SERODIAGNOSIS OF CLONORCHIASIS BY ENZYME—LINKED IMMUNOSORBENT ASSAY WITH HRP—SPA

In thes paper the authors used the Horseradish peroxidase labelledstaphylococcal protein A(HRP—SPA)in ELISA,for the detection of Clo-norchis sinensis infection.Serum tests were made on 116 confirmed cases ofclonorchiasis,103(88.8%)of them showed positive,while only 6(4.4%)werepositive among 138 healthy people.Samples were collected on filter paperstrips,111(95.7%)cases were positive among 116 comfirmed cases tested,but only 2(1.5%)were positive out of 138 healthy persons.The resultswere similar to those obtained by sheep antihuman IgG.Animal experimentalso showed that the SPA—ELISA can be used for the diagnosis ofclonorchiasis.In an endemic area,stool egg positive rate was 8.8%(62/703).whenchecked with SPA—ELISA,the rate of conformity in both filter paperstrips and stool examinations was 90.3(56/62).Among 641 serum testsfrom individuals negative in stool examinations,only 35(5.5%)reactedpositively.The authors suggested—that SPA—ELISA with soluble Clo-norchis antigens could be used in a large scale seroepidemiological surveyin endemic areas.

Comparison of chemiluminescence enzyme immunoassay based on magnetic microparticles with traditional colorimetric ELISA for the detection of serum α-fetoprotein

A chemiluminescence enzyme immunoassay based on magnetic microparticles (MmPs-CLEIA) was developed to evaluate serum a-fetoprotein (AFP) in parallel with traditional colorimetric enzyme-linked immunosorbent assay (ELISA).A systematic comparison between the MmPs-CLEIA and colorimetric ELISA concluded that the MPs-CLEIA exhibited fewer dosages of immunoreagents,less total assay time,and better linearity,recovery,precision,sensitivity and validity.AFP was detected in forty human serum samples by the proposed MPs-CLEIA and ELISA,and the results were compared with commercial electrochemiluminescence immunoassay (ECLIA) kit.The correlation coefficient between MPs-CLEIA and ELISA was obtained with R 2 0.6703;however,the correlation between MPs-CLEIA and ECLIA (R 2 0.9582) was obviously better than that between colorimetric ELISA and ECLIA (R 2 0.6866).

Serological diagnosis of nasopharyngeal carcinoma by enzyme linked immunosorbant assay:optimization,standardization and diagnostic criteria

Objectives To produce an enzyme linked immunosorbant assay (ELISA) to detect antibodies against Epstein Barr virus (EBV) specified nuclear antigen 1 (EBNA 1) and the 18kD EBV matrix protein, and to determine and optimize its sensitivity and specificity for the diagnosis of nasopharyngeal carcinoma (NPC).Methods We used a combination of highly purified glutathione transferase fusion proteins of the 40kD carboxy domain of EBNA1 and the 18kD EBV matrix protein for coating ELISA plates. In three separate studies, we tested for IgA antibodies in serum specimens from 28 EBV seronegative donors, 284 EBV seropositive donors and 160 newly diagnosed NPC patients. By comparing the sensitivity and specificity of diagnosis obtained for different cutoff values, we derived several quantitative parameters to evaluate assay performance, establish objective diagnostic criteria which optimize the intrinsic diagnostic capability of the assay and assess the significance of individual test results, respectively. Optimum cutoff optical density (OD) is defined as the cutoff OD where sensitivity of the assay equals its specificity, and resolution of the assay is indicated by the value of sensitivity (or specificity) determined at the optimum cutoff OD. Diagnosis of NPC was achieved by setting a cutoff zone at +/-20% of this value.Results All the EBV seronegative donors tested were not reactive, and most of the EBV seropositive donors were weakly reactive, while the majority of NPC patients were moderately or strongly reactive. While the assay was thus shown to be specific for EBV, there was an overlap in the level of these serum antibodies between few individuals of the two latter groups. It was shown that the assay performed equally well in two separate studies conducted under different testing conditions and using different collections of sera in that assay resolution determined on these occasions were 86% and 87% respectively. Diagnosis of NPC can be achieved at the same expected sensitivity of 89% and 83% determined at the lower and upper limits of the cutoff zones, with the corresponding values of specificity being 78% and 91%. It was further shown in the third study that resolution of the assay can be increased to 90% using an assay produced with a higher concentration of the same antigens, and that diagnosis of NPC can be achieved at a higher sensitivity ranging between 86% and 95% at a corresponding specificity of 93% and 86%.Conclusions After optimization and standardization, the ELISA can achieve a sensitivity ranging from 86% to 95%, with corresponding specificities of 93% and 86% respectively for the diagnosis of NPC.

Concerns arise: wheat allergy risk in pre-packaged food products from China

Understanding and monitoring the cross-contamination of food allergens is crucial for safeguarding public health and ensuring food safety.Food allergen risk assessment,derived from classical toxicological principles,can identify and quantify the risk of allergies.This study aimed to investigate the risk of wheat allergic reactions to prepackaged foods from China through the utilization of food allergen risk assessment.A total of 575 products have been surveyed,wheat/gluten,milk and egg were major allergens labelled on products.According to voluntary incidental trace allergen labelling 3.0(VITAL®3.0)program,the number of products belonged to Action Level 2 were 303.Integration of precautionary allergen labeling(PAL)analysis indicated that 9.57%products would pose a potential risk to wheat allergic individuals.The probabilistic risk assessment results suggest that 7984 allergic reactions may arise among wheat-allergic consumers during 10000 eating occasions due to the consumption of pre-packaged food products with incorrect wheat-related allergen labelling.This study demonstrated that a risk assessment-based approach can support the guidance of allergen labelling and management of food allergen for pre-packaged food products,providing protection for allergic individuals in food consumption and for food manufacturers in food production and trade.

A clinical evaluation of serum concentrations of intercellular adhesion molecule-1 in patients with gastric cancer

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Development and evaluation of immunoassay for zeranol in bovine urine

A high affinity polyclonal antibody-based enzyme linked immunosorbent assay （ELISA） was developed for the quantification of zeranol in bovine urine. On the basis of urine matrix studies, the optimized dilution factors producing insignificant matrix interference were selected as 1：5 in pretreatment. In the improved ELISA, the linear response range was between 0.02 and 1 μg/ml, and the detection limit was 0.02 μg/ml for the assay. The overall recoveries and the coefficients of variation （CVs） were in the range of 82%-127% and 3.5%-8.8%, respectively. Thirty-six bovine urine samples spiked with zeranol （ranging from 0.2 to 10 μg/ml） were detected by the ELISA and liquid chromatography （LC） method, and good correlations were obtained between the two methods （R^2=0.9643）. We conclude that this improved ELISA is suitable tool for a mass zeranol screening and can be an altemative for the conventional LC method for zeranol in bovine urine.

Association of Preoperative Serum IGF-Ⅰ Concentration with Clinicopathological Parameters in Patients with Non-Small Cell Lung Cancer

Insulin-like growth factor- I （IGF- I ） is a mitogenic and anti-apoptotic factor. Serum IGF-I concentration is related to some cancer risk and tumor progression. The aim of this research was to study the association of preoperative serum IGF- I concentration with clinicopathological parameters and prognosis of non-small cell lung cancer （NSCLC）. Preoperative serum IGF- I concentration was measured in 80 consecutive patients with NSCLC who underwent radical lung cancer resection, and 45 patients with benign pulmonary lesion （BPL） by Using enzyme linked immunosorbent assay （ELISA）. The results showed that the serum IGF- I concentration was elevated and correlated with clinicopa- thological parameters and overall survival （OS） in NSCLC patients. Serum IGF- I concentration was significantly higher in patients with NSCLC tfian in those with BPL. The IGF- I concentrations were significantly higher in NSCLC patients with 〉T2, NI-3, and in IIIA-IV but not in those with 〈T2, NO, or I A- IIB. The increased serum IGF- I concentration was significantly correlated with poor prog- nosis. Our data show the positive correlation between IGF-I serum concentration and the tumor size for the first time. It seems that IGF-I related to the progression of lung cancer may depend on autocrine/paracrine function. In addition, our study reveals that higher serum IGF- I concentration is correlated with larger tumor size, advanced stages, local lymph node metastasis and worse prognosis, indicating that endocrine IGF- I is also important for the progression for NSCLC.

DETERMINATION OF SERUM SOLUBLE MACROPHAGE COLONY-STIMULATING FACTOR RECEPTOR LEVELS IN PATIENTS WITH HEMATOLOGICAL DISEASES

Objective: To investigate the serum levels of soluble macrophage colony-stimulating factor receptor (M-CSFsR) in normal subjects and patients with hematological diseases and its clinical implications in hematological diseases. Methods: The concentration of M-CSFsR was determined by ELISA. The serum M-CSFsR was identified and characterized by immunoprecipitation and Western blotting. Results: The mean serum level of M-CSFsR of 123 normal individuals was 0.48 ng/ml ± 0.41 ng/ml. Immunoprecipitation and Western blotting assay revealed a ～ 90kD band of serum M-CSFsR. The mean serum M-CSFsR level of 60 patients with acute lymphoblastic leukemia (ALL), 36 patients with acute myeloblastic leukemia (AML), 13 patients with myelodysplastic syndrome (MDS) and 42 patients with aplastic anemia (AA) .were 0.22 ng/ml±0.23 ng/ml, 0.17 ng/ml±0.16 ng/ml, 0.19 ng/ml±0.16 ng/ml and 0.23 ng/ml±0.21 ng/ml, respectively, which were significantly lower than that of normal subjects (P=0.002 ,P<0.0001,P<0.0001 andP<0.0001). The mean serum M-CSFsR level of 51 idiopathic thrombocytopenic purpura (ITP) patients was significantly higher than that of normal subjects (2.05 ng/ml±2.75 ng/ml,P<0.0001). Conclusion: The serum M-CSFsR levels of patients with ALL, AML, MDS and AA were significantly lower, while the level of patients with ITP was significantly higher than that of normal individuals. Patients with severe ITP (platelet count<30×l09/L) had the highest M-CSFsR level. It suggested that the abnormal levels of serum M-CSFsR may associate with some hematological diseases and may contribute to the pathological process.

Levels of soluble delta-like ligand 1 in the serum and cerebrospinal fluid of tuberculous meningitis patients

In this study, the levels of soluble delta-like ligand 1 in cerebmspinal fluid and serum of 50 patients with tuberculous meningitis, 30 patients with viral meningitis, 20 patients with purulent meningitis and 40 subjects without central nervous system disease were determined using an enzyme-linked immunosorbent assay. The mean levels of soluble delta-like ligand 1 in both cerebrospinal fluid and serum from patients with tuberculous meningitis were significantly higher compared with those from patients with viral meningitis or purulent meningitis or from subjects without central nervous system disease. Meanwhile, the level of soluble delta-like ligand 1 gradually decreased as tuberculous meningitis patients recovered. If patients deteriorated after treatment, the level of soluble delta-like ligand 1 in cerebrospinal fluid gradually increased. There was no correlation between the level of soluble delta-like ligand 1 and the protein level/cell number in cerebrospinal fluid. Our findings indicate that the levels of soluble delta-like ligand 1 in cerebrospinal fluid and serum are reliable markers for the diagnosis of tuberculous meningitis and for monitoring treatment progress. At the same time, this index is not influenced by protein levels or cell numbers in cerebrospinal fluid.

Development of PPA-ELISA for Detecting Antibodies against Porcine Pseudorabies Virus Using Truncated Recombinant Glycoprotein gD Expressed in E.coli

The purpose of this study was to develop a method for detecting antibodies against porcine pseudorabies virus （PRV）. According to the published genomic sequence of PRV SA strain, an approximately 1 070-bp gD gene fragment was amplified by PCR. The PCR products were cloned into the prokaryotic expression vector pET30a and the positive recombinant plasmid was transformed into E. coli BL21. Through induction with IPTG, the recombinant gD protein was expressed as inclusion bodies. As analyzed by western blot assay, the purified recombinant gD protein had good antigenicity and high specificity. Using the purified gD protein as coating antigen and horseradish peroxidase labeled staphylococcal protein A （PPA） as secondary antibody, we developed a PPA-ELISA for detecting antibodies against porcine PPV. No cross-reaction with the positive sera against seven common pathogens in pigs including classical swine fever virus, porcine parvovirus, porcine reproductive and respiratory syndrome, Japanese encephalitis virus, porcine circovirus type 2, porcine epidemic diarrhea virus, transmissible gastroenteritis virus was observed. The repeatability test showed that the intra- and inter-assay coefficients of variation were lower than 5% and 10%, respectively. Compared with the ELISA gD antibody test kit produced by IDEXX, the coincidence, sensitivity and specificity of the developed PPA-ELISA were 92.0%, 95.1% and 88.1%, respectively. The developed PPA-ELISA had good repeatability, sensitivity and specificity and was a rapid and simple serological method for surveillance of PRV antibodies in pig herds as well as for rapid diagnosis and epidemiological investigation of PRV infection.

ELISA与CMIA检测血清中抗-HCV的比较

目的比较酶联免疫吸附试验(ELISA)与化学发光微粒子免疫分析(CMIA)检测血清中丙型肝炎抗体(抗-HCV)的优越性。方法首先选择200份质控品对两种方法检测的准确性及一致性进行分析,然后选择本院门诊及住院患者抗-HCV样本2000例,分别采用ELISA法与CMIA法对患者血清中抗-HCV进行测定、分析,并对比两种方法对抗-HCV的阳性检测率。结果质控品试验结果:CIMA法与ELISA法检测准确率分别为98.50%与93.00%,两种方法检测的一致率为93.00%;对两种检测方法下反馈结果不一致的样本进行分析,CIMA法检测抗-HCV阳性结果为100.00%,占总样本数的1.50%,ELISA法检测抗-HCV阳性结果为92.86%,占总样本数的6.50%。2000例抗-HCV样本检测结果:ELISA法阳性检测率为1.00%,CIMA法阳性检测率为2.10%,两种方法抗-HCV阳性检测率比较,差异有统计学意义(P<0.05)。结论 CMIA检测抗-HCV的准确率、特异性以及灵敏度均明显优于ELISA法,更适合用于丙型肝炎的临床筛查。

A NEW QUANTITATIVE DETECTION METHOD OF RECOMBINANT CFP10-ESAT6 AMALGAMATION PROTEINS FROM MYCOBACTERIUM TUBERCULOSIS BASED ON MICRO-MAGNETIC PROBES STRATEGY

A new rapid,specific and sensitive method for assay of recombinant CFP10-ESAT6 amalgamation proteins from Mycobacterium tuberculosis was proposed.The method used streptavidincoated magnetic beads to enrich the specific biotinylated anti-CFP10 antibody,then adopted a sandwich-type enzyme linked immunosorbent assay technology with two kinds of monoclonal antibodies:biotinylated anti-CFP10 antibody and HRP-labeled anti-CFP10 antibody to identify the target CFP10-ESAT6 proteins,and finally detected chemiluminescence intensity by a small home-made optical sensor.It was shown that,the corresponding chemiluminescence intensity had a good logarithmic linear response to the concentration of CFP10-ESAT6 proteins when ranging at 1~1000 ng/mL,and the correlation coefficient is 0.9937.The proposed method could detect the CFP10-ESAT6 proteins with low detection limit(1 ng/mL)and the detection time could be controlled within 45 min.Compared with commonly used detection methods of M.tuberculosis,this method was easy to operate,faster,and of higher sensitivity.The achievement of the quantitative detection of CFP10-ESAT6 proteins has important scientific significance and wide application prospects in tuberculosis control.

Study on the serum levels of soluble intercellular adhesion molecule-1 (sICAM-1) in patients with Helicobacter pylori Infection

Objective: To evaluate the interaction between serum levels of soluble intercellular adhesion molecule 1 (sICAM 1) and Helicobacter pylori (H. pylori) infection in patients with chronic gastritis and peptic ulcer. Methods: The serum levels of sICAM 1 in 205 patients with chronic gastric diseases were detected by ELISA method and the status of H. pylori was determined by histologic examination, RUT, 14 C UBT, and serology. The sera obtained from 18 healthy volunteers served as controls. Results: The serum levels of sICAM 1 were significantly higher in patients with H. pylori positive than those of H. pylori negative (889.43±32.52 ng/ml vs. 747.07±30.45 ng/ml, P <0.05). The serum levels of sICAM 1 in patients with mild, moderate and severe infection of H. pylori were 841.68±72.36 ng/ml, 905.43±37.59 ng/ml and 1012.54±49.34 ng/ml,respectively ( P <0.05). The serum levels of sICAM 1 proved to be significantly correlated with the density of H. pylori colonization in gastric mucosa ( r s =0.316, P < 0.001) . The serum levels of sICAM 1 in patients with chronic gastritis and peptic ulcer were significantly higher than those in healthy controls ( P <0.05). Conclusions: These results indicated that H. pylori infection up regulates the expression of sICAM 1.

Therapeutic Mechanism of Santeng Dingtong Recipe (三藤定痛方) on Monosodium Urate Crystal-Induced Rabbit Arthritis

Objective: To study the therapeutic mechanism of Santeng Dingtong recipe (STDT) on monosodium urate crystal (MSU) induced rabbit arthritis Methods: Forty-two rabbits were randomly divided into six groups, 7 in each group. Group 1 received 0.9% saline 2. 5 ml/kg per day by gastrogavage (ig) for 10 days; Group 2, 3 and 4 received STDT 0.125 g/kg, 1.0 g/kg and 8.0 g/kg per day respectively by ig for 10 days; Group 5 received colchicine 4. 5 mg/kg per day by ig for 4 days; and Group 6 was untreated. MSU crystals 10 mg /500ul containing polymyxin B 10 u/ml was injected into the knee joints of Group 1-5 to make rabbit arthritis models. Leukocytes in synovial lavage fluids was then counted and differentiated; pathological injury of synovial membranes was observed under HE staining; interleukin-1 beta (IL-1B), tumor necrosis factor alpha (TNFa) and leukotriene B4 (LTB4) content in synovial lavage fluids were determined by ELISA. Results: MSU caused a rapid leukocyte infiltration and increased production of IL-1B, TNFa and LTB4 2 hrs after intra-articular injection. STDT inhibited neutrophil infiltration in synovial fluids dose-dependently, protected the synovial membrane against pathological injury and reduced the production of IL-1B, TNFa and LTB4; while colchicine did not decrease the level of TNFa, but significantly inhibited neutrophil infiltration in synovial fluid and reduced the production of IL-11B and LTB4. Conclusion: STDT exerts an anti-inflammatory effect in rabbit model of acute MSU arthritis, its mechanism being probably due to the decrease of XL-1B, TNFa and LTB4 synthesis.

Study on matrix metalloproteinase-2, 9 in peri-implant sulcular fluid

Objective: To study the expression of matrix metalloproteinases-2, 9 (MMP-2, MMP-9) of healthy implant and peri-implant sulcular fluid (PISF) by enzyme-linked immunosorbent assay (ELISA) method, and evaluate the level of MMP-2 and MMP-9 in sulcular fluid as an objective indicator of tissue inflammation around implants. Methods: A total of 40 implants were selected from 30 patients who were treated with dental implants and were divided into two groups: the inflammatory group and the healthy control group with 20 pieces respectively. ELISA double antibody sandwich method was used to detect the levels of MMP-2 and MMP-9 in PISF. Results: The MMP-2 and MMP-9 expressions were significantly different between the healthy implant group and the peri-implant group (p < .05). The concentration of MMP-2, MMP-9, and the amount of sulcular fluid in the inflammatory implant group were positively correlated with the clinical parameters (probing depth [PD], modified sulcus bleeding index [mSBI]). Conclusions: Under physiological conditions, the levels of MMP-2 and MMP-9 were low. When the periodontal tissue was stimulated by inflammation, the expression levels of MMP-2 and MMP-9 were increased, which could reflect the severity of inflammation. The increase levels of MMP-2 and MMP-9 in PISF could better reflect the health status of peri-implant tissues, which could be used as an objective indicator to assist in the diagnosis of peri-implant inflammation.

全自动酶标免疫分析仪的技术原理与故障案例分析

分析全自动酶标免疫分析仪的技术原理及典型故障案例,以提升全自动酶标免疫分析仪的使用效果。通过微粒子酶免疫分析(MEIA)技术完成酶免试验,以主定标、标准定标、定性定标及定标液修正为全自动酶标免疫分析仪的定标方式,提升酶免试验分析精度。通过分析全自动酶标免疫分析仪使用中遇到的洗板机、开机初始化报警、启动软盘、加样臂和滤光器等典型故障案例,提出故障解决应对措施,为全自动酶标免疫分析仪后期维修与管理提供参考。

新霉素ELISA检测方法的建立

目的:比较直接和间接竞争酶联免疫法(enzyme linked immunosorbent assay,ELISA)的优缺点,建立新霉素残留ELISA检测方法。方法:利用自制的新霉素多克隆抗体,采用直接竞争和间接竞争ELISA方法检测新霉素残留,并比较两种方法的优缺点。结果:新霉素抗血清和庆大霉素的交叉反应率为2.04%,和卡那霉素的交叉反应率为0.02%,和氨苄青霉素、红霉素、四环素的交叉反应率均小于0.01%。初步测试新霉素间接竞争ELISA法的准确性和回收率。板内误差小于4%,板间误差小于11%,回收率为135.5%～191.3%。直接竞争和间接竞争ELISA方法的检测极限分别为28.58ng/mL和51.74ng/mL,达到了国家对新霉素规定的500μg/kg MRL检测限。结论:建立了直接竞争和间接ELISA吸附检测方法,条件优化更成功的间接竞争ELISA可用于开发新霉素检测试剂盒。

重症大疱性类天疱疮患者血清抗体变化规律与病情相关性的研究

目的：研究重症大疱性类天疱疮（ bullous pemphigoid ， BP ）患者血清中抗体BP180NC16a的酶联免疫吸附试验（ELISA）指数变化情况，观察其与病情变化的相关性，并分析用于病情监测和指导治疗的临床意义。方法对12例皮损面积＞50％的重症大疱性类天疱疮患者血清抗体BP180 NC16 a水平在不同时期进行监测及评分，并分析之间的关系。结果12例患者，平均年龄65岁，皮损面积均大于全身体表面积的50％以上。皮疹主要表现为疱壁紧张的大疱、水疱，部分有口腔黏膜损害。患者皮损面积和病情评分与血清抗体BP180NC16a-ELISA指数具有显著性关联（P＜0．05），患者疾病活动期和临床缓解期抗体BP180NC16a-ELISA指数几乎与病情呈平行变化，并且该指数可以预测病情，从而指导治疗。结论重症大疱性类天疱疮多为老年患者，病情危重，在发病早期不易诊断，因而延误治疗导致死亡。血清中抗体BP180 NC16 a-ELISA 指数可反映疾病的活动程度，用于病情监测，为治疗时根据个体差异选用适量的糖皮质激素快速控制病情提供了有利的实验室证据。

免疫人群乙肝抗体阳性率调查及乙肝核心抗体检测方法探讨

目的调查我院检测人群乙型肝炎病毒表面抗体（HBsAb）及乙型肝炎病毒核心抗体（HBcAb）阳性率,并探讨检测方法选择及检测操作模式对免疫人群乙肝核心抗体结果的影响。方法统计2012—2013年用化学发光微粒子免疫检测法（CMIA）和酶联免疫竞争抑制一步法（ELISA）检测乙肝人群的HBsAb及HBcAb阳性率,并按≤2岁、2~20岁、〉20岁3个年龄分段比较;收集92例免疫人群样本用CMIA和3种ELISA法检测HBcAb;用同种ELISA法试剂,改变操作模式进行HBcAb检测。结果 3组年龄段检测人群HBsAb两种检测方法统计的阳性率无统计学差异,≤2岁组阳性率最高;HBcAb用CMIA法统计的阳性率在≤2岁组和2~20岁组的免疫人群组低于ELISA法。92例样本用CMIA法检测HBcAb阳性率为2.2%;用3种ELISA法试剂检测阳性率分别为79.3%、82.6%及94.6%;3种ELISA法试剂检测阳性率无统计学差异。92例样本改变操作模式,用同种ELISA法检测试剂检测结果有19例为阴性,差异有统计学意义。结论检测人群HBsAb检出率在2岁及以下人群最高,随年龄增长抗体下降。HBcAb用CMIA法检测在免疫人群中检出阳性率明显低于EIISA法。ELISA竞争抑制一步法检测HBcAb易造成假阳性,如改用HBcAb单项加样操作或选用化学发光微粒子免疫检测法（CMIA）检测,可明显减少假阳性。

化学发光微粒子免疫分析法、酶联免疫吸附法在丙肝病毒抗体检测中的应用对比观察

目的比较化学发光微粒子免疫分析(CMIA)法、酶联免疫吸附(ELISA)法在丙肝病毒抗体(HCV-Ab)检测中的应用效果。方法 190例疑似丙肝病毒感染者,收集空腹促凝血,分别采用CMIA法、ELISA法检测HCVAb,采用RFQ-RT-PCR检测HCV RNA。529例健康查体者,收集空腹促凝血,分别采用CMIA法、ELISA法检测HCV-Ab。精密度试验分析CMIA法、ELISA法检测HCV-Ab的精密度,绘制浓度与S/CO曲线分析CMIA法、ELISA法检测HCV-Ab的灵敏度。特异度实验分析CMIA法、ELISA法检测HCV-Ab的特异度。根据719例份(190例疑似丙肝病毒感染者+529例健康查体者)空腹促凝血HCV-Ab检测结果,比较CMIA法、ELISA法检测HCV-Ab的阴性、阳性一致率及总一致率。结果 190例份疑似丙肝病毒感染者中,CMIA法检测HCV-Ab阳性、阴性分别为190、0例,ELISA法分别为145、45例。529例份健康查体者标本中CMIA法检测阳性、阴性分别为0、529例,ELISA法分别为156、563例。CMIA法、ELISA法检测HCV-Ab的批内精密度水平1分别为4. 70%±0. 27%、7. 11%±0. 90%(P <0. 05),水平2分别为19. 10%±0. 59%、22. 08%±2. 22%(P <0. 05),CMIA法、ELISA法检测HCV-Ab的批间精密度水平1分别为4. 64%±0. 16%、6. 71%±0. 81%(P <0. 05),水平2分别为19. 11%±0. 48%、21. 39%±1. 67%(P <0. 05)。CMIA法检测HCV-Ab的灵敏度高于ELISA法(P <0. 05)。CMIA法与ELISA法检测HCV-Ab阴性一致率为97. 92%,阳性一致率为72. 32%,总一致率为92. 21%,两者一致率比较,χ2=4. 400,P <0. 05;CMIA与ELISA法HCV RNA检测阳性率分别为54. 21%和46. 32%,CMIA法的HCV RNA检测阳性率高于ELISA法(χ2=51. 045,P <0. 05)。结论与ELISA法比较,CMIA法测定HCV-Ab的精密度、灵敏度、特异度、阳性预测值均较高。