Dependence of TIMP-1 plasma levels on preanalytical specimen handling

Background: Tissue inhibitor of metalloproteinases-1 (TIMP-1) in blood might be a helpful biomarker in various diseases. However, various authors report that TIMP-1 is dependent on preanalytical procedures. Our study was performed to determine how storage conditions and time to centrifugation influence TIMP-1. Materials and Methods: Twenty-six blood specimens were collected from each of 20 volunteers. Two specimens from each person were centrifuged/measured within 1 h after venipuncture and frozen at -80 degrees C. They were thawed once or twice within 72 h. Eight specimens were stored at 20 degrees C in daylight, 8 at 20 degrees C covered and 8 at 4 C in daylight. Four of each of these 8 specimens were mixed once a day until centrifugation. A mixed and an unmixed specimen of each group was centrifuged/measured after 3, 6, 24 and 72 h. Results: TIMP-1 increased after freeze/ thaw (p < 0.001). Mixing blood specimens more than once caused increased TIMP-1 (p < 0.001). TIMP-1 increased within 3 h of storage (p < 0.001). The increase was lower in specimens covered and refrigerated (p < 0.001). Conclusion: TIMP-1 is unstable and has to be evaluated carefully. Blood should be centrifuged directly after venipuncture. For routine application, specimen handling must be standardized and carefully followed. Research should be done on specimens handled identically. Copyright (C) 2008 S. Karger AG, Basel

Unlocking biomarker discovery: Large scale application of aptamer proteomic technology for early detection of lung cancer

Lung cancer is the leading cause of cancer deaths, because ~84% of cases are diagnosed at an advanced stage. Worldwide in 2008, ~1.5 million people were diagnosed and ~1.3 million died &#x2013; a survival rate unchanged since 1960. However, patients diagnosed at an early stage and have surgery experience an 86% overall 5-year survival. New diagnostics are therefore needed to identify lung cancer at this stage. Here we present the first large scale clinical use of aptamers to discover blood protein biomarkers in disease with our breakthrough proteomic technology. This multi-center case-control study was conducted in archived samples from 1,326 subjects from four independent studies of non-small cell lung cancer (NSCLC) in long-term tobacco-exposed populations. We measured &#x3e;800 proteins in 15uL of serum, identified 44 candidate biomarkers, and developed a 12-protein panel that distinguished NSCLC from controls with 91% sensitivity and 84% specificity in a training set and 89% sensitivity and 83% specificity in a blinded, independent verification set. Performance was similar for early and late stage NSCLC. This is a significant advance in proteomics in an area of high clinical need

Effect of Preanalytical Processing of ThinPrep Specimens on Detection of High-Risk Human Papillomavirus by the Aptima HPV Assay

Two important preanalytical protocols performed on liquid-based cytological specimens, namely, automated cytology processing and glacial acetic acid (GAA) treatment, may occur prior to the arrival of specimens in a molecular diagnostics laboratory. Ninety-two ThinPrep vials previously positive for high-risk human papillomavirus (HPV) via the Cervista HPV HR test were preselected and alternated with 92 previously negative ThinPrep vials. The specimen set was processed in a consecutive fashion by an automated cytology processor without fastidious decontamination precautions. Carryover potential was subsequently assessed by performance of the Aptima HPV assay on aliquots from reprocessed ThinPrep vials. All previously negative ThinPrep vials yielded a negative result following routine automated cytology processing, despite close proximity to known-positive ThinPrep vials. In separate experiments, aliquots from 236 ThinPrep vials were forwarded for tandem analysis with and without GAA treatment. Data from GAA- and mock-treated specimens generated by Aptima HPV were compared to correlate data generated by Cervista. A 99.2% concordance of Aptima HPV results from GAA-treated and mock-treated specimens was noted. This result differed from the concordance result derived from Cervista (91.5%; P \u3c 0.0002). Of the initially positive Cervista results, 21.9% reverted to negative following GAA treatment; the correlate value was 2.7% for Aptima HPV (P = 0.01). While deleterious effects of GAA treatment on genomic DNA were noted with Cervista (P = 0.0015), GAA treatment had no significant effects on Aptima HPV specimen signal/cutoff ratios or amplification of internal control RNA (P ≥ 0.07). The validity of an Aptima HPV result is independent of GAA treatment and routine automated cytology processing

Point-of-care testing for disasters: needs assessment, strategic planning, and future design.

Objective evidence-based national surveys serve as a first step in identifying suitable point-of-care device designs, effective test clusters, and environmental operating conditions. Preliminary survey results show the need for point-of-care testing (POCT) devices using test clusters that specifically detect pathogens found in disaster scenarios. Hurricane Katrina, the tsunami in southeast Asia, and the current influenza pandemic (H1N1, "swine flu") vividly illustrate lack of national and global preparedness. Gap analysis of current POCT devices versus survey results reveals how POCT needs can be fulfilled. Future thinking will help avoid the worst consequences of disasters on the horizon, such as extensively drug-resistant tuberculosis and pandemic influenzas. A global effort must be made to improve POC technologies to rapidly diagnose and treat patients to improve triaging, on-site decision making, and, ultimately, economic and medical outcomes

ANALISIS AKUNTABILITAS DAN TRANSPARANSI PENGELOLAAN ANGGARAN DAN BELANJA DESA (studi kasus : Desa Andonosari Kecamatan Tutur Kabupaten Pasuruan)

This study seeks to examine the accountability and transparency of village budget and spending management in Andonosari Village, Tutur District, Pasuruan Regency. APBDes management begins with the planning stage, followed by the execution step, and finally by the reporting stage. This study employs a qualitative descriptive research approach, with data derived from interviews with the leader of Andonosari village. According to the findings of the study, Accountability and Transparency in Andonosari Village, Tutur District, Pasuruan Regency has adopted accountable and transparent indicators, despite the fact that it is not perfect and there are many things that can be improved

Biobank quality management in the BBMRI.be network

From as early as 2005, different guidelines and quality standards covering biobank activities and sample handling methods have been developed to improve and guarantee the reproducibility of biomarker research. Ten years on, the BBMRI.be Quality working group wanted to gauge the current situation of these aspects in the biobanks of the BBMRI.be network. To this end, two online surveys were launched (fall 2017 and fall 2018) to the biobank quality managers in the BBMRI.be network to determine the status and setup of their current quality management system (QMS) and how their QMS and related practices have evolved over a 14 month time period. All biobanks addressed by the two surveys provided a complete response (12 and 13, respectively). A QMS was implemented in 85% of biobanks, with 4 standards emerging as primary basis. Supplementary guidelines were used, with a strong preference for the ISBER best practices for biobanks. The Standard Preanalytical Code-an indicator of the preanalytical lifecycle of a biospecimen impacting the downstream analysis results-was already implemented in 50% of the biobanks while the other half intends future implementation. To assess and maintain the quality of their QMS, 62% of biobanks used self-assessment tools and 71% participated in proficiency testing schemes. The majority of biobanks had implemented procedures for general and biobank specific activities. However, policies regarding the business and sustainability aspect of biobank were only implemented in a limited number of biobanks. A clear desire for a peer-review audit was expressed by 69% of biobanks, with over half of them intending to implement the recently published biobank standard ISO20387. Overall, the biobanks of the BBMRI.be network have actively implemented a solid quality approach in their practices. The implementation of ISO 20387 may bring further professionalization of activities. Based on the needs expressed in this survey, the Quality working group will be setting up an audit program for the BBMRI.be biobanks, to enhance, harmonize and streamline their activities. On the whole, the biobanks in the BBMRI.be network are able to substantially contribute to translational research, as a primary facilitator guaranteeing high quality standards and reproducibility

Effect of storage time and temperature on serum analytes

Information on the measured concentration of serum analytes during storage of serum samples is often incomplete and sometimes contradictory. The 10 analytes have not studied in this area in healthy subjects. The aim of present study was designed to determine the effect of storage time and temperature on the laboratory results of 10 analytes in sera from apparently healthy adult males in city of Gorgan.We studied the effect of storage temperature and time on the measured roncentration of 10 serum analytes (2006). Serum was separated from the clot within 20 min of the collection. The sera were stored at 4±1°C and 23±1°C for 0,1, 2, 3, 4, 5, 6, 7, 8, 24, 48 and 72 h, then assayed. Glucose, Phosphorus and creatinine were the least stable and the serum should be determined within 48 h at 4±1°C and 24 h at 23±1°C for these analytes. The other analytes were stable for 72 h. Proper storage temperatures and times must be considered for these analytes (glucose, phosphorus and Creatinine) if measurement is not to take place immediately after specimen collection. Beyond this, it is even very useful to check the reliability of technical and instrumental resources that the laboratory will use during the study because molecular alterations of the analytes due to variable storage conditions can cause misleading results. © 2008 Science Publications

Perbedaan Kadar Alanine Aminotransferase (Alt) Dalam Serum Dari Darah Yang Disentrifugasi Pada Kecepatan 3000 Rpm Selama 5 Menit Dan 4400 Rpm Selama 3 Menit

Background : Laboratory tests for liver and heart are emergency, so the examination must be carried out quickly including ALT examination. One way is by reducing the time of centrifugation without reducing the quality of serum. Reducing the time of centrifugation to 3 minutes at 4400 rpm is expected to provide the same results by centrifuging for 5 minutes at 3000 rpm. So that, the duration of ALT examination can be faster, reduces Turnaround Time (TAT) or patient waiting time, and saves electrical energy which can reduce the variable cost. Method : This research was a pre-experimental study with Static Group Comparison research design. The examination used IFCC without pyridoxal method. The subjects of research were 22 people. Samples were serum of blood that were frozen for 30 minutes then centrifuged at 3000 rpm for 5 minutes and 4400 rpm for 3 minutes. Samples were examined using A15 biosystem instrument. Data were analyzed by Wilcoxon test. Result : The results showed mean value of ALT centrifuged at 3000 rpm for 5 minutes was 16,32 U/L and 4400 rpm for 3 minutes was 16,50 U/L. Based on Wilcoxon test, there was no difference in ALT level from centrifuged blood samples at 3000 rpm for 5 minutes and 4400 rpm for 3 minutes, p-value (sig) = 0.676 with a significant level (α = 0.05) then p-value (sig. 2 tailed) > 0.025. Conclusion : There was no difference in ALT level in serum from blood that was centrifuged at 3000 rpm for 5 minutes and 4400 rpm for 3 minutes

Contribution of EQA to improve Preanalytical practices by systematic verification of Laboratory Services

International literature describes the preanalytical phase as the most susceptible to errors due to the numerous non automated activities it involves Most EQA organizers offer preanalytical schemes to participants. There are basically three types of surveys procedures registration, samples circulation and errors registration The Portuguese EQA Programme ( provides these type of schemes for 13 years, using as a guide the ISO 15189 2012 In order to improve the evaluation of the preanalytical phase, PNAEQ recently launched two other preanalytical EQA schemes, mystery client and presential audits in 2015 and 2016 respectively. The aim of the mystery client survey is to verify whether the information provided to the patient is constant regardless the day and time or if it is dependent on the collaborator. The aim of the presential audit survey is to give the participants a tool to verify if the procedures performed daily are in accordance with laboratorial good practices recommendations. Conclusions: Results from Mystery Client surveys demonstrate the need for written procedures and harmonization of practices for all collaborators, as more than a third of the responses differed in date/time and operator in a global view. In the Presential Audit surveys we highlight as critical points the results regarding questions 3 5 and 6 as they point to specific problems that occurred during the blood collection procedure, such as operator and patient safety, as well as the quality of the sample collected, suggesting the need to review legal and normative issues and to train collaborators. Participants who use systematically these two methodologies are monitoring some of the requirements of ISO 15189:2012, namely 4. 1.2.6, 4.3, 4.4.1, 4.14, 5.4.2 (both), 5.4.4.2 (mystery client) and 5.1.2, 5.2.2, 5.2.5, 5.3.2.5, 5.3.2.7, 5.4.4 (presential audit), contributing to release reliable results for medical decisions. For the future, we will extend the questions and items in evaluation in these two surveys to Microbiology area and continuing to offer training in Preanalytical matters.N/

Patient and Sample Identification. out of the Maze?

Background: Patient and sample misidentification may cause significant harm or discomfort to the patients, especially when incorrect data is used for performing specific healthcare activities. It is hence obvious that efficient and quality care can only start from accurate patient identification. There are many opportunities for misidentification in healthcare and laboratory medicine, including homonymy, incorrect patient registration, reliance on wrong patient data, mistakes in order entry, collection of biological specimens from wrong patients, inappropriate sample labeling and inaccurate entry or erroneous transmission of test results through the laboratory information system. Many ongoing efforts are made to prevent this important healthcare problem, entailing streamlined strategies for identifying patients throughout the healthcare industry by means of traditional and innovative identifiers, as well as using technologic tools that may enhance both the quality and efficiency of blood tubes labeling. The aim of this article is to provide an overview about the liability of identification errors in healthcare, thus providing a pragmatic approach for diverging the so-called patient identification crisis