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【Objective】 To analyze the profile, preliminary screening and laboratory test results of voluntary blood donors in the past five years, so as to provide basis for formulating the recruitment strategy, ensuring clinical blood use and improving blood safety and quality. 【Methods】 789 570 voluntary blood donors from 2016 to 2020 were classified according to the category, and the positive rate of blood testing results was statistically analyzed. 【Results】 The proportion of transfusion-transmitted infections (TTI), including HBsAg, anti-HCV, anti-T, and anti-HIV, was led by HBsAg, except for anti-TP leading in 2018. The positive rate of ELISA items and ALT tests showed statistical significance by age groups(P0.05). The positive rate of preliminary screening and laboratory testing showed differences among occupation and educational background(P0.05). The number of HIV positive males (n=228) was higher than that of females(n=3), and the proportion of workers (23.08%~40.74%) and staff (16.67%~46.67%) were large. In 2020, however, the proportion of HIV infected students increased sharply to 21.62%. Sole HBV DNA positive cases was the most (n=460), while the number of sole HIV RNA(n=3) and HCV RNA positive cases (n=6) were rather low. 【Conclusion】 Targeted recruitment strategies should be formulated according to the profile and test results of voluntary blood donors to further improve blood test ability and ensure blood safety.
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【Objective】 To explore the viability of improved comparability verification method for the performance verification of automatic biochemical analyzer in blood centers. 【Methods】 According to the relevant requirements of User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) and Guideline for Comparability Verification of Quantitative Results with One Health Care System(WS/T 407-2012), the performance of the newly purchased Beckman Coulter AU480 automatic biochemical analyzer was confirmed by means of comparability verification, and compared with the current Olympus AU400 automatic biochemical analyzer. 【Results】 The detection results given by Beckman AU480 biochemical analyzer on 5 samples for ALT detection performance test were significantly correlated with the target value (R2=0.998), and the trueness verification results met the requirements.The CV of medium and high ALT levels was 2.36% and 1.20%, respectively, within the acceptable standard range(<5%), and the precision verification results meet the requirement.The comparison deviation of two devices for medium and high ALT levels was 0.47% and 1.62%, respectively, within the acceptable standard range (<5%). The detection results of ALT from 40 blood donors given by two devices were significantly correlated (R2=0.956), and the precision verification results met the requirements.In the validation of linear evaluation, there was a good linear relationship between the expected and measured results (r=0.997)among samples with 6 levels of concentrations. 【Conclusion】 The comparability verification method is suitable for the performance verification of automatic biochemical analyzer in blood centers.
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【Objective】 To investigate the confirmatory status of HIV-1 antibody detection and Western blot (WB) test among voluntary blood donors in Wuhu, and to explore the strategies and methods to further ensure blood quality and safety. 【Methods】 Blood samples were preliminarily screened by ELISA and NAT, and the reactive samples were sent to Wuhu CDC for further WB test of HIV-1 antibody. The confirmation results of HIV-1 antibodies of voluntary blood donors in Wuhu in the past 10 years were retrospectively collected. The characteristics of WB bands of positive samples were analyzed, and the demographic characteristics of HIV-infected voluntary blood donors were sorted out. 【Results】 A total of 354 864 blood samples from voluntary blood donors in Wuhu during January 2011 to May 2021 were investigated, among which 42 were confirmed HIV positive (HIV-1 antibody positive in 41, and solo HIV-RNA reactive in 1), with a total HIV positive rate of 11.8/100 000(42/354 864). Statistical differences were found in gender [males 97.6% (41/42) vs females 2.4% (1/42)], marital status [unmarried 17.3/100 000 vs married 8.0/100 000] and occupation [staff/workers 37.5/100 000 vs students11.4/100 000 vs others 7.7/100 000]. Among the positive samples, the yield rate of WB bands gp160 was 100% (41/41), both gp41 and p24 were 97.6% (40/41),, and p55 was the lowest 46.3% (19/41). P51 and P66 presented the highest yield consistency (Kappa=1.000, P5 000 cps/mL by viral load (VL) testing, indicating HIV window period infection. 【Conclusion】 HIV infection statistically affected male donors more than females in Wuhu area, and most were early infection that revealed by WB band analysis. NAT plays an important role in the detection and confirmation of HIV infection during the window period, and is essential for blood safety.
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【Objective】 To perform electrochemiluminescence immunoassay (ECLIA) and Western blotting (WB) confirmation tests for HIV reactive samples in blood screening, and analyze the correlation between ELISA (enzyme-linked immunosorbent assay), ECLIA results and confirmed infection, so as to provide data support for the application of ECLIA in blood screening. 【Methods】 177 HIV reactive samples in blood screening testing detected by our laboratory from February to October 2019 were collected, of which 137 were reactiv to isolated ELISA reagent e, 39 to dual ELISA reagent, and 1 in window period. Ten maker-negative samples were randomly selected to undergo ECLIA with the above 177 samples. HIV reactive samples were sent to Centers for Disease Control and Prevention (CDC) for confirmation tests, and the results were analyzed and compared. 【Results】 Among the 177 HIV reactive samples, 66 were ECLIA reactive, 111 negative, and the 10 maker-negative samples remained negative. The sensitivity, specificity, positive predictive value, negative predictive value and total concordance rate of ECLIA were 97.1%, 81.1%, 55%, 99.1% and 84.2%, respectively, showing better performance than that of two ELISA reagents(P0.05). The positive predictive value and specificity were tested by chi-square test, and the difference between ECLIA and reagent 2 was statistically significant (P<0.05). The ECLIA results showed significant correlation with the confirmation results with good consistency(examed by Kappa test). Among the three reagents, ECLIA presented highest accuracy and largest Youden index. 【Conclusion】 ECLIA presents high detection sensitivity, which can improve the detection ability of early HIV infection and shorten the window period of HIV detection, therefore should be popularized in blood screening.
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【Objective】 To analyze the HIV infection among voluntary blood donors in Wuhu area, so as to provide effective data for improving blood donation recruitment strategies and clinical safe blood use. 【Methods】 All reactive samples from HIV screening among voluntary blood donors in Wuhu from January 2017 to September 2020 were selected and sent to Wuhu CDC for confirmation test.The receiver operating characteristic (ROC) curve was used to compare the accuracy of enzyme-immune reagents. The optimal critical value of ELISA was used to analyze the setting of serological gray area. The preliminary screening S/CO values of confirmed positive, negative and indeterminate samples were compared, and the significance of differences were analyzed by SPSS 22.0 software. 【Results】 75 cases of initially HIV reactive samples were submitted for testing: 17 cases were confirmed positive, 17 indeterminate and 41 negative.The area under curve (AUC) of the 4th generation anti-HIV ELISA reagent was greater than that of the 3rd generation reagent, and the 4th generation reagent was better than the 3rd generation reagent in accuracy. All the 17 confirmed positive samples had high S/CO reactivity with duplicate reagents, and the initial screening S/CO value was significantly higher than that of confirmed negative and indeterminate samples (P0.05). 【Conclusion】 Voluntary blood donors in Wuhu is a middle-endemic population for HIV infection. The setting of grey areas for serological testing is of little significance. Blood safety should be further guaranteed through standardized pre-donation interventions, sensitive nucleic acid detection technologies and shared regional data platforms.
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In this paper, the notice of "Opinions of the State Administration for Market Regulation on further promoting the reform of qualification accreditation of inspection and testing institutions" (No. 206 [2019] which issued on October 25, 2019 has aroused our reflection to concern the development trend of qualification accreditation of radiological health technical service institutions. In order to adapt to the changes under the new situation and avoid the risks of technical review that may be faced in the qualification accreditation of radiation health technical service institutions in the future and to discussed the ways that radiological health technical service institutions can be used to confirm the testing ability in the qualification certification process.
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@#The high-purity impurity C was isolated and purified from a new anti-allergic drug, rupatifen, by nucleophilic substitution reaction with bromobutaric acid, and its structure was confirmed by IR, UV, MS, 1H NMR, 13C NMR, DEPT135°,HSQC, HMBC, and 1H-1HCOSY. The preparation process of impurity C in this study was simple and easy to obtain under mild conditions, with the purity of 99.0% and the yield of 25%-30%;and the sample met the target compound by structural confirmation. The preparation process and structure confirmation provided sufficient impurity C reference substance for impurity research of raw materials and preparations of rupatifen fumarate, which laid a solid foundation for quality research of new drugs.
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Objective To analyze the results of HIV antibody screening test and confirmation test results in Pudong New Area from 2014 to 2018, and to understand the situation of HIV infection in the region in recent years. Methods Samples that responded to initial screening of HIV in this jurisdiction area were tested by enzyme-linked immunosorbent assay (ELISA), chemiluminescence assay or immunochromatographic rapid diagnosis test. The samples that showed a positive response to one of the reexamination methods were subjected to confirmatory tests by Western blot assay. EXCEL and SPSS 16.0 statistical software were used to collate and analyze the data. Results Confirmatory tests were performed on a total of 2 100 retested samples. HIV positive samples were 1485 (70.7%), and HIV negative and uncertainty samples were 452 (21.5%) and 163 (7.8%), respectively. The confirmed positive male/female sex ratio was 7.95:1, and the difference was statistically significant (χ2=3.745, P<0.001). The age of confirmed positive patients was mainly 15~39 years old. The proportion of voluntary testing and counseling was the highest among the population receiving HIV tests. The positive coincidence rate between the review test and confirmation test was 91.3%. The gp160 and gp120 bands appeared most frequently in WB-confirmed positive samples, which was 100%. The gp160 band was the most frequent band of uncertain samples, accounting for 71.4%. Conclusion The positive rate was high in the confirmatory test of samples with positive results by both methods, and the samples with one negative and one positive were mostly uncertain or negative in the confirmatory test. When the results were uncertain, CD4, nucleic acid detection, and viral load detection should be used as auxiliary diagnosis.
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BACKGROUND:Before advent of cross section imaging radiologists were of limited help in diagnosis of neck lesions, especially those involving deep neck spaces of suprahyoid neck (SHN). AIM:Aim of our study is to characterise neck lesion by its morphological characteristics and enhancement pattern, outlining the extent, assessment of lymphadenopathy, look for criteria for operability and histopathological confirmation. METHODS & MATERIALS:In this study 100 cases of neck masses were evaluated retrospectively in our department. The CTscan was performed prior to the treatment in all these patients. CTimaging feature includes location, size/diameter, degree & pattern of enhancement, intraluminal/exophytic, internal necrosis & hemorrhage, local spread, nodal & distant metastasis.RESULTS:Out of 100 patients studied 27% were benign and 73% were malignant neck lesions, overall there was a male preponderance with a male to female ratio of 2.1:1. Benign lesion were common in the age group of 16-45 yrs. while malignant lesions were more common in the elderly age group of >45 years. Most of the benign (26%) and malignant lesions (81%) showed heterogeneous enhancement pattern. Bone invasion seen in 15% benign lesions, 19% of malignant lesions and cartilage invasion seen in 7% of malignant lesions. On correlation with HPE, among malignant lesions most common was Squamous cell carcinoma (48%) and among benign lesions most common was nonspecific inflammation. The sensitivity and specificity of study is 95.7% & 77.5% respectively, with positive predictive value and negative predictive value of 90.4% & 88.9% respectively and Accuracy is 90%.
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BACKGROUND@# Patients intubated in the prehospital setting require quick and definitive confirmation of endotracheal (ET) tube placement upon arrival to the emergency department (ED). Direct and adjunct strategies exist, but each has limitations and there is no definitive gold standard. The utility of bronchoscopy in ED intubation has been studied, but scant literature exists on its use for ET tube confirmation. This study aims to assess effectiveness, ease and speed with which ET tube placement can be confirmed with disposable fiberoptic bronchoscopy.@*METHODS@# Emergency medicine residents recruited from a 3-year urban residency program received 5 minutes of active learning on a simulation mannequin using a disposable, flexible Ambu aScope interfaced with a monitor. With residents blinded, the researcher randomly placed the ET tube in the trachea, esophagus or right mainstem. Residents identified ET tube position by threading the bronchoscope through the tube and viewing distal anatomy. Each resident underwent 4 trials. Accuracy, speed and perceptions of difficulty were measured.@*RESULTS@# Residents accurately identified the location of the ET tube in 88 out of 92 trials (95.7%). The median time-to-guess was 7.0 seconds, IQR (5.0–10.0). Average perceived difficulty was 1.6 on a scale from 1–5 (1 being very easy and 5 being very difficult). No tubes were damaged or dislodged.@*CONCLUSION@# While simulation cannot completely replicate the live experience, fiberoptic bronchoscopy appears to be a quick and accurate method for ET tube confirmation. Further studies directly comparing this novel approach to established practices on actual patients are warranted.
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Objective To explore the clinical value of echocardiography in differential diagnosis of segmental wall motion abnormalities in coronary heart disease ( CHD), and to provide help for clinical treatment.Methods From January 2017 to November 2018,56 patients with segmental abnormal wall motion of CHD in Yuyao People＇s Hospital of Zhejiang Province were selected in the study.All patients were diagnosed by echocardiography and coronary angiography.The diagnostic coincidence rate ,specificity,sensitivity,false negative rate,false positive rate and accuracy of echocardiography were evaluated.Results Coronary angiography showed abnormal segmental wall motion in 56 patients, with 100.00% anastomosis rate.Echocardiography revealed abnormal segmental wall motion in 54 patients with CHD,2 patients showed normal segmental wall motion ,anastomosis rate was 96.43%.There was no statistically significant difference between the two diagnostic methods (χ2 ＝0.635,P＝0.152),but the specificity of ultrasound diagnosis (80.36%),sensitivity (78.57%) and accuracy (80.36%) were lower than those of coronary angiography(100.00%,98.21%,100.00%),there were statistically significant differences (χ2 ＝4.173,P＝0.034;χ2 ＝5.154,P＝0.024;χ2 ＝4.173,P＝0.034).Conclusion Cardiac echocardiography has a high diagnostic value in differential diagnosis of segmental wall motion abnormalities in CHD.It can guide the clinical treatment of these patients to formulate a reasonable treatment plan.Moreover,it is easy to operate,with low cost and more acceptable to patients.
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The purpose of current study is to investigate the metabolic profile of a triptolide derivative (5R)-5-hydroxytriptolide in vitro. (5R)-5-Hydroxytriptolide was incubated with the hepatocytes of human, monkey, dog, rat or mouse, respectively. Compared with inactivated hepatocytes, four metabolites were identified in hepatocytes from all five species: oxidative ring-opening metabolite (M1), glutathione-conjugating metabolite (M2), and monooxidative combined with glutathione-conjugating metabolites (M3-1 and M3-2), respectively. In human or rat liver microsomes, seven metabolites of (5R)-5-hydroxytriptolide were found, dehydrogenated metabolite (M4) and monooxidative metabolites (M5-1–M5-6), respectively. Reference standards for the metabolites were obtained either through chemical semisynthesis or biotransformation through rat primary hepatocytes. The structures of five metabolites were confirmed, which were 12,13-epoxy ring-opening metabolite M1, 12-glutathione-conjugating metabolite M2, (16S)-, (2R)- and (19R)-monohydroxylated metabolites M5-1, M5-4, and M5-5, respectively. In vitro activity assay revealed that only (2R)-hydroxylated metabolite exhibited weak immunosuppressive activity with less than one-tenth the activity of its parent drug, and a significant decrease in toxicity was observed. It is suggested that (5R)-5-hydroxytriptolide might undergo metabolic inactivation and detoxification in vivo.
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OBJECTIVE: To establish the national reference standards of sulfadimidine impurities thus to provide guarantee for improving the standard of quality control of sulfadiazine in China. METHODS: First, the structures of sulfadimidine impurities A and E were validated by infrared spectrocopy, mass spectrum and nuclear magnetic resonance method. Then, the purities of impurities A and E were determined using the method of related substance test for sulphadiazine in the European Pharmacopoeia (version 9.0),their water content and residue on ignition were determined as well. The contents of sulfadimidine impurities A and E were determined by using mass balance method. Meanwhile, external standard method and nuclear magnetic quantitative method were used to calculate the content, which were mutually verified with the mass balance method. Finally, the correction factors of sulfadiazine impurities A and E at 241 nm were determined using standard curve method. RESULTS: The structures of sulfadimidine impurities A and E were confirmed, and the contents of impurities A and E were 99.1% and 98.7%, respectively, which were calculated by mass balance method. The results were consistent with those obtained from external standard method and nuclear magnetic quantification method. The correction factors of impurities A and E to sulfadimidine were 0.97 and 0.63, respectively. CONCLUSION: The first batch of national standard substances of sulfadimidine impurities A and E were established successfully.
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Objective@#To explore the clinical value of echocardiography in differential diagnosis of segmental wall motion abnormalities in coronary heart disease(CHD), and to provide help for clinical treatment.@*Methods@#From January 2017 to November 2018, 56 patients with segmental abnormal wall motion of CHD in Yuyao People's Hospital of Zhejiang Province were selected in the study.All patients were diagnosed by echocardiography and coronary angiography.The diagnostic coincidence rate, specificity, sensitivity, false negative rate, false positive rate and accuracy of echocardiography were evaluated.@*Results@#Coronary angiography showed abnormal segmental wall motion in 56 patients, with 100.00% anastomosis rate.Echocardiography revealed abnormal segmental wall motion in 54 patients with CHD, 2 patients showed normal segmental wall motion, anastomosis rate was 96.43%.There was no statistically significant difference between the two diagnostic methods(χ2=0.635, P=0.152), but the specificity of ultrasound diagnosis(80.36%), sensitivity(78.57%) and accuracy(80.36%) were lower than those of coronary angiography(100.00%, 98.21%, 100.00%), there were statistically significant differences (χ2=4.173, P=0.034; χ2=5.154, P=0.024; χ2=4.173, P=0.034).@*Conclusion@#Cardiac echocardiography has a high diagnostic value in differential diagnosis of segmental wall motion abnormalities in CHD.It can guide the clinical treatment of these patients to formulate a reasonable treatment plan.Moreover, it is easy to operate, with low cost and more acceptable to patients.
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This study examined the customers' perception on Home Meal Replacement (HMR) products. Specifically, there were three research objectives: 1. to identify the customers' HMR purchase patterns and preference of HMR product development; 2. to identify the attributes of the HMR products that the customers perceive; and 3. to examine the customers' level of expectation-confirmation toward HMR product attributes according to the demographic characteristics. This study employed a self-administered survey that was distributed online from November 21~24, 2017. The sample of the study was the customers who had purchased HMR products in the six months prior to taking the survey. A total of 553 respondents completed the survey, which was used for data analysis. The results revealed the customers' HMR purchase patterns. The major HMR product type of purchase was ready to heat (52.6%), while the main reason for purchasing HMR products was convenience (83.2%). For the differences in the level of expectation-confirmation toward HMR products in accordance with the demographic characteristics of customers, the results indicated that there was a difference in the expectation-confirmation level according to age, whereas the respondents aged 29 and under showed a significantly higher level of time-saving for the preparation and ease of cooking (P < 0.05) than the other age groups. In addition, there was a significant difference in the expectation-confirmation level for saving meal preparation time (P < 0.05) and convenience (P < 0.01) among the customer's occupation. These findings can provide the basis for a strategy for developing HMR products reflecting the rapidly changing customers' needs. HMR products should be developed according to the specific target market, as the study indicated that the respective customer segmentation resulted in a difference in their expectation toward HMR products.
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Humans , Cooking , Hot Temperature , Meals , Occupations , Statistics as Topic , Surveys and QuestionnairesABSTRACT
Objective To investigate the effect of lactation confirmationon breastfeeding behavior and confidence in maternal breastfeeding nursing. Methods 63 puerperas admitted and treated from June 2015 to June 2016 in our hospital was assigned as control group, and another 63 ones from July 2016 to July 2017 in our hospital as observation group. The control group was treated with routine postpartum care and the latter with lactation confirmation. The two groups were compared in terms of breastfeeding behavior, confidence and lactation volume. Results The breastfeeding rates of the observation group at 24h, 48h, 72h after delivery were significantly higher than those of the control group (all P＜0.05). The confidence scores of the observation group at 24h, 48h, 72h after delivery weresignificantly higher than those of the control group (all P＜0.05).The amount of milk produced by the observation group at 24h, 48h, 72h after delivery was significantly higher than that of the control group (all P＜0.05). Conclusion Lactation confirmation used in puerperal breastfeeding can effectively improve the rate of breastfeeding, increase their confidence in breastfeeding and improve milk yield, worthy of clinical promotion.
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At present,domestic and foreign have not yet formed a unified understanding of telemedicine.The distribution of medical resources in our country is not balanced,the grassroots or remote areas are lack of medical resources,especially high quality human resources,thus our country has the inner demand of developing on telemedicine.Due to the lagging of legislation and policy,telemedicine puts forward many legal and ethical challenges on the practicing qualification of physicians,the practicing registration of physicians,the protection of the rights of patients' informed consent and privacy,and so on.We should carefully distinguish the behavior of health counseling or diagnoses & treatment in telemedicine,in order to clarify the legal relationships among of the invitational medical institution,invitee medical institution,and patient,it will be the basis of bearing of legal liability.
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Objective To detect the reactive samples of enzyme-linked immunosorbent assay (ELISA1) by chemiluminescence microparticle immunoassay (CMIA),and to analyze the application value of CMIA in HCV infection validation of blood donors.Methods Nucleic acid 3-item combined testing (NAT),another ELISA2,HCV antibody supplementary test(Western Blot test,WB) and CMIA test supplemented in blood samples of 102 ELISA1 anti-HCV reactive blood donors were retrospectively analysed.Results Among 102 blood donors of anti-HCV positive,32 cases (31.37%,32/102) were HCV RNA reactive samples,50 cases (49.02%,50/102) were ELISA2/WB reactive simultaneously.With CMIA NAT results as the reference standard,CMIA was poorly correlated with HCV RNA (Spearman correlation coefficient rs=0.395,P<0.01),and the consistency between them was weak by Kappa test (Kappa=0.270,P<0.01).With ELISA2/WB detection results as the reference standard,CMIA was highly correlated with the results(Spearman correlation coefficient rs=0.713,P<0.01),and which showed high consistency by Kappa test (Kappa=0.674,P<0.01).Conclusion CMIA as a detection method of protein label after HCV infection has great value in the HCV infection confirmation in low-risk population.
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Objective An analytical method for rapid screening and confirmation of multiple pesticide residues in vegetable and fruit was established according to GB 2763-2014 national food safety standard-maximum residue limits for pesticides in food,using ultra performance liquid chromatography-Q-time of flight mass spectrometry (UPLC-Q-TOF-MS).Methods Pesticide residues in vegetable and fruit were screened by comparing the accurate mass,isotope distribution and abundance in the accurate mass database,and confirmed by comparing with the spectra in the spectra library or by the spectral analysis method.Results The method was verified by spiked samples,and all pesticides were detected at the addition level of 10.0 and 50.0 μg/kg.The recovery of 90％ of the pesticides was in the range of 70％-120％,with relative standard deviation (RSD) ≤ 20％ (n =5).The method was applied to screen pesticides in 30 samples of vegetables and fruits.Twenty-seven pesticides were found and 2 samples exceeded the limit.Conclusion The method was sensitive,accurate and reproducible.Hundreds of pesticides in GB 2763-2014 could be screened and confirmed in a short period of time even without standard substance.It could provide an effective method for food safety control.
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Objective To understand the factors associated with high risk behaviors among people newly diagnosed to be infected with HIV through heterosexual contact before and after diagnoses in some areas in Henan province,and evaluate the risk of secondary transmission.Methods A face to face interview was conducted among people infected with HIV through heterosexual contact by using self-designed questionnaires during January-May in 2015.Results Among 361 HIV infected persons,the proportions of those with commercial heterosexual behaviors or sex with irregular sex partners decreased from 77.3％(279/361) and 28.5％(103/361) before diagnosis to 13.6％ (49/361) and 2.5％(9/361) after diagnosis,the difference was significant (x2=16.66,P＜0.001;x2=4.80,P=0.03).The subjects surveyed always had more commercial heterosexual behaviors in Henan,Guangdong and Zhejiang provinces before and after diagnosis.After HIV infection confirmation,the condom use rates were 51.0％(25/49) for commercial heterosexual behaviors,88.5％ (184/208) for sex with regular partners and 88.9％(8/9) for sex with irregular partners,respectively.Multivariate logistic regression analysis indicated that risk behaviors associated with HIV transmission included commercial sexual behaviors,previous HIV detection and age of 35 years or older.Conclusions Extra-marital heterosexual behavior has posed serious challenge to the prevention and control of HIV spread.It is necessary to inform the HIV test results,improve the intervention and promote condom use in people with history of commercial sex and people aged ≥35 years.