2016年 · 第39卷第03期

1972, Lundberg^[1]For the first time, the critical value is defined as a laboratory test value that can directly endanger a patient's life if clinical intervention is not performed in a timely manner. To this end, the Joint Commission on Accreditation of Healthcare Organizations (JACHO), the College of American Pathologists (CAP) And International Standardization authorities such as the International Standardization Organization (ISO) have put forward specific requirements for the management of critical values^[2,3,4]。 The National Patient Safety Targets issued by the Ministry of Health in 2007 include critical value management^[5,6]。 The National Health and Family Planning Commission released 15 professional medical quality control indicators for clinical laboratory in 2015, including 2 quality indicators related to critical value, emphasizing the timeliness of critical value notification.

Establishing and perfecting standardized operating procedures for pathogen identification and in vitro drug susceptibility test is one of the basic requirements for strengthening the capacity building of microbiology laboratory. It is of great significance to optimize clinical drug selection and slow down the production of drug-resistant bacteria. The drug susceptibility test standards formulated by CLSI are the guiding documents followed by laboratories in China. As a supplement to the CLSI-approved drug susceptibility testing standards (including M02-A12, M07-A10, and M11-A8), M100-S26 was officially renamed M100S (version 26) in 2016. This article will focus on the interpretation of the CLSI M100S (26th Edition) document^[1]Main updates in for clinical laboratory reference.

hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease. HCV RNA detection is of great significance for HCV diagnosis, efficacy monitoring and treatment endpoint assessment. At present, most of the HCV RNA quantitative detection reagents widely used at home and abroad are based on real-time fluorescence quantitative PCR technology. Due to different standards, there will be great differences between the test results of instruments of different manufacturers. Even for the same method, due to different environments and operators, the amplification efficiency of the reaction itself will change to some extent, resulting in differences in results. Therefore, in actual clinical work, patients are usually required to use the same detection method in the same laboratory as much as possible when detecting HCV RNA at different time points to ensure the consistency of results^[1,2]。 In addition, the sensitivity of the detection method is a key index to evaluate the detection technology, which has important clinical application value. The microdroplet digital PCR technology is that the sample is microdroplet processed through a microdroplet generator, and the PCR reaction system is made into tens of thousands of water-in-oil droplets with the size of picoscale to ensure the realization of single molecule amplification. After the PCR amplification reaction is completed, each droplet is detected one by one by a microdroplet detector, and finally, the copy number of the target molecule is calculated by software analysis^[3]。 Because of the high sensitivity of this method, the application direction of this technology is mainly focused on obtaining molecular biomarkers from peripheral blood and screening for low-frequency specific mutations. There are few reports about its quantitative detection of viral nucleic acids^[4]。 In order to evaluate the application value of this technique in the quantitative detection of HCV RNA, especially its ability to quantify low-copy HCV RNA, we evaluated the performance of microdrop digital PCR in the detection of HCV RNA.

mycophenolic acid (MPA) is an immunosuppressant widely used in various solid organ transplant patients. It inhibits inosine monophosphate dehydrogenase (IMPDH) in T and B lymphocytes.^[1]。 The first generation of finished drugs containing mycophenolate acid is mycophenolate mofetil (MMF). The combination of MMF and calcineurin inhibitor hormone has become the preferred medication regimen after renal transplantation. Although it can effectively reduce the rejection of organs after transplantation and improve the survival time of organs in the body, many studies have shown that bleeding and gastrointestinal adverse reactions have been serious problems encountered by patients using MMF.

human cytomegalovirus (HCMV) is a linear double-stranded DNA virus belonging to the herpesvirus beta subfamily, and infection in humans is quite common. For those with normal immune function, HCMV infection is often a latent infection without obvious clinical symptoms, but for those with low immunity (such as infants and young children) or immunosuppressed (such as organ transplantation), it usually causes serious injury and even death^[1,2]。 Rapid and accurate diagnosis of early HCMV infection and monitoring of antiviral therapy are the key to effectively prevent and reduce the incidence and mortality of HCMV disease. Real-time fluorescence quantitative PCR (Real-time PCR) has the advantages of high specificity, high sensitivity and accurate quantification. It is especially suitable for monitoring the dynamic changes of HCMV viral load in the body^[3,4,5,6]。 However, recent foreign multi-center studies have shown that there are significant differences in HCMV nucleic acid detection results between laboratories, which greatly affects the clinical application of real-time PCR in HCMV DNA detection^[7,8,9]。 This study intends to select HCMV quality control (AD169) as the interlaboratory quality assessment sample, which is used for the first time in the interlaboratory quality assessment of HCMV DNA in clinical laboratories in Shanghai, in order to evaluate the consistency of clinical laboratory test results and ultimately promote the improvement of HCMV nucleic acid detection quality.

Clostridium difficile is a gram-positive obligate anaerobic bacillus, which is the normal flora of the human intestine. Since 2003, Clostridium difficile infection (Clostridium difficile infectionThe incidence and disease severity of CDI are on the rise worldwide, especially the emergence and outbreak of high-producing strains of C. difficile (BI/NAP1/027/toxin type III), making C. difficile one of the main pathogens of nosocomial acquired diarrhea. Strain 027 was resistant to many kinds of antibiotics and played a certain role in its outbreak^[1]。 In recent years, it has been reported that the sensitivity of metronidazole and vancomycin, the traditional treatment drugs for CDI, has decreased, and the recurrence rate after cure is as high as 25% ~60%^[2]。 Domestic attention to CDI is also gradually increasing^[3,4]However, there are few relevant reports on drug resistance of Clostridium difficile, and the number of strains is small, and the specimen source is single. Therefore, this study performed antibiotic susceptibility analysis of C. difficile isolates collected from different populations in Hebei in recent years, providing reliable data for the prevention and treatment of clinical CDI.