The paper analyzes deficiencies in traditional manual screening of critical values , telephone notifications and manual record-ing of critical value reports , as well as problems existing in current critical value reporting systems in China .It designs a stable , timely and accurate reporting system for test critical values and mainly introduces the system design , system function and application features .

This paper introduces the current status of Chinese medical device testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.
China ; Equipment and Supplies ; standards ; Health Systems Agencies ; Reference Standards

Objective To identify the biomarkers which can be used of estimating the biological behaviors of prostate cancer with osseous metastasis by SELDI-TOF-MS. Methods Screening for potential tumor biomarkers of serum samples from 19 prostate cancer patients and 35 prostate cancer patients with osseous metastasis by using the technology of SELDI-TOF-MS and CM 10 protein chips (Ciphergen Inc. USA).The PBS Ⅱ protein chip reader was used to analyze the CM10 protein chips and transform the protein information into the form of spectra. The protein contents of two groups in the same mass-to-charge ratio (M/Z value) were analyzed and preceded the analysis of variance by Biomarker Wizard software. The proteins whose contents in serum were significantly different, which was distinguished the correctly groups by Biomarker Pattern software. Results The contents of 4 proteins in the two groups were significantly different and the M/Z values of these 6 proteins were from 2000 to 20 000. The relative protein content of prostate cancer patients group was higher than that of Prostate Cancer patients with osseous metastasis group at the M/Z value of 2089,4281, 3507 and 4178 [(4.63±8.03) vs (9.88±10.77), (19.78±21.46) vs (26.73±19.41), (5.46±10.14) vs (8.10±8.74), (38.01 ±26.27) vs (45.25±20.40), (P＜0.05)]. The relative protein content of prostate cancer patients group was lower than that of prostate cancer patients with osseous metastasis group at the M/Z value of 15 900 and 16 081 [(11.52±16.80) vs (4.84±5.83), (8.55±12.64) vs (3.56±3.90), (P＜0.05)]. Conclusion The associated serum protein in prostate cancer with osseous metastasis can be quickly and exactly diagnosed by SELDI-TOF-MS with high sensitivity and specificity. This new method will be widely used in clinical application.

0.05).The death rate of cases with pneumonia combined with ascites was higher than that of cases with ascites only(?2=4.894,P=0.027) and cases without ascites and infections(?2=9.260,P=0.002).Unfavorable prognosis was found in cases with Enterococcus faecium isolated before OLT.CONCLUSIONS Severe lung infection before OLT is one of the main reasons of death.It is important to grasp characteristics of infection,evaluate risk fully,control infections and screen cases strictly before OLT to improve survival rate.

OBJECTIVE To investigate the value of fibrobronchoscopy and bronchoalveolar lavage in etiologic diagnosis of pneumonia in immunocompromised patients.METHODS The clinical document and results of fibrobronchoscopy and bronchoalveolar lavage in 36 immunocompromised patients with pneumonia were retrospectively analyzed,whose conditions were mainly after organ transplantation and hematologic neoplasia.RESULTS Through fibrobronchoscopy and(or) bronchoalveolar lavage,22 cases(61.1%) were etiologically diagnosed.In 19 cases taking cytomegalovirus(CMV) quantitative PCR test of both peripheral blood and BALF,the positive rate of blood and BALF was 14.3% and 42.9%,respectively(P

Objective To find differential expression proteins in patients with T cell non-Hodgkin’ s lymphoma (T-NHL) by using surface-enhanced laser desorption and ionization time-of-flight mass spectrometry (SELDI-TOF-MS) technique and study their related clinical application value and prospect.Methods Serum protein of 36 T-NHL patients and 30 DLBCL patients were detected by the SELD1-TOF-MS technique and weak cation exchange (wcx-2) chip.Lactate dehydrogenase (LDH) was detected by biochemistry method.Beta2-microglobulin (β2-MG) was detected by enzyme-linked immunesorbent assay (ELISA).The significant different protein spectrometry were analyzed between DLBCL patients and T-NHL patients.The correlation analysis with protein spectrometry,disease staging,LDH and β2-MG were analyzed with Spearman.Results Nine potential candidate proteins,including the peak intensity of M/Z 1142.67,1451.43,1472.49,1512.03,3194.22,3267.41,3933.86,4593.12 and 9182.24,were identified in T-NHL patients.The 9 protein markers had no contact with disease staging of T-NHL (P ＞ 0.05).The protein markers of 4593.12 and 9182.24 were high level in T-NHL patients.LDH in these two protein markers’ positive group [(290.82±29.95) U/L,(283.94±100.94) U/L] was higher than that in negative group [(169.22±55.42) U/L,(169.50±59.25) U/L](t =-3.199,P =0.004; t =-2.378,P =0.026),and LDH was positive correlation with these two protein spectrometry (r =0.265,r =0.178,P ＜ 0.01).There was no statistically significant difference ofβ2-MG between these two protein markers’ positive group and negative group (P ＞ 0.05).The other 7 protein markers were low level in T-NHL patients,and there was no statistically significant difference of LDH and β2-MG in these 7 protein markers (P ＞ 0.05).Conclusion The protein marker of 4593.12 and 9182.24 may be the specific serological markers to identify T-NHL.The combination of these two protein markers and LDH may assess the tumor load,and provide guiding value for clinical treatment.

Objective To test serum differentially expressed proteins between early-stage (stage IB-ⅢA) and late-stage (stage Ⅳ) lung cancer patients by proteinchip technology and investigate its clinical value. Methods SELDI-TOF-MS and WCX-2 protein chip were used to detect the serum protein of 30 cases of early stage lung cancer patients and 30 cases of late stage lung cancer patients. The data were analyzed by using Biomarker Wizard software. Results There are ten different proteins in the serum between the two groups of lung cancer patients. Four protein markers 7978, 8139, 15 951 and 16 133 are over expressed and seven protein markers 2867, 6885, 8701, 8840, 13 781 and 13 955 are low expressed in the late group. Conclusion SELDI-TOF-MS proteinchip technology is a convenient, sensitive and high-throughput analysis method which can screen several relatively specific protein markers for late stage lung cancer from the serum samples. This selected protein markers can predict metastasis of lung cancer patients.

Obiective To screen serum biomarkers in patients with hepatocellular carcinoma (HCC)by SELDI-TOF-MS technique.Methods SELDI-TOF-MS technique and CM10 Protein Chip were used to detect serum protein patterns of 46 patients with primary hepatic carcinoma and 64 healthy persons.The different proteins were obtained by the Biomarker Wizard software between the patients and healthy persons.The best biomarker of primary hepatic carcinoma was selected by evaluating the sensitivity and specificity of the protein.Results 16 protein peaks were obviously different between the patients and the healthy persons (P ＜0.05).The protein peaks of m/z 6845.70 had the highest diagnosis value with a sensitivity of 89.1％ (41/46)and specificity of 87.5 ％ (56/64).This protein was likely to be a part of the immunoglobulin heavy chain variable region.Conclusion The protein of m/z 6845.70 is potential biomarkers for the diagnosis of HCC.SELDI-TOF-MS technique is a quick,simple,convenient and high through-put technology for diagnosis of hepatocellular carcinoma.

Objective To explore the application of serum SELDI proteomic patterns to screen breast cancer biomarkers.Methods Serum protein profiles of 110 breast cancer patients and 100 healthy controls were analyzed with surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOFMS).The spectra were generated on weak cation exchange (WCX2) chips and protein peaks clustering and classification analyses were made using Biomaker Wizard software.Differences in protein intensity between breast cancer cases and controls were measured with the Mann-Whitney U test and adjusted for confounding in a multivariate logistic regression model.Results Forty-nine of these proteins were found to have statistically differential expression levels between breast cancer and normal control sera (P ＜ 0.05).Based on literatures reported,six protein biomarkers,with mass-to-charge ratio (M/Z) (4376,8126,8924,3264,3968,and 9180) were selected.Proteins with M/Z 4376,4126,and 8924 were statistically significantly decreased in breast cancer cases compared to those in healthy controls (P ＜ 0.05).Proteins with M/Z 3264,3968,and 9180 were significantly increased in breast cancer cases compared to those in healthy controls,Protein with M/Z 9180 was associated with TNM stage and Her-2 expression in breast cancer (P ＜ 0.05).Protein with M/Z 8926 was related with lymph node metastasis (P ＜0.05).Conclusion These results suggest that serum SELDI protein profiling can distinguish breast cancer patients from normal subjects with relatively high sensitivity and specificity.SELDI-TOF-MS plays a valuable role in the diagnosis of breast cancer and the discovery of new tumor-specific protein biomarkers.

The prevalence of acute flaccid paralysis (AFP) associated with EV71 and the genetic variation in Fujian , China from 2003 to 2012 was investigated in this study .Descriptive epidemiology was used to analyze the epidemiologic and clinical features of AFP cases associated with EV 71 .Phylogenetic analysis was performed to explore the genetical characteris-tics of EV71 based on the complete VP1 nucleotide and amino acid sequences .Results showed that the mean incidence of EV71-associated AFP in children under 15 years old was 2 .24/10 000 000 in Fujian Province during 2003 and 2012 ,based on the number of EV71 isolates and the reported AFP cases .And the incidence has increased since 2008 .The EV71 strains isolated from the AFP cases or from the healthy contacts were distributed in 9 prefectures of Fujian Province ,most in the months of May and June .Of 76 .0% (19/25) of AFP cases associated with EV 71 were the children under 3 years and the male-to-female ratio was 1 .5 :1 .Twenty out of twenty-two cases (90 .91% ) had fevers before the onset of paralysis .Most cases had unilater-al limb paralysis (14/22 ,63 .6% ) .Typical manifestations of hand-foot-and-mouth disease (HFMD) were observed in five cases before the onset of paralysis .Residual paralysis was observed in two cases during the follow-up visits .The strains isolated from 25 cases belonged to genotype C4 .All other strains belonged to subtype C4a except the subtype C4b strains isolated in 2003 .The homology among the strains was high in 2009-2011 ,and the homology among these strains and the representative strains in Fuyang ,Anhui Province was also in the high level .Therefore ,it was possible that the isolated strains had the same origin and might cause the epidemic .In conclusion ,an AFP surveillance system could be developed for analyzing the incidence of AFP associated with EV71 ,determining the features of the isolates ,and describing the intensity and trends of EV71 epidem-ics .