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The present study aims to correlate the sample-to-cutoff ratios (S/CO) distributions of reactive results for HTLV-1/2 antibodies with the detection of proviral DNA in a population of blood donor candidates. It was carried out a retrospective data search of 632 HTLV-1/2 reactive samples, submitted to confirmatory testing from January 2015 to December 2019. Serological screening was performed by chemiluminescent microparticle immunoassay Architect rHTLV-I/II, whereas confirmatory testing was performed by in-house real-time polymerase chain reaction method. 496 out of 632 samples (78%) had undetectable HTLV-1/2 proviral DNA and 136 (22%) had detectable proviral DNA. HTLV infection was not confirmed in any individual for whom the S/CO ratio value was <4, and proviral DNA detection rates gradually escalated as S/CO ratio values increased. The sensitivity and predictive positive value found for the Architect rHTLV-I/II was 100% and 22%, respectively. The receiver operating characteristic (ROC) curve analysis showed that the optimal S/CO ratio value for predicting the presence of HTLV-1/2 was 18.11. High S/CO ratios were more associated with the detection of proviral DNA. The S/CO ratio value <4 suggests excluding true HTLV infection and the risk of blood transmission (AU).
O estudo tem como objetivo correlacionar às distribuições das razões sample-to-cutoff (S/CO) de resultados reagentes para anticorpos HTLV-1/2 com a detecção de DNA proviral em uma população de candidatos à doação de sangue. Realizou-se uma busca retrospectiva de dados de 632 amostras reagentes para HTLV-1/2 submetidas à testagem confirmatória entre janeiro de 2015 a dezembro de 2019. A triagem sorológica foi realizada pelo imunoensaio quimioluminescente de micropartículas Architect rHTLV-I/II, enquanto o teste confirmatório foi realizado pelo método de PCR em tempo real in-house. 496 de 632 amostras (78%) apresentaram DNA proviral indetectável e 136 (22%) apresentaram DNA proviral detectável. A infecção por HTLV não foi confirmada em nenhum indivíduo com valor de S/CO <4 e as taxas de detecção de DNA proviral escalonaram gradualmente à medida que as razões S/CO aumentaram. A sensibilidade e valor preditivo positivo encontrados para o Architect rHTLV-I/II foram 100% e 22%, respectivamente. Utilizando análise de curva ROC, o valor de razão S/CO ideal para predizer a presença de DNA proviral foi de 18,11. Razões S/CO elevadas foram mais associadas à detecção de DNA proviral. Em suma, o valor de S/CO <4 sugere a exclusão de infecção por HTLV e o risco de transmissão pelo sangue (AU).
Subject(s)
Blood Donors , Immunoassay , Human T-lymphotropic virus 1 , Human T-lymphotropic virus 2 , Real-Time Polymerase Chain Reaction , InfectionsABSTRACT
BACKGROUND: The syphilis diagnostic algorithms applied in different countries vary significantly depending on the local syphilis epidemiology and other considerations, including the expected workload, the need for automation in the laboratory and budget factors. This study was performed to investigate the efficacy of traditional and reverse syphilis diagnostic algorithms during general health checkups. METHODS: In total, 1,000 blood specimens were obtained from 908 men and 92 women during their regular health checkups. Traditional screening and reverse screening were applied to the same specimens using automatic rapid plasma regain (RPR) and Treponema pallidum latex agglutination (TPLA) tests, respectively. Specimens that were reverse algorithm (TPLA) reactive, were subjected to a second treponemal test performed by using the chemiluminescent microparticle immunoassay (CMIA). RESULTS: Of the 1,000 specimens tested, 68 (6.8%) were reactive by reverse screening (TPLA) compared with 11 (1.1%) by traditional screening (RPR). The traditional algorithm failed to detect 48 specimens [TPLA(+)/RPR(−)/CMIA(+)]. The median TPLA cutoff index (COI) was higher in CMIA-reactive cases than in CMIA-nonreactive cases (90.5 vs 12.5 U). CONCLUSIONS: The reverse screening algorithm could detect the subjects with possible latent syphilis who were not detected by the traditional algorithm. Those individuals could be provided with opportunities for evaluating syphilis during their health checkups. The COI values of the initial TPLA test may be helpful in excluding false-positive TPLA test results in the reverse algorithm.
Subject(s)
Female , Humans , Male , Agglutination , Automation , Budgets , Epidemiology , Immunoassay , Latex , Mass Screening , Plasma , Syphilis , Syphilis, Latent , Treponema pallidumABSTRACT
Objective To investigate the incidence of prozone phenomenon of rapid plasma reagin (RPR) test in syphilis serolog-ic testing and its correlation with the intensity of chemiluminescent microparticle immunoassay (CMIA) results.Methods A total of 101493 patients in our hospital from January 2014 to December 2015 were performed syphilis serologic testing by CMIA ,RPR and treponema pallidum particle agglutination (TPPA).The incidence rate of prozone phenomenon in RPR testing was evaluated.Its in-fluencing factors were investigated by using the Logistic regression.Results Among 101493 serum samples ,2180 cases were posi-tive by CMIA and 767 cases were positive by RPR ,the incidence rate of prozone phenomenon was 3.3% (26/767)in RPR.The Lo-gistic regression results indicated that the incidence of prozone phenomenon was significantly correlated with CMIA S /CO values and RPR titer ,but had no correlation with sex ,age and seasonality.Conclusion Although the incidence of prozone phenomenon is low in syphilis serologic testing ,but it is enough important.The patients with higher S/CO value in CMIA test have a higher inci-dence rate of RPR prozone phenomenon.
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Objective:To compare the performance of chemiluminescent microparticle immunoassay ( CMIA) and enzyme-linked immunosorbent assay ( ELISA) for the determination of Anti-PR3 and Anti-MPO.Methods:Concentration of Anti-PR3 and Anti-MPO in serum samples from 166 patients with autoimmune diseases and 50 healthy donors were determined by using CMIA (Method A) and ELISA(Method B),respectively.The results from both assays were analyzed and compared by statistical methods .Results:Method A showed better intra-assay reproducibility and inter-assay reproducibility than Method B for the determination of high ,medium and low levels of control serum .Both methods met the accuracy requirement .The correlation coefficient of Anti-PR3 and Anti-MPO were 0.987 8 and 0.989 6 for Method A and Method B ,respectively.And the Kappa coefficients were 0.897 and 0.882 for Method A and Method B,respectively.Conclusion:The performance of Method A is superior to Method B for the deter-mination of Anti-PR3 and Anti-MPO, which makes Method A to be a potentially better choice for clinical application .
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Objective To detect serum anti-Treponema pallidum specific antibody of 26 707 cases by Abbott I2000SR auto-matic chemiluminescent microparticle immunoassay analyzer,and treponema pallidum particle agglutination assay (TPPA) was regarded as a standard reference method which was used to detect anti-Treponema pallidum specific antibody.To analyze the false positive rate of Abbott I2000SR according to the TPPA.Methods Collected 26 707 serums from inpatients and outpatients of the hospital during September 1,2013 to March 5,2014.The subjects were asked to fasting conditions taking venous blood 3 ml,3 000 r/min centrifugal 10 min utes after the separation of serum,detected the Anti-TP by CMIA (Ab-bott I2000SR)and the TPPA testing,analyzed test results by statistical methods.Results There were 52 cases detected by I2000SR whose S/CO values of 26 707 cases of serum Treponema pallidum specific antibodies were 1 to 2,of which 9 cases were verified positive by TPPA,and the positive rate was 17.31%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 2 to 3,of which 9 cases were verified positive by TPPA,and the posi-tive rate was 34.62%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific anti-bodies were 3 to 5,of which 9 cases were verified positive by TPPA,and the positive rate was 34.62%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 5 to 7,of which 11 cases were veri-fied positive by TPPA,and the positive rate was 44%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 7 to 10,of which 17 cases were verified positive by TPPA,and the positive rate was 68%.There were 28 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 10to 13,of which 24 cases were verified positive by TPPA,and the positive rate was 85.71%.There were 23 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 13 to 17,of which 20 cases were verified posi-tive by TPPA,and the positive rate was 86.96%.There were 24 cases detected by I2000SR whose S/CO values of Trepone-ma pallidum specific antibodies were 17 to 21,of which 22 cases were verified positive by TPPA,and the positive rate was 91.67%.There were 29 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 21 to 26,of which 28 cases were verified positive by TPPA,and the positive rate was 96.55%.There were 104 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were above 26,of which 104 cases were verified posi-tive by TPPA,and the positive rate was 100%.The total number of positive cases were 364,of which 254 were positive ca-ses,the positive rate was 69.78%.False positive rate was 0.42% and positive predictive value was 69.78%.Conclusion Abbott I2000SR automated chemiluminescent microparticle immunoassay analyzer has the feature of automated detection, closed reagents,simple operation,speed,and more accurate results and so on.Although high sensitivity but its results have false positive,so cannot diagnose based on the results of Abbott I2000SR,and need use of the TPPA to test and corroborate.
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In this study ,we detected the positive rate of anti‐HBs and anti‐HBc antibody among the subject population in Fujian Medical University Union Hospital ,and to evaluate different detection methods of anti‐HBc antibody .The positive rate of anti‐HBs and anti‐HBc antibody were detected by chemiluminescent microparticle immunoassay (CMIA) and one‐step com‐petitive enzyme‐linked immunosorbent assay (ELISA) from the year 2012 to 2013 .The subject population was divided into three groups :group 1 with the age of less than 2 years old ,group 2 with the age of 2‐20 years old ,and group 3 with the age of more than 20 years old .The positive rates of anti‐HBV antibody in the different groups were analyzed .Furthermore ,anti‐HBc antibody of 92 samples selected from the immunized population was detected by CMIA and three kinds of ELISA reagents . Meanwhile ,the detection of anti‐HBc antibody by the same ELISA reagent but different operating modes were performed in these samples .The highest positive rate of anti‐HBs antibody was detected in group 1 ,and there was no significance difference of positive rate between two detection methods of anti‐HBs antibody among three groups .The positive rate of anti‐HBc anti‐body using CMIA was significantly lower than those with ELISA among group 1 and 2 .Among the 92 samples ,the positive rate of anti‐HBc antibody was 2 .2% using CMIA .With three kinds of method of ELISA reagent ,the positive rate of anti‐HBc antibody were 79 .3% ,82 .6% and 94 .6% ,respectively ,and there was no statistical significance among the results of three ELISA reagents .Anti‐HBc was not detected from 19 samples using ELISA methods with different operating modes .It's con‐cluded that the anti‐HBs antibody declined with the increase of age ,and it is necessary to discriminate the specific population to strengthen immune system .The obviously higher positive rate of anti‐HBc antibody was found by ELISA in immunized popula‐tion than that by CM IA . Concerning on the false positive of ELISA , specimen sampling with one specific test item or the CMIA method was recommended to detect the anti‐HBc antibody .
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Objective To evaluate the clinical value of the chemiluminescence immunoassay particles (CMIA)in the diagnosis of syphilis.Methods The serum specimens from 150 cases of syphilis in our hospital were selected as the observation group and con-temporaneous 150 serum samples from non-syphilis healthy people were selected as the control group.The toluidine red unheated serum test (TRUST),treponema pallidum particle agglutination test (TPPA)and CMIA were adopted to conduct the detection. The sensitivity,accuracy and specificity of the three kinds of method were calculated and their differences were compared and ana-lyzed.Results The sensitivity of TRUST and TPPA and CMIA was 65.3%,97.7% and 99.3% respectively,the specificity was 74.7%,97.3% and 100.0% respectively,the accuracy was 70.0%,97.0% and 99.7% respectively,the difference among three kinds of methods had statistical significance (P 0.017).Conclu-sion CMIA is equivalent to TPPA in the sensitivity,specificity and accuracy,is superior to TRUST,and has the advantages of sim-ple operation,objective results and good repeatability.
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OBJECTIVE: To discuss the application of conversion method based on lognormal distribution in comparison of different detection methods, taking cyclosporine A trough concentration in renal transplant patients for example. To establish a more accurate method for conversion of the results by different detection methods. METHODS: Cyclosporine A trough concentration data measured by UPLC-MS/MS and CMIA were changed to logarithmic form, and nonparametric Kolmogorov-Smirnov test was used to analyze whether they accorded with normal distribution. The conversion coefficient (CCop) was determined by the ratio of optimal trough concentrations by the two detection methods. This conversion method was used for the rapid switch of results of the two methods, and was compared with the traditional linear regression method and average comparison method. RESULTS: The results of two methods accorded with normal distribution (P > 0.05) after transformed logarithmically. The conversion coefficient CCop was 1.29. Compared with linear regression method, the developed lognormal distribution method had smaller weight residues (WRES) in the low concentration region. The determined optimal c0 concentration can better reflect the target concentration for ideal pharmacological effect than the average. CONCLUSION: Lognormal distribution method developed in this study can be used to switch results of the different detection methods better when detection methods change in therapeutic drug monitoring, which is available for adjustment of individualized dosing regimens.
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Objective To compare the difference of the HBsAg detected results between the Roche cobas e601 electrochemilumi-nescence immunoassay instrument and the Abbott Architect i2000chemiluminescent microparticle immunoassay instrument.Methods The HBsAg positive specimens with the quantitation results of lower than 250IU/mL detected by the Abbott Architect i2000 were selected and simultaneously detected by the Roche cobas e601.The differences of detected results were compared and per-formed the linear correlation and analysis regression.Results 46 clinical specimens were detected.The detected results had best correlation between the two instruments by getting rid of 1 specimen with unconformable reactivity of detected results.15 speci-mens had the HBsAg detected result of 0.05-1.00 IU/mL by the Abbott Architect i2000,the linear regression equation was Y =17.49X+0.843(r=0.979);15 specimens had the HBsAg detected result of 1.1 -10.00 IU/mL IU/mL by the Abbott Architect i2000,the linear regression equation was Y =15.72X +21.06(r=0.952);15 specimens had the HBsAg detected result of 11 -250 IU/mL by the Abbott Architect i2000,the linear regression equation was Y =29.17X -129(r=1.000).Conclusion The detected results have better correlation between the two instruments and can be mutually converted by the formulas.
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Objective To investigate the clinical significance of quantitative detection of serum HBsAg.Methods Serum concentrations of HBsAg were detected by chemiluminescent microparticle immunoassay in 7612 hospitalized non-hepatitis patients.The distribution of HBsAg positive patients and the relationship of HBsAg concentration with serum anti.HBs.HBeAg and HBV DNA were analyzed.Results The HBsAg positive rate was 11.4%(870/7612)in this series.The serum HBsAg ranged from 0.08 U/mL to 125 000 U/mL with a median of 932.28 U/mL.No significant difference of HBsAg concentrations between male and female patients was observed(Z=-0.366,P＞0.05).1.There were negative correlation of HBsAg concentration with the age of patients(r=-0.370,P＜0.01),and positive correlations of HBsAg with HBeAg(r=0.654,P＜0.01)and HBV DNA levels(r=0.765,P＜0.01).Conclusion The quantitative determination of seFum HBsAg may be useful in estimating the hepatitis B viral replication and clearance.
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BACKGROUND: The prevalence of Hepatitis B virus (HBV) in Korea is still higher than that of devel-oped countries. Recently, the automated chemiluminescent microparticle immunoassay analyzer ARCHITECT i2000 (Abbott Laboratories, Abbott Park, IL USA) was introduced in Korea and we evaluated performance of the tests for serological markers for HBV infection. METHODS: We analyzed precision, agreement, sensitivity, specificity and throughput of the HBs antigen, anti-HBs and anti-HBc as well as linearity and compared with the AxSYM (Abbott Labora-tories, Abbott Park, IL USA) for anti-HBs. Precision, linearity and comparison were performed on the basis of the National Committee for Clinical Laboratory Standards guidelines. Random patients 'sera were used for this study. RESULTS: The coefficients of variations of precision were below 5% for anti-HBs and anti-HBc (total) except for the HBs antigen. The agreements, sensitivities and specificities for serologic mark-ers were more than 90%. The linearity and comparison for anti-HBs were statistically significant (P < 0.001). The throughput of ARCHITECT i2000 was 110 tests/hours and that was 2.8 times faster than that of the AxSYM. CONCLUSIONS: These results suggest that ARCHITECT i2000 can provide rapid and effective results for serologic markers for HBV infection. However, each laboratory should decide the utiliza-tion of this analyzer on the basis of volume of samples, other items tested concurrently, and the inter-face of existing facilities etc.