The allergic symptoms induced by food allergy (FA) are complex and varied, which not only impact negatively on quality of life, but also threatens the lives in severe cases. In recent years, component-resolved diagnostics (CRD) has aroused extensive attention and has certain clinical value in the diagnosis of food allergies. In this review, the research status of food CRD at home and abroad, the characteristics of common allergenic food components, the application value of CRD in food allergy, and the detection technology of food components were summarized, so as to provide new ideas for the research direction of CRD in food allergy and reference for the prevention, clinical diagnosis and treatment of food allergy.

The reporting of clinical values are directly related to the life safety of patients, involving in laboratory, information department and clinician. Selecting the items of clinical values and alert limits of the test results, establishing the critical value reporting system and modifying the laboratory information system is the key to accurate reports and medical security.

Acute ischemic stroke (AIS), also known as cerebral infarction, is an acute cerebrovascular disease with more than 7 million new cases worldwide every year, which is the second leading cause of death in the world. There are more than 24 million patients in China. Among the many risk factors, hypertension is the most important independent related factor of AIS, which is closely related to its morbidity and mortality. The hemodynamic changes after AIS affect the prognosis of the disease, so the management of blood pressure in the acute phase should be throughout the whole process. However, for patients with AIS, the management of blood pressure with different treatment methods is still an important outstanding issue. This paper reviews the research progress of blood pressure management in AIS in recent years.

Adult onset Still’s disease(AOSD) is an inflammatory systematic disorder with unknown etiology and a wide clinical presentation. It is easy to be misdiagnosed or missed diagnosed. Therefore, it is very important to have a highly specific and sensitive laboratory indicator reasonably. This review will focus on the pathogenesis and clinical laboratory indicators of the disease in order to provide the reference of diagnosis and treatment of AOSD efficiently.

Count the median turn around time (TAT), the compliance rate of the specified time limit of the test report and the overtime rate of the report before and after the operation of the ISO15189 quality management system of the laboratory, and analyze the management effect of the ISO15189 quality management system on the primary hospitals on the TAT of the emergency test, so as to provide an objective basis for the continuous improvement of the service ability of the laboratory in the primary hospitals.

The raw data of the test items was exported by the LIS system exports. Emergency data was filtered out by Mircosoft Excel 2019 and statistics of the TAT of the emergency items was carried out. Median TAT, the test report time limit compliance rate and test report timeout rate were calculated. The reasons for reporting timeout was listed and statistically analyzed.

The median TAT of emergency examination items before the establishment of ISO15189 quality management system (January-October, 2018) and after the establishment of ISO15189 quality management system (January-October, 2019), with the exception of troponin (CTNI), all other items had different degrees of TAT shortening, and the difference was statistically significant (P<0.05); the average compliance rate of the four emergency examination items with the test report time limit increased from 93.4% to 96.8%, an increase of 3.4 percentages, and the top four main reasons for timeout were, in order, the increase in specimen volume (64.1%), review of suspicious results (16.3%), instrument failure (14.2%) and staff post rotation (5.4%).

The establishment of ISO15189 quality management system in primary hospitals can shorten the TAT of emergency testing programs and improve the ability of medical laboratories to provide clinical services.

The Clinical Laboratory Improvement Amendments (CLIA) individualized quality control plan (IQCP) is a risk-based, objective approach to performing quality control testing. It is based on assessment of the unique laboratory testing in use, patient populations and other aspects (for example, internal quality checks built into new instruments). IQCP is the implemented under the Centers for Medicare & Medicaid Services (CMS) regulation 42 CFR 493.1256 Standard: Control Procedures, and apply to most CMS-certified current and new non-waived tests. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process.

In this article, we introduce the concept of IQCP and discuss the overall situation of IQCP implementation so far. Hopefully, this new idea of quality plan could provide clues on how to improve quality management based on each clinical lab′s specific situation in China.

High-throughput sequencing, also known as the high-throughput next generation sequencing (NGS), can sequence thousands of genes at one time, greatly improve the efficiency of DNA sequencing and reduce the cost. Recently, NGS has been widely used in medical research and clinical diagnosis. It has extensive applications in non-invasive prenatal screening, tumor screening, diagnosis and treatment, microbial pathogens detection, genetic diseases screening and diagnosis as well as organ transplantation rejection screening. However, as a new technology, NGS also has many issues in related clinical application. The quality management system is still imperfect and faces many challenges. Thus the joint efforts of medical laboratories and related departments are needed to promote the standardization of NGS in clinical diagnosis.

In precision medicine. whole genome sequencing data, related molecular information and individual clinical data, are often employed forselecting appropriate and optmal therepiesbased on the contect of a patient′s genetic conten, and then prepare for the development of targeted drugs and achieve accurate medical care. At present, the concept of precision medicine is infiltrating into the fields of clinical tumor diagnosis and treatment. Tumor will be diagnosed and classified according to underlying molecular and related factors to achieve "treating the same disease with different governance" and "treating different diseases with the same protocol". In addition, the next generation sequencing(NGS) technology will be an indispensable technology in precision medicine, which promotes the application of precision medical treatment in the clinical setting. Mereover, it also need to improve the regulatory policies, to achieve the goal of standardized management of NGS in clinical application.

Tuberculosis (TB) is a major infectious disease in our country. The untypical clinical manifestation of latent tuberculosis infection and the drug-resistance TB resulted in the serious situation of prevention and control. Early and accurate detection of TB is an effective means to reduce the incidence. With the rapid development of molecular biology and immunology, the time for bacteriology examination and drug sensitive test has been greatly shortened. This review summarizes clinical diagnosis, laboratory diagnosis and development of new diagnosis technology of TB. We hope it could help to improve the sensitivity and specificity of clinical diagnosis, and to determine the unified diagnostic criteria.

To investigate the clinical features, laboratory results, treatment and prognosis of children with hemophagocytic syndrome (HPS) for improving the clinical understanding of the disease

The clinical data of 17 children with HPS admitted to the pediatric intensive care unit (PICU) in Guangdong Women and Children Hospital from January 2016 to March 2020 were retrospectively analyzed.

The most common clinical symptoms of the 17 children with HPS were fever (100%), hepatomegaly (52.94%) and rash (52.94%), followed by superficial lymphadenopathy (23.53%), tricavitary sign (17.65%), splenomegaly (11.76%) and jaundice (11.76%). In laboratory examination, 14 cases (82.35%) of hemocyte secondary or tertiary lines decreased, 17 cases (100%) of ferritin increased, 16 cases (94.12%) of D-dimer increased, 16 cases (94.12%) of hemoglobin decreased, 15 cases (88.24%) of partially activated thromboplastin time prolonged. Hemophilic phenomenon of bone marrow was observed in all patients. There were 5 cases of autoimmune diseases related antibodies and 7 cases of EB virus positive. After treatment, 12 patients recovered and 5 cases died.

Considering the complex clinical presentation and various etiology of children with HPS, dynamic observation of laboratory results and expansion of diagnostic strategy were needed to achieve the purpose of early diagnosis

Estrogen in human serum plays the irreplaceable roles in pregnancy. It can establish and maintain female secondary sexual characteristics in a low concentration. Determination of estrogen concentrations is an effective means to understand the female endocrine function and diagnose diseases associated with endocrine disorders clinically. With the development of analysis techniques, various types of estrogen determination methods in medical laboratory are established from radioimmunoassay and enzyme immunoassay to enzyme immunoassay and gas or liquid chromatography/mass spectrometry. These technologies play vital roles in estrogen detection, related disease monitoring and prognosis.

To investigate the detection performance of Whole-exome sequencing (WES) for calling variants by the established second-generation sequencing technology.

Four CAP proficiency testing samples and 4 known results samples were detected by WES. Point mutations and insertion deletion mutations were analyzed. Detection performance was evaluated in terms of accuracy, sensitivity, specificity, precision and reportable range of calling variants. Data quality control was performed based on coverage of target region, capture specificity and mean depth.

Output data should not be less than 8G. In this case, coverage of target region is over 99.7%. Capture specificity is over 86%. Mean depth is over 100×. Q30 is over 90%, The detection of single nucleotide variations and small insertion and deletion under 50bp is up to 100%.

The standard operating procedure within the scope of validation can meet the application requirement of mutation detection.

To present the main problems in the use of chemistry analyzing daily, through analyzing the common nonconformities in ISO 15189 assessment. We put forward the reasonable advices in corrective action, according to the ISO 15189 standard and the guidance on the application in chemistry. To help the laboratory improve the use of analyzer in operation, maintenance, repair. To reduce the troubleshooting, and to ensure the accuracy. This paper also provides the beneficial reference for the deep understanding of the terms of ISO 15189.

Streptococcus pneumoniae (S.pn), as the major pathogen of bacterial pneumonia, otitis media, meningitis and septicemia, its infection has always been a global health problem that cannot be ignored. In recent years, the growing virulence and resistance of Streptococcus pneumoniae has posed an increasing threat to public health. New laboratory diagnostic approaches in the genomic field such as PCR and gene sequencing are gradually gaining attention. This article aims to provide reference for in-depth understanding of Streptococcus pneumoniae and seeking effective prevention and treatment measures by analyzing the etiology, adhesion and invasion modes, virulence factors, and existing laboratory diagnosis and prevention methods of Streptococcus pneumoniae.

In recent years, the treatment of multiple myeloma (MM) has progressed from the era of chemotherapy into the targeted therapy times, the targeted therapy focus on inhibiting the myeloma cell growth and survival in the bone marrow microenvironment. With the further investigation of MM, numerous novel agents and new regimens of combined chemotherapy are currently emerging. The clinical application of Immunomodulatory drugs (IMids), proteasome inhibitor based single or combined regimens has had profound effects a MM therapy, which promises for MM patients.

To explore the application effect of rare phenotype of common pathogenic bacteria in clinical microbiological examination practice.

The knowledge related to the rare phenotype of common pathogenic bacteria was summarized and introduced into the teaching process of clinical microbiology laboratory practice.

The rare phenotype of common pathogenic bacteria enriches the teaching content, arouses students' initiative and enthusiasm, and improves the quality and effect of clinical microbiological examination practice teaching.

It is an effective teaching method to introduce the rare phenotype of common pathogenic bacteria into the practice teaching of clinical microbiological examination.

Investigate the significance of Royal Marsden Hospital(RMH) Immunophenotyping Score System in the diagnosis of chronic lymphocytic leukemia (CLL) of China, devote to achieve CLL′s diagnosis and differential diagnosis by flow cytometry.

Case-control study method was utilized to compare the diagnostic efficacy of 43 CLL patients and 43 B cell chronic lymphoproliferative disorders (B-CLPD, control group). These cases were collected during January 2015 to February 2017 in our laboratory. The samples were labeled by a series of monoclone antibodys, and all cells were definitely classified using CD45-SS gating. B cells could be easily gated from other cell clusters according to the surface expression of CD19. Then the B cell markers expression was analyzed to statistic the RMH score (CD5, CD23, FMC7, sIgM and CD22). Finally, the differences of RMH score and markers expression levels between CLL group and control group were acquired.

The RMH score between the two groups showed significantly difference (χ² =74.459, P<0.05). The expression levels of CD5, CD23, FMC7, sIgM and CD22 between the two groups all showed significantly difference (χ² =27.158, 33.907, 9.685, 12.452 and 11.417 respectively; P<0.05 or 0.001). However, there were still two special cases. The first was a case that tended to have CLL clinical manifestations and cell morphology, while the RMH score was only 3; and the seconed case was a case maintained low RMH score which is only 4, but the morphological characteristics and other inspections showed it was PLL. In addition, CD5 and CD22 showed no significantly difference between CLL and MCL(χ²=2.057, 0.813; P>0.05) ; CD10 usually expressed on FL; CD20 can distinguish CLL from MCL(χ²=5.816, P<0.05), but there was largely unhelpful in distinguishing between CLL and other subgroups. FMC7 showed statistical difference between CLL and FL, MCL, SMZL and CD5^-CD10^-subgroups(χ²=10.228, 7.984, 8.905, 13.478; P<0.01 or P<0.05). The difference was also seen between CLL and non-FL subgroup. sIgM can only be used to distinguish CLL from MCL and CD5^-CD10^-subgroups(χ²=8.441, 4.722; P<0.05).

In this study, 98% of CLL cases could be diagnosed by RMH Immunophenotyping score system, and could be differentiated from B-CLPD cases. In a few cases, it is necessary to combine the clinical and other examination results before making final diagnosis, as the other results, such as morphotogy, are inconsistent with flow cytometry resulots.

The global pandemic of novel coronavirus has brought great threat to the life and health of people all over the world. Currently, the prevention and treatment measures for novel coronavirus remain very limited. Nucleic acid testing is crucial for the rapid diagnosis of infected cases, the exclusion of suspected cases, and the promotion of epidemic prevention and control and clinical treatment. In this paper, the application and challenges of RT-PCR technology in novel coronavirus nucleic acid detection are reviewed, and the practical experience accumulated in our laboratory for a long time is summarized, such as increasing instruments and equipment, optimizing experimental process, strengthening information construction, and improving working conditions, to improve the ability and efficiency of nucleic acid testing, and provide a reference for nucleic acid detection of novel coronavirus in the laboratory.

To analyze the effect of PDCA cycle in improving the biosafety management of pathogenic microorganisms in hospitals.

The pre-implementation control group from April 2018 to March 2019 and the research group after the implementation of the PDCA cycle from April 2019 to March 2021 were compared the correct treatment rate of safety accidents, laboratory disinfection, medical waste, and the infectious disease-positive specimens before and after implementation.

Through PDCA cycle management, compared with the control group, the correct treatment rate of safety accidents in the research group increased by 14.30%, the correct treatment rate of laboratory disinfection increased by 17.40%, the correct treatment rate of medical waste increased by 10.56%, and the correct treatment rate of infectious disease positive specimens increased by 12.48%, and the difference was statistically significant (P＜0.05).

In view of the problems that are easy to occur in the laboratory, the rational use of PDCA cycle management according to the actual situation of the laboratory can reduce laboratory safety problems such as irregular laboratory disinfection, improve laboratory safety quality, and have high application value.