Progress and Challenges of Reference Standard and Its New Form: Digital Reference Standard

Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development of RS including physical RS, paper atlas, substitute RS and electronic databases. The advantages and disadvantages of each generation were summarized. The concept of digital RS (DRS) was proposed based on this, and summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.

A SERIES OF STRATEGIES FOR SOLVING THE SHORTAGE OF REFERENCE STANDARDS FOR MULTI-COMPONENTS DETERMINATION OF TRADITIONAL CHINESE MEDICINE

The shortage of reference standards has become the bottleneck of quality control of TCMs.In this study,a series of strategies,including one single reference standard to determine multi-compounds(SSDMC),quantitative analysis by standardized reference extract(QASRE),and quantitative nuclear magnetic resonance

DEVELOPING AND PREPARING TCM REFERENCE STANDARDS FOR PHARMACOPEIAS

TCM reference standard(TCM RS)plays an important role in identification,characterization and quality control of herbal raw material,slices,extracts and finished products.It is widely used in:1)authentication of TCM material;2)quantitative determination of herbal chemicals and marker compounds;and 3)limit tests of toxic impurities.TCM RS are provided in three different categories in the form

Preparation of bovine liver candidate reference material

The bovine liver candidate reference material specially for micro analytical techniques was prepared. The preparation process including material collection, dried, pulverize, sieve, homogenization and preliminary test was described in detail. The more effective grinding methods were established to achieve the median particle size of 22μm.

Scanning proton microprobe microanalysis for the assessmentof homogeneity of IAEA urban dust reference materials

In order to develop new reference materials for microanalytical nuclear techniques, scanning proton microprobe (SPM) technique was used to determine homogeneity level within 100×200 μm 2 micro area on the small pieces of IAEA urban dust reference materials. The experimental methods were described in detail. The results show that IAEA 396A/M Vienna urban dust is homogeneous enough for small sample analysis of standard reference material (SRM).

Significance of carcinoembryonic antigen detection in the early diagnosis of colorectal cancer:A systematic review and metaanalysis

BACKGROUND Colorectal cancer(CRC)is a prevalent malignant tumor involving adenomas that develop into malignant lesions.Carcinoembryonic antigen(CEA)is a non-specific serum biomarker upregulated in CRC.The concentration of CEA is modulated by tumor stage and grade,tumor site in the colon,ploidy status,and patient smoking status.This study aimed to evaluate current evidence regarding the diagnostic power of CEA levels in the early detection of CRC recurrence in adults.AIM To evaluate current evidence regarding the diagnostic power of CEA levels in the early detection of CRC recurrence in adults.METHODS A systematic search was performed using four databases:MEDLINE,Cochrane Trials,EMBASE,and the Web of Science.The inclusion criteria were as follows:Adult patients aged≥18 years who had completed CRC curative treatment and were followed up postoperatively;reporting the number of CRC recurrences as an outcome;and randomized,clinical,cohort,and case-control study designs.Studies that were not published in English and animal studies were excluded.The following data were extracted by three independent reviewers:Study design,index tests,follow-up,patient characteristics,and primary outcomes.All statistical analyses were performed using the RevMan 5.4.1.RESULTS A total of 3232 studies were identified,with 73 remaining following the elimination of duplicates.After screening on predetermined criteria,12 studies were included in the final analysis.At a reference standard of 5 mg/L,CEA detected only approximately half of recurrent CRCs,with a pooled sensitivity of 59%(range,33%–83%)and sensitivity of 89%(range,58%–97%).CONCLUSION CEA is a significant marker for CRC diagnosis.However,it has insufficient sensitivity and specificity to be used as a single biomarker of early CRC recurrence,with an essential proportion of false negatives.

Simultaneous determination of five major components of Glycyrrhizae Radix et Rhizoma in Xiaoer Zhike Tangjiang with standardized reference extract

In this study, we developed a novel and simple HPLC-DAD method for simultaneous qualitative and quantitative determination of five major components of Glycyrrhizae Radix et Rhizoma （GRR） in Xiaoer Zhike Tangjiang （XEZKTJ） with standardized reference extract （SRE）. The five analytes （liquiritin apioside, liquiritin, isoliquiritin apioside, liquirigenin and glycyrrhizic acid） were well separated with good linearity, precision, stability and repeatability. The recovery rates ranged from 95.69% to 100.80%. The content of the five compounds in 34 batches of commercial XEZKTJ products was determined using standardized GRR extract （SRE method） and individual chemical reference standards （CRS method）. Highly similar results were obtained from the two methods, demonstrating the feasibility of the proposed SRE method. Taken together, we proposed an efficient and low-cost way to perform multi-component quality control of XEZKTJ in this study.

微波溶样ICP-MS测定海产品中元素方法研究

本文利用微波消解电感藕合等离子体质谱法 (ICP -MS)测定了海产品中Na、Mg、Al、P、Cr、Mn、Fe、Ni、Ca、Zn、As、Sr、Mo、Cd、Pb、Hg,并利用国家标准物质贻贝GBW0 85 71验证了方法的准确度、准确度在 85 %～ 115 % ,平均值为 96 .7% ,测定值与标准值吻合 ,相对标准偏差均小于 5 % ,并用多内标法有效地校正了基体干扰 ,方法简便、快速、准确。

Diagnostic role of Xpert-MTB RIF assay in osteoarticular tuberculosis:A retrospective study

BACKGROUND Osteoarticular tuberculosis(OATB) is a severe form of extrapulmonary TB, which causes notable morbidity and warrants a high index of suspicion for prompt management. The diagnosis of OATB poses a challenge, because of the difficulty of collecting the samples and, secondarily, the paucibacillary nature of lesion, which gives poor sensitivity and reproducibility, with long turnaround time of routine/conventional laboratory tests and the requirement for invasive procedures and expertise. The Xpert MTB/RIF assay has been approved by the World Health Organization as a rapid diagnostic tool for diagnosing pulmonary and extrapulmonary TB.AIM To emphasize the diagnostic efficiency of gene Xpert for OATB in suspected patients in a tertiary care hospital of Eastern India.METHODS This retrospective study was conducted in the Department of Microbiology and Orthopaedics by analyzing the data of the gene Xpert assay over a 3-year duration from January 2018 to February 2021. Demographic and clinical data were recorded. The diagnostic efficiency of gene Xpert was evaluated against the composite reference standard(CRS).RESULTS A total of 37 cases fell into positive, probable, and possible categories of osteoarticular TB out of 112 patients included in the study by CRS;gene Xpert result was positive in 35 out of the 37 different CRS categorized cases. Of the 112 cases, culture was put in 40 cases, and, of these cultures, 5 cases showed the growth of MTB. Of these, 4 cases were included in the 35 cases diagnosed by gene Xpert.Smear microscopy was positive in 6 out of 37 CRS categorized cases. When compared with CRS, the sensitivity of gene Xpert assay, culture, and smear was found to be 94.6%, 13.5%, and 16.2%, respectively, while specificity in all the three types of tests was 100%. When kappa statistics were applied, the percentage of agreement gene Xpert, culture, and microscopy with CRS was found to be 95%, 20%, and 22.6%, respectively. Follow-up of the gene Xpert positive patients after getting anti-tubercular treatment revealed improved conditions.CONCLUSION Gene Xpert could detect 31 extra cases with a low and very low mycobacterial load that were missed by the routine culture methods. Hence, more samples should be processed for molecular diagnostic methods like gene Xpert along with other conventional methods for the validation of the molecular test prospectively for the timely diagnosis of osteoarticular TB.

X-Ray Image Interpretation Guide for Aviation Aluminum Alloy Castings

The purpose of this paper is to introduce the basic steps of X-ray image interpretation of aviation castings,so as to provide a learning guidance for beginners and reduce the exploration time.Among them,the introduction of specifications,the requirements for image quality,and the application of reference radiographs are just a sorting out the key points.If there is a need for practical application,we should conduct a deeper exploration and understanding of each specification,not just cite this article.

Lyophilized standards for the calibration of real time PCR assay for hepatitis C virus RNA

Background Since October 1997, an international standard for hepatitis C virus （HCV） nucleic acid amplification technology assay, 96/790, has been available. We compared a series of lyophilized standards with known HCV RNA concentrations against the international standard in fluorescence quantitative PCR detection. Methods A series of lyophilized sera were calibrated by ROCHE COBAS AMPLICOR HCV Monitor test against the international standard and sent to various manufacturers to analyse the samples using their own kits. Then calibration curves from the series were compared with that obtained from the external standard calibration curve with the manufacture＇s series. Results The standard calibration curve with the series of lyophilized serum showed an excellent correlation （R^2〉0.98）, slope and intercept that were similar to those from the manufacture＇s series. When the standard calibration curve from the series of lyophilized standards were used to define the values of the given sample, lower coefficients of variation between kits from different manufactures were obtained. Conclusion The results showed that the lyophilized standards could be used to setup the standard calibration curve for clinical HCV RNA quantitative PCR detection.

Situation analysis of trauma based on Arizona trauma center standards in university hospitals of Tehran, Iran

Objective: Injuries are common and important problem in Tehran, capital of Iran. Although therapeutic centers are not essentially established following the constructional principles of developed countries, the present opportunities and equipments have to be used properly. We should recognize and reduce the deficits based on the global standards.This study deliberates the trauma resources and capacities in university hospitals of Tehran based on Arizona trauma center standards, which are suitable for the assessment of trauma centers.Methods: Forty-one university hospitals in Tehran were evaluated for their conformity with "Arizona trauma center standards" in 2008. A structured interview was arranged with the "Educational Supervisor" of all hospitals regarding their institutional organization, departments, clini-cal capabilities, clinical qualifications, facilities and resources, rehabilitation services, performance improvement, continuing education, prevention, research and additional requirements for pediatric trauma patients. Relative frequencies and percentages were calculated and Student's t test was used to compare the mean values.Results: Forty-one hospitals had the average of 77.7 (50.7%) standards from 153 Arizona trauma center standards and these standards were present in 97.5 out of 153 (63.7%) in 17 general hospitals. Based on the subgroups of the standards, 64.8% items of hospital resources and capabilities were considered as a subgroup with the maximum criteria, and 17.7% items of research section as another subgroup with the minimum standards.Conclusions: On the basis of our findings, no hospital meet all the Arizona trauma center standards completely. The hospitals as trauma centers at different levels must be promoted to manage trauma patients desirably.

Status and strategies analysis on international standardization of auricular acupuncture points

OBJECTIVE： To supply literature for developing an international standard of auricular acupuncture points. METHODS： Electronic database searches were con- ducted in the Chinese National Knowledge Infra- structure and VlP, and the Western databases, Pubmed, the National Science and Technology Li- brary, and the German Journal of Acupuncture, from 1990 to April, 2012. We also searched the doc- uments of international symposiums for auricular acupuncture points （AAPs）. Keywords were ＂auricu- lar points＂, ＂auricular acupuncture points＂, ＂ear points＂, or ＂auriculotherapy＂ RESULTS： Basic and clinical research on AAPs was performed in China, the United States, France, andGermany. Clinical AAP research was done in Italy, Austria, Switzerland, Spain, the UK, Holland, Japan, Russia, and Africa. However, AAP research was not communicated internationally. The World Federa- tion of Acupuncture-Moxibustion Societies recom- mended international standard of auricular acu- puncture points （ISAAPs）. Standardized nomencla- ture and locations of AAPs would provide a solid basis to draft an international standard organiza- tion. CONCLUSION： Experts need to find common points from different countries or regions, provide evidence of different ideas, and list the proposal as a recommendation for an international standard.

Clinical studies on diffuse axonal injury in patients with severe closed head injury

OBJECTIVE: To discuss the clinical criteria for diagnosing diffuse axonal injury (DAI). METHODS: Clinical and computed tomographic features of 117 patients with severe closed head injury were analyzed. The authors preliminarily put forward CT diagnostic criteria of DAI, that is, 1) single or multiple small intraparenchymal hemorrhages in the cerebral hemispheres (

A new method for improving the accuracy of miRNA detection with NaYF4：Yb,Er upconversion nanoparticles

MicroRNAs(miRNAs)are small noncoding RNAs,which play a central role in gene expression regulation and have been considered as excellent biomarker candidates for clinical diagnosis and prognosis.So far,many miRNAs detection methods require polymerase chain reaction(PCR)amplification following reverse transcription of miRNAs.These processes are complicated and time-consuming.In this work,we have developed a simpler method for miRNA detection based on base stacking hybridization happening on the surface of NaYF_4:Yb,Er upconversion nanoparticles.In this method,the fluorescence of NaYF_4:Yb,Er upconversion nanoparticles were functionalized as a reference standard,which can improve the accuracy of miRNA detection.On the basis of these findings,we suggest this novel approach for miRNA detection could be applied as an accurate and specific technique for miRNAs detection.

Development of a valid and reliable seven emotions impairment questionnaire and assessment of its predictability for phlegm and blood stasis

OBJECTIVE:To develop and validate a Seven Emotions Impairment questionnaire(SEIQ),to define an optimum cut-off point for the SEIQ,and to examine whether SEI was predictive of Phlegm and Blood Stasis(BS).METHODS:Two hundred outpatients and 75 college students were asked to complete the SEIQ,the Profile of Mood States(POMS),Phlegm Pattern Questionnaire(PPQ),and BS Questionnaire(BSQ).Twelve clinicians determined whether the outpatients exhibited SEI.SEIQ data were used to examine the internal consistency and determine validity for the outpatients.SEIQ,POMS,PPQ,and BSQ data were used to examine concurrent validity and predictability of SEI for Phlegm and BS in the college students.Total SEIQ scores and the clinicians' diagnoses of the outpatients were considered to define an optimum cut-off score for the SEIQ.RESULTS:The 18-item SEIQ had satisfactory internal consistency(α = 0.905) and concurrent validity.In the construct validity test,four factors(chest-anxiety,fatigue-depression,working-family-troubles,and sleep-memory) were identified.In the receiver operator characteristic curve curve analysis,the sensitivity,specificity,and area under the curve of the SEIQ were 67.2%,72.1%,and 73%,respectively.The optimum cut-off score was defined as nine points.SEIQ scores were strongly predictive of Phlegm and BS(β = 0.862 and 0.673,respectively).CONCLUSION:Based on our results,we concluded that the SEIQ is a reliable and valid instrument for evaluating SEI,and is strongly predictive of Phlegm and BS.

Diagnostic value of chest computed tomography imaging for COVID-19 based on reverse transcription-polymerase chain reaction: a meta-analysis

Background:The computed tomography(CT)diagnostic value of COVID-19 is controversial.We summarized the value of chest CT in the diagnosis of COVID-19 through a meta-analysis based on the reference standard.Methods:All Chinese and English studies related to the diagnostic value of CT for COVID-19 across multiple publication platforms,was searched for and collected.Studies quality evaluation and plotting the risk of bias were estimated.A heterogeneity test and meta-analysis,including plotting sensitivity(Sen),specifcity(Spe)forest plots,pooled positive likelihood ratio(+LR),negative likelihood ratio(-LR),dignostic odds ratio(DOR)values and 95%confdence interval(CI),were estimated.If there was a threshold efect,summary receiver operating characteristic curves(SROC)was further plotted.Pooled area under the receiver operating characteristic curve(AUROC)and 95%CI were also calculated.Results:Twenty diagnostic studies that represented a total of 9004 patients were included from 20 pieces of literatures after assessing all the aggregated studies.The reason for heterogeneity was caused by the threshold efect,so the AUROC=0.91(95%CI:0.89–0.94)for chest CT of COVID-19.Pooled sensitivity,specifcity,+LR,-LR from 20 studies were 0.91(95%CI:0.88–0.94),0.71(95%CI:0.59–0.80),3.1(95%CI:2.2–4.4),0.12(95%CI:0.09–0.17),separately.The I 2 was 85.6%(P=0.001)by Q-test.Conclusions:The results of this study showed that CT diagnosis of COVID-19 was close to the reference standard.The diagnostic value of chest CT may be further enhanced if there is a unifed COVID-19 diagnostic standard.However,please pay attention to rational use of CT.

Simultaneous measurement of 16 bisphenol A analogues in house dust and evaluation of two sampling techniques

Bisphenol A(BPA)is a high production volume(HPV)chemical used to make polycarbonate(PC)plastics and epoxy resins.Due to its potential adverse health effects,BPA has been restricted or banned in some products and thus many alternatives to BPA have been introduced into the market.Most of these alternatives such as bisphenol S(BPS),bisphenol F(BPF),and bisphenol M(BPM),have similar chemical structures to BPA and termed as BPA analogues(BPAAs).In this study,a method was developed for the simultaneous determination of 16 BPAAs in indoor dust by gas chromatography coupled with tandem mass spectrometry(GC-MS/MS).The method was sensitive,with method detection limits(MDLs)ranging from 0.001 mg/g to 0.017 mg/g.The method demonstrated good recoveries(>80%)for the majority of the target compounds and was applied to the analysis of dust samples collected from 2007 to 2010 in 13 cities across Canada under the Canadian House Dust Study(CHDS).Samples were collected using two different techniques:household vacuum dust samples collected from household vacuum bags(HD);fresh vacuum dust(FD)samples collected by a trained technician from dry floor surfaces.In addition to BPA with 100%detection in 119 HD samples,BPS,BPF,and BPM were detected with high detection frequencies(>75%)with median(range)concentrations of 0.242(<0.017-35.1)mg/g,0.123(<0.007-2.67)mg/g,and 0.028(<0.005-0.908)mg/g,respectively,suggesting their wide use in various applications.Other BPAAs were not detected or detected with very low frequencies and at low levels.This study shows that BPAA concentrations in dust sampled from household vacuum bags compare well with concentrations observed in fresh dust collected from the same homes,suggesting that HD sampling could be a cost-effective alternative to FD sampling.The method was also applied to the analysis of a standard reference material e NIST SRM 2585(organic contaminants in house dust).So far there are no certified values for BPAAs in SRM 2585.In this study only three BPAAs were detected in SRM 2585,with mean values of 34.2(±2.3)mg/g for BPA,1.88(±0.22)mg/g for BPS,and 0.297(±0.052)mg/g for BPF.