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

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

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

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 compare the prevalence of the metabolic syndrome (MS) using 3 working definitions proposed respectively by the World Health Organization (WHO, 1999) , the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults ( ATP III, 2001 ), and the Chinese Diabetes Society ( CDS, 2003). METHODS: MS was diagnosed in 739 male medical examinees by the 3 working definitions respectively, then the prevalence and the concordance of 3 working definitions was compared. RESULTS: Among 739 participants the prevalence was 36.9% by the WHO definition, 11.8% by the ATP III definition and 21.0% by the CDS definition. Among all the testees 68.6% were classified as either having or not having the MS under the 3 definitions. The consistency in the diagnosis of MS was 72.5% by the WHO definition and the ATP III definition, 81.2% by the WHO definition and the CDS definition, and 83.5% by the ATP III definition and the CDS definition. The prevalence of insulin resistance was the highest among the components of the WHO definition. The prevalence of hypertension was the highest while the prevalence of obesity was the lowest by the ATP III definition. Among the components of the CDS definition, the prevalence of obesity was the highest. The fasting insulin and insulin resistant index (HOMA-IR) were both significantly higher in the MS subjects than that in the non-MS subjects. CONCLUSION A universally accepted definition of the metabolic syndrome is needed.
Adult ; China ; epidemiology ; Humans ; Male ; Mass Screening ; Metabolic Syndrome ; diagnosis ; epidemiology ; prevention & control ; Prevalence ; Reference Standards

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

BACKGROUNDTo evaluate homemade and imported HbsAg ELISA kits on screening blood donors.

METHODSSamples for evaluation included 120 HbsAg serum plates for the golden criteria and 400 sets of serum from blood donors in Dongguan. The samples underwent blind screening with homemade and imported ELISA kits respectively.

RESULTSThe sensitivity of homemade (Xinchuang) and imported (Diasorin) HbsAg ELISA kit were 85.71% (72/84) and 100% (84/84), respectively. Their specificity was 100% (436/436) and 96.55% (421/436) respectively. The consistency of two ELISA kits was 100%.

CONCLUSIONThe imported ELISA kit had the highest sensitivity, but its specificity was not as good as that of homemade ELISA kit. The two kinds of ELISA kits had good repetition. The combination of the two reagents may ensure the safety of blood transfusion.

Blood Donors ; China ; Enzyme-Linked Immunosorbent Assay ; instrumentation ; methods ; standards ; Hepatitis B ; blood ; diagnosis ; prevention & control ; Hepatitis B Surface Antigens ; blood ; Humans ; Mass Screening ; methods ; standards ; Reagent Kits, Diagnostic ; standards ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity

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

OBJECTIVE: To develop a simple screening table for primary osteoporosis (POP) in senior men and women. METHODS: Questionnaires were designed to obtain the risk factors associated with osteoporosis and bone mineral density (BMD), which were measured in 146 community residents over 60. The multiple stepwise regression was used to find out the risk factors and establish the screening index. Then the cut-off point of sensitivity and specificity were obtained. Simple screening table for POP in senior people was established according to the screening index and the cut-off point. Validity and reliability of the simple screening table for POP in senior people were testified by 61 outpatients whose BMD was measured with dual energy X-ray (DEXA). RESULTS: Percentage of the height loss,body weight, age, and gender were selected with multiple stepwise regression.Percentage of height loss and body weight were selected to develop the simple screening table for POP in senior people. The cut-off point was 270, sensitivity was 88.9 %, specificity was 75.7 %, the agreement rate was 75.4%,and the Kappa value was 0.489. CONCLUSION The simple screening table for POP in senior people based on the percentage of height loss and body weight is simple, economic, suitable for both men and women, and is useful in basic public health.
Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Mass Screening ; methods ; Middle Aged ; Osteoporosis ; prevention & control ; Surveys and Questionnaires ; standards

Nationwide neonatal mass screening for inherited metabolic diseases has started in Japan since 1977. At least 8000 children have probably been spared from handicaps resulting from such diseases over the past 30 years. Recently remarkable changes have been made to the evolving neonatal screening system. Declining birth rate and economic problems in Japan have demanded a more effective neonatal screening system. Development of new innovative screening methods and treatment tools, e.g. tandem mass spectrometry (MS/MS) technology and enzyme replacement therapy for mucopolysaccharidosis (MPS), have facilitated expansion of target diseases in neonatal screening. We have carried out pilot screening using MS/MS in 6 laboratories in Japan. The incidence of inherited metabolic diseases was found to be 1 in 9330 (65 cases out of 606,380 babies screened) during the period between 1997 and 2007. The incidence was lower than those of Europe or USA (about 1 in 4000 to 5000). The disease frequency between unscreened symptomatic cases and asymptomatic cases detected through MS/MS screening were also found to be different. In MS/MS screening, the most common organic acidemia was propionic acidemia, whereas in symptomatic cases, methylmalonic acidemia was the most common. Further study of ethnic diversity in severity of propionic academia is required. The outcomes of patients detected in the MS/MS screening were significantly favourable. The results showed the benefits of MS/ MS screening. The diagnostic support network for gas chromatography-mass spectrometry (GC/ MS) analysis and enzyme determination has also been developed. We have developed an automated system of GC/MS data processing and auto-diagnosis which allowed the GC/MS data processing to be extremely fast and simple. Enzyme evaluation for diagnostic support for screening, including a method using peripheral blood and high performance liquid chromatography (HPLC), and another method of in-vitro probe assay using cultured cells and MS/MS. Furthermore, re-location of screening laboratories for a more efficient screening network will be required such that at least 30,000 samples can be analysed in each laboratory.
Humans ; Infant, Newborn ; Japan ; Metabolism, Inborn Errors ; diagnosis ; Neonatal Screening ; methods ; organization & administration ; standards ; Tandem Mass Spectrometry