Comparison of an enzyme immunoassay to an indirect fluorescent immunoassay for the detection of antinuclear antibodies

The standard method for detecting antinuclear antibodies (ANAs) is by immunofluorescence assay (IFA), a method that is labor intensive and subjective. In an attempt to overcome these limitations, several commercial enzyme immunoassays (EIAs) have been developed. We report the results of our evaluation of the ANA Microplate EIA (Sanofi Diagnostics Pasteur, Chaska, MN). For the evaluation, 808 serum samples were tested by EIA and IFA; 52 specimens were positive by both assays, 561 were negative by both assays, 91 were positive by EIA only, and 3 were positive by IFA only. Borderline results (not positive or negative) were obtained for 101 specimens, which were excluded when calculating the sensitivity, specificity, and positive and negative predictive values of this assay, which were 94.6%, 86.0%, 36.4%, and 99.5%, respectively. Because of its high negative predictive value, this assay can be used reliably to detect ANA-negative samples; however, the low positive predictive value indicates that EIA-positive specimens should be retested by an IFA to determine the final result.     

Tubuloreticular structures and antinuclear antibodies in autoimmune and non-autoimmune diseases.

Tissues obtained at random from patients suffering from autoimmune and non-autoimmune diseases were studied for the presence of tubuloreticular structures (TRS). It could be demonstrated that the occurrence of TRS in renal tissue is not a specific characteristic of systemic lupus erythematosus whereas the presence of such structures in skin tissue might be suggestive for this disease. The serum of some of the patients could be studied for the presence of antinuclear antibodies (ANA). A statistically significant correlation was found between TRS and ANA in the group of patients with autoimmune diseases. The possibility is discussed that this correlation might favour the theory that viruses may be involved in the aetiology of autoimmune diseases, particularly of systemic lupus erythematosus.     

Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay

A fully automated chemiluminescent microparticle immunoassay (Architect HBsAg QT) was used for the detection and quantitation of hepatitis B surface antigen (HBsAg). The assay is capable of processing up to 800 HBsAg tests per hour. The concentration of HBsAg is determined by utilizing a previously generated Architect HBsAg calibration curve. Architect HBsAg QT sensitivity was found to be around 0.2ng/ml which is equivalent or superior to other known and commercially available enzyme immunoassays and/or chemiluminescent immunoassays. We performed a quantitative study of HBsAg, HBeAg, HBV-DNA and HBV-DNA polymerase in over 733 sera obtained from 43 chronic hepatitis B carriers. Serum HBsAg levels detected by Architect HBsAg QT were found to be higher in HBeAg-positive than in anti-HBe-positive HBV chronic carriers and correlated with the level of serum HBV-DNA and HBV-DNA polymerase.     

抗核抗体与抗核抗体谱联合检测在自身免疫性疾病诊断上的应用

目的探讨抗核抗体(antinuclear antibody,ANA)和抗核抗体谱(antinuclear antibodies spectrum,ANAs)联合检测在自身免疫性疾病(autoimmune diseases,AID)诊断上的应用方案及价值,从而降低现症及潜在AID患者的漏检率。方法对1 231份本院门诊和住院疑似AID患者的血清标本分别采用间接免疫荧光法(indirect immunofluorescence,IIF)和免疫印迹法(immumoblottest,IBT)检测ANA和ANAs,对其中IIF-ANA1∶100(-)/IBT-ANAs(+)标本分别进行1∶10及1∶32稀释后采用IIF检测ANA,最后对上述检测结果进行统计分析。结果 1 231份血清标本中ANA阳性414份,占33.63%,ANAs阳性429份,占34.85%。按不同检测方案进行分组,发现同时检测IIF-ANA与IBT-ANAs的方案对确诊/疑似AID病人检出率最高(43.05%),分别与应用IIF-ANA进行AID的初筛的方案、仅检测IBT-ANAs的方案相比均有统计学意义(χ2=23.12,P<0.05,χ2=17.42,P<0.05)。对116份(9.42%)IIF-ANA 1∶100(-)/IBT-ANAs(+)的标本分别进行1∶32及1∶10稀释后再采用IIF检测ANA,发现其中103份标本ANA荧光结果≥1∶32,10份标本ANA荧光结果<1∶32而≥1∶10,3份标本ANA荧光结果<1∶10;将标本增加1∶32和1∶10稀释度可将AID确诊/疑似病例检出率分别提高8.37%(χ2=20.84,P<0.05)与9.18%(χ2=24.70,P<0.05),但二者之间相比则无统计学意义(χ2=0.17,P>0.5)。结论 IIF-ANA可应用于大范围AID病人初筛以减轻病人经济负担及实验室工作量压力。但是仅检测IIF-ANA或IBT-ANAs均可导致临床上患有AID或潜在的AID病人的漏检。联合检测IIF-ANA和IBT-ANAs,尤其是对临床高度怀疑AID、且ANA荧光结果≥1:32的标本进行IBT-ANAs的检测可显著提高检出率,从而降低现症及潜在AID患者的漏检率。     

Evaluation of a new, fully automated immunoassay for detection of HTLV-I and HTLV-II antibodies

Screening blood donations for human T-lymphotropic virus types I and II (HTLV-I/II) continues to be important in protecting the safety of blood products and controlling the global spread of these retroviruses. We have developed a fully automated, third generation chemiluminescent immunoassay, ARCHITECT rHTLV-I/II, for detection of antibodies to HTLV-I/II. The assay utilizes recombinant proteins and synthetic peptides and is configured in a double antigen sandwich assay format. Specificity of the assay was 99.98% (9,254/9,256, 95% CI = 99.92-100%) with the negative specimens from the general population including blood donors, hospital patients and pregnant women from the US, Japan and Nicaragua. The assay demonstrated 100% sensitivity by detecting 498 specimens from individuals infected with HTLV-I (n = 385) and HTLV-II (n = 113). ARCHITECT rHTLV-I/II results were in complete agreement with the Murex HTLV-I/II reference assay and 99.7% agreement with the Genelabs HTLV Blot 2.4 confirmatory assay. Analytical sensitivity of the assay was equivalent to Murex HTLV-I/II assay based on end point dilutions. Furthermore, using a panel of 397 specimens from Japan, the ARCHITECT rHTLV-I/II assay exhibited distinct discrimination between the antibody negative (Delta Value = -7.6) and positive (Delta Value = 7.6) populations. Based on the excellent specificity and sensitivity, the new ARCHITECT rHTLV-I/II assay should be an effective test for the diagnosis of HTLV-I/II infection and also for blood donor screening.     

Solid phase assays versus automated indirect immunofluorescence for detection of antinuclear antibodies

Solid phase assays (SPAs) and automated microscope systems are increasingly used to screen for antinuclear antibodies (ANAs). The goal of this study was to evaluate the performance of three automated ANA screening assays; NOVA Lite HEp-2 using NOVA View® (NV, Inova Diagnostics), an automated indirect immunofluorescence method, EliA? CTD Screen (Fluorescence Enzyme Immunoassay, FEIA; Thermo Fisher) and QUANTA Flash® CTD Screen Plus (Chemiluminescence immunoassay, CIA; Inova Diagnostics).The assays were performed on 480 diagnostic samples from patients with an ANA-associated rheumatic disease (AARD; systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, inflammatory myopathy, mixed connective tissue disease) and on 767 samples from diseased and healthy controls.Using cut-offs proposed by the manufacturers, the sensitivity was 95%, 80.5% and 86% for NV, FEIA and CIA, respectively. The corresponding specificity was 61% (NV), 97.5% (FEIA) and 88% (CIA). The sensitivity associated with a specificity of ~95% was 79%, 82% and 78% for NV, FEIA, and CIA, respectively. Receiver operating characteristics (ROC) curve analysis revealed no differences in area under the curve (AUC) between the 3 assays when all diseases were grouped. For Sjögren's syndrome, the AUC was higher for SPAs than for NV, whereas for systemic sclerosis, the AUC was higher for NV than for CIA. For all assays, the likelihood ratio for AARD increased with increasing antibody levels and for double positivity of NV with SPA.In conclusion, the performance of automated SPA and IIF was assay- and disease-dependent. Taking into account antibody levels and combining IIF with SPA adds value.     

Progranulin antibodies in autoimmune diseases

Systemic vasculitides constitute a heterogeneous group of diseases. Autoimmunity mediated by B lymphocytes and their humoral effector mechanisms play a major role in ANCA-associated vasculitis (AAV) as well as in non-ANCA associated primary systemic vasculitides and in the different types of autoimmune connective tissue disorders and rheumatoid arthritis. In order to detect autoantibodies in systemic vasculitides, we screened protein macroarrays of human cDNA expression libraries with sera from patients with ANCA-associated and ANCA-negative primary systemic vasculitides. This approach led to the identification of antibodies against progranulin, a 88 kDA secreted glycoprotein with strong anti-inflammatory activity in the course of disease of giant-cell arteritis/polymyalgia rheumatica (14/65), Takayasu's arteritis (4/13), classical panarteritis nodosa (4/10), Behcet's disease (2/6) and in the course of disease in granulomatosis with polyangiitis (31/75), Churg–Strauss syndrome (7/23) and in microscopic polyangiitis (7/19). In extended screenings the progranulin antibodies were also detected in other autoimmune diseases such as systemic lupus erythematosus (39/91) and rheumatoid arthritis (16/44). Progranulin antibodies were detected only in 1 of 97 healthy controls. Anti-progranulin positive patients with systemic vasculitides, systemic lupus erythematosus or rheumatoid arthritis had significant lower progranulin plasma levels, indicating a neutralizing effect. In light of the anti-inflammatory effects of progranulin, progranulin antibodies might exert pro-inflammatory effects thus contributing to the pathogenesis of the respective autoimmune diseases and might serve as a marker for disease activity. This hypothesis is supported by the fact that a positive progranulin antibody status was associated with active disease in granulomatosis with polyangiitis.     

Evaluation of an enzyme immunoassay kit for detecting cryptosporidium in faeces and environmental samples.

AIMS: To evaluate a commercially available enzyme immunoassay based on a monoclonal antibody to a genus specific Cryptosporidium (IDEIA Cryptosporidium; Dako) antigen for detecting Cryptosporidium oocysts in faecal and environmental samples. METHODS: 435 human faecal samples and post-filtration deposits from 10 reservoir samples, and from six tap water samples seeded with Cryptosporidium oocysts, were examined by EIA according to the manufacturer's instructions, and by microscopic examination of phenolauramine stained smears. Samples giving discrepant results were examined by specific immunofluorescence, before and after concentration of oocysts. RESULTS: Sixteen (3.6%) faecal samples were positive by both microscopy and EIA; five (1.1%) were positive by microscopy of auramine-phenol stained smears (but were not confirmed by specific immunofluorescence) and negative by EIA; one (0.2%) was positive by EIA alone, but confirmed by specific immunofluorescence; and 362 (83.2%) were negative by both microscopy and EIA. Compared with immunofluorescence positive faecal samples, the sensitivity of conventional microscopy and EIA were 94% and 100%, and specificity 76.4% and 100%, respectively. Fifty one (11.7%) were not examined by microscopy due to detection of other pathogens in a previous sample from that patient, but were found to be negative by EIA. Ten reservoir water samples (not suspected of being linked to cases of cryptosporidiosis) were negative by both microscopy and EIA. Of six samples of tap water seeded with varying concentrations of Cryptosporidium oocysts, two (10(2) and 10(3) oocysts/l) were positive by both microscopy and EIA, two (10 and 1/l) by EIA alone, and two (0.1/l and unseeded water) were negative by both microscopy and EIA. CONCLUSIONS: The kit is simple and rapid to use and offers a less subjective method than microscopy for detecting Cryptosporidium in faecal samples submitted to a busy diagnostic laboratory.     

Evaluation of diagnostic tests for antinuclear antibodies in rheumatological practice

To investigate and compare the accuracy and usefulness of diagnostic tests for antinuclear antibodies (ANA) a cross‐sectional study of sera derived from patients admitted to the Department of Rheumatology was tested for the presence of ANA using either indirect immunofluorescence on HEp‐2 cells, indirect immunoperoxidase techniques on HEp‐2 cells and mouse kidney, or two commercial enzyme‐linked immunosorbent assays (ELISA). The diagnostic sensitivity and predictive values of the tests were calculated and compared. The accuracy of tests was compared using receiver‐operating characteristics (ROC) methodology. All ANA‐positive sera were further analysed for the presence of antibodies against extractable nuclear antigens (anti‐ENA) and anti‐DNA. A moderate to good agreement was found between tests, with κ ranging from 0.469 to 0.659. Highest sensitivity for systemic lupus erythematosus (SLE; 93.3%) and primary Sjögren's syndrome (SS; 70%) was found using immunofluorescence on HEp‐2 cells. Immunofluorescence on HEp‐2 cells performed statistically better than the other tests in predicting SLE but not SS. All tests except mouse kidney showed good and comparable performance in detecting sera with anti‐ENA and anti‐DNA. At the given cut‐off values indirect immunofluorescence on HEp‐2 cells performed best. All assays except mouse kidney showed performance characteristics sufficient for use in routine analysis of ANA.     

Multiplexed AtheNA multi-lyte immunoassay for ANA screening in autoimmune diseases

Background: Multiplexed assays using fluorescence microspheres is an exciting technology with multiple applications including the detection of antinuclear autoantibodies (ANA) and autoantibody profiles. It is a rapid, sensitive and automatic method for simultaneous quantitative detection of several autoantibodies. The aim of our study was to determinate ANA and other autoantibodies to the nine extractable nuclear antigens by the AtheNA Multi-Lyte ANA system and compare the results achieved by this method to the routinely used enzyme immunoassay.

Methods: Four hundred eighteen serum samples were tested utililizing the multiplexed method: 96 healthy donors, 86 requested ANA specimens obtained from routine lab, and 236 samples from patients with known autoimmune diseases (43-scleroderma, 113-systemic lupus erythematosus, 38-Sjogren's syndrome, and 42 rheumatoid arthritis). The ANA and antibodies to nine different analytes (SS/A, SS/B, Sm, RNP, Jo-1, Scl-70, dsDNA, Centromere B and Histone) were tested.

Results: ANA screening by AtheNA system revealed high concordance of 99 and 97.7% with the enzyme immunoassay test in samples obtained from healthy donors and ANA requested samples, respectively. Evaluation of autoimmune disease-related samples for ANA by AtheNA technology also confirmed a high rate of concordance of 92–97.7% and correlated with the enzyme immunoassay. Positive discrepant results were found for Scl-70 specificity in 12.7% of SLE specimens by AtheNA technology, while all tested sera were negative for this antibody by enzyme immunoassay. Negative discrepant results were observed by the AtheNA system for anti-dsDNA. The sera (15 randomly obtained samples from SLE patients) were positive for anti-dsDNA in 50% of samples in Farr assay and 55% in enzyme immunoassay, respectively.

Conclusion: We suggest that the AtheNA technology may be a useful diagnostic tool for ANA screening. Additional investigations are required to compare an analytic performance between AtheNA and routine methods in determination of the individual autoantibody profile.     

Multiplexed AtheNA multi-lyte immunoassay for ANA screening in autoimmune diseases

BACKGROUND: Multiplexed assays using fluorescence microspheres is an exciting technology with multiple applications including the detection of antinuclear autoantibodies (ANA) and autoantibody profiles. It is a rapid, sensitive and automatic method for simultaneous quantitative detection of several autoantibodies. The aim of our study was to determinate ANA and other autoantibodies to the nine extractable nuclear antigens by the AtheNA Multi-Lyte ANA system and compare the results achieved by this method to the routinely used enzyme immunoassay. METHODS: Four hundred eighteen serum samples were tested utililizing the multiplexed method: 96 healthy donors, 86 requested ANA specimens obtained from routine lab, and 236 samples from patients with known autoimmune diseases (43-scleroderma, 113-systemic lupus erythematosus, 38-Sjogren's syndrome, and 42 rheumatoid arthritis). The ANA and antibodies to nine different analytes (SS/A, SS/B, Sm, RNP, Jo-1, Scl-70, dsDNA, Centromere B and Histone) were tested. RESULTS: ANA screening by AtheNA system revealed high concordance of 99 and 97.7% with the enzyme immunoassay test in samples obtained from healthy donors and ANA requested samples, respectively. Evaluation of autoimmune disease-related samples for ANA by AtheNA technology also confirmed a high rate of concordance of 92-97.7% and correlated with the enzyme immunoassay. Positive discrepant results were found for Scl-70 specificity in 12.7% of SLE specimens by AtheNA technology, while all tested sera were negative for this antibody by enzyme immunoassay. Negative discrepant results were observed by the AtheNA system for anti-dsDNA. The sera (15 randomly obtained samples from SLE patients) were positive for anti-dsDNA in 50% of samples in Farr assay and 55% in enzyme immunoassay, respectively. CONCLUSION: We suggest that the AtheNA technology may be a useful diagnostic tool for ANA screening. Additional investigations are required to compare an analytic performance between AtheNA and routine methods in determination of the individual autoantibody profile.     

竞争性化学发光酶免疫分析法检测睾酮

目的：建立高灵敏度的化学发光酶免疫分析法（ＣＬＥＩＡ）检测睾酮。方法：包被抗体、标记抗原或包被抗原、标记抗体,用辣根过氧化物酶标记,鲁米诺增敏化学发光体系作为酶底物。结果：包被二抗、标记睾酮的方法灵敏度高、操作简便,灵敏度为０．０６３ｎｇ／ｍｌ,睾酮浓度为１．０、５．０和１０．０ｎｇ／ｍｌ时,批内变异５．８％～７．４％（ｎ＝２０）,批间变异为６．６％～８．７％（ｎ＝２０）,回收率为９８．２％～１０     

Novel opportunities in automated classification of antinuclear antibodies on HEp-2 cells

The recommended method for antinuclear antibodies (ANA) detection is IIF but it is influenced by many different factors. In order to pursue a high image quality without artefacts and to reduce inter-observer variability, this study aims to evaluate the reliability of using automatically acquired digital images for diagnostic purposes. In this paper we present SLIM-system a comprehensive system that supports the two sides of IIF tests classification. It is based on two systems: the first labels the fluorescence intensity, whereas the second recognizes the staining pattern of positive wells. We populated a dataset of 600 images obtained from sera screened for ANA by IIF on Hep-2 cells. The error rate has been evaluated according to eight-fold cross validation method; the rates reported in the following are the mean of the tests. Performance of the system in positive/negative recognition ranges from 87% up to more than 94%. Staining pattern classification accuracy of main classes ranges from 71% to 74%. The system provides high and reliable identification of negative samples and a flexibility that permits to use this application for different purposes. The analysis of its perspective performance shows the system potential in lowering the method variability, in increasing the level of standardization and in reducing the specialist workload of more than 80%. Our data represent a first step to validate the use of Computer Aided Diagnosis (CAD), thus offering an opportunity for standardizing and automatizing the detection of ANA by IIF.     

Analytical and clinical performance of an automated chemiluminescent immunoassay for direct renin measurement: comparison with PRA and aldosterone assays

The analytical performance of a fully automated chemiluminescentimmunoassay (CLIA) by Nichols Institute Diagnostic for direct renin, was evaluated. Within-assay imprecision (CV) resulted 5.6% at 4.7 μU/ml; 1.9% at 33.7 μU/ml and 2.3% at 194.9 μU/ml; between-assay imprecision 12.4% at 5.3 μU/ml; 8.7% at 32.4 μU/ml, 8.2%at 90.2 μU/ml, 5.5% at 196.5 μU/ml. Direct renin CLIA showed good linear relationship with direct renin IRMA and with plasma renin activity (PRA). The clinical performance of direct renin CLIA, PRA and aldosterone assays was tested by ROC analysis in patients with heart failure (HF). For mild HF, areas under the curve were: PRA = 0.733, direct renin = 0.671, aldosterone = 0.789; for severe HF: PRA = 0.855, direct renin = 0.792, aldosterone = 0.801. In conclusion, direct renin CLIA measurement showed good analytical performance (shorter turn around time, better precision and practicability than IRMA and PRA) and good clinical performance in HF patients with different severity of disease similar to that of aldosterone and PRA measurement.     

化学发光酶免疫分析法在乙肝病毒及核心抗体定性检测中的应用分析

目的 通过对比,探讨了化学发光酶免疫分析法在乙肝病毒及核心抗体定性检测中的应用价值.方法 选取2013年5月至2015年5月在我院的疑似乙型肝炎患者80例,抽取空腹血液样本后都分别进行乙肝病毒以及核心抗体的化学发光酶免疫分析法及ELISA法检测,并对其检测结果进行分析.结果 化学发光酶免疫分析法检出乙型肝炎病毒阳性78例,检出率为97.5％;而ELISA检出乙型肝炎病毒阳性76例,检出率为95.0％,两种方法的检出率对比差异无统计学意义(P＞0.05).化学发光酶免疫分析法对于乙肝病毒核心抗体IgM与IgG的检测阳性率分别为80.0％和70.0％,而ELISA法检测两种抗体的阳性率则分别为18.8％和20.0％,化学发光酶免疫分析法对乙肝核心抗体IgM与IgG的检测阳性率明显高于ELISA法(P＜0.05).ELISA法检出HBc-IgM的最低限为0.135 IU/ml,检出HBc-IgM最低限为0.143 IU/ml;化学发光酶免疫分析法检出HBc-IgM最低限为0.032 IU/ml,检出HBc-IgG最低限为0.038 IU/ml.结论 化学发光酶免疫分析法在乙型肝炎检测中具有高的检出率,尤其对乙肝病毒的核心抗体的检测敏感度较高,值得在临床推广应用.     

Detection of antibodies to hepatitis C virus: false-negative results in an automated chemiluminescent microparticle immunoassay (ARCHITECT Anti-HCV) compared to a microparticle enzyme immunoassay (AxSYM HCV Version 3.0).

BACKGROUND: Following an accidental observation of reduced sensitivity for detection of antibodies to hepatitis C virus (HCV) with a novel commercially available automated chemiluminescent microparticle immunoassay (CMIA, ARCHITECT Anti-HCV) compared to a well-established microparticle enzyme immunoassay (MEIA, AxSYM HCV Version 3.0), we wanted to explore whether this could be explained by a variation in marginal sensitivity, to be expected between highly sensitive assays of different formats, or represented a reduced sensitivity of the CMIA to certain antibody profiles. OBJECTIVES: To evaluate the ability of the CMIA to detect low concentrations of anti-HCV antibodies as defined by various patterns in the recombinant immunoblot assay (RIBA) and already detected in the MEIA system. STUDY DESIGN: All patient sera tested for anti-HCV reactivity during a period of 3 years (27,978) were evaluated. A total of 90 sera had a sample/cut-off ratio (S/CO) between 1.0 and 1.5 in the MEIA test and were available for further testing. Of these, 19 had a probable/possible presence of anti-HCV antibodies based on presence of at least two bands of > or = 1+ strength in the RIBA, or because the patient was known to be anti-HCV positive. These 19 sera were tested with the CMIA. In addition, 16 sera with strong reactivity to various antigen combinations in the RIBA were serially diluted until testing negative in both microparticle test systems. RESULTS: Seven of the 19 sera (37%) were negative (S/CO < 1.0) in the CMIA. At least 3 (16%) of these 19 sera were very likely to be true anti-HCV positive sera (from infants with known anti-HCV positive mothers). HCV-RNA was not detected in any of the sera tested. Testing of sera after serial dilution indicates that the CMIA has a lower sensitivity to c22- and c33c-antibodies than the MEIA, possibly also to c100-3-antibodies. CONCLUSION: Our findings indicate that ARCHITECT Anti-HCV is less sensitive than AxSYM HCV Version 3.0 in detecting antibodies to c22 and c33c in patients who have cleared their HCV-infection and have naturally declining levels of antibodies.     

Evaluation of a novel automated chemiluminescent assay system for antimicrobial susceptibility testing

The newly developed Rapid Lumi Eiken/IS60 (RL/IS60) system automatically determines MICs by detecting chemiluminescence produced in the reaction of a chemiluminescent probe and oxygen metabolites from living microorganisms. The present study evaluated this system for accuracy in antimicrobial susceptibility testing. Chemiluminescence intensities after 4 h of cultivation of clinically important strains were plotted against various concentrations of antimicrobial agents, which resulted in curves reflecting the levels of susceptibility. Sixty-percent inhibitory concentrations based on the susceptibility curves agreed with MICs determined by the reference microdilution method. When the MICs of antimicrobial agents for four quality control (QC) strains (Staphylococcus aureus, Enterococcus faecalis, Escherichia coli, and Pseudomonas aeruginosa) were determined by the RL/IS60 system, most (91.1%) of them were within the QC limits proposed by the National Committee for Clinical Laboratory Standards. The system was further assessed for a total of 162 clinical isolates, including E. coli, Citrobacter freundii, Enterobacter cloacae, Klebsiella pneumoniae, Serratia marcescens, Proteus mirabilis, Morganella morganii, P. aeruginosa, Haemophilus influenzae, S. aureus, coagulase-negative staphylococci, Enterococcus faecalis, Enterococcus faecium, and Streptococcus pneumoniae. Overall, there was 90.6% agreement between the RL/IS60 system and the reference microdilution method. Our results suggest that the RL/IS60 system provides rapid and reliable MICs of a variety of antimicrobial agents for clinical isolates as well as QC strains.     

磁微粒化学发光法与酶联免疫吸附法测定抗中性粒细胞胞浆抗体的结果比较

目的:比较分析磁微粒化学发光法与酶联免疫吸附法测定抗PR3 抗体、抗MPO 抗体的检测结果。方法:分别采用磁微粒化学发光法(A 方法)和酶联免疫吸附法(B 方法)对166 例自身免疫病患者血清、50 例健康者血清中抗PR3 抗体、抗MPO 抗体进行定量检测,对检测结果进行统计分析。结果:A 方法测定高、中、低质控血清的批内和批间重复性优于B方法,A、B 方法测定质控血清的准确度均符合要求;A、B 方法测定抗PR3 抗体、抗MPO 抗体临床样本的线性相关系数r 分别为0.987 8,0.989 6;A、B 方法的检测结果采用kappa 分析,kappa 系数分别为0.897 和0.882。结论:磁微粒化学发光法(A 方法)测定抗PR3 抗体、抗MPO 抗体优于酶联免疫吸附法(B 方法),更符合临床应用要求。