Laboratory developed tests ( LDT) are usually referred to the diagnostic methods for the medical laboratory , which can only be used in the medical laboratory and can not be sold to other medical laboratories , hospitals and individuals .The paper shows the draft guideline of LDT issued by Food and Drug Administration ( FDA) and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.

The mortality of chronic kidney disease (CKD) is increasing because of renal failure,cardiovascular diseases and other reasons which has been a global public health problem.Glomerular filtration rate (GFR) is the important biomarker of kidney function evaluation and early diagnosis of CKD,whose direct measurement methods cannot be widely applied in clinical laboratory.With the development of studies on estimating glomerular filtration rate (eGFR) equations,eGFR has been a biomarker of kidney function evaluation in clinical diagnosis.The current paper reviews the research progress and clinical application of different eGFR equations.

Objective Improving the hospital operation management , preparing for the establishment of the digital operation room and achieving the fine management goal .Methods Based on the actual medical and clinical demand, combined with the standard of the operation management , designed and analyzed the management rules and processes of the perioperative information management system .Results Straightened out the information management rules and procedures of the operation room , strengthened the communication , feedback and sharing of the periopera-tive medical information , and improved the work efficiency , the operation quality and the utilization rate of the opera-tion room.Conclusion The smooth management process and the efficient use of information are the keys to promote the hospital management by means of informationization .

Purpose: This study is to investigate the influence of acupuncture at acupoints Neiguan (PC 6) and Ximen (PC 4) on the stroke volume and the flow rate of peak value of left ventricle ejection in the patients with coronary heart disease. Methods: 60 cases of coronary heart disease were divided into acupoint Neiguan (PC 6) group and acupoint Ximen (PC 4) group, and the stroke volume and the flow rate of peak value of left ventricle ejection were detected 3 min after manipulating needles and 20 min after retaining needles respectively, then were compared with those before acupuncture. Results: 3 min after manipulating needles, the stroke volume and the flow rate of peak value of left ventricle ejection were enhanced in 46 cases, and 20 min after retaining needles, both the stroke volume and the flow rate of peak value of left ventricle ejection were all enhanced in 34 cases. Conclusion: Puncturing acupoints Neiguan (PC 6) and Ximen (PC 4) could enhance the contractility of left ventricle wall, increase the stroke volume of the heart and improve the myocardial ischemia in the patients with coronary heart disease

A novel coronavirus (COVID-19) that broke out in December 2019 has been declared a public health emergency of international concern. Nucleic acid detection has an irreplaceable role in the diagnosis of 2019-novel coronavirus (2019-nCoV) infection. However, due to the high requirements of laboratories and technicians, cumbersome operations, and the possibility of omission, nucleic acid detection should be combined with specific antibodies to achieve large-scale screening of suspected patients and close contacts. Moreover, antibody detection can reduce the exposure risk of medical personnel during the collection of respiratory tract samples.

AIM To establish the methods for assaying the activities of tolbutamide hydroxylase (CYP2C8/9) and chlorzoxazone 6-hydroxylase(CYP2E1) from adult human livers microsomes. METHODS The microsomes was isolated from human adults liver and the contents of microsomal protein were determined. Using the tolbutamide and chlorzoxazone as substrates, the amount of hydroxytoblbutamide and hydroxychlorzoxazone formed during the incubation period was quantified by extroppolating from the standard curve and the specific activity of CYP2C8/9 and CYP2E1 were calculated. RESULTS There was no siginificant influence on the activities of CYP2C8/9 and CYP2E1 in different times. CONCLUSIONS The methods utilized to estimate the activity of CYP2C8/9 and CYP2E1 were simple, stable, and repeatable. These methods can be used in new drug screening, safety evaluation and reseasch on pathology and toxicology of liver.

According to the Rules for the Implementation of the Standards for Review of Level 3 General Hospital (2011) of Formor Ministry of Health,the paper analyzes the requirements of review of level 3 general hospital for decision support,and takes the Sixth Affiliated Hospital of Sun Yat-sen University as an example to introduce the decision support solution and the application of Decision Support System (DSS).

Objective To investigate the clinical value of quality intima-media thicknes (QIMT),quality arterial stiffness(QAS) and XStrain in assessing the ventricular-arterial coupling (VAC) in patients with uremia.Methods Sixty-five patients with uremia and 30 normal subjects were enrolled in this study as the uremic group and control group respectively.Ultrasound examination for the cardiac and carotid artery was performed and some parameters were obtained,such as left ventricular ejection fraction(LVEF),E/e,Tei index,stiffness (β),compliance coefficinet (CC),pulse wave velocity (PWV),intima-media thicknes (IMT),strain,and so on.The sum of left ventricular systolic radial strain and carotid arterial diastolic radial strain was used as a new parameter (VACs) for assessing VAC.The correlation between VACs and VACv,a traditional method to evaluate VAC,was analyzed.The parameters obtained by ultrasonic techniques were compared between two groups.The intra-and inter-observer reliability of XStrain was assessed by intraclass correlation coefficient.The multiple linear regression and ROC curve were used to analyze the independent factor of cardiovascular dysfunction.Results ①The pulse pressure,E/e,Tei index,as well as β,PWV and IMT were larger in uremic group than control group significantly (P ＜0.05).②The function of VAC was decreased in uremic group,and the VACv and VACs were lower than control group significantly (P ＜0.05).③There was strong positive relation between VACs and VACv (r =0.908,P =0.000).The reproducibility of XStrain technique was well.④VACs,β,VACv and PWV could be considered as independent factor of cardiovascular dysfunction and performance of VACs was the largest (standardized coefficient was-0.582).A cutoff value of VACs for assessing cardiovascular dysfunction was less than 23.60,which had both higher sensitivity and specificity (96.4％,81.1％).Conclusions The QIMT,QAS and XStrain can be used to assess cardiovascular structure,function and VAC accurately and globally,which can be consider as an effective method for detecting cardiovascular complication and improving prognosis of uremic patients.

Objective To establish the reference interval for CA 72-4 in indirect method.Methods All results for CA72-4 that were stored in our laboratory information system of Zhongshan hospital between Jan.2010 and Dec.2012 were included in this study.Outliers were identified and omitted using Stem-and-Leaf&Box Plots in SPSS statistical software.The treated data was divided into several groups according to gender and age.Nonparametric rank sum test was used to observe the difference between male and female participants and Spearman correlation analysis was used to examine the correlation between CA 72-4 and age.Nonparametric reference intervals for CA 72-4 were estimated statistically in two gender sub-groups.Results After 139 cases excluded, there were 1 548 cases of male (Median 1.7, 0.4 to 18.9) and 773 cases of female ( Median 1.8, 0.2 to 18.9 ).There was a significant difference in serum CA 72-4 between male and female participants.No significant difference was found in serum CA 72-4 among age sub-groups.Indirect reference values for CA 72-4 of male and female were respectively 0 to 8.9 U/ml and 0 to 11.6 U/ml.Conclusion Indirect method to establish biological reference interval is a relatively simple and less expensive method under the high rapid development of the hospital information network .It can be used in the periodical review and establishing the reference intervals where the direct method can not be used.

Objective To elucidate the prevalence and risk factors of cardiovascular disease (CVD) in end-stage renal disease (ESRD) patients on peritoneal dialysis (PD), and to investigate the associated problems in treatment. Methods A total of 254 PD patients in our division were enrolled in this study. CVD history, laboratory measurements, examinations of carotid atherosclerosis and left ventricular hypertrophy by ultrasonography were collected and associated factors were analyzed. The median follow-up time was 49 months. Results The overall prevalence of CVD was 37% (93/254). Diabetes, longer dialysis duration, hypertfiglyceridemia, hypoalbuminemia, hypoprealbuminemia were commonly found in the patients with new CVD event. The patients without pre-existing CVD had the higher Ccr, Kt/V, D/Pr, nPCR, serum albumin level. In those with pre-existing CVD, the hypertriglyceridemia and the duration of dialysis were independent predictors of progression of CVD. Differences of LAD, LVST, LVMI and IMT were significant between with and without pre-existing CVD groups. Kaplan-Meier curves showed that the presence of CVD was the independent risk factor of survival. Alb<330 g/L, LAD>39.6 mm and peritonitis were risk factors of CVD. Conclusion The prevalence of CVD in PD patients is quite high. CVD history should be realized, dialysis adequacy should be maintained, and peritonitis should be prevented.