GENE ENGINEERING EB VIRUS MEMBRANE ANTIGEN IN DETECTION OF MA-IgA ANTIBODY(COMPARISON WITH VCA-IgA AND EA-IgA ANTIBODIES)

With gene engineering EB virus membrane antigen as the diagnostic antigen, indirect immunofluo-rescence (IF) assay was used to detect IgA antibody against EB virus membrane antigen (MA-IgA) in sera from 202 nasopharyngeal carcinoma (NPC) patients and 315 controls (normal and patients with other tumors). MA-IgA antibody was positive in 96.8% of the pretreatment NPC patients with a GMT of 1:36.3. MA-IgA detection by this method was more sensitive than EA-IgA detection by IE. In contrast, patients with tumors other than NPC were negative for MA-IgA antibody. 9.1% of VCA-IgA positive persons were MA-IgA positive with a GMT of less than 1:5. No MA-IgA positive was found in VCA-IgA negatives. The results indicated that this method was relatively specific. In the treatment group, the positive rate and GMT of MA-IgA antibody declined with increase in survival time and the decline was faster than VCA-IgA. When recurrence or distant metastasis developed, similar to VCA-IgA and EA-IgA antibodies, the positive rate and GMT of MA-IgA antibody increased to its pretreatment level. Therefore, MA-IgA detection might be valuable in the early diagnosis and monitor of NPC.

Antigen Detection in Canine Blastomycosis: Comparison of Different Antibody-Antigen Combinations in Two Competitive ELISAs

This present study was designed to evaluate four different Blastomyces dermatitidis antibody-antigen combinations (B5896 and T-58 antibodies and B5896 and WI-R antigens) for the detection of antigen in 36 urine specimens from dogs with blastomycosis using a standard indirect ELISA (STD) and a biotin-streptavidin ELISA (B-SA). The antigen detection sensitivity values ranged from 81% (B-SA: T-58 Ab + WI-R Ag) to 100% (STD and B-SA: B5896 Ab + WI-R Ag;B5896 Ab + B5896 Ag) with the antibody-antigen combinations in the two assays. Optimal detection was evidenced when the B5896 Ab was allowed to react with the urine specimens for 30 min at 37?C and then placed in the B-SA ELISA plates containing the B5896 Ag. The greatest absorbance value obtained with this antibody-antigen com-bination was 0.903 (range of 0.596 - 0.903) as compared to the control value of 1.246. The difference between the control absorbance and the test absorbance values was 0.343 which was considerably greater than the control-test values with the other combinations. This study thus showed that the results obtained in antigen detection assays are dependent upon the antibody used to react with the urine specimens as well as the antigen used in the enzyme immunoassay.

Comparison of Antibody Detection with Yeast Lysate Antigens Prepared from Blastomyces dermatitidis Dog Isolates from Wisconsin and Tennessee

Blastomyces dermatitidis, the causative agent of blastomycosis, a potentially lethal dimorphic fungal disease of humans and animals has been difficult to diagnose in the clinical laboratory. We are attempting to develop and improve immunodiagnostic assays by producing novel yeast lysate reagents for the detection of antibodies in blastomycosis. The objective of this study was to use lysate antigens prepared from four B. dermatitidis antigens isolated from dogs infected with blastomycosis from two different endemic areas (Wisconsin and Tennessee) testing for the detection of antibodies in serum specimens from immunized rabbits and infected dogs using the indirect ELISA. In the dog sera, absorbance values ranged from 0.774 to 1.350, while the rabbit sera values ranged from 0.533 to 1.191. Antigen T-58 appeared to lack any geographical specificity in antibody detection, which could prove useful in future immunodiagnostic detection of blastomycosis infections.

Comparison of Detection of Antibodies with Yeast Lysate Antigens Prepared from Two Isolates of <i>Blastomyces dermatitidis</i>by Two Different Methods: Sensitivity and Specificity Evaluations

Blastomycosis, a systemic fungal disease, caused by the dimorphic fungus Blastomyces dermatitidis, has continually presented clinicians with concerns with regard to laboratory diagnosis and prevention. For years researchers have strived to develop antigens with a high degree of sensitivity and specificity. The purpose of this study was to gain a bet- ter understanding of how two novel yeast lysate antigens, prepared from two B. dermatitidis isolates by different meth- ods, would be able to detect antibody responses in immunized rabbits in a specific and sensitive manner. The en- zyme-linked immunosorbent assay (ELISA) was used to evaluate antibody in serum specimens with yeast lysate re- agents prepared after allowing yeast cells to lyse for 1 or 7 days. The results indicated that reactivity was greater with the day 7 antigens, with both the B5896 and 597 B. dermatitidis isolates, when compared to the day 1 antigens;in con- trast the day 1 preparations exhibited less cross reactivity when assayed against anti-Histoplasma capsulatum serum specimens.

Detection of Antibodies in Serum Specimens from Dogs with Blastomycosis with Lysate Antigens Prepared from Four <i>Blastomyces dermatitidis</i>Dog Isolates: Individual Antigens vs Antigen Combinations

Blastomycosis, the systemic fungal infection of humans and animals, has presented a diagnostic challenge to clinicians and laboratory personnel for many years. Our laboratory has been concentrating on attempting to develop antigenic reagents from the yeast phase of various isolates of Blastomyces dermatitidis and to evaluate these lysate antigens with regard to antibody detection in blastomycosis. The aim of this current study was to evaluate yeast phase antigens prepared from four dog isolates of B. dermatitidis and to evaluate their efficacy, when used individually or in combination, for antibody detection in sera from dogs with blastomycosis. Mean absorbance values using the ELISA to assay 24 serum specimens (Trial 1) ranged from 0.588 with an individual lysate antigen to 0.992 when three reagents were combined. Eight of the lysates exhibited mean absorbance values ranging from 0.992 to 0.915 with 7 out of 8 being lysate antigen combinations. Mean absorbance values with the other 6 lysates ranged from 0.899 to 0.588. In Trial 2, the 6 most sensitive reagents from Trial 1 were assayed against 10 highly reactive dog sera. The results of Trial 2 showed that 5 antigen combinations detected antibody to a greater degree than the individual lysate antigen. Combinations of northern and southern antigens were able to detect antibody in serum specimens from either of these geographical regions. Comparative studies are continuing to further evaluate various lysate antigen combinations for antibody detection in blastomycosis.

Comparison of antibody detection with <i>Blastomycesdermatitidis</i>yeast lysate antigens in serum specimens from immunized rabbits and infected dogs

This present study was designed to evaluate B. dermatitidis antigens, prepared from two isolates (B5896, 597), when the yeast cells were allowed to lyse in distilled water for one day or seven days. The indirect enzyme-linked immunosorbent assay (ELISA) was used to determine the ability of the lysate reagents to detect antibodies in 30 rabbit and 30 dog serum specimens. Mean absorbance values with B5896 lysate antigen ranged from 1.637 (day 1) to 1.461 (day 7) and absorbance values with 597 antigen ranged from 1.579(day 1) to 1.396 (day 7) with the serum specimens from immunized rabbits. Serum specimens from infected dogs yielded absorbance values ranging from 1.672 (day 1) to 1.763 (day 7) with the B5896 and values ranging from 1.909 (day 1) to 1.224 (day 7) with the 597. Optimal reactivity was obtained with the day 1 lysate using both lysate antigens against the rabbit sera and with the 597 antigen against the dog sera. Slightly greater reactivity was evidenced with the day 7 B5896 antigen when the dog sera was tested. Comparative studies are continuing in order to produce an optimal anti-genic preparation for antibody detection in blastomycosis.

Clinical significance of the detection of Rh blood group antigens and irregular antibodies in pregnant women with a second pregnancy

Objective:To investigate the phenotype distribution of five antigens of Rh blood group system and the specificity of Rh blood group irregular antibodies in pregnant women with second child.To analyze the relationship between Rh blood group antibody and hemolytic disease of the newborn(HDN)in second-child pregnant women,and to provide laboratory basis for the diagnosis and treatment of hemolytic disease of the newborn(Rh-HDN).Methods:500 pregnant women with second child were collected as the study group and 500 pregnant women with first pregnancy as the control group(all pregnant women underwent obstetric examination in the integrated obsteric clinic of our hospital from January 2020 to January 2021).To detectethe Rh blood group antigens(D,C,c,E,e)of the two groups of samples,screene the irregular antibodies,identify the specificity of irregular antibodies,determine the titer and record the hemolytic disease of the newborn of pregnant women with positive Rh blood group antibodies.Results:There were 11 Rh phenotypes in the pregnant women with second child in the study group:CCDee(152cases,30.4%),CcDEe(136cases,27.2%)CcDee(84cases,16.8%),ccDEE(30cases,6%),ccDee(31cases,6.2%),CCDEe(14cases,2.8%),ccDEe(9cases,1.8%),cc dee(18cases,3.6%),CCDEE(2cases,0.4%),CcdEe(12cases,2.4%),Ccdee(6cases,1.2%),CCd ee(6cases,1.2%).A total of 42 cases(8.4%)in the pregnant women with second child were negative for RhD.There were 10 Rh phenotypes in the pregnant women with first pregnancy in the control group:CCDee(144cases,28.8%),CcDEe(138cases,27.6%),CcDee(90cases,18%),ccDEE(42cases,8.4%),ccDee(28cases,5.6%),CCDEe(10cases,2%),ccDEe(8cases,1.6%),cc dee(19cases,3.8%),CCDEE(1cases,0.2%),CcdEe(11cases,2.2%),Ccdee(9cases,1.8%).A total of 39 cases(7.8%)in the pregnant women with first pregnancy were negative for RhD.In the pregnant women with second child in the study group,the positive rate of irregular antibody screening was 4.0%(20/500),and the specificity of Rh blood group antibodies was found as follows:anti-E 1.8%(9/500),anti-D 1.4%(7/500),anti-C 0.4%(2/500)and anti-Ec 0.4%(2/500).The positive rate of irregular antibody screening in the pregnant women with first pregnancy in the control group was 0,and the difference between the two groups was statistically significant(P<0.05).Rh-HDN was found in 10 newborns(2%)of the 20 women with positive irregular antibodies in the pregnant women with second child,and the antibody titer during pregnancy was more than 32.No Rh-HDN occurred in newborns in the pregnant women with first pregnancy,and the difference between the two groups was statistically significant(P<0.05).Conclusion:Pregnancy stimulation can increase the probability of irregular antibodies in pregnant women,and irregular antibodies in Rh blood group can easily cause Rh-HDN,so attention should be paid to routine detection of five antigens of Rh blood group and irregular antibody screening during prenatal examination.It is helpful for the early detection of Rh-blood irregular antibodies and the assessment of fetal or neonatal risk of Rh-HDN.

Comparison of Two Enzyme Immunoassays and Four Lysate Antigens for the Detection of Antibody in Canine Blastomycosis

Blastomycosis, the systemic fungal disease of humans and animals caused by Blastomyces dermatitidis and the cryptic species Blastomyces gilchristii, is often misdiagnosed as a bacterial or viral pulmonary disease. Therefore, the development of improved immunodiagnostic assays for this disease has been the primary focus of research in our laboratory. The present study was designed to evaluate four Blastomyces yeast-phase lysate antigenic preparations (human, 597, Eagle River, WI;dog, ERC-2, WI;Human, B5927, Mountain Iron, MN;soil, 85, Georgia, ATCC 56920) for their ability to detect antibody in 48 serum specimens from dogs with diagnosed blastomycosis using an indirect ELISA (STD) compared to a biotin-streptavidin ELISA (B-SA). All four lysate antigens were able to detect antibodies in the specimens with mean absorbance values ranging from 0.930 (B5927) to 1.142 (ERC-2) with the STD ELSA and from 1.395 (B5927) to 1.775 (85) with the B-SA ELISA. The results indicated that both ELISA methods could be utilized for antibody detection, but the B-SA ELISA exhibited greater sensitivity than the STD ELISA with all four of the lysates.

DETECTION OF CANCER-ASSOCIATED ANTIGEN IN FECES USING MONOCLONAL ANTIBODIES IN THE DIAGNOSIS OF COLON CARCINOMA

Monoclonal antibodies against colon and pancreatic cancer, CL-2, CL-3, PS-9, PS-10, were used to detect the associated antigens in feces of patients with gastrointestinal carcinoma and non-cancer diseases. Binding inhibition test by SABC-ELISA method were performed for the measurement of the antigen level. Results showed that the associated antigen detected in feces of patients with colon cancer were significantly higher than that of non-cancer disease or normal subjects. The positive rates were 61.1% as detected with CL-2; 53.4% with CL-3; 55.0%, PS-9; and 53.3% PS-10 in cancer patients while that in normal subjects were 7%; 9%; 8%; and 8% respectively. When 'cocktail' of CL-2, PS-9 and PS-10 were used, the positive rates were 92.5% in colon cancer and 14% in normal subjects. In seven out of the sixty patients with colon cancer studied who were graded as Dukes A, the results were all positive. The results seem superior to the serologic detection and may provide a promising new approach in the early diagnosis of colon cancer.

Application of an indirect immunofluorescent staining method for detection of Salmonella enteritidis in paraffin slices and antigen location in infected duck tissues

AIM:To detect Salmonella enteritidis (S. enteritidis) in paraffin slices and antigen location in infected duck tissues. METHODS:Rabbits were immunized with purified bacillus to obtain S. enteritidis-specific antibody, which were then extracted by the caprylic-ammonium sulphate method, purified through High-Q columns. An indirect immuno-fluorescent staining method (IFA) was established to detect the S. enteritidis antigen in paraffin slices. S. enteritidis was detected in each organ tissue of ducklings experimentally infected with S. enteritidis. RESULTS:The gland of Garder, heart, kidney, spleen, liver, brain, ileum, jejunum, bursa of Fabricius from S. enteritidis experimentally infected ducklings were positive or strongly positive, and the S. enteritidis antigen was mainly distributed in the infected cell cytoplasm.CONCLUSION:IFA is an intuitionist, sensitive and specific method in detecting S. enteritidis antigen in paraffin wax slices, and it is a good method in diagnosis and antigen location of S. enteritidis. We also conclude that the gland of Garder, heart, kidney, spleen, liver, ileum, jejunum are target organs in S. enteritidis infections of duck, and S. enteritidis is an intracellular parasitic bacterium.

Sensitivity and Specificity Determinations with Isoelectric Focusing Fractions of <i>Blastomyces dermatitidis</i>for Antibody Detection in Serum Specimens from Infected Dogs

Blastomycosis and histoplasmosis manifest as lung and systemic fungal infections in mammals caused by Histoplasma capsulatum, and Blastomyces dermatitidis. These infections exhibit cross reactivity of antibodies which makes a correct diagnosis potentially elusive. The purpose of this study was to gain an understanding of which isoelectric focusing fractions (RotoforTM) of B. dermatitidis were reactive or cross reactive with serum specimens from dogs infected with B. dermatitidis, H. capsulatum, and Cryptococcus neoformans. Three serum specimens from dogs that were infected with B. dermatitidis, two dogs infected with H. capsulatum, and one dog infected with C. neoformans were assayed against the 20 B. dermatitidis RotoforTM fractions. Reactivity was determined using the indirect enzyme linked immunoassay (ELISA). Reactivity with B. dermatitidis was found predominantly in the protein fractions 1 - 6, and cross reactivity with H. capsulatum, and C. neoformans sera was found within the B. dermatitidis protein fractions 15 - 19.

HIV抗原抗体化学发光免疫检测方法的建立及优化

目的:建立并优化HIV抗原抗体化学发光免疫检测方法(CLIA)。方法:采用化学发光免疫的方法,通过对包被条件、HIV酶用量、反应加入量、反应时间和温度等反应参数进行优化,建立HIV抗原抗体联合检测方法,使用HIV国家参考品评价所建立方法的准确性。结果:包被比例取HIV-1抗原1∶5 000、HIV-2抗原1∶1 0000、HIV P24单抗1∶2 000;检测酶比例取Biotin-P24多抗1∶2 000;HRP-HIV-1抗原1∶5 000、HRP-HIV-2抗原1∶20 000、SA-HRP 1∶4 000;待测样本75μL/孔;第一步反应温度和时间分别为37℃和60 min,第二步反应温度和时间分别为37℃和30 min,为检测方法的较佳反应条件。检测国家参考品结果表明,阴性参考品符合率、阳性参考品符合率、灵敏度和精密性均符合国家参考品标准要求。结论:成功建立了特异、灵敏的HIV抗原抗体化学发光免疫检测方法,为在临床上推广应用提供了科学依据。

<i>Blastomyces dermatitidis</i>Antibody Responses in Serial Serum Specimens from Dogs with Blastomycosis: Comparison of Different Yeast Lysate Antigens

The systemic fungal organism, Blastomyces dermatitidis causes blastomycosis in animals and hu-mans. This study was designed to evaluate antibody detection in 55 serial serum specimens from 9 dogs with blastomycosis using B. dermatitidis yeast lysate antigens produced from two human isolates (B5896;B5931) and two dog isolates (ERC-2;T-58) with the indirect enzyme linked im-munosorbent assay (ELISA;peroxidase system) to determine an optimal lysate antigen(s) for use in the ELISA to detect antibody in the dog serum specimens. The mean absorbance values when the lysate antigens were compared with respect to their ability to detect antibody in the day 0 sera from the 9 dogs were 1.024 (ERC-2), 1.351 (B5896), 1.700 (B5931) and 2.084 (T-58) respectively. All of the reagents exhibited a high level of sensitivity and in all instances the amount of antibody declined as the time interval post-treatment increased, but the T-58 lysate prepared from the dog isolate from Tennessee was the optimal reagent. We continue to evaluate antigens for B. derma-titidis antibody detection in different immunodiagnostic assays.

HIV区分抗原抗体检测试剂指导下的HIV确证流程优化

目的探讨人类免疫缺陷病毒(HIV)区分抗原抗体检测试剂对HIV确证流程的指导意义,并对现有的确证流程进行优化。方法回顾性分析2021年1至12月我院接受HIV区分抗原抗体检测试剂筛查患者数据,分析试剂的检测值和抗原抗体反应模式对HIV感染者和假阳性者的区分能力,探讨基于HIV抗原抗体反应模式优化HIV确证流程的可行性。结果2021年接受HIV区分抗原抗体检测试剂筛查的患者共225094例,其中676例筛查阳性,513例真阳,2例失访,总体阳性预测值达76.11%。区分抗原抗体检测试剂检测值可以区分真阳性者(即HIV感染者)和假阳性者,检测值越高,阳性预测值越高(Z=22.033,P<0.001),受试者工作特征曲线下面积达0.995,最佳阈值为24.90,此时方法灵敏度为96.70%,特异度为98.10%。区分抗原抗体检测试剂反应模式同样可以区分真阳性者和假阳性者,其三种反应模式中,“抗原抗体双阳性(Ag+Ab+)”阳性预测值最高(卡方检验及两两比较均P<0.05),在本研究中高达100%。此外,区分抗原抗体检测试剂反应模式对HIV确证流程具有指导意义,7例反应模式呈抗原单阳性(Ag+Ab-)患者,首次HIV-RNA定量均>5000拷贝/ml,但此时HIV抗体确证试验(免疫印迹试验,WB)均未达到阳性标准,因此这类患者应直接采用HIV-RNA定量进行确证,证实了《全国艾滋病检测技术规范》技术规范中确证流程的价值。在反应模式呈Ag+Ab+的患者中,尽管HIV-RNA定量相对于WB的诊断效能优势并不显著,但可以显著减少诊断时间(V=78,P<0.001),有助于加快患者(尤其是急性HIV感染者)启动治疗,因此我们对技术规范中的确证流程进行优化,推荐Ag+Ab+患者直接采用HIV-RNA定量进行确证。在实践中,对Ag+Ab-和Ag+Ab+患者直接进行HIV-RNA定量显著缩短了急性HIV感染者的确证耗时。结论对HIV区分抗原抗体检测试剂检测值高的患者和反应模式呈Ag+Ab-的患者,应当加强患者的管理和随访;对于反应模式呈Ag+Ab-或Ag+Ab+的患者,可以直接采用HIV-RNA定量进行确证。

住院患者HIV抗体检测结果分析及防范

目的了解住院患者人免疫缺陷病毒（HIV）感染情况并探讨其防范措施。方法对2003～2008年106001例住院患者进行HIV抗体检测，并分析其阳性结果。结果初筛阳性160例，确认阳性140例，符合率为87．50％，阳性率为0．132％。140例感染者中男102例，女38例，年龄19～93岁，其中31～40岁最多（40％）。科室分布：内科55．71％，外科43．57％，其他科室0．71％。结论常规对住院患者进行HIV抗体检测对预防医源性感染、减少医疗纠纷、防止医务人员职业暴露有重要意义。

中国HIV阳性参比品库的建立以及HIV不同生物标志物的意义

为建立HIV阳性样品库并分析HIV不同生物标志物的意义,从我国不同地区以及不同人群中收集HIV感染者或可疑感染者血浆,对其进行HIV抗体、抗原、核酸以及基因型的检测,并用WB试剂对其进行抗体的确认检测。结果显示,该样品库共有样品190份,均为HIV阳性,含有我国流行的主要基因型,即B′、BC、AE和B亚型;HIV抗体S/CO值小于10者占11.1%,在10-15之间者占63.2%,大于15的占25.8%;病毒载量在50-10^3copies/mL者占7.9%,在10^3-10^5copies/mL者占82.2%,大于10^5copies/mL者占10.0%。而且抗体S/CO值大于10者,均为HIV抗体确认阳性,小于10者仅有61.9%为抗体确认阳性,但核酸均大于50copies/mL,而且抗体不确定样品的病毒载量均大于10^5copies/mL,但抗体不确定的8份样品中仅有4份样品为P24抗原阳性。结果提示该样品库样品来自于HIV感染的不同时期,可用于对HIV的不同试剂进行评价;而且核酸的检测可有助于对HIV早期感染的明确诊断。

快速检测、抗原-抗体联合酶联检测和集合核酸检测在MSM人群HIV-1检测中的应用研究

目的比较快速检测(胶体硒)和抗原-抗体联合酶联检测(4代酶联检测)以及集合核酸检测对男男同性恋人群(MSM)HIV急性感染的检验效能。方法结合该市2008年男男同性恋人群HIV感染专项调查工作,应用快速检测、4代酶联检测对接受调查的2 165例MSM进行HIV抗体初筛,对结果阴性者进行集合核酸检测,直至找到急性期感染者;对不同方法的检测成本进行估算,比较发现1例感染者的性价比。结果快速检测和4代酶联检测应用于MSM人群HIV筛查时,分别存在7.6%和2.9%的漏检率。本次调查使用集合核酸检测共发现10例急性期感染者。使用快速检测、4代酶联检测发现1例感染者的成本分别为48.8、50.5元,使用集合核酸检测发现1例急性期感染者的成本为7 380.2元。结论 4代酶联检测与快速检测成本接近,但前者功效更高,应该成为目前针对MSM人群HIV检测策略的组成部分,集合核酸检测应成为必要的补充,在该市MSM人群中使用上述方法的成本低于国外同类报道。

第四代HIV诊断试剂检测HIV抗体假阳性原因分析

目的分析第四代HIV诊断试剂检测HIV抗体假阳性的原因,减少假阳性检出率。方法选取119例HIV四代试剂检测初筛阳性的标本,送HIV确认实验室确认HIV抗体结果,分析比对两者的结果,探讨出现假阳性的原因。结果119例HIV抗体初筛阳性的标本,送至确认实验室回报结果 40例HIV抗体阳性,28例HIV抗体不确定,51例HIV抗体阴性。随着S/CO值的增高,初筛结果与确证结果阳性符合率也随之升高。结论 HIV四代检测试剂假阳性率较高,这与试剂同时检测HIV抗体和P24抗原有关。当1<S/CO≤10时,实验室检测人员应依据实验检测结果,结合受检者相应病史和个体状况进行综合分析。

抗HIV-1核心抗原p24单克隆抗体的制备及特性的初步鉴定

目的 :建立分泌抗HIV 1p2 4单克隆抗体 (mAb)的杂交瘤细胞株 ,并对其特性进行初步鉴定。方法 :以纯化的基因工程制备的p2 4抗原免疫BALB/c小鼠 ,取免疫小鼠的脾细胞与Sp2 /0骨髓瘤细胞融合 ,经HAT、HT选择培养及有限稀释法进行克隆化后 ,用间接ELISA法及Dotblot对其进行筛选和特性鉴定。结果 :筛选到 2株可分泌抗HIV 1p2 4mAb的杂交瘤细胞 ,其腹水效价为 1×10 -5,亲和力为 1.7× 10 4～ 1.8×10 4mol/L ,mAb的Ig亚类均为IgG1。两株mAb与HBcAg、HCVRNA阳性血清及HIVgp4 1等均无交叉反应 ,只与HIV 1p2 4抗原阳性血清产生特异反应。结论 :成功地建立了 2株可分泌抗HIV 1p2 4mAb的杂交瘤细胞 ,为进一步研制HIV 1p2

HIV抗原抗体光激化学发光法联合检测试剂的评价

目的评价北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIV Ag/Ab)检测试剂盒(光激化学发光法)与已上市HIV抗原抗体检测试剂盒的一致性以及血清转化灵敏度。方法收集363例血清样本,包括HIV患者样本、健康人员样本、以及类风湿因子样本、孕妇样本、ANA阳性样本、乙型病毒性肝炎和丙型病毒性肝炎患者等干扰样本;另外有10套HIV血清转换盘共120份血清样本。检测采用LiCA 500自动光激化学发光检测仪和相应的检测试剂、校准品和质控品以及检测参数,定性检测血清HIV1 p24抗原和HIV1/2抗体并评价与参比试剂结果一致性和血清转化灵敏度。结果北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIVAg/Ab)检测试剂盒(光激化学发光法)血清样本检测结果和参比试剂检测结果具有较好一致性;评估试剂的血清转化灵敏度同参比试剂相当。结论北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIVAg/Ab)检测试剂盒(光激化学发光法)与已上市同品种试剂盒检测结果具有一致性,血清转换灵敏度较高,有利于筛查HIV早期感染,为临床HIV早期诊断提供有效的实验室诊断依据。