Analytical Specifications Research Articles

Biological variation and reference change values of serum Mac-2-binding protein glycosylation isomer (M2BPGi).

BackgroundLimited data are available with regard to biological variations of the Mac‐2–binding protein glycosylation isomer (M2BPGi), a liver fibrosis biomarker.MethodsLong‐term biological variation of M2BPGi was investigated using longitudinally measured M2BPGi test results from healthy Korean adult subjects. One‐way analysis of variance (ANOVA) tests were used to calculate the reference change value (RCV) of M2BPGi based on biological variation estimates. Furthermore, asymmetric RCV was calculated according to a recent publication of the European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation and Task Group for the Biological Variation Database (EFLM TG‐BVD).ResultsA total of 363 test results from 174 Korean subjects undergoing general health checkups were requested from 13 local clinics and hospitals during a 38‐month period. The within‐subjects biological variation (CVI), between‐subject biological variation (CVG), analytical variation (CVA), RCV, and individuality index (II) values for serum M2BPGi were 23.3%, 30.0%, 4.3%, 65.6%, and 0.78, respectively. Asymmetric RCV calculated using formulae by a recent EFLM TG‐BVD publication ranged from −41.9 to 72.0%. Desirable analytical performance specifications for M2BPGi derived from biological variation were as follows: imprecision 11.6%, bias 9.6%, and total allowable error 28.7%.ConclusionsRCV based on biological estimates may be helpful for evaluating and interpreting serial M2BPGi measurements by physicians and in clinical laboratories.

The Practical Barriers to Auction of Confiscated Objects for Corruption Crime

This study aims to determine the implementation of the auction of confiscated objects of corruption carried out by the Kulon Progo District Attorney, as well as to find out the obstacles that exist in the process of auctioning confiscated objects of corruption. This study uses a research method with an empirical juridical approach, and a descriptive analytical research specification. This research was conducted at the Kulon Progo District Attorney's Office. The crime of corruption in recent decades has become an issue that has been widely discussed in both print and electronic media by all members of the public, because several persons suspected of committing a criminal act of corruption cannot be separated from office holders in Indonesia, consisting of executives, Legislative and even up to the Judiciary. Based on the research results, it is known that the auction implementation based on PMK No. 27/PMK.06/2016 concerning Instructions for Implementation of Auctions and PMK No. 13/PMK.06/2018 Concerning the Auction of Confiscated Objects, State Loot, or Executed Confiscated Objects Originating from the Prosecutor's Office of the Republic of Indonesia. The obstacles encountered by the Kulon Progo District Attorney's Office in the auction process, such as in the case of correspondence between the Prosecutor's Office and the KPKNL, the length of time the results of the trial came out which could result in a decrease in the value of the confiscated goods. Problems related to the implementation of electronic auctions are also still an obstacle.

The Development of Corporate Financing Law: Empirical Practices of Business Financing in the "PaDi UMKM" Marketplace

Micro Small Medium Enterprises (MSMEs) are the largest segment of national economic actors that can continue to grow. Still, in practice, MSMEs are difficult to develop because several obstacles are faced, especially in the digital world, which is difficult to get financing because of the unfulfilled collateral requirements. In its development, corporate financing also uses information technology media. This research aims to analyze juridical reviews of Corporate Finance Law in digital platforms, business financing practices on MSMEs Digital Market (PaDi) Marketplace in MSMEs development efforts, and invoice financing as collateral development in MSMEs company financing. The research methods used are normative juridical with analytical descriptive research specifications. The results of this study show: (1) corporate financing has been regulated in several laws and regulations and related to its development in digital platforms is implied to be regulated through Financial Services Authority Regulation Number 13/POJK.02/2018; (2) MSMEs Digital Market (PaDi) Marketplace acts as a facilitator of buying and selling as well as providing finance; and (3) the new securities theory of Performance Securities is realized through invoice financing as finance without collateral.

Impact of Individualized Hemolysis Management Based on Biological Variation Cut-offs in a Clinical Laboratory.

BackgroundHemolysis is the most common type of preanalytical interference. Cut-offs based on the hemolysis index level can be established using different approaches. The Working Group for Preanalytical Phase of the European Federation of Laboratory Medicine has developed a protocol for hemolysis management based on cut-offs estimated from biological variation (BV) and the use of interpretative comments. We developed and assessed the implementation of the protocol in our laboratory.MethodsHemolysates from whole blood were prepared following the Meites method, and pooled serum samples with known Hb concentrations were prepared. For each analyte (42 ), interferograms were generated and used to establish cut-offs desirable analytical quality specification and reference change value. This protocol was assessed, both pre- and post-implementation, according to expert rules in the Laboratory Information System.ResultsAmong the analytes evaluated, we selected those that showed the highest degree of hemolysis interference lactate dehydrogenase (LDH), aspartate aminotransferase, direct bilirubin, potassium, and folic acid. The cut-offs for LDH and direct bilirubin were the lowest. Only 28.16% of all LDH values were adequately reported in the pre-implantation retrospective study, but this percentage improved in the post-implementation stage.ConclusionsThe development and implementation of a harmonized protocol for hemolysis management based on BV cut-offs and result reporting significantly improve hemolysis detection and lead to a decrease in the number of hemolyzed samples over time.

Philosophy Of Law And The Development Of Law As A Normative Legal Science

Philosophy is an attempt to fundamentally study and express a man's depiction in the world towards the afterlife. The object is material and formal. Through this normalization of human behavior, the law traces almost all areas of human life. Legal philosophy analyzes the legal principles and answers questions related to legal problems in both normative and empirical juridical forms so that legal objectives can be achieved, namely for improvement in human life. The method of approach used is normative juridical, analytical descriptive research specifications are expected to provide a detailed, systematic, and comprehensive picture based on the correlation of data with each other on the Philosophy of Law and The Development of Law Normative Legal Sciences. The type and source of data used are secondary as a primary data source, consisting of primary legal materials, secondary legal materials, and tertiary legal materials. The data analysis method is qualitative. The legal theory does speak of many things that can fit into the political field of law, legal philosophy, legal science, or a combination of those three fields. Therefore, the theory of law may at some point talk about something universally numbered. Still, he may be talking about very specific things according to a particular place. The function of the law is not enough just as social control, but more than that. The function of the law expected today is to move the community to behave by new ways of acting or behaving by the provisions of the law.

An approach for determining allowable between reagent lot variation.

Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation and verification experiments to daily quality control procedures. All these procedures verify, on different moments, that the results of a certain examination procedure have analytical performance characteristics (APC) that meet analytical performance specifications (APS) set for a particular intended use. The APC can in part be determined by estimating the measurement uncertainty component under conditions of within-laboratory precision (uRw), which comprises all components influencing the measurement uncertainty of random sources. To maintain the adequacy of their measurement procedures, laboratories need to distinguish aspects that are manageable vs. those that are not. One of the aspects that may influence uRw is the momentary significant bias caused by shifts in reagent and/or calibrator lots, which, when accepted or unnoticed, become a factor of the APC. In this paper, we postulate a model for allocating a part of allowable uRw to between-reagent lot variation, based on the need for long-term consistency of the measurement variability for that specific measurand. The allocation manages the ratio between short-term and long-term variation and indicates laboratories when to reject or correct certain variations due to reagent lots.

Critical review and meta-analysis of biological variation estimates for tumor markers.

Biological variation data (BV) can be used for different applications, but this depends on the availability of robust and relevant BV data. In this study, we aimed to summarize and appraise BV studies for tumor markers, to examine the influence of study population characteristics and concentrations on BV estimates and to discuss the applicability of BV data for tumor markers in clinical practice. Studies reporting BV data for tumor markers related to gastrointestinal, prostate, breast, ovarian, haematological, lung, and dermatological cancers were identified by a systematic literature search. Relevant studies were evaluated by the Biological Variation Data Critical Appraisal Checklist (BIVAC) and meta-analyses were performed for BIVAC compliant studies to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV with 95% CI. The systematic review identified 49 studies delivering results for 22 tumor markers; four papers received BIVAC grade A, 3 B, 27 C and 15 D. Out of these, 29 CVI and 29 CVG estimates met the criteria to be included in the meta-analysis. Robust data are lacking to conclude on the relationship between BV and different disease states and tumor marker concentrations. This review identifies a lack of high-quality BV studies for many tumor markers and a need for delivery of BIVAC compliant studies, including in different disease states and tumor marker concentrations. As of yet, the state-of-the-art may still be the most appropriate model to establish analytical performance specifications for the majority of tumor markers.

Comparison of four indirect (data mining) approaches to derive within-subject biological variation.

Within-subject biological variation (CVi ) is a fundamental aspect of laboratory medicine, from interpretation of serial results, partitioning of reference intervals and setting analytical performance specifications. Four indirect (data mining) approaches in determination of CVi were directly compared. Paired serial laboratory results for 5,000 patients was simulated using four parameters, d the percentage difference in the means between the pathological and non-pathological populations, CVi the within-subject coefficient of variation for non-pathological values, f the fraction of pathological values, and e the relative increase in CVi of the pathological distribution. These parameters resulted in a total of 128 permutations. Performance of theExpected Mean Squares method (EMS), the median method, a result ratio method with Tukey's outlier exclusion method and a modified result ratio method with Tukey's outlier exclusion were compared. Within the 128 permutations examined in this study, the EMS method performed the best with 101/128 permutations falling within ±0.20 fractional error of the 'true' simulated CVi , followed by the result ratio method with Tukey's exclusion method for 78/128 permutations. The median method grossly under-estimated the CVi . The modified result ratio with Tukey's rule performed best overall with 114/128 permutations within allowable error. This simulation study demonstrates that with careful selection of the statistical approach the influence of outliers from pathological populations can be minimised, and it is possible to recover CVi values close to the 'true' underlying non-pathological population. This finding provides further evidence for use of routine laboratory databases in derivation of biological variation components.

Legal Protection of Inventor Employees through Patent Ownership Agreements in Indonesia

Intellectual property born in the production process in a company is usually a patent produced by inventor employees through research and development activities. However, arrangements regarding the ownership of patents generated by inventor employees in employment or service relations in Article 12 and Article 13 of the Patent Law grant the patent ownership rights automatically to the employer so as not to provide adequate legal protection to the inventor employee. Legal protection for an employed inventor is important to note because it will spur IPR productivity and motivate inventors' creativity to produce intellectual property work. This research used normative juridical methods with analytical descriptive research specifications. Data collection was done through interviews together with company representatives at PT. Martina Berto (Tbk) and PT. Bio Farma (Persero). The results showed that the practice of patent ownership produced by inventor employees at PT. Martina Berto (Tbk) and PT. Bio Farma (Persero) based on Article 12 and Article 13 of the Patent Law is contrary to the principle of alter ego. Inventor employees can negotiate with the company by forming a patent ownership agreement that will clarify the ownership rights and the number of rewards that will be obtained by inventor employees based on Article 12 paragraph (1) and Article 153 of the Patent Law

A national surveillance program for evaluating new reagent lots in medical laboratories.

Differences between laboratory results attributable to the use of different reagent lots can potentially affect the diagnosis and monitoring of patients. To minimize patient risks, all laboratories should verify that new reagent lots meet agreed analytical performance specifications (APS). We propose a simplified, pragmatic approach for laboratories that involves compilating results into a national surveillance program, and present the first results obtained when applying this approach to troponins, glycated hemoglobin (HbA1c), prostate-specific antigen (PSA) and D-dimer. In the surveillance program we have (i)determined APS for selected analytes, (ii) implemented a simplified procedure for lot evaluation with patient samples used in laboratories across Norway and (iii) performed central processing of the results from the participating laboratories. Over a one-year period, 27 Norwegian laboratories returned results from 28 lot changes for troponin I, 11 for troponin T, and 29 for HbA1c, PSA and D-dimer. The mean difference between two reagent lots was 4.5% for troponin I (for a concentration interval of 20-32ng/L), 5.1% for troponin T (10.7-17.5ng/L), 2.2% for HbA1c (40-50mmol/mol), 3.7% for PSA (3-5μg/L) and 5.5% for D-dimer (0.4-1.0mg/L FEU). A novel procedure for reagent lot evaluation is proposed in which information about multiple lotchanges from different medical laboratories can be accumulated nationally. Sharing this information allows simplification of lot evaluations in individual laboratories and provides real-world data about lot-to-lot variations.

PENYIDIKAN TINDAK PIDANA PERBANKAN DALAM BENTUK KREDIT FIKTIF PADA BANK PERKREDITAN RAKYAT (BPR) MITRA DANAGUNG (Studi Pada Satreskrim Polres Pesisir Selatan)

Article 49 of Law no. 10 of 1998 concerning Banking has explicitly regulated criminal acts related to bank business. However, there are still many parties who commit criminal acts in the banking sector, one of which is fictitious credit. Like the fictitious credit that happened to the Rural Bank (BPR) Mitra Danagung, which was carried out by the Director of Bank Mitra Danagung himself, in the period from 2011 to 2012. The formulation of the problems studied in this thesis are: First, how is the investigation of banking crimes in the form of fictitious loans at BPR Mitra Danagung Bank? Second, what are the obstacles faced by the Satreskrim Investigator of the Pesisir Selatan Police in the investigation of banking crimes in the form of fictitious credit at Bank BPR MitraDanagung? This research is a legal research with a descriptive analytical specification. The main approach used is a normative juridical approach and is supported by an empirical juridical approach. The data used are secondary data as primary data, and primary data as supporting data collected through library research and field research. The data is then analyzed qualitatively and presented in a qualitative descriptive form. Based on the results of the study, it can be concluded, first, that the investigation of banking crimes in the form of fictitious credit at PBR Mitra Danagung Bank was carried out based on the principle of lex specialis derogat legi generalis. After receiving the report, the investigative team conducts an investigation and review of the report to prepare a plan for investigative activities, followed by examining witnesses and collecting evidence and expert testimony, then a case is held to determine the suspect, then arrests and detentions are made. After the filing is complete, the investigator submits the case file to the Public Prosecutor accompanied by witnesses and evidence. Second, the obstacles faced by the investigators of the Satreskrim Polres Pesisir Selatan in the investigation of banking crimes in the form of fictitious credit at Bank BPR Mitra Danagung are: the overlapping authority of investigating banking crimes as regulated by a law that gives authority to the Police, Prosecutors, and Investigators. OJK, limited human resources for investigators, level of education and low knowledge of investigators about advances in information technology, as well as supporting facilities and infrastructure in conducting investigations.

Specification of oil leakage points based on the operation data of pipelines

The paper deals with the analysis of negative effect of the complications in the operation of oil pipelines on environment and the analytical specification of oil leakages from the pipelines as well. An empiric expression for the approximation of oil leakage due to the failures based on the ratio of corresponding losses considering the changes of combined characteristics of pump station and pipeline before and after the leakage is offered. The paper presents the calculations on the definition of leakage points based on the data of chronicality of oil leakages from the pipelines due to the failures and the changes of operation parameters; good results have been obtained. Thus, it is possible to specify the leakage sites in the reference point by the values of rate and pressure at the moment of leakage, although in the practice it is an approximate value.

THE INDEPENDENT CAMPUS, FREEDOM TO LEARN (MBKM) POLICY SOCIALIZATION MODEL AS AN EFFORT TO ACHIEVE THE MAIN PERFORMANCE INDICATORS OF HIGHER EDUCATION

Independent campus learning provides challenges and opportunities to develop innovation, creativity, capacity, personality, and student needs. Through an independent learning program that is well designed and implemented, students' hard and soft skills can be improved. The implementation of MBKM at Universitas Suryakancana is based on several main principles: referring to the Achievement of Graduate Profiles, Referring to the Demands of 21st Century Capabilities, Increasing Collaborative Competencies, Increasing Independent Learning, Adapting to Demands and Needs. The research method uses a normative juridical approach with analytical descriptive specifications. The results showed that the MBKM policy socialization process could be carried out in stages and continuously with the assistance of persons or people who represent the academic community in carrying out socialization activities.

New way to select analytical performance specifications based on the state-of-the-art

<h3></h3> Настоящая публикация преследует две цели: привлечь внимание коллег к новым возможностям использования модели «текущее состояние аналитического качества» (state-of-the-art) для выбора требований к качеству и попытаться понять, почему использование требований к аналитическому качеству все еще редкая практика в наших лабораториях.

ParMA: Parallelized Bayesian Model Averaging for Generalized Linear Models

This paper describes the gretl function package ParMA, which provides Bayesian model averaging (BMA) in generalized linear models. In order to overcome the lack of analytical specification for many of the models covered, the package features an implementation of the reversible jump Markov chain Monte Carlo technique, following the original idea by Green (1995), as a flexible tool to model several specifications. Particular attention is devoted to computational aspects such as the automatization of the model building procedure and the parallelization of the sampling scheme.

The Role of Bhabinkamtibmas in Supporting Motor Vehicle Tax Arrears Collection During the Covid-19 Pandemic

This study aims to analyze the role of Bhabinkamtibmas in supporting the collection of motor vehicle tax arrears during the covid-19 pandemic in the Demak police jurisdiction and the obstacles to implementing the role of Bhabinkamtibmas in supporting the collection of motor vehicle tax arrears during the covid-19 pandemic in the Demak police jurisdiction and the solutions. The approach method is sociological juridical; analytical descriptive research specifications; data sources are primary data and secondary data; data collection methods through field studies and literature studies; while the data analysis method used qualitative analysis. As an analytical tool, role theory, legal effectiveness theory and benefit theory are used. The results of the study show that the role of Bhabinkamtibmas in supporting the collection of motor vehicle tax arrears in the jurisdiction of the Demak police station is to submit a motor vehicle tax bill to motorized vehicle taxpayers. This role is effective in increasing the realization of PKB revenue in the Demak Regency. The obstacles to implementing the role of Bhabinkamtibmas in supporting the collection of motor vehicle tax arrears come from internal and external factors.

The Importance of Expertly Evaluated Tests Underlined by COVID-19 Pandemic: A Mini Review

Background: The joint interest of clinicians and the laboratory test industry during the recent pandemic of the Coronavirus Disease 2019 (COVID-19) resulted in an explosion of accessible assays for COVID-19 serological testing. Content: The need of properly evaluated laboratory tests is more apparent today than ever before. Clinical application of the assay, analytical specifications, and performance convenience are the key criteria that must be followed while selecting an analytical method. An analytical evaluation is always performed before deciding to apply a procedure in the laboratory routine practice. Summary: Only after the evaluation, data collection, and analysis of the results in accordance with the established eligibility criteria can be concluded that the new assay is suitable for laboratory use.

Analisis Pembatalan Perjanjian Secara Sepihak Dalam Reservasi Akomodasi Pariwisata Secara Online Melalui Agoda Berdasarkan Prinsip Hukum Perdata Internasional

The rapid development of information and communication technology is bringing changes to human interaction in entering the business transaction area. As one of the multisectors needed by society, tourism sector continues to innovate and diversify in its various products and services, one of which is through the application of technology in digital-based business activities called e-tourism. Agoda is one of the e-tourism platforms originating and operating in Singapore. Transactions between consumers and Agoda can cause quite complex problems due to the presence of foreign elements in it. This research aims to clearly know the provisions regarding unilateral cancellation of the agreement and its settlement based on the principles of International Civil Law and obtain legal certainty regarding the legal protection of the aggrieved party under applicable law. This research uses normative juridical approach methods with descriptive analytical research specifications. The type of data used is secondary data using qualitative juridical analysis methods. The research results explain that settlement was resolved using principles of International Civil Law, customer can take legal steps by conducting a civil damages prosecution through the Singapore court and under Singapore law. Under applicable regulations, aggrieved customers still get full legal rights and have the right to claim damages for unfair practices in transactions.

PERAN PEMERINTAH DESA DALAM PENGELOLAAN WISATA ALAM NEGERI DI ATAS AWAN DI DESA CITOREK KIDUL LEBAK BANTEN BERDASARKAN PERATURAN DAERAH NOMOR 2 TAHUN 2016 TENTANG PENYELENGGARAAN KEPARIWISATAAN

Tourism is one of the natural resources owned by the Indonesian state. Lebak Regency, especially Citorek Village, has natural tourism from the Country Above the Clouds which is currently the center of attention of tourists, the development of the Country Above the Clouds natural tourism has had a positive impact and problems on the surrounding community, especially in Citorek Kidul Village. Thus the need to increase the role of the community and interested parties, especially the government in managing the country &amp; natural tourism above the clouds, so that it becomes a tourist attraction that attracts tourists so as to increase the economic growth of the Citorek community. The author is interested in researching how the role of the village government in managing the country &amp; natural tourism above the clouds in the village of Citorek Kidul Lebak Banten based on Regional Regulation Number 2 of 2016 concerning the Implementation of Tourism? and what is the licensing procedure for the management of natural tourism in the country above the clouds in the village of Citorek Kidul Lebak Banten based on Regional Regulation Number 2 of 2016 concerning the Implementation of Tourism? This study used an empirical juridical method with descriptive analytical research specifications. The data used in this study are secondary data supported by primary data in the form of interviews with the Head of the Tourism Destination Division of Lebak Regency and the Head of the Citorek Kidul Village who were analyzed descriptively qualitatively. The results of this study indicate that the role of the village government in managing natural tourism is still not optimal because the principle of independence and the principle of equality in Regional Regulation No.2 of 2016 concerning the Implementation of Tourism has not been fulfilled and there are several inhibiting and driving factors in the licensing process, the inhibiting factor is the source. Human power, namely the lack of understanding of the OSS system is still not evenly studied by the village community, the lack of facilities and infrastructure and lack of budgets, while the driving factor is the potential for tourism, namely the natural tourism of the country above the clouds which has the charm of a cloud that is witnessed on the mountain. sublime has a tourist attraction, community cooperation as social capital for the growth of natural tourism in the megeri above the clouds is formed by the presence of pokdarwis, support and motivation from the village government .

Tinjauan Hukum Pendanaan Pelaku Usaha Mikro, Kecil, dan Menengah Sebagai Bantuan Modal Kerja pada Masa Pandemi Covid-19 di Kota Tangerang Berdasarkan Peraturan Menteri Koperasi, Usaha Kecil, dan Menengah Republik Indonesia Nomor 6 Tahun 2020

The 2019 Corona Virus Disease pandemic poses a threat to Micro, Small, and Medium Enterprises, as seen from the decline in turnover to no income and causing bankruptcy. Government policies in dealing with the economic impact during the 2019 Corona Virus Disease pandemic, the government gives priority to support for Micro Enterprises with large budget allocations. Therefore, this study discusses how the legal aspects of funding micro, small, and medium enterprises as working capital assistance during the Corona Virus Disease 2019 pandemic in Tangerang City based on the Regulation of the Minister of Cooperatives, Small and Medium Enterprises Number 6 of 2020? from the implementation of micro, small and medium business capital assistance in the Tangerang City area to the sustainability of Micro, Small, and Medium Enterprises?. The research method used in the preparation of this legal writing is empirical juridical research, namely research that sees the law as a rule in society to be obeyed, with analytical descriptive specifications that discuss working capital assistance during the Corona Virus Disease 2019 pandemic in Tangerang City which is sourced from data The primary sources are legislation, books, legal science journals, and other library materials which were analyzed qualitatively. The results of this study, that the Government implements policies through the Direct Assistance Program for Micro Enterprises with the aim of strengthening the business of Micro, Small, and Medium Enterprises. The existence of such capital assistance has a positive impact on the economy in the community, thereby increasing employment opportunities.