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.

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 .

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.

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.

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).

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.

Objective To explore the predictive value of Kinetics of white blood cell (WBC) elimination following induction chemotherapy for eider with acute myeloid leukemia(AML). Methods 71 elder with AML were reviewed. Chi-square and the Kaplan-Meier methods were used to identify the relationship between the nadir WBC count and time to WBC nadir with efficacy and survival. Results 28 patients (39.44%) achieved a complete re-mission(CR),another 19 (26.76%) had a partial remission,17(23.94%) patients had a non-remission,and 7 pa-tients(9.86%)died. Overall survival over 3 years was about 11.27% (8 cases),over 2 years about 23.94 % (17 cases),and over 1 years about 47.89 % (34 cases). The low WBC nadir and high WBC nadir in the bone marrow CR (9.86% and 12.68%)and the total survival rate (8.45% and 11.27%)were lower than the median absolute WBC nadir (16.90%, 15.49%), but were no statistical discrepancy (χ23.32,1.22, P=0.77, 0.54). The pa-tients who achieved WBC nadir in less than or equal to 10 days in the bone marrow CR(12.68%) and the total sur-vival rate(8.45%) were statistical significantly higher than those achieved it in greater than 10 days(26.76%). The patients whose WBC attained at low level less than or equal to 3 days in the bone marrow CR(16.90%) and the total survival rate(12.68%) were statistical significantly higher than those greater than 3 days (22.54%) (χ2 15, 57,11.71,4.85,9.54,P=0.001,0.01,0.03,0.04). Conclusion WBC nadir in loss than or equal to 10 days and WBC attained at low level greater than 3 days may serve as a worse prognosis.

Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards.Methods According to the experimental designs and computing methods from foreign counterparts,the results of biological variation,individual indexes and quality goals were calculated through the serum detection of 22 subjects from clinical laboratory of Zhongshan Hospital in Shanghai (male 12,female 10,ages varying from 20 to 40 years old,median age 30) in short-term (five blood draws within one day at 8:00,10:00,12:00,14:00 and 16:00) and long-term (one blood draw at 8:00 in 6 weeks consecutively) and serum controls (mixed from healthy people).Results (1) Based on the results of shortterm and long-term biological variation in 32 routine itens,the individual indexes and quality goals were obtained.(2)The influence of diet on the biological variation of part of the test items could be observed,especially free fatty acid (the mean value of post-meal was less than pre-meal about 30％),and then followed by high-sensitivity C-reactive protein (the mean value of post-meal was lower than pre-meal about 20％) and triglyceride (the mean value of post-meal was higher than pre-meal about 10％).(3)There were some differences between the quality goals we accessed and the the indicators from Europe and CLIA.Conclusions (1)The results of apolipoprotein E and free fatty acid in this study made up for the inadequate of the European biology database.(2) Only a small part of the 32 routine items were affected by dietary factors.(3) Most quality goals obtained from this study generally consisted with Europe biology quality goals,but a few items existed different.(4)It's more practical and effective to use the results of biological variatiou than CLIA standards for setting up quality goals.

ObjectiveTo investigate the outcome and risk factors for kidney involvement by analyzing 64 patients with anti-neutrophil cytoplasmic antibody(ANCA)-associated vasculitis.MethodsData analyzed including the demographic information,survival status,renal survival status and laboratory parameters such asserum albumin level,serum creatinine level,urinary protein excretion level,hematuria,high sensitivity C-reactive protein(CRP),ANCA titer,and the Birmingham vasculitis activity score (BVAS).Logistic regression analysis,Cox regression analysis and ROC curve were used to evaluate the risk factors of patients with renal involvement and all-event survival.ResultsTotally 64 patients were enrolled [24 females with the average age of (59.9±2.0) years] and followed up for a median of (38±16) months.The morality rate was 14％,and the prevalence of end stage renal disease was 39％.Compared with those who had better outcomes,patients who died or with end stage renal disease had higher serum creatinine level [ (624±246),(245±127 ) μ mol/L,respectively,t=7.17,P＝0.005 ] and erythrocyte sediment rate [ (112±24),(76±48) mm/1 h,respectively,t=3.74,P＜0.01 ],but lower serum albumin level [(294±31 ),(316±42) g/L,respectively,t=-2.27,P=0.01 ] and hemoglobin level [ (79±13),(99±33) g/L,respectively,t=-3.23,P＜0.01 ] at baseline.Logistic regression analysis found that serum creatinine level and erythrocyte sediment rate at baseline were associated with poor outcome and Cox regression analysis further confirmed this result[Scrβ=1.004,95％CI1.002～1.006,P＜0.01; ESR β=l.018,95％CI 1.000～1.037,P=0.046].ROC curve analysis showed that serum creatinine and erythrocyte sediment rate were predictors for AAV patients' prognosis and their AUC were 0.95 and 0.80,the sensitivity of these parameters was both 94％,and the specificity was 93％ and 70％respectively.ConclusionThe intensity of initial treatment should be based on disease severity and activity in order to improve the prognosis of those with ANCA-associated vasculitis with renal involvement.Increased serum creatinine and erythrocyte sediment rate may serve as predictors for poor prognosis in this patient cohort.