Blood analysis and detection plays an important role in diagnosis, monitor of curative effect and prevention of disease. Blood analysis and detection system has been widely used in the laboratories of centers of disease control and prevention and hospitals, and standardized application is an important prerequisite to ensure the quality of blood analysis. Based on the core content of blood analysis and detection system application in laboratories, especially in primary medical laboratories, and referring to relevant documents such as national laws and regulations, national standards, industry standards, guidelines and specifications, the Grassroots Inspection Technology Standardization Branch of China Health Care International Exchange Promotion Association formulates this consensus. And the consensus focus on the personnel management, equipment, reagents and consumables management and use, the whole process of test, quality control, result report and other related elements involved in the application of blood analysis system, so as to guide the primary medical laboratories to improve the quality management system, standardize the application of blood analysis and testing system, and improve the quality of blood analysis and testing.
China ; Consensus ; Humans ; Laboratories ; Quality Control ; Reference Standards

Laboratories ; organization & administration ; standards ; statistics & numerical data ; Nigeria ; United Nations ; standards ; Veterinary Medicine ; organization & administration

The teaching laboratory is the central place to teach lab courses to undergraduate students. It is thus critical to evaluate how lab skills of students will be affected by the management of this lab. This study attempts to introduce the 6S concept, referring to "Seiri", "Seiton", "Seiso", "Seiketsu", "Shisuke", and "Safety", to the management of teaching laboratory, in particular, to the management of environments, safety, item deposition, reagents and consumables in the laboratory. We find that applying the "6S" management maintains a tidy lab environment, facilitates teaching the lab skills, and improves the quality of teaching, which together achieves the goal of education with the atmosphere. This study can provide a guideline for establishing and managing teaching laboratories in universities.
Education ; organization & administration ; standards ; Environment Design ; Humans ; Laboratories ; organization & administration ; standards ; Students ; Universities ; organization & administration ; standards

Genetics ; Laboratories ; Technology ; standards ; United States

This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.
Cadmium ; analysis ; Laboratories ; Laboratory Proficiency Testing ; Lonicera ; chemistry ; Pharmaceutical Preparations ; standards ; Plant Preparations ; standards ; Trace Elements ; analysis

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.
Anticoagulants/therapeutic use ; Antidepressive Agents/therapeutic use ; Antimetabolites, Antineoplastic/therapeutic use ; Antitubercular Agents/therapeutic use ; Arylamine N-Acetyltransferase/genetics ; Coronary Artery Disease/drug therapy/genetics ; Cytochrome P-450 CYP2C19/genetics ; Cytochrome P-450 CYP2C9/genetics ; Cytochrome P-450 CYP2D6/genetics ; Depressive Disorder/drug therapy/genetics ; Genotype ; Isoniazid/therapeutic use ; Laboratories, Hospital/standards ; Methyltransferases/genetics ; Pharmacogenomic Testing/*methods/standards ; Platelet Aggregation Inhibitors/therapeutic use ; Pulmonary Embolism/drug therapy/genetics ; Ticlopidine/analogs & derivatives/therapeutic use ; Tuberculosis/drug therapy/genetics ; Vitamin K Epoxide Reductases/genetics ; Warfarin/therapeutic use

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.
China ; Ebolavirus ; classification ; genetics ; isolation & purification ; Hemorrhagic Fever, Ebola ; diagnosis ; virology ; Humans ; Laboratories ; manpower ; standards ; Laboratory Infection ; Quality Control ; RNA, Viral ; genetics ; Sierra Leone

To understand the potential causes of laboratory-acquired infections and to provide possible solutions that would protect laboratory personnel, samples from a viral laboratory were screened to determine the main sources of contamination with six subtypes of Rhinovirus. Rhinovirus contamination was found in the gloves, cuffs of protective wear, inner surface of biological safety cabinet (BSC) windows, and trash handles. Remarkably, high contamination was found on the inner walls of the centrifuge and the inner surface of centrifuge tube casing in the rotor. Spilling infectious medium on the surface of centrifuge tubes was found to contribute to contamination of centrifuge surfaces. Exposure to sodium hypochlorite containing no less than 0.2 g/L available chlorine decontaminated the surface of the centrifuge tubes from Rhinovirus after 2 min.
Equipment Contamination ; statistics & numerical data ; Humans ; Laboratories, Hospital ; manpower ; standards ; statistics & numerical data ; Occupational Exposure ; analysis ; statistics & numerical data ; Virus Diseases ; virology ; Viruses ; genetics ; growth & development ; isolation & purification

For two months between May and July 2015, a nationwide outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) occurred in Korea. On June 3, 2015, the Korean Society for Laboratory Medicine (KSLM) launched a MERS-CoV Laboratory Response Task Force (LR-TF) to facilitate clinical laboratories to set up the diagnosis of MERS-CoV infection. Based on the WHO interim recommendations, the Centers for Disease Control and Prevention of United States guidelines for MERS-CoV laboratory testing, and other available resources, the KSLM MERS-CoV LR-TF provided the first version of the laboratory practice guidelines for the molecular diagnosis of MERS-CoV to the clinical laboratories on June 12, 2015. The guidelines described here are an updated version that includes case definition, indications for testing, specimen type and protocols for specimen collection, specimen packing and transport, specimen handling and nucleic acid extraction, molecular detection of MERS-CoV, interpretation of results and reporting, and laboratory safety. The KSLM guidelines mainly focus on the molecular diagnosis of MERS-CoV, reflecting the unique situation in Korea and the state of knowledge at the time of publication.
Coronavirus Infections/*diagnosis/epidemiology/virology ; Disease Outbreaks ; Humans ; Laboratories/*standards ; Middle East Respiratory Syndrome Coronavirus/*genetics/isolation & purification ; Product Packaging/standards ; RNA, Viral/analysis ; Real-Time Polymerase Chain Reaction ; Republic of Korea/epidemiology ; Societies, Scientific ; Specimen Handling/standards

BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). METHODS: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. RESULTS: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=0.73 for PathFast vs Singulex. CONCLUSIONS: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.
Acute Coronary Syndrome/*diagnosis ; Biomarkers/analysis ; Emergency Service, Hospital ; Humans ; Laboratories/standards ; Myocardial Infarction/diagnosis ; *Point-of-Care Systems ; Prospective Studies ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Troponin I/*analysis