Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA detection is the key link for the precise epidemic prevention and control, and the urban detection bases have been proved to be achieved great successes in increasing the regional nucleic acid detection ability and efficiency. This expert advice contains ten aspects: environment and facilities management, personnel management and training, equipment management, materials management, quality management, bio-safety management, medical waste management, information system management, result report, supervision and continuous improvement. This manual aims to provide standards and suggestions for the SARS-CoV-2 RNA detection base management for ensuring the standardized, safe and orderly operation of the base to complete large-scale nucleic acid screening with high efficiency and quality. It also could be used by other SARS-CoV-2 RNA detection laboratory as reference.
COVID-19 ; Humans ; Mass Screening ; RNA, Viral ; Reference Standards ; SARS-CoV-2

OBJECTIVE: To explore effects of different delivery and storage conditions on concentrations of amino acids and carnitines in neonatal dried blood spots (DBS), so as to provide evidence for improving accurate and reliable detection by tandem mass spectrometry. METHODS: A total of 1 254 616 newborn DBS samples in Newborn Screening Center of Zhejiang Province were delivered and stored at room temperature (group A, RESULTS: The concentrations of amino acids and carnitines in the three groups were skewed, and the differences in amino acid and carnitine concentrations among groups were statistically significant (all CONCLUSIONS Cold-chain logistics system and storage in low temperature and low humidity can effectively reduce degradation of some amino acids and carnitines in DBS, improve the accuracy and reliability of detection, and thus ensures the quality of screening for neonatal metabolic diseases.
Amino Acids/analysis* ; Carnitine/analysis* ; Dried Blood Spot Testing/standards* ; Humans ; Humidity ; Infant, Newborn ; Neonatal Screening ; Reproducibility of Results ; Specimen Handling/standards* ; Tandem Mass Spectrometry ; Temperature ; Time Factors

To establish a fetal biparietal diameter (BPD)-gestational age formula based on the data of pregnant women from Xiaoshan District of Hangzhou, and to evaluate its application in prenatal screening.Data of 3500 pregnant women with gestational age between 15 weeks and 19 weeks+6 receiving prenatal screening in Xiaoshan Hospital during May 2014 and May 2015 were collected. BPDs were used to establish a localized BPD-gestational age formula. The localized formula was used to evaluate the prenatal screening risks in 1759 pregnant women with irregular menstrual cycles or uncertain last menstrual period (LMP) in Xiaoshan District, and the results were compared with those calculated using formula in LifeCycle 4.0.With localized formula, the total positive rate of Down syndrome, trisomy 18 syndrome and deformity of neural tube was decreased from 6.96% to 5.85% (<0.05), in which the positive rate of Down syndrome decreased (<0.05), that of deformity of neural tube increased (<0.05), and that of trisomy 18 syndrome remained the same (>0.05). The median MoMs of free-hCG β and α-fetoprotein calculated using localized formula were significantly different from those calculated using the formula in LifeCycle 4.0 (all<0.05), and the former ones were more closer to 1. For women of fetus diagnosed with the above diseases, the positive rate calculated using localized formula was almost the same as that calculated using the formula in LifeCycle 4.0.BPD-gestational age formula should be localized based on the statistical analysis of the local population, which will help to reduce the false positive rate, and make the results more accurate and reliable in prenatal screening.
Adult ; Body Weights and Measures ; standards ; Cephalometry ; standards ; statistics & numerical data ; Chorionic Gonadotropin, beta Subunit, Human ; blood ; standards ; Chromosomes, Human, Pair 18 ; Down Syndrome ; diagnosis ; embryology ; Epidemiologic Measurements ; Female ; Fetal Development ; Gestational Age ; Head ; embryology ; Humans ; Mass Screening ; methods ; standards ; statistics & numerical data ; Menstrual Cycle ; Neural Tube Defects ; diagnosis ; embryology ; Pregnancy ; Prenatal Diagnosis ; methods ; standards ; statistics & numerical data ; Reference Values ; Trisomy ; diagnosis ; Trisomy 18 Syndrome ; alpha-Fetoproteins ; analysis ; standards

Psychosocial problems increase the risk for mental health problems and increase the need for health care services in children and adolescents. Primary care practice is a valuable avenue for identifying the need for more specialized mental health care. We hypothesized that Korean version of the pediatric symptom checklist (PSC) would be a useful tool for early detection of psychosocial problems in children and adolescents in Korea and we aimed to suggest cut-off scores for detecting meaningful psychosocial problems. A total of 397 children with their parents and 97 child patients with their parents were asked to complete the PSC Korean version and the child behavior checklist (CBCL). The internal reliability and test-retest reliability of the PSC as well as the cut-off score of the PSC was determined via receiver operating characteristic analysis of the CBCL score, clinical group scores and non-clinical group scores. The internal consistency of the PSC-Korean version was excellent (Cronbach's alpha = 0.95). The test-retest reliability was r = 0.73 (P < 0.001). Using clinical CBCL scores (total score, externalizing score, internalizing score, respectively > or = 60) and presence of clinical diagnosis, the recommended cut-off score of the PSC was 14. Using 494 Korean children aged 7-12 yr, the current study assessed the reliability and validity of a Korean version of the PSC and suggested a cut-off for recommending further clinical assessment. The present results suggest that the Korean version of the PSC has good internal consistency and validity using the standard of CBCL scores.
Checklist/methods/*standards ; Child ; Child Behavior Disorders/*diagnosis/*psychology ; Female ; Humans ; Male ; Mass Screening/standards ; Pediatrics/*standards ; Population ; Psychometrics/methods/*standards ; Reproducibility of Results ; Republic of Korea ; Sensitivity and Specificity ; Surveys and Questionnaires/standards ; Symptom Assessment/methods/*standards ; Translating ; United States

We aimed to determine normal reference ranges for prostate volume (PV) and annual PV change rate in a Korean nationwide screening population. Data from men who underwent a routine health check-up were collected from 13 university hospitals. The cohort comprised men aged > or =40 yr who had undergone 2 or more serial transrectal ultrasonographies. Men with initial PV>100 mL; serum PSA level>10 ng/mL; PV reduction>20% compared with initial PV, or who had history of prostate cancer or prostate surgery, were excluded. Linear regression and mixed effects regression analyses were used to predict mean PV and longitudinal change in PV over time. A total of 2,967 men formed the study cohort. Age, body mass index (BMI), and serum prostate-specific antigen (PSA) level were found to be significant predictors of PV. A predicted PV table, with a 95% confidence interval (CIs), was developed after adjusting for these 3 variables. Annual PV change rate was 0.51 mL/year (95% CI, 0.47-0.55). Annual PV change rate according to age was 0.68 mL/year, 0.84 mL/year, 1.09 mL/year, and 0.50 mL/year for subjects in their 40s, 50s, 60s, and > or =70 yr, respectively. Predicted annual PV change rate differed depending on age, BMI, serum PSA level and baseline PV. From a nationwide screening database, we established age-, PSA-, and BMI-specific reference ranges for PV and annual PV change rate in Korean men. Our newly established reference ranges for PV and annual PV change rate will be valuable in interpreting PV data in Korean men.
Adult ; Aged ; Aged, 80 and over ; Aging/*pathology ; Humans ; Male ; Mass Screening/*standards ; Middle Aged ; Organ Size ; Prostate/*anatomy & histology/ultrasonography ; Reference Values ; Reproducibility of Results ; Republic of Korea ; Sensitivity and Specificity ; Ultrasonography/*standards ; Urology/*standards

INTRODUCTIONThe Short Portable Mental Status Questionnaire (SPMSQ) is a brief cognitive screening instrument, which is easy to use by a healthcare worker with little training. However, the validity of this instrument has not been established in Singapore. Thus, the primary aim of this study was to determine the diagnostic performance of SPMSQ for screening dementia among patients attending outpatient cognitive assessment clinics and to assess whether the appropriate cut-off score varies by patient's age and education. A secondary aim of the study was to map the SPMSQ scores with Mini-Mental State Examination (MMSE) scores.

MATERIALS AND METHODSSPMSQ and MMSE were administered by a trained interviewer to 127 patients visiting outpatient cognitive assessment clinics at the Singapore General Hospital, Changi General Hospital and Tan Tock Seng Hospital. The geriatricians at these clinics then diagnosed these patients with dementia or no dementia (reference standard). Sensitivity and specificity of SPMSQ with different cut-off points (number of errors) were calculated and compared to the reference standard using the Receiver Operator Characteristic (ROC) analysis. Correlation coefficient was also calculated between MMSE and SPMSQ scores.

RESULTSBased on the ROC analysis and a balance of sensitivity and specificity, the appropriate cut-off for SPMSQ was found to be 5 or more errors (sensitivity 78%, specificity 75%). The cut-off varied by education, but not by patient's age. There was a high correlation between SPMSQ and MMSE scores (r = 0.814, P <0.0001).

CONCLUSIONDespite the advantage of being a brief screening instrument for dementia, the use of SPMSQ is limited by its low sensitivity and specificity, especially among patients with less than 6 years of education.

Age Factors ; Aged ; Aged, 80 and over ; Ambulatory Care Facilities ; statistics & numerical data ; Comparative Effectiveness Research ; Dementia ; diagnosis ; epidemiology ; psychology ; Educational Status ; Female ; Geriatric Assessment ; methods ; statistics & numerical data ; Humans ; Intelligence Tests ; standards ; statistics & numerical data ; Male ; Mass Screening ; methods ; standards ; Mental Competency ; Middle Aged ; ROC Curve ; Reference Standards ; Reproducibility of Results ; Singapore ; epidemiology

BACKGROUND/AIMS: The application of glycated hemoglobin (HbA1c) for the diagnosis of diabetes is currently under extensive discussion. In this study, we explored the validity of using HbA1c as a screening and diagnostic test in Chinese subjects recruited in Nanjing, China. METHODS: In total, 497 subjects (361 men and 136 women) with fasting plasma glucose (PG) > or = 5.6 mmol/L were recruited to undergo the oral glucose tolerance test (OGTT) and HbA1c test. Plasma lipid, uric acid, and blood pressure were also measured. RESULTS: Using a receiver operating characteristic curve, the optimal cutoff point of HbA1c related to diabetes diagnosed by the OGTT was 6.3%, with a sensitivity and specificity of 79.6% and 82.2%, respectively, and the area under the curve was 0.87 (95% confidence interval, 0.83 to 0.92). A HbA1c level of 6.5% had a sensitivity and specificity of 62.7% and 93.5%, respectively. When comparing the HbA1c > or = 6.5% or OGTT methods for diagnosing diabetes, the former group had significantly higher HbA1c levels and lower levels of fasting and 2-hour PG than the latter group. No significant difference was observed in the other metabolism indexes between the two groups. CONCLUSIONS: Our results suggest that HbA1c > or = 6.5% has reasonably good specificity for diagnosing diabetes in Chinese subjects, which is in concordance with the American Diabetes Association recommendations.
Aged ; Analysis of Variance ; *Asian Continental Ancestry Group ; Biological Markers/blood ; Blood Glucose/analysis ; China/epidemiology ; *Chromatography, High Pressure Liquid/standards ; *Chromatography, Ion Exchange/standards ; Diabetes Mellitus, Type 2/blood/*diagnosis/ethnology ; Fasting/blood ; Female ; Glucose Tolerance Test/standards ; Hemoglobin A, Glycosylated/*analysis ; Humans ; Male ; Mass Screening/*methods/standards ; Middle Aged ; Predictive Value of Tests ; ROC Curve ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity

OBJECTIVETo discuss the effect of different positive criteria on the sensitivity and specificity of sputum cytology screening for lung cancer among Yunnan tin miners.

METHODS9223 Yunnan tin miners who received at least one annual sputum cytology screening for lung cancer during the period between 1992 and 1999 were recruited in the study. At time of enrollment, all participants were aged over 40 years old, had at least 10 years of employment as an underground miner and(or) smelter, and had not been diagnosed with malignancy. In our study, a true positive was categorized as having at least one prior positive sputum screening and a diagnosis of lung cancer, while a true negative, by our definition, signified negative sputum examinations and no diagnosis of lung cancer during the follow up time. Based on different positive criteria, sensitivity and specificity of sputum cytology were computed and receiver operating characteristic (ROC) curve analysis was conducted. Z statistic was used to test the differences of the area under ROC based on Hanley and McNeil method.

RESULTSBy the end of following up on December 31, 2001, a total 500 lung cancer cases were diagnosed among 9223 participants: most were squamous cell carcinoma (55.8% (222/398)) and central lung cancers (68.5% (316/461)). 150 lung cancer cases had a previous positive sputum screening result. When positive criteria were taken as grave atypical metaplasia, moderate atypical metaplasia and slight atypical metaplasia, the corresponding sensitivities were 30.0% (150/500), 36.4% (182/500), 53.0% (265/500) respectively; while the corresponding specificities were 98.9% (8628/8723), 95.1% (8611/8723), 77.9% (7033/8723) respectively. The areas under ROC curve according to different positive criterias were 0.645 (95%CI: 0.635 - 0.654), 0.657 (95%CI: 0.668 - 0.667), 0.655 (95%CI: 0.645 - 0.664) respectively. There were no significant differences found in the comparisons between grave and moderate atypical metaplasia, grave and slight atypical metaplasia, moderate and slight atypical metaplasia(Z statistics were 0.780, 0.645, 0.209 respectively, all P values > 0.05).

CONCLUSIONWhile the standard of positive criteria for diagnosis of lung cancer decreased, the sensitivity of sputum cytology screening increased and the specificity decreased. Since there were no significant differences of accuracy for different positive criteria.

Cytodiagnosis ; methods ; standards ; Female ; Humans ; Lung Neoplasms ; diagnosis ; Male ; Mass Screening ; methods ; Sensitivity and Specificity ; Sputum ; cytology

OBJECTIVETo study the validity and accuracy of differing cutoff scores of the Ages and Stages Questionnaires-Chinese (ASQ-C) for screening infants and toddlers in comparison with the gold standard, Bayley Scale of Infant Development, Second Edition (BSID II).

METHODThe 269 samples were enrolled from the normative children, aged 3 - 31 months, of the ASQ-C in Shanghai. The age-appropriate ASQ-Cs were completed by parents/caregivers and the BSIDIIwas administered by professionals. The cutoff scores of -2 standard deviation (s), -1.5 s, and -s for the ASQ-C were examined against BSID II with the cutoff scores set at -2 s as the standard of developmental delay, -s as the standard of suspected developmental delay and developmental delay respectively. Agreement between the classifications of the ASQ-C (i.e., typical, suspected, delay) was compared with the classification of the BSID II (typical, suspected, delay), sensitivity, specificity, Youden Index and area under ROC curve of ASQ-C were examined. The statistical analysis was carried out using SPSS 13.0.

RESULTWhen the cutoff score for BSID II was -2 s, the -2 s cutoff score for ASQ-C exhibited the following properties: the highest agreement of 83.64%, the sensitivity and specificity both above 80% being respectively 88.46% and 83.13%, the highest Youden Index of 0.72 and the largest area of 0.86 under ROC curve. The -1.5 s cutoff score for ASQ-C showed the following properties: 71.75% agreement, 100% sensitivity, 68.72% specificity, Youden Index = 0.69, the area under ROC curve = 0.84. The -s cutoff score for ASQ-C showed the following properties: the lowest agreement of 55.02%, 100% sensitivity, the lowest specificity of 50.21%, the lowest Youden Index of 0.50, and the smallest area of 0.75 under ROC curve. When the cutoff score for BSID II was set at -s, the -2 s for ASQ-C showed the following properties: the highest agreement of 85.87%, the lowest sensitivity of 68.57%, the highest specificity of 91.96%, Youden Index = 0.61, the smallest area = 0.77 under ROC curve. The -1.5 s for ASQ-C showed the following properties: the agreement of 80.67%, the sensitivity and specificity both above 70% being respectively 85.71% and 78.89%, the highest Youden Index of 0.65, the largest area of 0.82 under ROC. The -s cutoff score for ASQ-C showed the following properties: the lowest agreement of 68.40%, the highest sensitivity of 94.29%, the lowest specificity of 59.30%, the lowest Youden Index of 0.54, and the area under ROC curve = 0.80. When the cutoff score for BSID II was -1 to 2 s, the identifying percentages of the -2 s, -1.5 s and -s for the ASQ-C were 56.82%, 77.27% and 90.91%, respectively.

CONCLUSIONFor developmental delay identification, the -2 s cutoff score for ASQ-C produces the most robust validity and highest accuracy; for the identification of suspected developmental delay and developmental delay, the -1.5 s cutoff score for ASQ-C has the highest screening accuracy with appropriate sensitivity and specificity; for identifying the suspected developmental delay, the -s cutoff score for ASQ-C has the highest percentage of the identification. It is necessary to add 1 - 2 s to the ASQ-C's cutoff scores as the standard for screening suspected developmental delays.

Child Development ; Child, Preschool ; Humans ; Infant ; Mass Screening ; Reference Standards ; Sensitivity and Specificity ; Surveys and Questionnaires ; standards

Breast Neoplasms ; diagnosis ; China ; Female ; Humans ; Mass Screening ; standards