Objectives: The Xpert Carba-R Assay is a diagnostic test designed for the rapid detectionand differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1 genes. We verifiedthe performance of Xpert Carba-R Assay for identification of carbapenemase genein the clinical microbiology laboratory. Methods: The analytical limit of detection was determined with two suspensions ofcarbapenemase-producing Enterobacteriaceae (CPE) isolates (KPC and NDM). A totalof 52 specimens were evaluated: 21 bacterial isolates from clinical specimens, 21 rectalswabs, and 10 contrived stool specimens. Results: In bacterial isolates, concordant results between the Xpert Carba-R Assayand PCR were found in 20 of 21; 8 KPC, 8 NDM, 1 IMP, and 2 multiple carbapenamasegenes (KPC/NDM, NDM/OXA) were detected both by Xpert Carba-R Assay and PCR.In one GES-positive isolate, Xpert Carba-R Assay showed a negative result as expected.One VIM-positive isolate tested negative by Xpert Carba-R Assay. Complete concordancewas seen in rectal swab specimens: 4 specimens with KPC and 17 specimenswith negative results both by Xpert Carba-R Assay and surveillance culture. Among the10 contrived stool specimens, Xpert Carba-R Assay detected carbapenemase genes in9 specimens as expected according to the CPE strains spiked into the contrived stool; 2KPC, 4 NDM, 1 IMP, and 2 multiple carabapenamase genes (NDM/KPC, NDM/OXA).One VIM-positive specimen tested negative by Xpert Carba-R Assay. Conclusion In conclusion, the Xpert Carba-R Assay can be used to identify carbapenemasegene in bacterial isolates cultured from clinical specimens and detect CPE carrierusing rectal swab in clinical laboratories.

Inflammatory myofibroblastic tumor (IMT) is an uncommon mesenchymal solid tumor commonly documented in children and young adults. Here, we report a case of IMT in colon confirmed pathologically after laparoscopic anterior resection. A 35-year-old man presented with anal bleeding after defecation for 2 weeks. Colonoscopy demonstrated a mass with shallow ulceration in the central area and irregular margin accompanied by intact mucosa in the descending colon. Computer tomography showed a well-demarcated and homogenous solitary mass in the descending colon. We performed laparoscopic anterior resection. This case was diagnosed as IMT after microscopic examination. The tumor was composed of a proliferation of spindle-shaped cells arranged in the hyaline material with chronic inflammatory cells, composed mainly of plasma cells and lymphocytes. Immunohistochemically, tumor cells were positive for smooth muscle actin, and vimentin, and negative for desmin, CD117 (c-kit), anaplastic lymphoma kinase-1.
Actins ; Adult ; Child ; Colon ; Colon, Descending ; Colonoscopy ; Defecation ; Desmin ; Hemorrhage ; Humans ; Hyalin ; Lymphocytes ; Lymphoma ; Mucous Membrane ; Muscle, Smooth ; Myofibroblasts ; Plasma Cells ; Ulcer ; Vimentin ; Young Adult

Objective: Isotretinoin should not be used during pregnancy because of the risk of birth defects. Most pregnant women exposed to isotretinoin choose voluntary pregnancy termination due to concerns about birth defects. However, birth outcome data supporting the termination of pregnancy are lacking. This study aimed to evaluate pregnancy and neonatal outcomes after periconception exposure to isotretinoin. Methods: This was a prospective cohort study. We evaluated pregnancy and neonatal outcomes after exposure to isotretinoin in 151 pregnant women. Among 1,026 callers at the Korean Teratology Information Service from 2001 to 2017 exposed to isotretinoin during the periconception period, 151 pregnant women who received counseling on teratogenic risk after visiting the clinic were included. Results: Among the 151 participants who visited the clinic, only 42 were evaluated using ultrasonography until approximately 20 weeks of gestation. Ultimately, 23 patients were included in the study. The average gestation period during the last exposure to the drug was 2 weeks, and the average daily exposure dose was 12 mg. There were two cases of major birth defects in the exposure group. Spontaneous abortion rates were 17.7% and 8.7% in the exposure and nonexposure groups, respectively (P=0.035). There was no significant difference between the exposure and non-exposure groups in terms of pregnancy and neonatal outcomes. Conclusion There was no significant difference in pregnancy and neonatal outcomes, including birth defects, between the exposure and non-exposure groups. Further studies with larger sample sizes are required to validate our findings.

Objective: Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. Methods: Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3. Results: Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04. Conclusion The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.

Objective: Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. Methods: Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3. Results: Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04. Conclusion The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.