As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

Objective: To analyze the situation and influencing factors of school meals leftover among primary and secondary school students in the area of the Nutrition Improvement Program for Rural Compulsory Education Students, improve the quality of school meals, develop healthy dietary behavior, and reduce food waste. Methods: In 2019, among the 50 monitoring counties that implemented the Compulsory Education Student Nutrition Improvement Program, two primary schools and two junior schools were randomly selected according to different food supply patterns.This study randomly selected one or two classes from grade 3 to grade 9. Basic information and school meals of 26 778 students were collected by using a student questionnaire. Multivariate logistic regression was used to analyze the influencing factors of leftovers rate. Results: 54.93% (14 709) of students wasted school meals, in which the highest rate was the staple food, with the main reason as "not in favor". 11.87% (1 743) of the students wasted school meals 6-7 days a week, with 54.20% (7 957) of students wasted but in less amount. The leftover rate of staple food was the highest (29.78%), followed by vegetables and meat. The main reason of leftovers was that they didn't like this kind of food (33.52%). The rate of school meal waste was higher for girls (OR=1.19,95%CI:1.13-1.25), junior high school students (OR=1.17, 95%CI: 1.11-1.25), resident students (OR=1.06, 95%CI: 1.00-1.12), lower economic level (OR=1.06, 95%CI: 1.00-1.12), parents working outside their houses (OR=1.22, 95%CI: 1.13-1.30), health education classes (OR=1.70, 95%CI: 1.40-2.06), company-based meals (OR=1.89, 95%CI: 1.71-2.07) and school meals were not as good as home food(OR=1.89, 95%CI: 1.78-2.00)(P<0.05). Conclusions: It is common for poor rural primary and middle school students in central and western China to waste school meals, and the reasons were affected by many factors. Reducing food waste requires the joint efforts of individuals, families, schools and society.
Female ; Food Services ; Humans ; Meals ; Refuse Disposal ; Schools ; Students

Objective To investigate the current status of nutritional knowledge and skills of fast-food takeout practitioners in Chengdu City,so as to provide evidence for nutritional literacy education among takeout practitioners.Methods A questionnaire survey was conducted among 832 employees of fast-food takeout restaurants in Chengdu from April to September in 2019 through a multi-stage random sampling strategy.Results The awareness rate of nutritional knowledge of fast-food takeout practitioners in Chengdu was 77.28%,and the correct rates of answers to daily oil intake for adults,daily drinking water for adults and daily salt intake for adults in the Dietary Guidelines for Chinese Residents were respectively 17.43%,22.60% and 25.36%.In addition,the proportion of practitioners with the ability to estimate the recommended intake of food for a meal,the ability to estimate condiments intake and the ability to interpret nutrition labels were 8.77%,8.77% and 15.02%,respectively.The awareness rate of nutritional knowledge was the lowest(71.47%)in the practitioners aged≤25 and the highest(84.53%)in those aged 26-39,and the difference was statistically significant(χ
Adult ; Feeding Behavior ; Humans ; Nutritional Status ; Restaurants ; Surveys and Questionnaires

Objective To investigate the nutritional literacy levels of the takeaway platform practitioners in Chengdu,the takeaway food nutrients,and the correlation between them.Methods We employed a multi-stage random sampling method to investigate the nutritional literacy levels of 100 takeaway platform restaurants in the main urban area of Chengdu and examined the nutritional components of hot set meals in each restaurant.A questionnaire survey was conducted on the nutritional literacy levels of chefs and food matching staff.The correlations of nutrient energy supply rationality with nutritional literacy level and set meal price were then analyzed.Results The total pass rate of nutrition knowledge of chefs/food matching staff was 61.0%.Only 2.0% of the set meals had reasonable total energy supply.The set meals with reasonable energy supply of available carbohydrate,protein,and fat accounted for 3.0%,62.0%,and 21.0%,and those with over energy supply accounted for 97.0%,26.0%,and 73.0%,respectively.The rest set meals provided insufficient energy.There was a positive correlation between the nutritional literacy level and the rationality of protein energy supply(r=0.414,P=0.003).Conclusions The nutritional literacy levels of chefs/food matching staff of takeaway food restaurants in Chengdu are moderate.The hot set meals on the takeaway platform have the problem of excess energy supply.The nutrition knowledge of chefs/food matching staff cannot effectively satisfy rational nutrition matching.The nutritional literacy levels of chefs/food matching staff showed no significant correlation with the rationality of nutrient energy supply.
Fast Foods ; Humans ; Literacy ; Meals ; Nutrients ; Restaurants

OBJECTIVES: This study examined the salinity of soups provided at childcare centers by measuring the salinity for three years and providing basic data for sodium reduction.METHODS: The soup salinity was measured using a Bluetooth salinity meter from January 2015 to December 2017 at 80 childcare foodservice establishments enrolled in the Suseong Center for Children's Foodservice Management in Daegu.RESULTS: An analysis of the soup salinity each year showed that the salinity decreased significantly from 0.48% in 2015 to 0.41% in 2017, particularly in clear soups and soybean soups compared to other soups (P < 0.05). The salinity and sodium content in seafood soups (0.45% and 179.1 mg/100 g, respectively) were highest, followed by soybean soups (0.44%, 175.2 mg/100 g), with perilla seed soups containing the lowest (0.42%, 167.2 mg/100 g) (P < 0.05). The salinity was significantly higher in institutional foodservice establishments than small foodservice establishments (P < 0.001). The salinity and sodium content were the highest in foodservice establishments with a small number of measurements, and the salinity was the lowest in foodservice establishments with salinity measurements performed an average of 151 times each year (three times a week) or more (P < 0.05). The soup salinity was low in the order of winter, spring, summer, and autumn, and the salinity decreased significantly year by year in all seasons. (P < 0.05).CONCLUSIONS: The soup salinity was significantly lower in foodservice establishments where the salinity was measured more than three times a week, indicating that continuous salinity management is effective.
Daegu ; Food Services ; Perilla ; Salinity ; Seafood ; Seasons ; Sodium ; Soybeans

BACKGROUND: In the Emergency Department (ED), diagnosis and management of anaphylaxis are challenging with at least 50% of anaphylaxis episodes misdiagnosed when the diagnostic criteria of current guidelines are not used.OBJECTIVE: Objective of our study was to assess anaphylaxis diagnosis and management in patients presenting to the ED.METHODS: Retrospective chart review conducted on patients presenting to The Medical City Hospital ED, the Philippines from 2013–2015 was done. Cases were identified based on International Statistical Classification of Diseases, 10th revision coding for either anaphylaxis or other allergic related diagnosis. Cases fitting the definition of anaphylaxis as identified by the National Institute of Allergy and Infectious Disease and the Food Allergy and Anaphylaxis Network (NIAID/FAAN) were included. Data collected included demographics, signs and symptoms, triggers and management.RESULTS: A total of 105 cases were evaluated. Incidence of anaphylaxis for the 3-year study period was 0.03%. Of the 105 cases, 35 (33%) were diagnosed as “urticaria” or “hypersensitivity reaction” despite fulfilling the NIAID/FAAN anaphylaxis criteria. There was a significant difference in epinephrine administration between those given the diagnosis of anaphylaxis versus misdiagnosed cases (61 [87%] vs. 12 [34%], χ² = 30.77, p < 0.01); and a significant difference in time interval from arrival at the ED to epinephrine administration, with those diagnosed as anaphylaxis (48%) receiving epinephrine within 10 minutes, versus ≥ 60 minutes for most of the misdiagnosed group (χ² = 52.97, p < 0.01).CONCLUSION: Despite current guidelines, anaphylaxis is still misdiagnosed in the ED. Having an ED diagnosis of anaphylaxis significantly increases the likelihood of epinephrine administration, and at a shorter time interval.
Anaphylaxis ; Classification ; Clinical Coding ; Communicable Diseases ; Demography ; Diagnosis ; Emergencies ; Emergency Service, Hospital ; Epinephrine ; Food Hypersensitivity ; Hospitals, Urban ; Humans ; Hypersensitivity ; Incidence ; Philippines ; Retrospective Studies ; Tertiary Care Centers

PURPOSE: This study was conducted to develop standards for the salinity and sodium content in representative Korean foods high in sodium. METHODS: A total of 600 foods from four seasonings (soy sauce, soybean paste, red pepper paste, and ssamjang) and 16 representative Korean foods high in sodium were collected from 10 households, 10 industry foodservice establishments, and 10 Korean restaurants in 10 cities nationwide and analyzed for their salinity and sodium content. Based on the findings, the standards with a 20% ~ 30% reduced sodium content and salinity from the current level were presented. RESULTS: The suggested standards of salinity (and sodium content per 100 g) were less than 12% (4,500 mg) for soy sauce, 9% (3,500 mg) for soybean paste, 5% (2,000 mg) for red pepper paste, and 6% (2,500 mg) for ssamjang. The reduced standards of salinity for soups were suggested to less than 0.5% for clear soup and 0.7% for soybean paste soup, while for broths, it was 0.6% for clear broth and 0.7% for other broths. The standards of salinity for stews were suggested to less than 0.8% for soybean paste stew, 0.6% for other stews, 0.9% for steamed and stir-fried fish dishes, 1.0% for braised dishes, 4.0% for stir-fried dried fishes, 1.3% for other braised dishes including vegetables, and 1.5% for pickled vegetables and kimchi. CONCLUSION: Standards for the sodium content and salinity were suggested to reduce the sodium level in fermented soybean sauces and representative Korean high sodium dishes by 20% from the current levels. Nevertheless, it will be necessary to adjust the standards properly to reduce the sodium content and salinity further by considering the future status of sodium intake.
Capsicum ; Family Characteristics ; Fishes ; Restaurants ; Salinity ; Seasons ; Sodium ; Soy Foods ; Soybeans ; Steam ; Vegetables

BACKGROUND/OBJECTIVES: This study aimed to compare student consumption of school meals by school level, to identify the influencing factors of school meal consumption, and to assess improvement needs of school food service among students. SUBJECTS/METHODS: A total of 1,441 elementary, middle, and high school students attending 58 schools in Gyeonggi-do, South Korea participated in the survey in 2015. A questionnaire and informed consent forms for students and legal guardians were sent home and completed responses were returned to the researcher. RESULTS: Approximately 58% of the students perceived the portion sizes of school meals as appropriate and 76.1% consumed almost all or all of the meals served. More elementary and middle school students than high school students consumed almost all or all of the meals (P < 0.001). A regression analysis revealed that the students with a higher dietary behavior score (P < 0.001), higher satisfaction with food service (P < 0.001), a higher environmental protection practice score (P < 0.05), and more positive attitudes toward school meals (P < 0.01) consumed significantly more meals. The provision of foods that taste good and reflecting student opinions on menus were the most important factors for increasing school meal consumption. CONCLUSIONS: To increase consumption of school meals, food service staff should provide students with quality meals and engage students in school food service. Nutrition education that emphasizes healthy eating behaviors and cafeteria environment modification that applies strategies based on behavioral economics can encourage students to consume more school meals.
Consent Forms ; Conservation of Natural Resources ; Economics, Behavioral ; Education ; Feeding Behavior ; Food Habits ; Food Services ; Gyeonggi-do ; Humans ; Korea ; Legal Guardians ; Meals ; Portion Size

OBJECTIVE: The aim of this study is to assess the prevalence and determinants of folic acid supplementation among women referred to community health centers. METHODS: This was a cross-sectional study conducted in 325 women referred to community health centers. The subjects were selected from 8 community health centers, using a stratified sampling technique. Data regarding demographics, socioeconomic status, obstetrics, folic acid supplementation status, and household food security status were obtained via questionnaires. The data was analyzed in SPSS v22. RESULTS: The prevalence of folic acid supplementation both before and during pregnancy was 54.5%. The results of the study showed that folic acid supplementation had a significant positive association with education level (odds ratio [OR],0 .441; 95% confidence interval [CI], 0.199–0.977; P<0.05), being employed (OR, 0.353; 95% CI, 0.148–0.840; P<0.05), and planned pregnancy (OR, 18.113; 95% CI, 7.371–44.51; P<0.001). However, other variables, including age, husband's age, husband's education and employment status, the number of prior pregnancies, economic satisfaction, and household food security, were nonsignificant factors affecting folic acid supplementation. CONCLUSION: Women with lower socioeconomic status are less likely to take folic acid supplements, and more effort should be made to increase their awareness of the importance of supplementation. Unplanned pregnancy is another strong risk factor for not supplementing with folic acid, and thus should be avoided.
Community Health Centers ; Contraception ; Cross-Sectional Studies ; Demography ; Education ; Employment ; Family Characteristics ; Family Planning Services ; Female ; Folic Acid ; Food Supply ; Humans ; Obstetrics ; Pregnancy ; Pregnancy, Unplanned ; Prevalence ; Referral and Consultation ; Risk Factors ; Social Class

BACKGROUND: The food and food service influence the quality of life and the general health condition of older persons living in long-term care (LTC) facilities. Purchasing good food materials is a ground of good food service. In Korea, the residents in LTC facilities should pay for the cost of food materials and ingredients out of their pocket because it is not covered by LTC insurance. This study explored what factors affect the cost of food materials paid by LTC facility residents and which factor affects most. METHODS: We used data from the study on out-of-pocket payment on national LTC insurance, which surveyed 1,552 family caregivers of older residents in LTC facilities. We applied conditional multi-level model, of which the first level represents the characteristics of care receivers and caregivers and its second level reflects those of LTC facilities. RESULTS: We found that the facility residents with college-graduated family caregivers paid 11,545 Korean won more than those with less than elementary-graduated ones. However, the income level of family caregivers did not significantly affect the amount of the food material cost of the residents. The residents in privately owned, large, metropolitan-located facilities were likely to pay more than those in other types of facilities. The amount of the food material cost of the residents was mainly decided by the facility level factors rather than the characteristics of care recipients and their family caregivers (intra-class correlation=82%). CONCLUSION: These findings suggest that it might be effective to design a policy targeting facilities rather than residents in order to manage the cost of food materials of residents in LTC facilities. Setting a standard price for food materials in LTC facilities, like Japan, could be suggested as a feasible policy option. It needs to inform the choice of LTC users by providing comparable food material cost information. The staffing requirement of nutritionist also needs to be reviewed.
Caregivers ; Food Services ; Health Expenditures ; Humans ; Insurance ; Insurance, Long-Term Care ; Japan ; Korea ; Long-Term Care ; Nutritionists ; Quality of Life