The serological markers of infectious diseases, tumor markers, hormone, serum specific proteins and autoantibodies are tested by immunological methods in clinical laboratories. The immunological methods involved in classic immune agglutination assay, immune precipitation assay and label immunoaszay for trace antigen and antibody detection (such as enzyme-linked immunosorbent assay, chemiluminescence immunoassay and time resolved fluoroimmunoassay). Some of the new immunoassay such as protein chip and immune sensor also tried to be used in clinical laboratories, but it is important that these methods shall be evaluated before being used routine tests. Measurement traceability for quantitative immunoassay using international reference materials and standardization of reagent kit, methods and routine procedures are prerequisites to assure the results uniformity of different laboratories, reagent kits and methods. The carry out, analysis and evaluation of internal quality control are the sources of quality continued improvement of routine tests.

As a result of the molecular diagnosis blossoming , the time of clinical laboratory can be chronologically divided into two periods , the “pre-molecular diagnosis days” and the “post-molecular diagnosis days”.Functional genomics researches in the post-genome era reveal that gene encoding the drug metabolic enzyme influences on drug response.Based on studies of cell signaling pathways in targeted cancer therapy, curative effect is related to the mutations of corresponding target gene involved.Detection of the genotype and the specific mutation encouraged the era of specific diseases care into the era of individualized care, which allows the clinical laboratories working behind-the-scenes come to the fore in disease treatment.Gene amplification technology has been one of backbone technology used in molecular diagnosis.The key of whether the results of molecular diagnosis can be used in the diagnosis and treatment includes the standard laboratory partitions and the strict quality assurance measures during the pre -, during and post-analysis periods.The personnel team in future molecular diagnostic laboratory will consist of clinical laboratory physicians , pathologists , pharmacists and bioinformatics experts , genetic counselors and clinical experts, and so on.

Compared with commercial reagents manufactured by foreign companies for detection of HBV and HCV infection, domestic reagents have poorer performance because of the over-pursuit of easy operation and lack of metrological traceability in quantitative measurement. If "two-step" sandwich ELISA model and multiple monoclonal coating antibodies were used, false-negative results caused by the hook-effect and HBsAg mutant would be avoided. Moreover, sufficient incubation time in each step would improve the detection-limit of the reagents. By replacing the boiling lysis with nucleic acid purification in sample preparation and increasing the sample volume of nucleic acid purification and amplification detection could improve the detection-limit and reproducibility of HBV and HCV nucleic acid testing. The use of internal control could effectively monitor the of false negative results as well Application of international or national reference materials for metrological traceability of calibrators in reagents also plays an important role in assuring result concordance among different commercial reagent kits, methods and clinical laboratories.

Serological assay for hepatitis B virus (HBV) infection was the one of important parameters in China because of high prevalence of HBV. Here, some recommendations and reviews about detection of HBsAg, HBsAb, HBeAg, HBeAb,HBcAb,anti-HBc IgM and HBV DNA and explanation of the results were presented. It is important for correct application of the serological markers of HBV infection that pay attention to false negative and false positive resulted from limitation of reagent kits and methods used, genome mutation of the virus and so on . Suitable explanation and further confirmation of the results also is a key point in serological detection of HBV infection.

The molecular technology,which is involved in the detection of large molecules such as nucleic acid from pathogens,human genes and specific proteins,played a key role in the diagnosis of diseases in clinical Laboratory. The standardization of the reagents and its methodology,routine work procedures and application of reference materials are basic requirements for assuring the accuracy of the results of routine detection in clinical laboratories. It would improve significantly the comparison of the results among the different clinical laboratories that using reference materials in routine work,and realize step by step the results acceptance with conditions by each other.

It is possible that weak-reactive is false positive in serological testing for infectious diseases because of the uncertainty of cut-off values used and some interference factors of clinical samples. The confirmative tests of weak-reactive samples included neutralization assay for specific antigen and immune-blotting or immuno-fluorescence antibody assay for specific antibody. It is important to set up confirmative procedures for weak-reactive samples in clinical diagnosis of infectious diseases and body examination of normal population.

Objective To detect the HLA DRB1*12 by use of a new genotyping method for HLA SYBR Green Ⅰ PCR. Methods 1 HLA DRB1*12 sample and 12 unknown clinical sample were collected. The typing of these samples were determined by PCR, which includes a fluorescence dye, SYBR GreenⅠ,and the sequence specific primer. SYBR GreenⅠcould bind to the dsDNA to exhibit fluorescence. The fluorescence enhancement depends on the accumulation of the amplified product. Results 3 of the 12 unknown sample was proved to be DRB1*12 by the analysis of the melting curve of the amplified products. After purification, the type of these products were confirmed DRB1*12 by DNA based sequencing. Conclusions The results of SYBR GreenⅠPCR demonstrate that it can be a new strategy for HLA typing because of its convenience and accuracy.

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.