2种检测人肾综合征出血热IgG抗体ELISA试剂盒的比较

目的 探讨国产与进口人肾综合征出血热(hemorrhagic fever with renal syndrome, HFRS)IgG抗体ELISA检测试剂盒的性能差异. 方法 采用国产和进口ELISA试剂盒分别检测50例HFRS疫苗接种者血清样本中抗人HFRS IgG抗体含量,分析比较2种ELISA试剂盒的一致性、灵敏性、精密度以及方法学等的差异. 结果 2种ELISA试剂盒的精密度良好,批内变异系数均<5%;2种试剂阳性一致率为100%,阴性一致率为20%,相似率为60%;灵敏性检测结果显示,2种ELISA试剂盒的灵敏性差异较大(P<0.05),国产ELISA试剂盒的灵敏度约是进口ELISA试剂盒的5倍. 结论 国产人HFRS IgG抗体ELISA检测试剂盒灵敏性好,进口ELISA试剂盒特异性好,国产和进口ELISA试剂盒的精密度均良好,在实际应用中应根据具体情况合理选用.     

三种ELISA试剂盒检测猪流行性乙型脑炎病毒血清IgG抗体比较

目的 比较国内常用商品化ELISA试剂盒检测猪流行性乙型脑炎病毒血清IgG抗体的诊断效果。方法 选用3种猪乙脑病毒血清IgG抗体ELISA检测试剂盒(Keqian,Lvshiyuan,Tianchen),以微量中和试验为金标准,对90份猪血清进行检测分析。结果 中和试验的阳性检出率为34.4%(31/90),Keqian,Lvshiyuan和Tianchen阳性检出率分别为50.0%(45/90), 47.8%(43/90)和 38.9%(35/90)。灵敏度最高的是Keqian,为90.32%,但其特异度只有71.19%;Tianchen的灵敏度和特异度分别为83.87%和79.66%;Lvshiyuan的灵敏度和特异度分别仅为41.94%和16.95%。与中和试验比较,Tianchen试剂盒的κ系数最高为0.63,其次是Keqian为0.57,Lvshiyuan仅为0.04。显示3种试剂盒具稳定性。结论 目前国内商品化猪乙脑病毒血清IgG抗体ELISA检测试剂盒诊断结果差异较大,与中和试验相比存在较高的假阴性,质量有待提高。     

2种棘球绦虫IgG抗体检测试剂盒应用效果比较

目的 观察不同厂家生产的2种棘球绦虫IgG抗体检测试剂盒的检测效果。 方法 采用2种不同厂家生产的棘 球绦虫IgG抗体检测试剂盒检测相同数量的棘球蚴病人、 正常人血清, 以及卫氏并殖吸虫、 华支睾吸虫、 日本血吸虫和猪囊 尾蚴病人血清, 统计2种方法的特异性、 敏感性和交叉反应性。 结果 2个厂家生产的棘球绦虫IgG抗体检测试剂盒的特 异性和敏感性均为100％。深圳康百得公司生产的试剂盒与卫氏并殖吸虫病、 华支睾吸虫病、 日本血吸虫病和猪囊尾蚴病 的交叉反应率分别为25.00％、 26.09％、 10.00％和87.50％; 珠海海泰公司生产的试剂盒的交叉反应率分别为5.00％、 13.04％、 20.00％和93.75％。2种试剂盒间, 卫氏并殖吸虫病检出率差异有统计学意义 （P ＜ 0.05）, 其他检出率差异均无统 计学意义 （P均 ＞ 0.05）。结论 2个厂家生产的棘球绦虫IgG抗体检测试剂盒均具有敏感性高、 特异性强、 简便快速等优 点; 但需进一步解决与其他寄生虫病的交叉反应问题, 以提高早期诊断的准确性。     

The ability of two commercially available quick test kits to detect drug-facilitated sexual assault drugs in beverages

AIMS: Assessment of the sensitivity and specificity of two commercially available 'drug-facilitated sexual assault' drug detector kits, Drink Guard and Drink Detective. DESIGN: Experimental. SETTING: Laboratory. MEASUREMENTS: Gamma hydroxybutyrate (GHB) sodium salt, ketamine hydrochloride, temazepam, flunitrazepam and diazepam were dissolved (Tween added to benzodiazepine solutions) as separate stock solutions and added to 330 ml samples of cola (Pepsi Max), beer (Stella Artois), 'alcopop' (Bacardi Breezer) and placebo (distilled water). The doses used are reported to be common in cases of intoxication. Each kit was tested 10 times for each drink/drug combination. Two blind, independent observers scored each test (presence/absence of drug) in accordance with kit instructions; chi 2 was used to compare the proportion of times raters scored tests correctly and incorrectly. Sensitivity and specificity were calculated overall, for each drink, and sensitivity was calculated for each drug. Inter-observer agreement was evaluated using the kappa statistic. FINDINGS: While both raters were able to score significantly more tests correctly than incorrectly using Drink Detective, and one rater scored similarly using Drink Guard, the overall sensitivity of Drink Detective and Drink Guard was 69.0% (95% CI 64.2-73.5%) and 37.5% (95% CI 30.1-45.5%), respectively. Sensitivity was drink-dependent. Drink Detective was unable to detect our dose of GHB in water, with all tests scored negatively by both raters for this drink/drug combination (n = 20 negative scores). Overall, specificity was 76.6% (95% CI 71.5-81.0%) and 87.9% (95% CI 83.0-91.6%) for Drink Guard and Drink Detective, respectively, but was affected by the beverage. Inter-rater agreement was poor for Drink Guard (kappa = 0.278 +/- 0.069) but excellent for Drink Detective (kappa = 0.894 +/- 0.245). Inter-observer agreement was drug-dependent. CONCLUSIONS: Use of drug detector kits by the public in the night-time environment needs further investigation and may create a false sense of security (false negatives) and undue concern (false positives) among kit users.     

6种艾滋病病毒抗体初筛试剂质量评估

目的评估国内现行使用的部分HIV抗体ELISA试剂质量.方法 5种国产HIV-1/2 ELISA试剂用200份血清样品(其中已知结果血清和未知结果血清各100份)、进口试剂Vironostika(R)HIV Uni-FormⅡ plusO用其中未知结果的100份血清分别进行对比测试,初筛阳性和可疑血清用蛋白印迹(WB)确认.结果 6种试剂的敏感性、功效率和NPV值范围为90.14%～100%、96.5%～100%和94.85%～100%;其中4种试剂的特异性和PPV值均为100%,测试中未发现假阳性;另2种试剂特异性均为97.67%,假阳性率均为2.33%,PPV值分别为95.89 %和95.71%;除进口试剂Vironostika外,5种国产试剂均存在不同程度的HIV抗体阳性漏检,其漏检率分别为9.86%、4.23%、1.41%、7.04%、5.63%.结论 6种被评估试剂中,试剂Vironostika质量居第一,试剂B次之,余4种再次之.     

7种单纯疱疹病毒Ⅱ型IgG抗体检测试剂盒的比较

目的比较7种单纯疱疹病毒Ⅱ型(HSV-2)特异性IgG抗体检测试剂盒的优劣。方法对来自体检和性病门诊的生殖器疱疹可疑者的189份血清,同时用3种进口试剂盒(A、B、C)和4种国产试剂盒(D、E、F、G)进行检测。结果以"扩大金标准"为判断标准,7种检测试剂盒的敏感性:A、B、C分别为94.6%、100%、100%,D、E、F、G分别为98.5%、93.9%、96.9%、30.8%;特异性:A～G分别为98.2%、96.4%、96.4%、9.1%、43.6%、18.2%、100%;受试者工作特性曲线(ROC)下面积:A～G分别为0.964(0.933～0.995)、0.982(0.953～1.011)、0.982(0.953～1.011)、0.529(0.434～0.623)、0.664(0.567～0.761)、0.517(0.416～0.618)、0.654(0.576～0.732)。结论三种进口试剂盒检测结果可信度高,可用于临床实验室的辅助诊断、流行病学调查等。     

Validation of ELISA test kits for detection of beta-agonist residues in meat

Three ELISA test kits, the Randox ELISA beta-agonist test kit, Euro-Diagnostica test kit, and Ridascreen beta-agonist test kit, were evaluated for screening of meat and liver for beta-agonist residues in fortified and field-incurred samples. It was found that the Randox beta-agonist test kit was more suitable as a screening tool due to its accuracy, ease of use, and lower cost. The tests were able to detect beta-agonist residues at the minimum level of detection, as claimed by the suppliers. The performance of the method as assessed through recovery rates of beta-agonists in fortified samples was satisfactory with a low coefficient of variation (1-3%). Repeatability, as measured through the coefficient of correlation was also satisfactory. For field-incurred positive samples, the test kit showed a sensitivity of 100% and a low rate of false positives for goat and cow tissues. However, a high rate of apparent false positives was obtained for tissues of swine.     

检测两种猪源链球菌抗体间接ELISA方法的筛选与应用

目的建立检测马链球菌兽疫亚种（Streptococcus equi subsp zooepidemius，Sez）与猪链球菌2型（Streptococcus suis type2，Ss2）抗体的间接ELISA方法。方法选用Sez与Ss2的全菌（WAC）、超声波抗原（UA）、英膜多糖（capsular polysaccharide，CPS）作为抗原，筛选最优的检测两种抗体间接ELISA方法。结果3种抗原检测60份免疫后的血清表明，Sez与Ss2的CPS抗体阳性率分别为98．3％、96．7％，WAC为91．7％、85％，UA均为88．3％，前者与后两者差异显著（P〈0．05）。检测免疫前50份血清、免疫后156份血清、60份临床采集血样表明，10％猪免疫前呈现Sez与Ss2的CPS抗体阳性；免疫后CPS抗体阳性率均在90％以上，此结果与免疫保护率相一致；苏州与常州两个猪场的血清各30份，CPS抗体阳性率均在6．7％左右。结论CPS-ELISA方法具有较好的稳定性、特异性、灵敏性，此方法在诊断和流行病学调查方面有价值。     

Isolation of Coxiella burnetii from human sources

A total of 153 human milk samples were subjected to Capillary Agglutination Test (CAT) for determination of C. burnetii antibodies using phase-I CAT antigen and 22 (14.37%) samples were found to be positive. Twenty two CAT positive milk samples were further processed for the isolation of C. burnetii. Of seven samples positive in first screening, only four revealed presence of C. burnetii by giving specific seroconversion in guineapigs. Similarly, 16 aborted placentas were processed for C. burnetii and three yielded morphological evidence for rickettsial bodies on first screening. However, only one of three samples positive in first screening showed presence of C. burnetii in aborted placentas by specific seroconversion in guineapigs. Isolation of C. burnetii from aborted human placenta is the first report from India.     

Recombinant AgB8/1 ELISA test vs. commercially available IgG ELISA test in the diagnosis of cystic echinococcosis

The diagnosis and clinical management of cystic echinococcosis (CE) rely on imaging and serology, the latter still having a complementary role as its accuracy in assessing cyst viability is unsatisfactory. We used an experimental IgG ELISA test based on the recombinant antigen rEgAgB8/1 cloned from Echinococcus granulosus to differentiate active from inactive/cured CE infection, comparing its performance to that of a commercially available ELISA test used routinely in our hospital laboratory. Both tests were performed on sera from 88 patients with hepatic echinococcal cysts, grouped according to cyst stage based on ultrasonographical morphology, and on 17 patients surgically treated for echinococcosis and 18 patients with nonparasitic hepatic cysts included as controls. Tests’ performances did not differ significantly, but the overall concordance between tests drastically dropped when groups were analysed separately. Further longitudinal studies should evaluate whether these discrepancies reflect the different ability of either test to predict the evolution of cysts over time. Although the recombinant‐AgB8/1‐based ELISA test seems to have no clinical advantage over the commercially available ELISA test in the assessment of hepatic CE cyst viability, the easiness of production and reproducibility of high‐quality recombinant antigens makes rEgAgB8/1 a valid candidate for use in CE ELISA diagnostic tests.     

国产与进口弓形虫IgG抗体酶免检测试剂盒检测结果比较

目前,我国弓形虫ELISA试剂盒厂家多,产品质量参差不齐,其结果的真实性、可靠性等质量问题已引起许多学者的普遍关注。进口弓形虫ELISA试剂盒虽然灵敏度、特异度均较高,但价格高昂,应用受到局限。因此,对国产弓形虫ELISA试剂盒的质量进行客观的评价,使厂商和用户都能了解目前国内试剂盒质量的现状及实用价值,目的是推     

Comparison of the sensitive screening kit with two ELISA sets for detection of anti-Toxocara antibodies

Three serological tests (ELISA NOVUM, ELISA PU and ToxocaraCHEK) were compared using excretory-secretory (ES) antigen of second stage larvae of Toxocara canis on two sets of sera from patients aged 1-15 years, living in town and in the country, suspected of having larval toxocarosis. Of 60 serum samples examined for the presence of anti-Toxocara IgM and IgG antibodies 35 (58.3%) were positive with ELISA NOVUM, 30 (50.0%) with ELISA PU and 37 (61.6%) with ToxocaraCHEK. A significantly higher seropositivity with all the tests was detected in group of patients from the village (test chi2, p < 0.005) when compared with patients from the town. The highest sensitivity (100%) was detected for a rapid qualitative ToxocaraCHEK. Compared with this screening test, both ELISA sets showed higher specificity but a lower sensitivity. Consistent findings (+;-) with ELISA NOVUM and ELISA PU were 88.3%; ELISA NOVUM and ToxocaraCHEK 96.7% and ELISA PU and ToxocaraCHEK 86.7%. This comparison indicates the suitability of ToxocaraCHEK set for screening for its simplicity and rapidity in detecting anti-Toxocara antibodies.