Diverse technological advances in laboratory testing like DNA sequencing,have played important roles at the beginning of precision medicine.And the development of precision medicine will also require the advances of laboratory testing.However,with more new methods and biomarkers applied in clinical practice,the standardization of clinical laboratories testing is confronting great challenges.We will discuss the key challenges related to standardization of commercial reagents or systems and clinical tests,such as the choice of biomarkers,laboratory-developed tests and interpretation and reporting of the results.

Application of standard materials in clinical laboratory medicine plays an important role in assuring result concordance between different reagents, methods and clinical laboratories. This article provides an overview of the correct classification, selection and application of standard materials for clinical laboratory medicine.

Hepatitis B virus ( HBV) serological markers are common indicators for clinical diagnosis of hepatitis B.Qualitative anajysis of the markers is usually used in the diagnosis of HBV infection.while quantitative analysis is helpful to predict virological response of anti-virus therapy.Sometimes HBV serological markers will give unusual serological profiles,which make technicians and clinicians confused.This review discusses how to correc(t)ly report and explain the results of HBV scrological markers and how to apply the markers correctly for clinicians to analyse HBV infection status.

Modern medicine has entered the era of personalized medicine,the most mature of which is based on analysis of the specific gene polymorphism and tumor-related gene mutation and expression detection.Usually the test is related to the PCR technique such as real-time PCR,PCR-sequence,PCR-hybridization (on chip,membrane,latex particles),which leads to the gene amplification process.Now,some laboratories do or will to conduct such clinical tests.But most of them are non-classic clinical laboratories,which belong to the pathology,pharmacy or oncology department.There is a problem in front of us face that is how to standardize the clinical test on the key point of the test including design of the laboratory,collection and handling of the samples,quality control of testing procedure in the laboratory and report and results explanation for personalized testing and establish quality assurance system.

All previous literatures about Chinese herbal medicines show distinctive traditional Chinese medicine (TCM) flavors. Compendium of Materia Medica is an influential book in TCM history. The TCM flavor theory and flavor standardization principle in this book has important significance for modern TCM flavor standardization. Compendium of Materia Medica pays attention to the flavor theory, explain the relations between the flavor of medicine and its therapeutic effects by means of Neo-Confucianism of the Song and Ming Dynasties. However,the book has not reflected and further developed the systemic theory, which originated in the Jin and Yuan dynasty. In Compendium of Materia Medica , flavor are standardized just by tasting medicines, instead of deducing flavors. Therefore, medicine tasting should be adopted as the major method to standardize the flavor of medicine.
Materia Medica ; standards ; Medicine, Chinese Traditional ; Reference Standards ; Taste

Objective To explore the regularity of heat shock protein 70(HSP70)expression and its function in renal ischemia/reperfusion injury(IRI),and to reveal whether traditional Chinese medicine, Xuebijing injection(血必净注射液),induces HSP70 synthesis and has a protective effect on IRI.Methods One hundred and eight female Sprague-Dawley(SD)rats,(200?20)g in weight,were used in this experiment,and randomly divided into three groups(each n=36):control(A),model(B)and treatment group(C).The I/R model was established by clamping renal pedicles on both sides for 45 minutes to cause ischemia and then reperfusion was made.In group A,a similar model procedure was performed,but without ischemia.At 5-10 minutes before the IRI was performed,5 ml/kg of normal saline and 5 ml/kg of Xuebijing injection was injected through the femoral vein in group B and C respectively.In B and C groups,according to the durations of reperfusion for 0,6,12,24,36 and 48 hours,the rats were subdivided into six subgroups (each n=6).At the end of each time point,blood and renal tissue were collected to measure blood creatinine (SCr)and urea nitrogen(BUN),and Western blotting method was used to examine the expression of HSP70. In another kidney,renal tissue was obtained for hematoxylin and eosin(HE)staining pathological and immunohistochemical examinations.Results In B and C groups,the SCr and BUN levels at 6 hours after I/R were significantly higher than those in the A group,and those in the C group were lower than those in the B group(P

As a kind of common autoimmune diseases,rheumatoid arthritis (RA) affected the health of human beings seriously.In the past,serological diagnosis of RA solely relied on the detection of rheumatoid factor (RF),but its specificity was not satisfactory.Lately,people found that anti-cyclic citrullinated peptide (CCP) antibody was a serological indicator of RA.Now,there have been a series of kits for the detection of anti-CCP antibodies to diagnose RA.The sensitivity and specificity of anti-CCP antibody detection are better than those of RF detection.This paper reviews the significance and value of anti-CCP antibody detection used for clinical diagnosis in the recent years,while systematically compares the sensitivities and specificities between several common commercial kits and methods of anti-CCP antibodies detection.

China ; Conservation of Natural Resources ; Electricity

Adult ; Aged ; Benzamides ; therapeutic use ; Case-Control Studies ; Female ; Humans ; Imatinib Mesylate ; Immunoglobulins ; metabolism ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; immunology ; Male ; Middle Aged ; Piperazines ; therapeutic use ; Pyrimidines ; therapeutic use ; T-Lymphocyte Subsets

Objective To establish a kind of simple ,rapid ,accurate and reliable method to determine the phenobarbital in the biomaterial .Methods We pre‐treated biomaterial by the method that the reagent of acetone∶water (v/v 8∶2) was firstly used to soak the biomaterial ,and then we took use of ethyl acetate as reagent to extract the phenobarbital of the biomaterial in the present of pH=3-4 .We finally employed GC‐MS to determine these samples .On the one hand ,we not only took advantage of the reten‐tion time of the phenobarbital in total ion current (TIC) but also took advantage of the characteristic fragment ions of phenobarbital in mass spectrogram as qualitative basis .On the other hand ,we took advantage of the external standard method as quantitative ba‐sis .Results The method had the characteristics of the simple and easy operation .There was hardly background interference and there was good separation effect in the method .The method also had the characteristics of fast analytical speed such as the retention time of the phenobarbital was 8 .385 min .The characteristic fragment ions of phenobarbital was m/z 204 and m/z 232 .The charac‐teristic fragment ions of m/z 204 was served as quantitative ion fragments and we employed the external standard method to quanti‐fy in the method .In short ,the average recovery rate of the method was 87 .35% .Relative standard deviation (RSD) was 5 .43% in the method .The lowest limit of detection (LLOD) was 0 .005 mg/mL .Conclusion The method showes satisfactory result that it could be applied to determine the phenobarbital of the biomaterial of forensic toxicological analysis .