Effect of double heterozygous hemoglobin on the results of different glycosylated hemoglobin detection systems / 临床检验杂志

Objective@#To investigate the effects of glycosylated hemoglobin A1c (HbA1c) from the patients with double heterozygotes Hb Q-H and Hb J-Bangkok combined with β-thalassemia on the results of different HbA1c detection systems. @*Methods@#Blood samples from 20 healthy adults and 20 patients with type 2 diabetes mellitus (T2DM) were collected to assess the results of five glycosylated hemoglobin detection systems. Blood samples from one Hb Q-H patient and one Hb J-Bangkok patient with β-thalassemia were also collected, and they were performed hemoglobin capillary electrophoresis with Capillarys2 and globin gene analysis by gap-PCR, PCR-RDB and DNA sequencing. The levels of HbA1c in all samples were detected by BioRad VARIANT Ⅱ (VⅡ), BioRad VARIANT ⅡTurbo2.0 (V Ⅱ-T2.0), Capillarys 2 Flex Piercing (C2FP), Primus Ultra2 (Ultra2) and Roche PPI 800 (PPI 800) glycosy lated hemoglobin detection instruments, respectively. For the samples with double heterozygotes, the levels of HbA1c were detected for 3 times each sample, and the results were preserved and analyzed. @*Results@#The genotype of the Hb Q-H sample was --α QT /--SEA;β N /β N , and HbA1 CD74 G＞C mutation occurred in globin α1 chain, forming Hb Q-Thailand hemoglobin variant without normal α-globin peptide chain. The genotype of Hb J-Bangkok combined with β-thalassemia was αα/αα;βCD56/βCD41-42, and the point mutation of GGC＞GAC occurred at codon 56 of globin β-chain, forming Hb J-Bangkok hemoglobin variant without normal β-globin peptide chain. For the Hb Q-H sample, HbA1c results were reported by 3 of 5 HbA1c detection systems. The chromatograms of VⅡ and VⅡ-T2.0 detection systems were obviously different from normal chromatograms, and HbA1c results were not reported. However, the chromatograms of the C2FP system were similar to normal chromatograms, and the result of HbA1c was 3.7%. The Ultra2 system and PPI system reported the HbA1c results, 5.3% and 5.7%, respectively, without abnormal alarm. For the Hb J-Bangkok with β-thalassemia sample, HbA1c results were also reported by 3 of 5 HbA1c detection systems. The chromatograms of VⅡ and Sebia detection systems were obviously different from normal chromatograms, and HbA1c results were not reported. However, the chromatograms of VⅡ-T2.0 system were different from normal chromatograms, and a P4 peak (84.9%) was found. The HbA1c result was reported as 4.7%. The Ultra2 system and PPI system reported the HbA1c results, 4.7% and 3.8%, respectively, without abnormal alarm. @*Conclusion@#The samples from the Hb Q-H patient and the Hb J-Bangkok patient with β-thalassemia do not contain normal HbA, and there should be no HbA1c results. The chromatograms of VⅡ and VⅡ-T systems are obviously abnormal, indicating that the results can not be reported. The C2FP system is interfered obviously by Hb Q-H, but reports the HbA1c results, while it does not report the HbA1c results of Hb J-Bangkok combined with β-thalassemia. Both of Hb Q-H and Hb J-Bangkok have obvious interference to PPI and Ultra2 detection systems.

Bactericidal effect of ozonated camellia oil on Staphylococcus aureus in vitro / 中南大学学报(医学版)

Objective:To explore a new method for detecting the bactericidal effect of oiling agent in vitro,and to determine the disinfectant effecacy ofozonated camellia oil on Staphylococcus aureus.Methods:Suspension of Staphylococcus aureus was prepared and innoculated on the LB plate by plate scribing method.After culture overnight,21 bacterial monoclones with the same diameter were selected and divided into 3 groups:A negative control group,a baseoil (camellia oil) group and an ozonated camellia oil group.We used a ring to isolate the single clone and added oil inside the ring,cultured the whole plate over night,picked out each single clone (with gel) to 5 mL LB medium and cultured it for 12 h.The final concentration of the LB medium was detected by plate count method and turbidimetry.Results:According to the plate count method and turbidimetry,the bacterial concentration in the ozonated camellia oil group was lower than that in the negative control group and base oil group Conclusion:Bacterial monoclone culture method shows that ozonated camellia oil can significantly kill Staphylococcus aureus,and this method is an effective method for evaluating the bactericidal function of the oiling agent in vitro.

The effect of lens opacity on the measurement of retinal oxygen saturation / 中华眼底病杂志

Objective To analysis the effect of lens opacity on the measurement of retinal vessel oxygen saturation.Methods This was a cross sectional study.Forty four eyes of 44 patients with different degrees of lens opacity were enrolled.There were 23 males and 21 females.The patients aged from 48 to 84 years,with the mean age of(71.8± 10.3) years.The mean best corrected visual acuity was 0.65±0.22.The mean intraocular pressure was (14.2± 4.3) mmHg (1 mmHg=0.133 kPa).The mean equivalent spherical degree was (-0.05 ± 2.10) D.The opitical quality analysis system was applied to measure intraocular objective scattering index (OSI) caused by lens opacity.According to the OSI,the opacity of lens was divided into four groups.Patients with OSI value ＜ 1.0 was grouped to level 1,which indicated that the lens were basically transparent;patients with OSI value between 1.0 and 3.0 was grouped to level 2,which indicated early cataract;patients with OSI value between 3.0 and 7.0 was grouped to level 3,which indicated progressive cataract;patients with OSI value ＞ 7.0 was grouped to level 4,which indicated the mature stage of cataract.The retinal oximeter Oxymap T1 was used to capture the fundus images under different wavelengths.Pearson correlation analysis was used to analyze the correlation between retinal oxygen saturation and age,intraocular pressure,equivalent spherical degree and OSI.One way ANOVA was used to analyze the difference of retinal oxygen saturation among groups.Results The mean retinal arterial oxygen saturation,venous oxygen saturation and arteriovenous difference was (90.70± 6.46)％,(47.34 ± 13.51)％,(43.36 ± 10.09)％,respectively.The correlations of retinal arterial oxygen saturation,venous oxygen saturation and arteriovenous difference with age,intraocular pressure,equivalent spherical degree was not statistically significant (all P＞0.05).The retinal arterial oxygen saturation and venous oxygen saturation was negatively correlated with OSI (r=-0.462,-0.500;P=0.002,0.001),the arteriovenous difference and OSI was positively correlated (r=0.373,P=0.013).According to lens opacity,there were 11 eyes in level 1,9 eyes in level 2,14 eyes in level 3,10 eyes in level 4.There were significant differences of retinal artery and venous oxygen saturation among different lens opacity levels (F=5.340,4.710;P=0.003,0.007);meanwhile,the arteriovenous difference was not significantly different (F=2.048,P=0.123).The retinal arterial oxygen saturation and venous oxygen saturation was significantly lower in the level 4 lens opacity group than any other three groups (all P＜0.05),but there was no statistically significant difference among level 1 to level 3 lens opacity group.Conclusion The effect of lens opacity of level 1 to level 3 is limited on the measurement of retinal oxygen saturation,but level 4 lens opacity will cause decrease of retinal artery and venous oxygen saturation.

Comparison of early-warning ability of five different detection systems for erroneous glycosylated hemoglobin results from compand heterozygotes of hemoglobulin NewYork acompainying β-thalassemia / 临床检验杂志

Objective To analyze the HbA1c results of double heterozygotes of hemoglobin(Hb) NewYork and β-thalassemia detected by five different HbA1c detection systems,and compare the early-warning abilities of erroneous glycosylated hemoglobin results for Hb NewYork and β-thalassemia heterozygotes.Methods Peripheral blood samples from 40 patients without hemoglobinopathies with different range of HbA1c levels were collected to evaluate the consistency of the detected results.Variant Ⅱ system was used as the reference system which successfully completed NGSP Level Ⅰ laboratory certification.Variant Ⅱ Turbo 2.0 (V Ⅱ-T),Capillary 2 Flex Piercing(2FP),Primus Ultra2 (Ultra2)and Roche Modular PPI(PPI) 800 were used as the comparative systems.The HbA1 c in 2 sera from the patients with compand heterozygotes of Hb NewYork was detected by the above systems.Hemoglobin electrophoresis was performed.Gentypes of á-and β-globin genes were analyzed by GAP-PCR,hybridization and dideoxy chain termination method.Results The HbA1c values in non-hemoglobinophthy samples obtained using V Ⅱ-T 2.0,Ultra2,C2FP and PPI systems were well correlated with that of VⅡ system.The hemoglobin genotypes of the two cases of compand heterozygotes were aa/aa,βIVS-2-654/βNewYork and aa/aa,β41-42/βNewYork,respectively.The proportions of HbA were all 0 while the proportions of Hb NewYork were 93.5％ and 94.0％ respectively.The HbA1c results of the two cases detected were 4.3％ (23 mmol/mol)and 4.5％ (26 mmol/mol)by V Ⅱ,4.5 ％ (26 mmol/mol) and 4.6％ (27 mmol/mol) by VⅡ-T 2.0,no values and no values by C2FP,4.1％ (21 mmol/mol) and 4.3 ％ (23 mmol/mol) by Ultra2 and 4.2％ (22 mmol/mol) and 4.8 ％ (29 mmol/mol) by PPI systems,respectively.All the systems did not send warning for abnormal signs in profiles and results.Conclusion The five systems presented different early-warning ability for the double heterozygotes of Hb NewYork and β-thalassemia.The compand heterozygotes should theoretically not contain HbA1 c,but the systems V Ⅱ,V Ⅱ-T,Ultra2 and PPI showed detectable results of HbA1 c indicating all the four systems were not able to provide with early-warning.C2FP system did not report HbA1c result so it exhibited early-warning ability for the double heterozygote.

With rapid latex scattering immune turbidimetric method to detect the urine retinol binding protein and evaluate methodology / 中国生化药物杂志

Objective The rapid latex scattering immune turbidimetric method detecting urine retinol binding protein, and evaluate methodology.MethodsIn accordance with the commission of American clinical laboratory standards (NCCLS) requirements, evaluation of the research methods of reagent sensitivity, precision, accuracy, stability, linear range, interference analysis, specific degrees.ResultsWith rapid latex scattering immune turbidity method to detect the urine retinol binding protein, for instance, the minimum detection limit of 0.0381 mg/L;Repeatability precision is 1.198%, intermediate precision is 5.541%, reproducibility precision is 6.662%;The linear range is within 0~10 mg/L;Recovery rate were 99.00% and 104.00% respectively;When TBIL<100mg/L and Hb<10mg/L, the detection of Tbil, Hb, RBP interference;With the urine RBP than kit in automatic analyzer compared the test results of analysis showed that r2=0.9720, correlation can be;50 cases of clinical specimens using two methods showed no statistically significant difference positive rate (χ2=0.948, P=0.948).ConclusionRapid latex scattering immune turbidimetric method were used to detect the urine retinol binding protein, has high precision, high accuracy, the advantages of high sensitivity, stability and anti-jamming is strong, good.

Progress in laboratory diagnosis of heparin induced thrombocytopenia / 中华检验医学杂志

Heparin induced thrombocytopenia ( HIT ) is a severe side effect of heparin with antibody-mediation.Laboratory assays can be divided into two major categories, about functional assays and HIT antibodiesdetection.Thefunctional assays, such as the serotonin release assay ( SRA ) and heparin-induced platelet activationassay( HIPA) , are sensitive and specific for HIT.They arethe reference standard assays generally, but have thedeficiencies of complicated operation and time-consuming, and cannot be used as a routine examination. TheHIT antibodiesdetections, such as ELISA, immune turbidimetry assay, chemiluminescent assay and lateral flow immunoassay, have high diagnostic sensitivityandareavailable at routine laboratories.They can exclude the diagnosis of HIT or beused to diagnose HIT effectively combined with the pre-test probability score(4Ts score) of HIT.

Influences of hemoglobin variants on different HbA1c measurement systems / 中华检验医学杂志

Objective To assess influences of hemoglobin variants on different HbA 1c measurement systems.Methods HbA1c values of normal samples and samples with hemoglobin variants were measured respectively byenzymatic assay (Norudia N HbA1c,SEKISUI), immunity transmission turbidity (oneHbA1c FS,DiaSys), boronate affinity HPLC(Ultra2,Trinity Biotech), capillary electrophoresis(Capillary 2 Flex Piercing,Sebia)and ion exchange HPLC(HA8160,Arkary;Variant Ⅱ Turbo(VⅡ-T),Bio-Rad;Variant ⅡTurbo 2.0 (VⅡ-T 2.0), Bio-Rad).HbA1c values from different hemoglobin variants and HbA1c measurement systems were analyzed .Results The HbA1c values from the 7 HbA1c measurement systems were well correlatedin normal samples .For HbE heterozygote , the HbA1c values from VⅡ-T were divided into 2 groups comparing with CFP , and HbA1c differences between CFP and other measurement systems are minor except for HA8160 and VⅡ-T.The HbA1c values of homozygous HbE were given by Ultra 2 but CFP and VⅡ-T 2.0.The differences of HbA1c values from samples with J-Bangkok are much higher than those from the samples with other hemoglobin variants .The differences of HbA1c values from samples with all kinds of hemoglobin variants(Hb J-Bangkok, Hb J-Newyork, Hb G-Taipei and Hb G-Coushatta)are dramatic for VⅡ-T.For rare Kurosaki, CFP can give a hint that there existshemoglobin variant while measuring HbA 1c. Conclusions Capillary Flex 2 Piercingcan well recognize common hemoglobin variants . Different hemoglobin variants have different influences on different HbA 1c measurement systems.The influences of J-Bangkok among HbA1c measurement systems are more evident than the other common hemoglobin variants .

Assessment of the consistency of five standardized cystatin C measurement systems / 中华检验医学杂志

Objective To assess the consistency of four standardized cystatin C particle-enhanced turbidimetric assay (PETIA) and one particle-enhanced nephelometric immunoassay (PENIA) measurement systems Methods Performance verification test was conducted according to CLSI EP 15-A2 and EP9-A2. Fourty serum samples in comparative test were obtained from the remaining serum samples of outpatients in Peking Union Medical College Hospital in March 2013.Fourty serum samples were tested on Olympus AU5400 automatic biochemical analyzer ( four PETIA Cys C reagents:Shanghai Jingyuan Co ., Ltd, Beijing Leadman Biochemistry Co ., Ltd, Beijing Strong Biotechnologies , Maker Biotechnology in Sichuan , and labelled as A, B, C, D respectively) and PENIA N Latex Cys C measurement system on Siemens BNⅡ(labelled as E).Correlation analysis were performed among four PETIA methods one PENIA method Differences of each detection system were compared in the medical decision level 1,2,3,4 mg/L.The reference material ERM-DA471/IFCC was measured by five systems and bias ( percentage bias ) was calculate for each system.Results Results of systems A, B, C, D, E were 1.29(0.89-2.43), 1.30 (0.96-2.59), 1.22(0.90-2.44), 1.27(0.96-2.47), 1.14(0.82-2.05)mg/L.Chart shows bias among these five systems was small when Cys C concentration was less than 4mg/L.PETIA method A, B, C, D correlated with their mean value well , with the average deviation from their mean value ( percent deviation) at -0.017 -0.031 mg/L ( -3.1%-2.1%), and all were less than allowed bias from the biological variation (3.4%).The deviation of PETIA method A, B, C, D with their mean value in medical decision level at -0.176 -0.178 mg/L.Systems A, B, C, D correlated well with the result of PENIA method system E , and the mean deviation ( percent deviation ) was at 0.278 -0.326 mg/L ( 12.6%-18.5%) , and the deviation ( percent deviation ) in the medical decision level 0.055 -1.079 mg/L (5.51%-26.98%).Bias of PETIA method A, B, C, D Cys C system measuringERM -DA471/IFCC ranged from 0.22 to 0.39 mg/L ( 3.9%-7.0%) , which exceeded the allowable range of the reference material target value, and were larger than the allowable bias from biological variation (3.4%).Bias ( percent ) of PENIA method system E was -0.1 mg/L ( -1.7%) , within the allowable range of ERM-DA471/IFCC target value .Conclusions The consistency of four assesed PETIA Cys C reagents was relatively ideal, and improved markably after being traced to ERM-DA471/IFCC.Besides, the results of PETIA were higher than those of PENIA .Bias among these five systems was small when Cys C concentration was less than 4 mg/L, and the bias became larger in higher Cys C concentration.

Validation and development of an immunonephelometric assay for the determination of alpha-1 antitrypsin levels in dried blood spots from patients with COPD / Desenvolvimento e validação de um método de imunonefelometria em amostras de sangue em papel-filtro para a dosagem da alfa-1 antitripsina em pacientes com DPOC

OBJECTIVE: To validate and develop an immunonephelometric assay for the determination of alpha-1 antitrypsin (AAT) levels in dried blood spots from COPD patients in Brazil. METHODS: We determined AAT levels in serum samples and dried blood spots from 192 COPD patients. For the preparation of dried blood spots, a disk (diameter, 6 mm) was placed into a tube, eluted with 200 µL of PBS, and stored overnight at 4ºC. All of the samples were analyzed by immunonephelometry in duplicate. We used the bootstrap resampling method in order to determine a cut-off point for AAT levels in dried blood spots. RESULTS: The correlation coefficient between the AAT levels in serum samples and those in dried blood spots was r = 0.45. For dried blood spots, the cut-off value was 2.02 mg/dL (97% CI: 1.45-2.64 mg/dL), with a sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 95.7%, 27.2%, and 100%, respectively. CONCLUSIONS: This method for the determination of AAT levels in dried blood spots appears to be a reliable screening tool for patients with AAT deficiency. .

OBJETIVO: Validar e desenvolver um método de dosagem de alfa-1 antitripsina (AAT) por imunonefelometria em amostras de sangue em papel-filtro em pacientes com DPOC no Brasil. MÉTODOS: Amostras de soro e de sangue em papel-filtro de 192 pacientes com DPOC foram utilizadas para a dosagem de AAT. Para a preparação das amostras de sangue em papel-filtro, um disco do papel com diâmetro de 6 mm foi colocado em um tubo e eluído com 200 µL de PBS, permanecendo por toda a noite a 4ºC. Todas as amostras foram analisadas em duplicata por imunonefelometria. O método de reamostragem bootstrap foi utilizado para a determinação de um ponto de corte para o nível de AAT nas amostras de sangue em papel-filtro. RESULTADOS: O coeficiente de correlação entre os níveis de AAT em soro e em sangue em papel-filtro foi de r = 0,45. Para as amostras em papel-filtro, o ponto de corte foi de 2,02 mg/dL (IC97%: 1,45-2,64 mg/dL), com sensibilidade, especificidade, valor preditivo positivo e valor preditivo negativo de 100%, 95,7%, 27,2% e 100%, respectivamente. CONCLUSÕES: Este método de determinação dos níveis de AAT em sangue em papel-filtro se mostrou uma ferramenta confiável para o rastreamento de pacientes com deficiência de AAT. .

Peformance Evaluation of Bioporto Diagnostics' Neutrophil Gelatinase-associated Lipocalin Assay on Automated Clinical Chemistry Analyzer Hitachi 7600 / 임상검사와정도관리

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is known to be one of the ideal biomarkers for acute kidney injury providing early information on damage to the kidney. METHODS: We evaluated the performance for precision and the reportable range of the automated NGAL Test (Bioporto Diagnostics, Denmark) assay and compared the values of these tests with widely used point of care test. The reference interval of NGAL was established in Korean adults. RESULTS: Within run percent coefficient of variation (%CV) and total precision %CV for 2 levels were all within 5%. The reportable range was found to be acceptable for the range of 57.0 - 3182.0 ng/mL (r=0.999). The method comparison was made between Biosite's assay and Bioporto Diagnostics' (Passing and Bablok fit, y=1.94x - 5.29; x, Biosite; y, Bioporto; n=31; y range, 250 to 1,308 ng/mL; r2=0.959). The correlation was linear within the limit of 1,500 ng/mL, but not beyond this limit. The 2.5 and 97.5 percentile of the reference range for the samples were 43.2 ng/mL and 124.8 ng/mL, respectively. CONCLUSIONS: Since NGAL Test can be used in automated chemical analyzer, it can not only reduce the man power and time consumed in but also displayed excellent precision and linearity.

Light transmittance aggregometry with non-adjusted PRP is more suitable for clinical laboratory =monitoring antiplatelet therapy / 中华检验医学杂志

Objective In this study,maximum platelet aggregation rate of Light transmittance aggregometry (LTA) for coronary heart disease(CHD) patients taking antiplatelet drug and patients without antiplatelet therapy was measured in non-adjusted and platelet count-adjusted platelet-rich plasma (PRP).The aim of this study is to compare which method is superior in evaluation of antiplatelet drug effect.Methods This is a methodology comparative research.560 CHD outpatients and inpatients that visited Beijing Anzhen Hospital of the Capital University of Medical Sciences from May to June,2012 were chosen,who were treated with aspirin monotherapy,or patients on combination therapy with aspirin and clopidogrel,as well as patients without antiplatelet therapy.LTA was performed in non-adjusted (improved method) and platelet count (200 × 109/L)-adjusted PRP (original method),using 6 μmol/L adenosine diphosphate (ADP) and 0.5 mmol/L arachidonic acid (ARA) as agonists.The maximum aggregation rates in 5 min were detected,and consistency and differences of the two methods were compared.Results There is no statistically significant correlation between maximum aggregation rate and platelet count in PRP with 6 μmol/L ADP or 0.5 mmol/L ARA as agonists in all subgroups including aspirin monotherapy,combination therapy with aspirin and clopidogrel and patients without antiplatelet therapy (-0.21 ≤ r ≤0.111,P ＞ 0.05).The maximum aggregation rate using ADP as agonists in original method is decreased compared with improved method,there is statistically significant difference in all subgroups including patients without antiplatelet therapy,aspirin monotherapy,combination therapy with aspirin and clopidogrel less than one week and more than one week.The variability of platelet aggregation rate using ADP as agonists with improved method is lower than that with original method in all subgroups.Yet the maximum aggregation rates using ADP as agonists with improved method and original method correlate well with each other in all subgroups (r =0.78,0.73,0.40,0.71,P ＜0.01).In the subgroup of subjects without antiplatelet therapy using ARA as agonist,platelet aggregation rate is decreased in original method compared with improved method,there is statistically significant difference,and the variability of the aggregation rate with improved method is also lower than that with original method,ranging from 62％-98％ relative to 5％-89％.The decrease of aggregation rate using ARA as agonist for patients taking antiplatelet drug compared with patients without antiplatelet therapy can be detected both with improved method and original method.Conclusion Non-adjusted PRP in LTA is more convenient and time-saving,and it also means less effects on platelet in vitro.Therefore,non-adjusted PRP is more suitable for monitoring efficacy of antiplatelet therapy in clinical laboratory.

Performance evaluation of nine commonly used urine albumin assay systems / 中华检验医学杂志

Objective By investigating precision,linearity and accuracy of 9 commonly urine albumin assay systems (8 of immuno-turbidimetric assays and 1 of immuno-nephlometric assay),and comparing the concordance of measurement results,to elucidate the quality of the existing analytical systems.Methods Referring to Clinical and Laboratory Standards Institute (CLSI) EP15-A2,two mixed urines with U-Alb levels of 20 mg/L and 200 mg/L were made to validate precision; Referring to CLSI EP14-A2,fourty fresh urines were selected to evaluate matrix effect of saline diluted European Reference Materials (ERM) DA 470 and saline diluted urine,also to reflect the variation of measurement results among systems; Referring to EP6-A,saline diluted urines (10 levels) were made to validate linearity; Taking the theoretical concentration of precisely saline-diluted ERM-DA 470 as the target value,accuracy of each assay system was evaluated.Maximal allowable coefficient variation (CV) of ≤ 15％ was taken as the acceptable precision for each assay system,as rccommcnded by International Federation of Clinical Chemistry (IFCC)-and National Kidney Disease Education Program (NKDEP) ; maximum allowable bias of ≤25％ was taken as criteria for accuracy evaluation as used in Proficiency Test (PT) sponsored by College of American Pathologists (CAP).Results At level of micro-albuminuria(20-200 mg/L),all 9 systems total CVs were ≤ 15％ ; No matrix effect or interference were found in saline diluted ERM DA 470 and saline diluted urine.For A,B,E,F,G and I systems,validated linear regions were close to those stated in kit instruction;For C,D and H systems,the lower limits of validated linear region (18.7,3.6 and 12.0 mg/L,respectively) were higher than those stated in kits instruction (0,0.9 and 5.0 mg/L,respectively) ;For B and C systems,the lower limits of validated linear region were close to the upper limits of reference interval stated in kit instruction.When urine albumin was ≤ 12.6 mg/L,A,E,F,G and I systems showed good accuracy,absolute biases at all dilution were below 3 mg/L,D system showed higher positive bias (5.0-14.4 mg/L),B,C and H systems' biases were not evaluated because of high in-batch CV (the CV of B system≥ 18.1％,of C system ≥ 14.5％,of H system ≥ 39.1％); when U-Alb ranged in 25.2-201.0 mg/L,all 8 systems' relative biases were ≤25％,except D systems,which showed an un-acceptable positive bias (15.9％-44.3％).Good concordance among systems' results was present at level of microalbuminuria(20-200 mg/L),with CV among systems ＜ 15％ ;when urine albumin was ＜ 20 mg/L,CV among systems increased as allumin concentration decreased.The main contribution of variation came from B,C and H systems,which lower limits of linearity were relatively high.Conclusions At level of microalbuminuria(20-200 mg/L),except D system,the other 8 systems show good precision and accuracy;at low level of urine albumin(＜20 mg/L,especially ＜ 10 mg/L),precision and accuracy of some systems(B,C and H system) needs to be improved.

Establishment of age/gender-related serum cycstatin C reference intervals in children by transmission turbidimetry / 中华检验医学杂志

ObjectiveTo establish pediatric serum CysC reference intervals based on the children's hospital laboratory data in Zhejiang Province and analyse the effects of CysClevels on age and gender. MethodsCysC was one of tests of a routine biochemical screening panel employed for most outpatients and inpatients in the children's hospital, and 8 127 subjects (4 264 boys and 3 863 girls) were selected from 13 567 subjects from laboratory information system according to the exclusion criterion with seriously systemic diseases, cardiovascular diseases, kidney diseases, elevated values of creatinine, urea or ALT for which 1.5-fold upper limit, serum samples with hemolysis, icterus or lipid turbidity, same patients with non-first-time CysC results and living addresses which were not in Zhejiang. The serum CysC was determined by transmission turbidimetry on Roche DPP modular automatic biochemical analyzer. SPSS 17.0 software and EXCEL 2003 were employed for statistical analysis in this study. Results The serum CysC concentration was a Gaussian distribution after log transformation. The mean Log-transformated CysC lg (CysC) concentration of boys in five age groups ( ＜ 1 month, 1 to 3 months, 4 to 11 months, 1 to 2 years and 2 to 16 years) were 0. 224,0. 170,0. 112,0. 061, -0. 011 (mg/L,lg) respectively, and the mean Log-transformated CysC lg(CysC) concentration of girls in five age groups were 0. 222, 0. 164, 0. 089, 0. 057,-0. 010 ( mmg/L, lg) respectively, and no statistically significant differences between Ig( CysC ) and gender in five age groups were found ( t values were 0. 174, 0. 362, 0. 445,- 1. 464 and - 0. 093, respectively,and corresponding P values all were greater than 0. 05 ). The mean lg ( CysC ) concentrations in five age groups were 0. 222,0. 166,0. 100,0. 059, - 0. 010 ( mmg/L, lg), and significant differences between Lg ( CysC ) and ages by Analysis of Variance were observed ( F = 309. 785 and P = 0 in between-groups totally,P = 0 in any two groups). Serum CysC levels were highest in the age of ＜ 1 month, then declined to the age of 2 years and kept stable in the age of 2 to 16 years. The serum CysC reference intervals for children were as follows:0. 95 -2. 92 mg/L in the age of ＜ 1 month, 0. 81 -2.67 mg/L in the age of 1 to 3 months, 0. 65 -2.45 mg/L in the age of 4 tol2 months, 0. 56 -2. 35 mg/L in the age of 1 year and 0. 45 -2. 13 mg/L in the age of 2 to 16 years. ConclusionsThere is no significant effect on pediatric CysC levels with gender but close correlated with age below 2 years old. It is necessary to establish appropriate age-related reference intervals of serum CysC for efficiently evaluating renal function in local children.

Analytical performance of three cysteine proteinase inhibitor c reagents applied in the automatic biochemistry analyzer / 中华检验医学杂志

Objective To validate the analytical performance of three Cys C reagents with particle-enhanced turbidimetric immunoassay(PETIA) method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of three Cys C reagents (labeled as A, B, C) with PETIA method from Shanghai Jing Yuan Co., Beijing Leadman Co. and Beijing Jiuqiang Co. on OlympusAU2700 automatic biochemistry analyzer were assessed.According to the standard of CLSI EP6-A, EP15-A and EP7-P, the precision, linearity range, disturbance (bilirubin, hemoglobin, chyle) were assessed, and compared with those of Cys C reagent based on particle-enhanced nephelometric immunoassay(PENIA) from Dade Behring Co.. The reference ranges for Cys C in serum of 120 healthy individual were evaluated.Results The within-run CVs of the three reagents (A, B and C) were 3.08%-3.2%, 2.3%-4.15% and 1.38%-1.53% respectively.The total CV in A, B and C were 3.29%-3.44%, 2.65%-5.18% and 1.67%-1.69% respectively, lower than the stated.Limits of quantitative determination (LOQ) of the three reagents were 0.41, 0.23 and 0.07 mg/L, basically meeting the testing requirement.The linearity range was 0.22-7.26 mg/L(r=0.996), 0.20-7.72 mg/L(r=0.999)and 0.20-7.62 mg/L(r=0.997)in the three reagents, which demonstrated a sound linear correlation. For interference tests, no remarkable interference (<±10%) of reagent C was detected when bilirubin≤684 μmol/L, hemoglobin≤9.7 g/L and Chyle turbidity≤6 200 FTU; and no significant interference of reagent B was found when bilirubin≤684 μmol/L, hemoglobin≤6.79 g/L and Chyle turbidity≤6 200 FTU; when bilirubin≤684 μmol/L, hemoglobin≤4.85 g/L and Chyle turbidity≤1 240 FTU reagent A was not interfered significantly. The comparison afte and before the high-speed centrifugation reveals that the average percentage of bias for reagents A, B, C measured Cys C in chylous serum samples of patients was -8.31%, 1.52%, 1.32%, respectively.In method comparison tests, the regression equations of the three reagents compared with Dade Behring PENIA Cys C reagent were as follows:Y=0.787X+0.492 (R2=0.976), Y=1.098X+0.137 (R2=0.982) and Y=1.037X+0.249 (R2=0.996), respectively. Agreement rates of the high Cys C in reagent A, B, C and Dade Behring Cys C reagent were 80% (Kappa=0.615,P=0.000), 100% (Kappa=1.000,P=0.000), 91.2% (Kappa=0.824,P=0.000); While for reference range of preliminary clinical assessment, diagnosis coincidence rate of reagent A increased to 98.8% (Kappa=0.974,P=0.000). Conclusions When used in automatic biochemical analyzer, the three Cys C reagent with PETIA showed high precision,sensitivity, and sound correlation with Dade Behring PENIA reagents.The three reagents are all able to meet clinical test requirements, nevertheless, anti-interference capability were diffierent and the reference range should be further validated.

Comparative study of platelet aggregation by turbidimetric and impedance methods in patients under acetylsalicylic acid antiplatelet therapy

INTRODUÇÃO: A hiperagregação (agregação excessiva) das plaquetas pode causar a formação de um trombo e a posterior oclusão dos vasos sanguíneos levando à isquemia. Esse fenômeno é responsável por doenças isquêmicas cardiovasculares, como angina pectoris e aterosclerose, bem como outras formas de isquemia, como o acidente vascular cerebral. Visando diminuir a função das plaquetas para reduzir a formação de trombos, o ácido acetilsalicílico vem sendo utilizado para tratamento antitrombótico, com diversos estudos mostrando sua eficácia. Dessa forma faz-se mister o uso de uma ferramenta laboratorial para o monitoramento da efetividade do tratamento, o que é feito por meio do teste de agregação plaquetária. O objetivo desse estudo foi comparar duas metodologias para esse exame (impedância elétrica e turbidimetria) em relação a trinta pacientes adultos de ambos os sexos em uso do fármaco. CONCLUSÃO: Os resultados mostraram uma boa correlação entre os métodos, possibilitando o uso concomitante de ambas as técnicas em laboratórios clínicos de rotina.

INTRODUCTION: Hyperaggregation of platelets can cause the formation of thrombi and subsequent occlusion of blood vessels leading to ischemia. This phenomenon can be responsible for ischemic cardiovascular diseases such as angina pectoris and atherosclerosis as well as other forms of ischemia such as stroke. To decrease platelet function and reduce the formation of thrombi, acetylsalicylic acid has been used for antithrombotic treatment, with several studies showing its effectiveness. Therefore it is necessary to use a laboratory tool to monitor the effectiveness of treatment, which is achieved through laboratory testing of platelet aggregation. The aim of this study was to compare two different methods (impedance and turbidimetry) to test platelet aggregation in 30 adult patients of both genders taking acetylsalicylic acid. CONCLUSION: The results show that there is a good correlation between these two methods and so both these techniques can be used in the clinical routine.

Evaluación de un método de aglutinación con látex para la detección de proteína C reactiva / Agglutination evaluation method related to use of latex to detection of reactive C protein

Se evaluó un método de aglutinación con látex para la detección de proteína C reactiva (PCR) (PCR-Látex, CENTIS) empleándose como referencia un test turbidimétrico (PCR-Turbilátex, Spinreact). Se procesaron en paralelo 97 sueros de pacientes con clínica sugestiva de inflamación y sepsis. El análisis estadístico incluyó la determinación de la sensibilidad, especificidad, valor predictivo positivo (VPP), valor predictivo negativo (VPN) y límites de detección. Los resultados obtenidos de sensibilidad: 97,8 %; especificidad: 98,0 %; VPP: 97,8 %; VPN: 98,0 %, con un límite de detección de 6 mg/L, pueden considerarse de satisfactorios, lo que permite contar con un procedimiento sencillo, rápido y eficiente que no requiere de un equipamiento especial.

Agglutination evaluation method related to use of latex for detection of reactive C protein (RCP) (RCP-Latex, CENTIS) was evaluated, using as reference a turbidimetry test (RCP-Turbilatex, Spinreact). In parallel, 97 sera from patients with possibilities of inflammation and sepsis were processed. Statistical analysis included determination of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and detection limits. Results achieved for sensitivity: 97,8 %; specificity: 98,0 %; NVP: 97,8 %; NPV: 98 % with a detection limit of 6 mg/L, may be considered of satisfactory, allowing to have a simple, fast, and efficient procedure without a especial equipment.

The abnormal expressions of immunoglobulin light chains Kappa and Lambda in malignant tumors / 国际检验医学杂志

Objective To investigate the abnormal expressions of immunoglobulin light chains kappa(Igκ)and Lambda(Igλ)in malignant tumors.Methods The concentrations of the Igκ and Igλ in serum were measured by rat nephelometry in 60 cases of malignant tumors and 15 cases of healthy people.Results The liver tumor patients had a higher concentration of Igκ and Igλ in serum than normal people(P＜0.01).There wre not significant differences between the levels of Igκ,Igλ and κ/λ ratio in the stomach tumor,lung tumor,proctologic/colonic tumor,mammary tumor,oesophagus tumor and normal peoples(P＞0.05).Conclusion The measurment of Igκ,Igλ and κ/λ ratio in serum would be helpful for the diagnosis of the liver tumor.By continous observation with Igκ,Igλ and κ/λratio in serum could predict the development of disease.

Relationship between C-Reactive Protein and Atrial Fibrillation / 天津医药

Objective: To investigate the relationship between C-reactive protein(CRP)and its-717MG polymorphismin atrial fibrillation(AD of the population of the city of Nantong.Methods:The relationships between AF and AF risk factors were analyzed by comparing genders,ages and body nlagS index(BWI)in 92 AF patients and 60 non-AF control subjects.The serum CRP levels were detected by immunoturbidimetry in of the two groups.The CRP-717MG polymorphism wa8 detected by polymerage chain reaction-restriction fragment-length polymorphism in patients and control subjects.Results:The sel3utm CRP level wag positively correlated with the left atrium internal diameter(LAD)in AF patient group(r=0.58,P＜0.01).The level of CRP Wag significantly higher in AF patient group compared with that of control group(P＜0.01).The serum CRP level Wag higher in patients with non-paroxysmal atrial fibrillation than that of patients with paroxysmal atrial fibrillation(P＜0.05).There Wag no significant difference in the frequency of CRP genotype between AF and control groups(P＞0.05).But the alleles frequency of the G Wag lower in AF group than that of control group(P＜0.05).Conclusion:The semm CRP level is associated with AF and its subgroups.The serum CRP level is positively correlated with LAD.The results suggest that the inflammation influences the AF though atrium reconstruction.The relationship between CRP-7 17A/G and AF stir needs further large-scale perspective studies.

A Case of Multiple Myeloma Showing Marked Differences in Serum IgG Levels between Protein Electrophoresis and Turbidimetry / 대한진단검사의학회지

We report a case of multiple myeloma showing marked differences in serum Immunoglobulin G (IgG) levels between serum protein electrophoresis and turbidimetry. A 47-yr old man was admitted to our hospital due to severe back pain and diagnosed as having IgG-kappa type multiple myeloma. Serum protein level was 14.4 g/dL at the time of diagnosis. Serum IgG level was 8.5 g/dL by serum protein electrophoresis, but 11.6 g/dL by turbidimetry. The patient's clinical conditions had improved after receiving VAD (vincristine, adriamycin, dexamethasone) and VTD (vincristine, thalidomide, dexamethasone) chemotherapy and there were no differences in IgG levels between electrophoresis and turbidimetry when serum IgG levels were less than 3.0 g/dL. According to this, we considered that both protein electrophoresis and turbidimetry should be needed to quantify serum immunoglobulins for diagnosis and follow-up of the patients with monoclonal gammopathy.

Appraisal of determination of serum type Ⅳ collagen protein with latex-enhanced immunoturbidimetry / 国际检验医学杂志

Objective To appraise determination of serum type Ⅳ collagen protein with latex-enhanced immunoturbidimetry.Methods The evaluation test was performed including precision, linearity determination, prozone reaction, correlation, recovery test and interference test.Results The intra-batch CV% was within 2.47%-3.48%, inter-batch CV% was within 3.46%-4.07%, and recovery rate was within 96.2%-99.3%. There was a good linearity, and the tolerance limit was 800 ng/mL.Regression equation:Y=1.011 8X-1.788 3;detection correlation of different concentrations of standard preparations:r2=0.999 9,Y=1.003 1X-1.236 2.The assay had a very good anti-interference performance to bilirubin, cruorin, and triglyceride without exception.Conclusion Determination of serum type Ⅳ collagen protein attains the demand of the clinic with latex-enhanced immunoturbidimetry in fully automatic biochemical analyzer.