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.

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.

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

China ; Conservation of Natural Resources ; Electricity

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.

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

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 evaluate performance of the clinical laboratories for detection of TORCH immunoassay. Methods There were 2 times external quality assessment (EQA) for nuclear antibody detection. Each panel consisting of 5 liquid serum samples were distributed. Each participants of the EQA program had to reply the results, the methodological procedure and the kits. All data were analyzed and then provided to all laboratory in our EQA program. Results In 2007, the rate of good response were more than 80% for HSV immunoglobulin-M, Rubella immunoglobulin-M and CMV immunoglobulin-M. Response for Toxo immunoglobulin-M was poor (53.1%). The sensitivities of the commercial kits were quite low (<80%). Some clinical laboratories using the same kits gave quite different S/CO value. Conclusions A lot of clinical laboratories get good score in TORCH detection external quality program. False negative is the major problem.