Background Accurate and rapid diagnosis of Clostridium difficile infection (CDI) is critical for effective patient management and implementation of infection control measures to prevent transmission. Objectives We updated our previous meta-analysis to provide a more reliable evidence base for the clinical diagnosis of Xpert C. difficile (Xpert C. difficile ) assay. Methods We searched PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), and the Chinese Biomedical Literature Database (CBM) databases to identify studies according to predetermined criteria. STATA 13.0 software was used to analyze the tests for sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and area under the summary receiver operating characteristic curves (AUC). QUADAS-2 was used to assess the quality of included studies with RevMan 5.2. Heterogeneity in accuracy measures was tested with Spearman correlation coefficient and chi -square. Meta-regressions and subgroup analyses were performed to figure out the potential sources of heterogeneity. Model diagnostics were used to evaluate the veracity of the data. Results A total of 26 studies were included in the meta-analysis. The pooled sensitivity (95% confidence intervals [CI]) for diagnosis was 0.97(0.95–0.98), and specificity was 0.96(0.95–0.97). The AUC was 0.99 (0.98–1.00). Model diagnostics confirmed the robustness of our meta-analysis’s results. Significant heterogeneity was still observed when we pooled most of the accuracy measures of selected studies. Meta-regression and subgroup analyses showed that the sample size and type, ethnicity, and disease prevalence might be the conspicuous sources of heterogeneity. Conclusions The up-to-date meta-analysis showed the Xpert CD assay had good accuracy for detecting CDI. However, the diagnosis of CDI must combine clinical presentation with diagnostic testing to better answer the question of whether the patient actually has CDI in the future, and inclusion of preanalytical parameters and clinical outcomes in study design would provide a more objective evidence base.

Application of matrix‐assisted laser desorption ionization‐time of flight mass spectrometry (MALDI‐TOF MS) using positive blood cultures (BCs) is a revolution in identification of microorganisms in clinical microbiology laboratories. Although there are several commercial pretreat‐ ment protocols they are expensive. Here, we evaluated the performance of a locally produced Bioyong pre‐treatment kit for the direct identification of microorganisms in positive BCs by MALDI‐TOF MS method. The mocked positive BCs were performed using 200 Thermo aerobic blood culture bottles and 200 aerobic Scenker blood culture bottles. A total of 200 organisms were invovled, including 91 strains of Gram‐positive bacteria, 97 strains of Gram‐negative bacteria and 12 strains of Candida. The positive BCs were subcultured and identified by classical biochemical Vitek II testing as the gold standard of identification. The Bioyong pre‐treatment kit could successfully identify microorganisms in 189 (94.5%) Thermo positive BCs and 189 (94.5%) Scenker positive blood cultures, respectively. In total, 94 (96.9%) Gram‐negative bacteria, 86 (94.5%) Gram‐positive bacteria and 9 (75.0%) candida isolated from Thermo positive BCs were correctly identified to species level and 95 (97.9%) Gram‐negative bacteria, 86 (94.5%) Gram‐positive bacteria and 8 (66.7%) candida isolated from Scenker positive BCs were correctly identified to species level. This method provides a rapid, accu‐ rate identification of bacteria and Candida within one hour in positive blood cultures. Routine application of this technique will improve the antimicrobial treatment within 24 h among the patients with bacteremia and candidemia. Introduction Blood stream infections (BSIs) remain one of the most serious infections with high morbidity and mortality. Rapid identifica‐ tion of the causative microorganism and the correct initial anti‐infection treatment is especially critical for sepsis patients. The delay of appropriate anti‐infection treatment may increase the mortality of patients (1). Moreover, appropriate anti‐infection therapeutic option determines the survival rate of patients (2). Accurate and rapid diagnosis of etiological diagnosis is the key to reduce the time and cost of hospitalization (3). Blood culture is still the most important diagnostic method for BSIs. For positive blood cultures, the traditional laboratory process is performed based on Gram staining, subculture, biochemical identification and antimicrobial susceptibility tests. The laboratory reports commonly need 48‐72 h. If the pathogen grows harsh or inert, the cycle will be even longer. In recent years, a variety of new rapid identification methods such as real‐time quantitative PCR, multiple PCR, fluores‐ cence in situ hybridization (FISH) and peptide nucleic acid hybridization (PNAFISH) have been introduced into the field of microbial identification (4). However, these methods are limited to detecting the target microorganisms. In addition, the cost of reagents and instruments of these methods is high. In 2009, MALDI‐TOF MS was firstly introduced into the field of clinical microbiology identification directly from positive blood cultures (BCs) (5). At present, MALDI‐TOF MS is becoming more mature for pure colony identification with high accuracy and repeatability. In almost all studies, the identification accuracy of this method was better than the routinely used biochemical identification method, with the test cycle shortened and the required cost reduced (6). There are several in‐house methods for the identification of pathogens directly from BCs or other primary specimens developed. However, none is commonly used because there is no standardization. There are also several imported commer‐ cial kits in China, but the prices are relative high for routine operation in clinical laboratories. Bioyong kit is a recently developed pretreatment method to improve the performance of direct MALDI‐TOF MS identification from positive BCs. The Bioyong sample preparation kit was produced in China locally, aimed to cut down costs and increase sensitivity. The Rapid method for direct identification of positive blood cultures by MALDI‐TOF MS YUELING WANG1, YAN JIN1, YUANYUAN BAI1, ZHEN SONG1, WENJUN CHU1, MENGQI ZHAO1, YINGYING HAO1,2 and ZHIMING LU1,2 1Department of Clinical Laboratory, Shandong Provincial Hospital Affiliated to Shandong First Medical University; 2Department of Clinical Laboratory, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong 250021, P.R. China Received February 18, 2020; Accepted August 27, 2020 DOI: 10.3892/etm.2020.9365 Correspondence to: Dr Zhiming Lu or Dr Yingying Hao, Department of Clinical Laboratory, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 324 Jing‐Wu, Jinan, Shandong 250021, P.R. China E‐mail: r8s272@163.com E‐mail: luzhiming@sdu.edu.cn; haoyyjia@163.com

Application of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) using positive blood cultures (BCs) is a revolution in identification of microorganisms in clinical microbiology laboratories. Although there are several commercial pretreatment protocols they are expensive. Here, we evaluated the performance of a locally produced Bioyong pre-treatment kit for the direct identification of microorganisms in positive BCs by MALDI-TOF MS method. The mocked positive BCs were performed using 200 Thermo aerobic blood culture bottles and 200 aerobic Scenker blood culture bottles. A total of 200 organisms were invovled, including 91 strains of Gram-positive bacteria, 97 strains of Gram-negative bacteria and 12 strains of Candida. The positive BCs were subcultured and identified by classical biochemical Vitek II testing as the gold standard of identification. The Bioyong pre-treatment kit could successfully identify microorganisms in 189 (94.5%) Thermo positive BCs and 189 (94.5%) Scenker positive blood cultures, respectively. In total, 94 (96.9%) Gram-negative bacteria, 86 (94.5%) Gram-positive bacteria and 9 (75.0%) candida isolated from Thermo positive BCs were correctly identified to species level and 95 (97.9%) Gram-negative bacteria, 86 (94.5%) Gram-positive bacteria and 8 (66.7%) candida isolated from Scenker positive BCs were correctly identified to species level. This method provides a rapid, accurate identification of bacteria and Candida within one hour in positive blood cultures. Routine application of this technique will improve the antimicrobial treatment within 24 h among the patients with bacteremia and candidemia.

目的 探讨山东地区孕前妇女TORCH感染情况,为本地区孕前妇女保健提供参考依据,降低不良妊娠发生率. 方法 收集1035例孕前妇女外周血标本,利用化学发光免疫分析法(CLIA)对弓形虫(TOX)、巨细胞病毒(CMV)、风疹(RV)、单纯疱疹(HSV)的IgG以及IgM抗体进行检测,分析感染率. 结果 IgG抗体检测结果:TOX阳性率为1.64%(17/1035),CMV阳性率为89.47%(926/1035),RV 阳性率为87.73%(908/1035),HSV阳性率为94.98%(983/1035). IgM抗体检测结果:TOX阳性率为0.97%(10/1035),CMV阳性率为2.80%(29/1035),RV阳性率为5.12%(53/1035),HSV阳性率为15.75%(163/1035). HSV、CMV、RV感染模式均以IgM-/IgG+为主,而TOX感染模式则以IgM-/IgG-为主. 结论 山东地区孕前妇女TORCH的感染较普遍,急性感染以HSV为主,且HSV、CMV、RV既往感染率或疫苗接种率较高,人群存在一定免疫力,而对TOX抵抗力相对较差,需加强疫苗接种.