Comparison of the Improved Method and the Traditional Method for Toluidine Red Unheated Serum Test in Syphilis Screening / 现代检验医学杂志

Objective To compare the detection performance of the modified serum test (TRUST) method and the traditional method in syphilis screening.Methods A series of TRUST high titer syphilis serum was diluted,and the positive rate of each method was calculated by using the improved method and the traditional method.Comparison of two detection methods of C50,C5 ～ C95 interval,as well as the accuracy of the density curve,and the consistency of the two methods were compared,and diagnostic performance were compared.Results The improved method of C50 was less than the traditional method of C50,and the improved method of C5 ～ C95 range was narrower than the traditional method,compared with the traditional method.The improved method of the non precision density curve was steeper than the traditional method,and the two confidence interval of the consistency degree of the 95％ methods was 73.4％ to 95.8％.The diagnostic sensitivity (SEN),diagnostic specificity (SPE),positive predictive value (PPV),negative predictive value (NPV) and diagnostic efficiency(DF) of the improved method were 64.29 ％,99.1％,85.71％,97.05 ％ and 96.39 ％,respectively.The SEN,SPE,PPV,NPV and DF of the traditional methods were 3.75 ％,98.49 ％,75 ％,96.18 ％ and 95 ％,respectively.The improved method was superior to the traditional methods in the two aspects of SEN and PPV (x2 =8.25,10.03,all P＜0.05),with the statistically significant difference.The improved method was slightly higher than the traditional method in SPE,NPV and DF (x2 =2.39,3.45,4.03,all P＞0.05),with the no statistically significant difference.Conclusion The precision,diagnostic sensitivity and diagnostic specificity of the improved method was higher than that of the traditional method,and it can be applied to the detection of large batch samples with the aid of the full automatic enzyme immunoassay instrument.The improved method can be used to replace the traditional method for syphilis screening.

Establishment of Reference Interval for Serum Prostate-Specific Antigen (PSA) of Apparent Healthy Men in Nanjing / 现代检验医学杂志

Objective To establish the reference interval for serum prostate-specific antigen (PSA) in apparent healthy men of different ages in Nanjing.Methods A total of 25 820 healthy men undergoing routine physical examinations in the First Affiliated Hospital of Nanjing Medical University from October 2013 to September 2015 were selected for the study.All of them were screened by prostate B ultrasound,excluding abnormal urinary tract diseases.The concentration of serum PSA and free prostate-specific antigen (fPSA) were measured by automatic luminescence immunoassay analyzer,and the fPSA/PSA values were calculated.The participants were divided into four groups (20～ 39,40～ 59,60～ 79 and older than 80 years old groups),then the median,5th,25th,75th and 95th percentiles of both PSA and fPSA/PSA were counted,respectively.Results The median of PSA (95th percentile ranges) of these groups by age from low to high were 0.78 (1.93),0.90 (2.93),1.34(6.60) and 2.01(11.91),respectively.The 25th to 75th percentiles were 0.55～1.11,0.61～1.36,0.77～2.51 and 0.94 ～ 4.19,respectively.The median of fPSA/PSA (95 th percentile ranges) were 0.37 (0.60),0.31 (0.56),0.28 (0.53) and 0.29(0.52),respectively.The 25th to 75th percentiles were 0.28～0.46,0.23～0.40,0.22～0.36 and 0.23～ 0.37,respectively.Among all the groups,median differences of both PSA and fPSA/PSA were statistically significant (P＜0.05),and PSA levels rise with age.PSA levels in different regions were different.Conclusion The PSA level of men under 40 years in Nanjing should be 0～2.5 ng/ml,40～60 years should be 0～4 ng/ml,while men who are above 60 years,could use 0～5 ng/ml as reference interval.

Comparative Diagnostic Value of Chitinase 3-Like 1 Protein and AFP in the Diagnosis of Hepatocellular Carcinoma / 现代检验医学杂志

Objective To investigate the different diagnostic value of serum Chitinase 3-like 1 protein(CHI3L1)and Alpha-fe-toprotein(AFP)in diagnosing hepatocellular carcinoma (HCC).Methods One hundreds HCC patients confirmed by histopa-thology were recruited between December,2015 to April,2016 from the First Affiliated Hospital of Nanjing Medical Univer-sity.Simultaneously,100 patients with chronic hepatitis B and 59 healthy individuals,matched by sex and age with HCC pa-tients,were recruited as control groups.Serum CHI3L1and AFP were measured in different groups and the difference were analyzed by STATA 1 2.0 Statistical software.The ability of these two items in differentiating different group was analyzing by ROC curve using MedCal Ver 15.2.2 software.Results Serum CHI3L1 were significantly differences in the three groups using Kruskal-Wallis analysis (χ2=93.19,P=0.000),the differences were further compared in different two groups using Mann-Whitney analysis.The results showed that serum CHI3L1 in HCC group were significantly higher than in chronic hepatitis B and healthy control group (P=0.000,z=8.766,7.400).Serum AFP were significantly differences in the three groups using Kruskal-Wallis analysis (χ2=147.54,P=0.000),and the differences were further compared in different two groups using Mann-Whitney analysis.The results showed that serum AFP in HCC group were significantly higher than in chronic hepatitis B and healthy control group (P=0.000,z=10.938,9.033).The ROC curve analysis of serum CHI3L1 and AFP for differentiating HCC group from CHB group showed that CHI3L1 yield AUC of 0.859 (95% CI:0.803~0.904) with 85% sensitivity,79% specificity and 76.8 pg/ml cut-off value,AFP yield AUC of 0.948 (95% CI:0.904~0.974)with 85% sensitivity,98% specificity and 7.6 ng/ml cut-off value,in distinguishing HCC with CHB group,the power of AFP was superior to that of CHI3L1 (P=0.006).The ROC curve analysis of serum CHI3L1 and AFP for differentiating HCC group from healthy individuals group showed that CHI3L1 yield AUC of 0.852 (95% CI:0.787~0.903)with 85% sensi-tivity,76% specificity and 76.8 pg/ml cut-off value,AFP yield AUC of 0.929 (95% CI:0.878~0.964)with 84% sensitivi-ty,100% specificity and 7.8 ng/ml cut-off value,in distinguishing HCC with healthy individuals group,the power of AFP was also superior to that of CHI3L1 (P=0.045).Conclusion Serum CHI3L1 similar to AFP has much power ability to di-agnosis HCC,but AFP was superior to CHI3L1.

Development and Evaluation of a Duplex Real-Time PCR Assay With a Novel Internal Standard for Precise Quantification of Plasma DNA

BACKGROUND: Circulating levels of cell-free DNA increase in many pathologic conditions. However, notable discrepancies in the quantitative analysis of cell-free DNA from a large number of laboratories have become a considerable pitfall, hampering its clinical application. METHODS: We designed a novel recombinant DNA fragment that could be applied as an internal standard in a newly developed and validated duplex real-time PCR assay for the quantitative analysis of total cell-free plasma DNA, which was tested in 5,442 healthy adults and 200 trauma patients. RESULTS: Compared with two traditional methods, this novel assay showed a lower detection limit of 0.1 ng/mL, lower intra- and inter-assay CVs, and higher accuracy in the recovery test. The median plasma DNA concentration of healthy males (20.3 ng/mL, n=3,092) was significantly higher than that of healthy females (16.1 ng/mL, n=2,350) (Mann-Whitney two-sample rank sum test, P<0.0001). The reference intervals of plasma DNA concentration were 0-45.8 ng/mL and 0-52.5 ng/mL for healthy females and males, respectively. The plasma DNA concentrations of the majority of trauma patients (96%) were higher than the upper normal cutoff values and were closely related to the corresponding injury severity scores (R²=0.916, P<0.0001). CONCLUSIONS: This duplex real-time PCR assay with a new internal standard could eliminate variation and allow for more sensitive, repeatable, accurate, and stable quantitative measurements of plasma DNA, showing promising application in clinical diagnosis.

Correlation between Urine HCMV Virus Load and Liver Function Indications among HCMV-Infected Infants / 现代检验医学杂志

Objective To quantifying the urine human cytomegalovirus(HCMV)DNA from the HCMV infection infants and its corresponding liver function indications,and investigate the relationship between their concentrations.Methods The u-rine samples were collected from HCMV infection infants.HCMV DNA was measured by fluorescence quantitative polymer-ase chain reaction (FQ-PCR).Serum ALT,AST,ALP,GGT,T-Bil and D-Bil liver function indications were detected and the positive rate was analyzed,simultaneously.The correlation between the logarithm urine HCMV DNA (log HCMV DNA) concentration and ALT,AST,ALP,GGT,T-Bil and D-Bil were analyzed by Spearman correlation analysis.Results The dis-tribution range ofurine log HCMV DNA in 444 HCMV infection infants was <2.70~7.90;the positive rate of serum ALT, AST,ALP,GGT,T-Bil and D-Bil were 24.8%,59.0%,95.7%,31.1%,16.7% and 16.3%,respectively.The urine log HC-MV DNA was associated with GGT and the correlation coefficient was 0.099 (P < 0.05),but no associated with ALT, AST,ALP,T-Bil and D-Bil.Conclusion The positive rate of liver function indications will rise in HCMV infection infants, the urine log HCMV DNA was associated with GGT,but not associated with other liver function indications.

Results analysis of blood infectious indicators in 331 968 outpatients and inpatients / 国际检验医学杂志

Objective To analyze the results of detection of infectious indicators of patients from the first affiliated hospital of Nanjing Medical University in recent 5 years ,and to provide a scientific basis for the control and prevention of infectious diseases . Methods The patients with clinical data from January 2010 to April 2014 were retrospectively analyzed ,then the infectious indica‐tors of all the subjects were detected and analyzed .Results HIV positive rate was between 0 .043% to 0 .061% ,positive rate of HCV was between 1 .07 to 1 .41% ,positive rate of TP was between 2 .01% to 2 .17% .HBsAg positive rate in 2010 was 8 .36% ,the positive rate was 7 .81% in 2014 .HBsAb positive rate in 2010 was 35 .36% ,positive rate was 50 .96% in 2014 .Conclusion Effec‐tively cut off the route of transmission could prevent the further spread of infectious disease .

Application of Bone Gamma-Carboxyglutamic-Acid-Containing Protein(BGP)in Middle-Aged and Elder People’s Health Care / 现代检验医学杂志

Objective To evaluate differences of serum bone gamma-carboxyglutamic-acid-containing protein (BGP)levels be-tween different gender in the middle-aged and elder population and the correlation between serum BGP and osteoporosis,as well as the correlation between BGP and other bone metabolic markers.Methods The study population consisted of 270 health care middle-aged and elder people,who were excluded malignancy and chronic diseases,during 2011 January to Au-gust.Of all the Recipients,101 cases were male,aged 50 to 89 years,with a median age of 68 years old,female 169 cases, aged 50 to 89 years,with a median age of 64 years.Bone density were measured by absorptiometry and was evaluated by the T index values.Serum BGP,25-hydroxyvitamin D,calcium and phosphorus were measured by different assays systems.The different level of BGP between genders was also analyzed by Mann-Whitney test.Correlation between BGP and serum calci-um,phosphorus,25-hydroxyvitamin D,osteoporosis risk index were analyzed Spearman rank correlation analysis.Results T value,BGP,25-hydroxy vitamin D,calcium and phosphorus levels range of 270 cases were-3.5~-0.7 (median-1.6 ng/ml),3.59~264.90 ng/ml (median 12.84 ng/ml),4.0~34.0 ng/ml (media 10.5 ng/ml),1.79~2.69 mmol/L (median 2.36 ng/ml),0.43~2.89 mmol/L (median 1.12 ng/ml),respectively.BGP levels in the female groups were significantly higher than the male groups.Serum concentration of BGP was positively correlated with serum phosphorus,but the serum BGP with calcium,25-hydroxy vitamin D,age and osteoporosis risk indices were not correlated.Conclusion In the elder groups,female BGP levels were significantly higher than male,the gender factor should be considered in the clinical applica-tion of BGP.Since BGP and osteoporosis risk index T had positive correlation,those two tests can be combined to evaluate osteoporosis.

Difference of serum 25-hydroxyl vitamin D concentration level in common autoimmune diseases / 国际检验医学杂志

Objective To investigate the serum concentration of 25-hydroxyl vitamin D in the common autoimmune diseases and whether the differences of the 25-hydroxyl vitamin D level exist in different autoimmune diseases.Methods 137 cases of autoim-mune diseases,including 71 cases of rheumatoid arthritis(RA),36 cases of systemic lupus erythematosus(SLE),16 cases of Sjogren syndrome(SS)and 14 cases of ankylosing spondylitis(AS),in our hospital from January 2012 to April 2013 were selected as the re-spondents.The serum samples were collected for detecting the 25-hydroxyl vitamin D level by the electrochemiluminescence method and comparing the differences of the 25-hydroxyl vitamin D level among different autoimmune diseases.At the same time whether the differences in the proportion of the normal level,insufficiency and lack of 25-hydroxyl vitamin D exist among different kinds of disease.Results The serum 25-hydroxyl vitamin D concentration had statistically significant difference among the patients with dif-ferent autoimmune diseases(P =0.006),which in the RA group was significantly higher than that in the other groups;the propor-tion of 25-hydroxyl vitamin D insufficiency in RA,SLE,SS and AS were 29.6%,52.8%,62.5% and 57.1% respectively,which in the SLE,SS and AS groups was significantly higher than that in the RA group(P <0.05).Conclusion The 25-hydroxyl vitamin)D insufficiency is general in common autoimmune diseases,the vitamin D supplements needs to be strengthened.

Serum 25-hydroxy vitamin D status in the second-trimester women in winter / 中华临床营养杂志

ObjectiveTo investigate the serum concentration of 25-hydroxy vitamin D [25(OH)D] in the second-trimester women in winter and explore its correlation with age and blood hemoglobin level. Methods The blood samples of 78 second-trimester women were collected during the 24-28 gestational weeks. Serum 25 (OH) D and blood hemoglobin levels were measured. The correlations of serum 25 (OH) D with age and blood hemoglobin levels were analyzed by Pearson correlation. ResultsOf the 78 pregnant women, the rates of vitamin D deficiency ( ≤25.0 nmol/L), insufficiency [25.0 nmol/L ＜ 25(OH) D≤50.0 nmol/L], and sufficiency were 65.38％, 30.77％, and 3.85％, respectively. Serum concentration of 25 (OH) D was positively correlated with blood hemoglobin level ( r =0.2746, P =0.015 ). ConclusionVitamin D deficiency or insufficiency is common among the second-trimester women in winter, especially among those with low hemoglobin level.