comparative studies of diagnostic efficiency of excretory-secretory antigens of Trichinella spiralis and Trichinella nativa were performed using blood sera of rats from Wistar line experimentally infected with Arctic trichinellae. For animal infection and antigen preparation Trichinella from muscles of wild carnivorous mammals from Arctic regions of Russia were used. When antigen from T. nativa larvae was used to analyze titers of sera of rats experimentally infected with Arctic Trichinella, a significant increase in efficacy ofELISAwas detected. E.g., sera of rats infected with trichinellae from ringed seals retained in ELISA with T. nativa antigen values higher than diagnostic level at titers of 1:6400 - 1:12800, while titer of those same sera when using T. spiralis antigen was no higher than 1:200 - 1:400.
文摘Serum pancreatic tissue carcinoma antigen (PCA) was measured by ELISA in 396 patients with pancreatic carcinoma (PC) and other diseases diagnosed by clinical examination, histopathology and operation. Serum PCA more than 300 U/ml was considered as diagnostic value for PC and 30-299 U/ml as probable index for PC. The sensitivity of PCA for PC was 78.2% (43/55), and the specifity 94.6%. The positive rate of PCA in other diseases were 0-13.3%. Combining the determination of PCA with B-mode ultrasonic scanning (BU). CT and/or ERCP (endos-copic retrograde cholangiopancreatography) may increase the diagnostic rate of PC to 89-91%, and with the "cocktail" of CA19-9, CEA (carcino-embryonic antigen) and RNase-C, PC be diagnosed in 88.9%. Therefore, it is suggest that PCA si a promising tumor market of PC with high sensitivity and relative specificity.
文摘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.
基金This study was approved by the Institutional Review Board of Fukushima Medical University(Approval No.2451).
文摘BACKGROUND Pancreaticobiliary cancer(PB Ca)is a lethal disease,and a useful diagnostic marker is urgently needed.A correlation between the human microbiota and malignant gastrointestinal diseases was recently reported.AIM To investigate the efficacy of the duodenal microbiota for diagnosing PB Ca.METHODS We recruited 22 patients with benign pancreaticobiliary diseases(benign group)and 12 patients with PB Ca(malignant group).The duodenal microbiota of each patient was analyzed by the 16S rDNA terminal restriction fragment length polymorphism method.Patient characteristics,tumor markers,and relative abundances of the duodenal microbiota were compared between the benign and malignant groups.RESULTS Cancer antigen 19-9(CA19-9),Bifidobacterium,Clostridium cluster XVIII,and Prevotella levels differed significantly between the benign and malignant groups.Clostridium cluster XVIII had the greatest area under the receiver operating characteristic curve(AUC)among the four factors with respect to diagnosing PB Ca(cutoff value:3.038%;sensitivity:58.3%;specificity:95.2%;AUC:0.81).The combination of Clostridium cluster XVIII(cutoff value:3.038%)and CA19-9 Levels(cutoff value:18.8 U/mL)showed 91.7%sensitivity and 71.4%specificity for diagnosing PB Ca.CONCLUSION The duodenal microbiota may be useful for PB Ca screening.
文摘While hepatitis B virus(HBV)screening relies on hepatitis B surface antigen to confirm HBV infection since the early days of hepatitis B disease management,hepatitis C virus(HCV)infection screening is based on anti-HCV testing which does not discriminate active from past infection.Thus to confirm infection HCV RNA testing has been required;recently a HCV core antigen assay became widely commercially available which could serve to confirm infection.That assay is less sensitive than current HCV RNA assays,but as more than 50%of anti-HCV positive persons will be HCV core antigen positive,HCV core antigen testing can be a cost effective and reflex test to confirm HCV infection in anti-HCV positive individuals and will be easier as it can be applied on the same platform.For treatment monitoring,more data need to be generated,but the early data available at present suggest that HCV core antigen may be an alternative to HCV RNA monitoring.With direct antivirals,HCV core antigen could even be superior to HCV RNA testing,as direct antivirals might already prevent virus formation when HCV core antigen is still produced and thereby correlates better with eventual viral clearance.
文摘BACKGROUND Current diagnosis of hepatitis C virus(HCV)infection requires two sequential steps:testing for anti-HCV followed by HCV RNA PCR to confirm viremia.We have developed a highly sensitive and specific HCV-antigens enzyme immunoassay(HCV-Ags EIA)for one-step diagnosis of viremic HCV infection.AIM To assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in human immunodeficiency virus(HIV)-coinfected individuals.METHODS The study blindly tested HCV-Ags EIA for its performance in one-step diagnosing viremic HCV infection in 147 sera:10 without HCV or HIV infection;54 with viremic HCV monoinfection;38 with viremic HCV/HIV coinfection;and 45 with viremic HCV and non-viremic HIV coinfection.RESULTS Upon decoding,it was 100%accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR test.In five sera with HCV infection,HCV RNA was as low as 50-59 IU/mL,and four out of five tested positive for HCV-Ags EIA.Likewise,it was also 100%accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR in 83 sera with HCV and HIV coinfection,regardless if HIV infection was active or not.CONCLUSION The modified HCV-Ags EIA has a lower detection limit equivalent to serum HCV RNA levels of approximately 100 IU/mL.It is highly sensitive and specific in the setting of HIV coinfection,regardless of HIV infection status and CD4 count.These data support the clinical application of the HCV-Ags EIA in one-step diagnosis of HCV infection in HIV-infected individuals.
文摘Prostate cancer is one of the most common cancers in men. Traditional screening and diagnostic methods include digital rectal examinations （DREs）, biopsies and serum prostate-specific antigen （PSA） tests, with the latter being the more popular. PSA is a biomarker for prostate cancer; however, it is highly sensitive to external factors as well as other prostate diseases. As such, the reliability of of the serum PSA level as a sole screening and diagnostic tool for prostate cancer is controversial. Recently, it has been shown that fasting extremes can affect concentrations of serum chemistry analytes, thus raising the question of whether or not fasting has an effect on the highly sensitive PSA biomarker. Patients testing for serum PSA levels are often concomitantly submitting to other tests that require fasting, subjecting certain patients to a fasting PSA level while others not. The objective of this study was to investigate whether this discrepancy in fasting state translates into an effect on serum PSA levels. Serum PSA levels and fasting time records for 157 276 men who underwent testing at Calgary Laboratory Services （CLS; Calgary, Alberta, Canada） between 01 January 2010 and 31 March 2013 were accessed. Linear regression models of mean PSA levels and fasting times revealed a statistically important relationship at certain fasting times. Applying a dynamic mathematical model to explore the clinical effect of fasting suggests minimal impact on serum PSA result interpretation. Thus, patients can be tested for serum PSA levels regardless of their fasting state.
文摘Background: A new rapid Immunochromatographic test (ICT) kit (MPT64 TB Ag Kit) for detection of MPT64 Antigen in M. tuberculosis (MTB) isolates used for rapid identification of MTB isolates developed by SD (Standard Diagnostics) Bio line, South Korea was evaluated. The ICT is a rapid, reliable and cheaper method that can be used instead of conventional biochemical tests for confirming MTB in culture isolates in resource limited laboratories. The study also evaluated the ability of ICT to detect MPT64-Antigen before the micro MGIT could signal positive. Material/Methods: A total of 450 sputum samples of individual patients were used for the study. 152 isolates of Mycobacteria were recovered from solid and liquid media. These strains were tested for the detection of MPT64-antigen. H37Rv strain was served as the positive reference control and also used for early detection of Antigen experiment. Findings: The development of bands on both test and sample region when H37Rv strain was tested were seen (MPT64 antigen positive). When 138 MTB isolates were tested, it showed a similar banding pattern indicating 100% sensitivity. MPT64 band formation was not detected in any of the 14 isolates indicating 100% specificity. Both PPV & NPV were 100%. All the isolates negative for MPT64 Ag were confirmed as MOTT by conventional bio-chemical PNBA. The H37Rv strain showed a faint band from the 2nd day onwards from inoculation till 3rd day in the earlier Antigen detection experiment. Conclusion: Rapid identification of MTB culture isolate is a pressing need for diagnosis and proceeding to perform drug susceptibility testing. MPT64 TB Ag detection ICT kit is a rapid, reliable method, good substitute for molecular identification methods, and conventional biochemical test which is time-consuming and technically demanding. The early detection of Antigen can be used as an effective tool in diagnosis.
文摘目的:血清游离轻链(free light chain,FLC)在多种疾病中表达异常,但其在肺癌中的表达尚不清楚,本研究旨在探讨血清FLC在肺癌中的表达及诊断价值。方法:选取2021年1至12月湖南师范大学附属湘东医院收治的80例肺癌患者作为肺癌组,另选取同时期的80例健康体检人员作为对照组。收集所有参与者的一般资料、血清κFLC和λFLC水平;收集肺癌组患者住院期间的相关临床指标[血清癌胚抗原(carcinoembryonic antigen,CEA)、细胞角蛋白-19片段抗原(cytokeratin fragment antigen 21-1,CYFRA21-1)水平,以及肿瘤直径、组织学分型、TNM分期、是否有淋巴结转移]。比较肺癌组和对照组血清FLC[κFLC、λFLC、FLC(κ+λ)]的表达水平。将80例肺癌患者按性别、年龄、吸烟史、肿瘤直径、TNM分期、组织学分型、淋巴结转移进行分组,比较组间血清κFLC、λFLC表达水平的差异。采用受试者操作特征(receiver operating characteristic,ROC)曲线评价血清FLC水平单独及联合其他指标在肺癌中的诊断价值。结果:肺癌组血清FLC(κ+λ)、κFLC表达水平均显著高于对照组,差异均有统计学意义(均P<0.001);而2组间血清λFLC表达水平的差异无统计学意义(P>0.05)。不同肿瘤直径、组织学分型、TNM分期的肺癌血清κFLC表达水平差异均无统计学意义(均P>0.05);但是,有淋巴结转移的肺癌患者血清κFLC水平高于无淋巴结转移的肺癌患者,且差异有统计学意义(P=0.033)。不同肿瘤直径、组织学分型肺癌患者的血清λFLC表达水平差异均无统计学意义(均P>0.05);但是,TNM分期III期+IV期、有淋巴结转移的肺癌患者血清λFLC表达水平分别高于TNM分期I期+II期、无淋巴结转移的肺癌患者,差异均有统计学意义(分别P=0.033,P=0.019)。κFLC、CEA诊断肺癌的曲线下面积(area under the curve,AUC)差异无统计学意义(P=0.333)。在2项联合诊断肺癌的指标中,κFLC+CYFRA21-1的诊断效能(AUC=0.875)及敏感性(71.3%)最高。κFLC+λFLC+CEA+CYFRA21-1联合诊断肺癌的AUC为0.915(95%CI 0.860~0.953,P<0.001)。结论:血清FLC在肺癌中高表达,并且与肺癌的浸润和转移有关。血清FLC尤其是κFLC对肺癌的诊断具有价值,FLC、CEA、CYFRA21-1联合检测的诊断效能最佳。
文摘目的探讨甲状腺癌患者血清糖类抗原242(CA242)在甲状腺癌中的临床应用价值,为甲状腺癌的诊疗提供参考。方法筛选141例分化型甲状腺癌患者(甲状腺癌组)、82例甲状腺结节患者(甲状腺结节组)作为研究对象,24例健康查体者作为对照组,应用康乃格试剂采用ELISA方法检测各组CA242,比较各组受试者间的血清CA242水平,分析血清CA242对甲状腺癌诊断的特异性、灵敏度、阳性预测值、阴性预测值,并绘制受试者工作特征曲线(receiver operating characteristic curve,ROC),分析CA242的临床价值。结果甲状腺癌组血清CA242水平高于甲状腺结节组和健康对照组,差异具有统计学意义(P<0.05)。CA242对甲状腺癌诊断的灵敏度为29.8%、特异性为92.7%、阳性预测值87.5%、阴性预测值为43.4%,ROC曲线结果显示,曲线下面积(area under the curve,AUC)为0.626,差异具有统计学意义(P<0.05)。随访中,2例CA242升高的甲状腺结节患者经组织细胞学检查确诊为甲状腺癌。结论对于甲状腺结节患者,B超检查为主要手段,同时结合血CA242检测作为补充,可助于甲状腺癌的诊断。
