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Year : 2016  |  Volume : 4  |  Issue : 1  |  Page : 70-85

Proceedings of the 1st Annual Conference of the Saudi Society for Clinical Chemistry

Date of Web Publication13-Jan-2016

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How to cite this article:
. Proceedings of the 1st Annual Conference of the Saudi Society for Clinical Chemistry. J Health Spec 2016;4:70-85

How to cite this URL:
. Proceedings of the 1st Annual Conference of the Saudi Society for Clinical Chemistry. J Health Spec [serial online] 2016 [cited 2021 Jan 23];4:70-85. Available from: https://www.thejhs.org/text.asp?2016/4/1/70/173847

5-6 December, 2015 - Riyadh, Saudi Arabia

  Oral Presentation Abstracts Top

  Electronic Laboratory Critical Value Notification Top

Abdulmohsen Alsaawi

Department of Emergency Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia

E-mail: [email protected]

The project takes place at King Abdulaziz Medical City (KAMC) in Riyadh, a JCI-accredited healthcare system with 1000 beds, 500,000 annual outpatient visits, and 1.5 million active files. KAMC provides all levels of healthcare from primary to tertiary. The annual sample volume at the laboratory and pathology department exceeded 22 million samples in 2013. The project aims to improve the communication of outpatient critical laboratory values “CLVs”. The existing communication process was complex and performance was unsatisfactory. In 2012, an average of 200 outpatient CLVs were communicated per month, the average communication time was 25 minutes, which exceeds the communication time stated in our policy as 15 minutes. Additionally, the outlier rate (communication times exceeding 15 minutes) was 52% and the failure rate (CLVs which has not been communicated at all) was 5%.

Process observations, root-cause analysis of cases of delayed or failed communication and communications with frontline staff has helped us identify multiple improvement areas mainly existing communication process maps, results communication method, and the lack of a sustainable monitoring and evaluation system. We have also identified multiple non-value added steps and processes that contribute to delay.

  ISO 15189 – Requirements for Medical Laboratories Top

Siham Alzaid

Department of Pathology, King Abdulaziz Medical City, National Guard, Riyadh, Saudi Arabia

E-mail: [email protected]

Introduction: International Organization for Standardization (ISO) develop and publish International Standards to ensure that products and services are safe. ISO International Standards provide practical tools for tackling many of today's global challenges.

SCOPE: ISO 15189 which is based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories.

Purpose: It is to be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Preparation: The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. I Electronic Laboratory Critical Value nternational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Since its first publication in 2003, It has been recognized officially by the International Laboratory Accreditation Cooperation (ILAC) to be used as the international standard for the accreditation of medical laboratories worldwide BUT not Certification.

  Quality Application in Multicenter Study to Establish Common Reference Intervals for Saudi Population Top

Anwar Borai1, Kiyoshi Ichihara2, Abdulaziz Masoud3, Waleed Tamimi4, Suhad Bahijri5, David Armbuster6, Ali Bawazeer1, Mustafa Nawajha1, Nawaf Otaibi4, Haitham Khalil1, Reo Kawano2, Ibrahim Kaddam1, Mohamed Abdelaal1

1Department of Pathology, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia, 2Department of Pathology, Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine, Ube, Japan, 3Department of Pathology, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Hassa, Saudi Arabia, 4Department of Pathology, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia, 5Department of Clinical Biochemistry, Faculty of Medicine, King Abdulaziz University, Riyadh, Saudi Arabia, 6Global Scientific Affairs, Abbott Diagnostics, Chicago, Illinois, USA

E-mail: [email protected]

Objectives: This study is a part of the International Federation of Clinical Chemistry multicenter study formed to derive reference intervals (RIs) for chemistry and immunoassay analytes in Saudis by using updated methodologies in data analysis and technical procedures.

Methods: Inclusion and exclusion criteria were adopted from the common multicenter protocol. The recruited subjects were 826 healthy adults aged ≥18 years. 28 analytes were measured chemically and 20 immunologically. RIs were derived by parametric and nonparametric methods. The latent abnormal values exclusion (LAVE) method was applied. Sources of variations such as: age, body mass index (BMI), physical exercise and smoking levels were investigated by using the multiple regression analysis. A serum panel with assigned values was measured for the purpose of RIs alignment with other participating countries.

Results: Standard deviation ratios for gender, age and regional differences were significant for 14, 8 and 2 chemistry and for 12, 13 and 1 immunoassay analytes respectively. BMI-related changes in test results were noted conspicuously for C-reactive protein, insulin and C-peptide. For some metabolic related parameters the ranges of RIs, by non-parametric method, were wider than by the parametric method and the RIs derived using the LAVE method were significantly different than those without it. RIs were derived with and without gender partition (BMI, drugs and supplements were considered).

Conclusion: By using an updated quality of procedures, RIs applicable to Saudis were established for the majority of chemistry and immunoassay analytes. Gender, regional and age RI partitioning was required for some analytes. The elevated upper limits of metabolic analytes reflected the existence of high prevalence of metabolic syndrome in Saudi population.

  The Value of Utilization Management in Clinical Laboratory Sciences Top

Amal Saadallah

Section Head, Newborn Screening & Biochemical Genetics Laboratory, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Healthcare expenditures increase absolutely and relative to the national income. In Saudi Arabia, spending on health has increased by 26% since 2010. Part of the 9th National Saudi Development Plan (2010-2014) was to implement policies that would rationalize spending and ensure optimal use of resources. Even though clinical laboratory comprises about 4% of the hospital's budget the downstream costs, both appropriate and inappropriate, are substantial because laboratory tests impact 60 to 70% of medical decisions.

Inappropriate laboratory utilization received attention due to the increased pressure to reduce healthcare spending in many developed countries. Hospitals have hence highlighted the fact that opportunity to reduce utilization of laboratory services exists by monitoring variation in test ordering patterns between healthcare practices.

Utilization programs are a growing part of changing the culture of laboratory medicine from volume practicing to value practicing. Successful utilization management programs recruit institutional champions both for the overall utilization management program and for ad hoc assistance with specific utilization challenges. It is important that these individuals represent a cross-section of laboratory and clinical specialties that are organized as a committee established by the administrative and physician leadership of the organization.

In more specific terms, the goals of a laboratory utilization program is to employ utilization management techniques: 1) to curb use of tests and laboratory products (e.g. blood products) that are over-utilized, 2) increase use of tests and products that are under-utilized, and 3) to correct misuse of tests and products that are ordered incorrectly, at the wrong time, on the wrong patient, or at the wrong frequency.

In brief, the following points shall also be discussed:

  • Description of healthcare utilization management detailing the goals of laboratory utilization management
  • List toolbox for laboratory utilization management tactics with examples of their implementation
  • Using evidence based laboratory medicine (EBLM) as part of laboratory utilization management.

  Total Lab Automation Top

Rana Hasanato

Department of Pathology, College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

Total lab automation (TLA) is a system of laboratory instruments under a unified control that requires little or no human intervention at any stage of the process. It links and integrate instruments from different laboratory sections such as Chemistry, Microbiology, Hematology and Immunology, in one testing module based on high volume testing order. The aim is to provide cost-effective, high quality results in a timely manner. The great advantages are that it is operationally efficient by improving flow and optimizing resources and is scalable to meet planned demand in the future. It improves the workflow efficiency by reducing manual test steps; hence, the laboratory can increase the total workload with the same number of staff. This minimizes human error also. Automation gives the staff more time to devote to trouble-shooting critical cases, to develop new assays and special techniques. It not only reduces the total turnaround time (TAT), but also makes the tests 24/7 available. This enhances the patient care and can also possibly reduce the overall duration a patient stays in the hospital. Other benefits include reduced space requirement, consumables, hazardous waste and online sample storage and retrieval. TLA is cost-effective as it is based upon 'Guaranteed Price Per Reportable Result (GPPRR)'. The hospital pays the vendor company for only the number of laboratory test results released by the laboratory to the clinicians for patient management. To sum up, TLA combines the next generation of new technologies to improve the laboratory's capabilities in providing the best possible patient care long into the future.

  Implementing Total Laboratory Automation: a Story of Success Top

Huda M Hassan

Clinical Scientist & Technical Director, Department of Pathology & Laboratory Medicine, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: The Department of Pathology and Laboratory Medicine (DPLM) in King Faisal Specialist Hospital and Research Center (KFSH&RC) has accomplished the project of launching a 'Total Laboratory Automation (TLA)', that consolidates several clinical laboratories' services under one core lab, the DPLM. Validation data was processed using the statispro method evaluation software from Clinical and Laboratory Standards Institute (CLSI) to evaluate the performance of the new equipments and analytical methods by comparing the analytical errors with the allowable errors of analyte being tested. The TLA system allowed consolidation of four blood collection tubes into one. TLA project included preanalytical, analytical and post analytical phases which made it a unique project worldwide. TLA project involved multidisciplinary teams from inside and outside the hospital and various educational and training sessions were conducted throughout and at the conclusion of the project.

Aims: To improve patient care through accuracy, consistency of laboratory results, improve turnaround time (TAT), improve efficiency, accommodate future growth of tests volume, improve satisfaction of physicians and lab personnel as well as reduce number of 'STAT' samples.

Conclusion: Implementation of TLA was not limited to consolidation of several clinical laboratories' services under one core lab; it improved safety for patients through accuracy, consistency of laboratory results by allowing the use of CLSI validation software to evaluate and verify the performance of the analytical systems and methods. It also improved patient satisfaction as less blood is collected from the patient while it allows conducting blood collection tube consolidations project. TLA project improved technical staff satisfaction due to automation, reliability of the system and improved efficiency with less turnaround time (TAT). It also demonstrated high-quality standards by adhering to the accreditation standards of the College of American Pathologists (CAP) and CLSI total quality management guidelines.

  Quality Control Data Management Top

Mohammad Qaderi

Bio-Rad Laboratories, UAE

E-mail: [email protected]

Since quality control is an essential part of daily laboratory practice, it is important to analyze the data that we have from running the controls every day. This practice requires a lot of effort and time to do statistics and retrieve data from each instrument.

Now many quality control requirements are mandatory by accreditating bodies in order to calculate the error effect on patient result and whether the released result should be recalled or not. Not only that, it is also used to evaluate the in use method performance and trueness and cross lot variation.

To be able to provide this amount of data and calculation, a good reliable tool is needed to reduce the amount of manual work and provide a solid statistic performance.

  Copeptin: a New Biomarker in the Cardiovascular Field Top

Mohamed A Habbab

Senior Consultant Cardiologist & Electrophysiologist, Director of Clinical Audit & Effectiveness Department, Prince Sultan Cardiac Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Arginine vasopressin (AVP), also termed antidiuretic hormone (ADH), is a hormone that plays a major role in the regulation of the endogenous stress response and is one of the key hormones for cardiovascular homeostasis. It is present at elevated levels in myocardial infarction, heart failure and different states of shock. Despite its pivotal role in cardiovascular disease, the measurement and diagnostic use of AVP have never reached clinical practicability, due to considerable technical challenges related to AVP's short plasma half-life, interaction with platelets in the serum, and small size. Copeptin is a stable fragment of the AVP precursor. Physiologically, it contributes to the correct structural formation of AVP prior to release into the circulation. The measurement of copeptin appears to be a clinically relevant method for reliably assessing AVP plasma concentrations, which cannot be determined in routine practice. This would be particularly helpful in diseases where disturbances of the vasopressinergic system contribute to or are the immediate result of the pathogenesis. Accordingly, Copeptin is viewed as a general marker of stress. Recently, it was shown that it can be used in combination with cardiac Troponin to improve the speed of diagnosing or ruling out myocardial infarction. Also, its increased levels were found to be associated with increased frequencies of typical co-morbidities of heart failure, increased severity of heart failure, and increased risk of all-cause death. Therefore, measurement of copeptin may improve the management of patients with cardiovascular diseases. In addition, the nonosmotic release of AVP depicted by a sharp increase in plasma copeptin, in severe diseases or states, such as shock, sepsis or stroke can have diagnostic and prognostic value in such conditions.

  Healthcare Changes! Are We Prepared for the Future? Top

Liane Bauer

Enterprise Solutions Director, Africa, Middle East & Turkey, Abbott Diagnostics, Germany

E-mail: [email protected]

It has never been a more challenging and yet exciting time to work in healthcare as demand, macroeconomics and healthcare systems are changing: growing and ageing population, shift from communicable to chronic diseases and recent economic pressures. Healthcare is at a crossroad - the intersection between intensifying budget constraints and ever-increasing demands for higher quality and improved access by consumers.

Given the laboratory's role in the healthcare ecosystem, in the management of patients throughout the healthcare sector, it is in an excellent position to support the sustainability of its institutions and even entire health systems.

Pathology services need to choose to adapt to this transforming environment, understanding the complex interdependencies of pathology with other departments to identify where additional value can be generated: when each piece works together seamlessly, both quality and efficiency are increased. Integrated pathway thinking is needed to ensure faster diagnosis to shorten the length of stay and the time to treatment for our patients.

In almost every other industry, technology makes things better and cheaper. One exception is in healthcare. Technology alone does not comprehend interdependencies and interrelations across all ecosystems. Pathology needs to seek value creating innovation including people, processes, strategy and technology, which will allow the development of a long term-plan which drives down costs while increasing quality and access, and thus improve our patient's lives.

  New Renal Biomarkers Top

Ibrahim El-Maghawry

Ministry of Health, Riyadh, Saudi Arabia

E-mail: [email protected]

Kidney function tests can be categorized according to the diagnostic purpose as follows:

  1. Glomerular function tests
    • Blood urea: Urea is the end product of protein metabolism.
    • Plasma creatinine: Creatinine (creatine anhydride) is the end product of creatine metabolism.
    • Creatinine clearance: This is the practical and most convenient method of obtaining an acceptable accurate estimation of glomerular filtration rate (GFR). The test has particular value in the general assessment of renal function especially when plasma analysis is invalid e.g. after renal dialysis.
  2. Tubular function tests
    • Plasma electrolytes and minerals: used in assessing the tubular function of the kidney.
    • Measurement of urine specific gravity: reflects the renal concentrating mechanism.
    • Measurement of urine osmolality: used to assess concentrating ability of the kidney.
    • Urine concentration test (Water deprivation test): This is a test for renal concentration ability.
    • Vasopressin test (Pitressin test): This is more pleasant than water deprivation test.
    • Urine dilution test (Water load test): Less sensitive than water deprivation test.
  3. Special function tests
    • Urinary Microalbumin: Elevated concentrations (30 to 300 mg/L) on at least two occasions.
    • Cystatin C: Cystatin C has a low molecular weight (~13.3 KDs). Due to its small size it is freely filtered by the glomerulus, and is not secreted but is fully reabsorbed and broken down by the renal tubules. It is an alternative and more sensitive endogenous marker for the estimation of GFR than serum creatinine and serum creatinine based GFR estimations.
    • Neutrophil gelatinase-associated lipocalin (NGAL): NGAL is a protein of a small molecular weight (25 kD). It is a promising biomarker for early detection of acute kidney injury (AKI). It is specifically released by the damaged kidney and can be detected in both urine and plasma.
    • Urinary Biomarkers IGFBP-7 and TIMP-2: A recent multicenter international investigation reported the discovery and validation of two G1 cell-cycle arrest biomarkers (CCABs), tissue inhibitor of metalloproteinases (TIMP-2) and insulin-like growth factor binding protein (IGFBP-7). Urinary [TIMP-2]×[IGFBP7] test sufficiently detects patients with risk of AKI after cardiac and major non-cardiac surgery. Due to its rapid responsiveness it extends the time frame for intervention to prevent development of AKI.

  Advances in Graves' Disease Diagnosis With TSI Testing Top

Paul EC Sibley

Associate Director, Global Commercial Assay Marketing, Siemens Healthcare Laboratory Diagnostics

E-mail: [email protected]

Graves' disease is an autoimmune disease characterized by hyperthyroidism due to circulating thyroid-stimulating immunoglobulins (TSIs). TSIs bind to and activate thyrotropin receptors, causing the thyroid gland to grow and the thyroid follicles to increase synthesis of thyroid hormone. Prompt diagnosis and treatment of Graves' disease can result in a good prognosis, and even a cure in some cases. A new test for TSI has recently been made available on the IMMULITE platform, which detects only the stimulating antibodies. Characteristics of the new assay will be presented as well as the performance. Clinicians can have reassurance of an accurate Graves' disease diagnosis with the TSI test and the proper treatment can be initiated and monitored with more confidence.

  The Utility of Freelite and Hevylite in the Diagnosis, Prognosis and Monitoring of Multiple Myeloma Top

James Last

The Binding Site Group, UK

E-mail: [email protected]

Monoclonal free light chains (FLC) are important disease biomarkers in patients with plasma cell proliferative disorders. The increasing evidence for clonal diversity and evolution in multiple myeloma highlights the importance of laboratory algorithms that measure both intact immunoglobulins and monoclonal FLC, both at diagnosis and when monitoring response to treatment.

Freelite is a latex-enhanced immunoassay that provides an independent measurement of serum κ and λ FLC. The calculation of a κ/λ serum FLC ratio provides a sensitive numerical indicator of clonality. Freelite was developed using polyclonal antibodies to detect the diverse variety of pathological monoclonal FLC produced by patients with monoclonal gammopathies. Hevylite immunoassays quantify different light chain types of each immunoglobulin class (i.e. IgGκ, IgGλ, IgAκ, IgAλ, IgMκ and IgMλ), which are measured in pairs (e.g. IgAκ/IgAλ) to produce ratios of involved immunoglobulin to background uninvolved immunoglobulin, similar to FLC κ/λ ratios.

The introduction of serum FLC immunoassays has impacted on laboratory practice for the management of monoclonal gammopathies. Recently an involved/uninvolved sFLC ratio · 100 (iFLC · 100 mg/L) has been included as part of the IMWG diagnostic criteria for MM patients without evidence of end organ damage. The clinical utility of these immunoassays at diagnosis, for patient monitoring and for prognosis has been acknowledged in guidelines published by the International Myeloma Working Group (IMWG). These consensus guidelines recommend serum FLC assessment in combination with serum protein electrophoresis (SPE) at diagnosis of clonal plasma cell disorders. This simple serum-based algorithm at diagnosis negates the need for 24 hour urine studies for diagnoses other than light chain amyloidosis. Serum FLC measurement should be routinely performed during the monitoring of AL amyloidosis, oligosecretory multiple myeloma and light chain deposition disease with periodic measurement for the detection of light chain escape. Furthermore, the uniform response criteria also define a stringent complete response (sCR) as requiring a normal serum FLC ratio.

Recently, novel Hevylite immunoassays have been developed for the quantification of intact immunoglobulins. Accurate quantification of monoclonal immunoglobulins by SPE can be difficult due to co-migration with other serum proteins, and can impact the assessment of patient responses. Total immunoglobulin quantification may be used; however, it does not distinguish between monoclonal and polyclonal immunoglobulins. Hevylite analysis provides an alternative, sensitive method of identifying and quantifying monoclonal immunoglobulins in patients, irrespective of co-migration. Hevylite immunoassays also allow quantitation of uninvolved polyclonal immunoglobulins of the same isotype as the monoclonal immunoglobulin (HLC-pair), offering unique insights into tumour biology.

The incorporation of serum FLC immunoassays into diagnostic, prognostic and monitoring algorithms for plasma cell disorders has led to a paradigm shift in the understanding of these diseases. The introduction of the novel Hevylite immunoassays, which allows the quantification of immunoglobulins by isotype–specific light chains, may add to this understanding.

  High-Sensitivity Troponin I: Interpretations, Analytical Implications & Clinical Applications Top

Salam M Saadeddin

Principal Scientist, Division of Clinical Chemistry, Central Military Laboratory & Blood Bank, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Previous-generation troponin assays have been used as diagnostic and prognostic markers in acute coronary syndrome patients and for risk stratification to guide triage decisions and aid in treatment selection. New high-sensitivity cardiac troponin (hs-cTn) assays are increasingly being used in many countries worldwide. These assays enable cTn measurement with a high degree of analytical sensitivity with a low analytical imprecision at the low measuring range of cTn assays (coefficient of variation of < 10% at the 99th percentile upper reference limit). They represent an important advance with added sensitivity for cardiac myocyte necrosis, but there remains a need for judicious interpretation with these tests. These new troponin assays could have several distinct roles in clinical practice: (1) facilitation of earlier diagnosis and rule out of myocardial infarction; (2) risk stratification in acute cardiac conditions and prognostic information in stable disease states; and (3) therapeutic monitoring and drug toxicity evaluation. However, because they are not specific for the etiology of cardiac cell death, the clinician has an increasing responsibility to interpret each test in clinical context. These high-sensitivity analyses are expected to offer both advantages and disadvantages to practicing clinicians and to enhance current roles of the troponin assay as well as to open doors to new uses for troponin testing. However, they will also create new challenges in clinical applications, epidemiology, and research.

  Anti-Müllerian Hormone & Ovarian Reserve Top

Saad Baher El Badawi

Laboratory Director Erfan & Bagedo Hospitals, Jeddah, Saudi Arabia

E-mail: [email protected]

Objectives: Understand ovarian reserve, anti-müllerian hormone (AMH) biochemistry and its role in assisted reproductive technology together with its role in individualization of ovarian stimulation. Moreover, understand the potential of using AMH in patients with polycystic ovarian syndrome (PCOS).

AMH is a glycoprotein that belongs to the transforming growth factors family (TGF-β).

Methodology: AMH plays a fundamental role in the regression of müllerian ducts in male embryos. In females, AMH is secreted by granulosa cells of small follicles in the ovary. Serum values are almost undetectable during infancy but then rapidly increase with the onset of puberty, reflecting the initial recruitment of primordial follicles. Measuring AMH serum levels during a woman's reproductive life represents an ideal tool for assessing the ovarian follicular reserve. It correlates with antral follicular count (AFC) visualized by ultrasound of the ovary. As the number and quality of the oocytes diminish throughout the woman's reproductive life, serum concentration of AMH gradually decrease and fall below detectable levels in menopause.

Conclusion: Technical advances in the measurements of AMH has been achieved. The role of AMH in assisted reproductive technology (IVF) has gained great popularity. AMH has proved to be a predictor of both over and poor responders in controlled ovarian stimulation with lower cancellation cycles and lesser ovarian hyper stimulation syndrome. Recently, its role in the individualization of appropriate stimulation regimens in IVF has been recognized. The emerging role of AMH in the diagnosis of PCOS, predicting the age of menopause and predicting ovarian reserve following chemotherapy is discussed.

  Monitoring Liver Transplantation With Innovative Assays (Elf and Tacrolimus) Top

Paul E.C. Sibley, PhD

Associate Director, Global Commercial Assay Marketing, Siemens Healthcare Laboratory Diagnostics

E-mail: [email protected]

Chronic liver disease (CLD) is a major problem worldwide with more than 1 billion people at risk of this disease. Diagnosis of liver fibrosis is often made through biopsy, although there are limitations to this procedure. A simple blood test has been developed to detect enhanced liver fibrosis (ELF) differentiating between stages of fibrosis and cirrhosis. Changing values over time are associated with changes in fibrosis. Extensive studies have been reported showing the value of this test. In the event of liver transplantation, immunosuppressant drugs are used to prevent graft rejection. A new, sensitive tacrolimus assay has been developed on Dimension clinical chemistry systems as an aid in the management of tacrolimus therapy in both liver and kidney transplant patients. Characteristics of this new assay and its performance will be discussed.

  Point of Care Testing New Technology Generation Top

Najwa Awad Adlan

King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

E-mail: [email protected]

Point of care testing (POCT) can be defined as any laboratory testing done outside the official hospital laboratories. It is most likely that these kinds of tests performed at the patient's bedside. In a unique way, it revolutionizes the way clinical laboratory routine services are operated. It thrives on improving patient outcome by eliminating many pre-analytical, analytical and post-analytical steps to improve the turnaround time of the results remarkably. Improving turnaround time will impact positively the patient care through the fast clinical decision and/or therapeutic intervention. Thus, the patient care, satisfaction, and physician efficiency will be improved. Add to the above the cost effectiveness of the testing that is a desirable managerial benefit.

POCT is perceived to have a growth in the global market from $13.8 billion in 2011 to $16.5 billion in 2016, according to a new report Point-of-Care Diagnostics from BCC Research. And will reach $34.6bn by 2021 according to a report by Visiongain, a London-based business information provider. Such financial prospect has its effect on endorsing bigger responsibility on the health providers to ensure quality over profitability. As it delivers those uncontested benefits to patient care services, it, also, comes with its challenges. When establishing POCT service in an organization, it is important to include all stakeholders in decision-making on how to manage the program that will make the change management executed smoothly. Solid POCT program has to have a scope, not only for improvement, but also for adaptation for changes and evolving challenges such as expanding the testing menu, changes in regulations requirements and immerging technologies in instrumentations and informatics. Many factors are driving the force for innovation and technology in POCT. However, one of the major drivers are the shift in healthcare from disease incidents to chronic health incidents as a result of changing lifestyles, rising life expectancy, increasing educated population and the need in remote locations were conventional laboratory is not available. The evolving healthcare approach towards centered and individualized patient care gave a solid opportunity for driving the innovation of point of care, besides economic factors and the cost effectiveness demands.

The future of innovation in point of care technology is progressing very fast towards novel technologies like cellphone-based technologies, lab-on-a-chip (LOC) technologies. The industry will continue moving towards meeting demands in technologies which supports quality, patient safety and meet regulatory aspects including automation, reagent stabilization and storage and ease of use that is an important factor as the result will mean nothing without quality.

With the strongly growing field supported by many evidence-based practices, the application of POCT will play a vital role in healthcare decentralization.

  Establishment of Poct at King Khalid University Hospital Top

Rana Hasanato

Department of Pathology, College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

The point of care testing (POCT) program at King Khalid University Hospital (KKUH) was launched five years ago in 2010 with the formation of the POCT committee. The POCT committee was established to provide oversight supervision and guidance in the implementation process. The committee determines the actual patient care needs for POCT and identifies 'best practices' and 'recognized standards', and adapts these for use at KKUH.

POCT testing was established first in the ICU with the creation of purchasing orders, complete inventory check, quality control monitoring, and establishment of operating guidelines.

By the end of 2010, POCT was established in the Critical Care Department, HDU, Radiology, Diabetes Center, and in the Cardiac and Surgical Operating theaters.

In 2011, the POCT program expanded to more sites. The hospital introduced 150 glucose meters to be put into services after end-users have been trained by the POCT department. By the end of 2011, Internal Policies and Procedures (IPP) for each of the POCT devices in all existing POCT sites were prepared and placed alongside the devices.

In 2012, and after only one and half year of its existence, the POCT program attained the College of American Pathologist (CAP) accreditation which was a great accomplishment credited to the hard work and dedication of all of those who were involved.

During its first years, the POCT program managed to train 600 end-users on blood gas analyzers, 500 end-users on coagulation analyzers, and 70 end-users were trained on creatinine analyzer.

The POCT program today is a well-established asset to KKUH. It continues to provide proper training and competency assessment of POCT end-users, inventory oversight, safety guidance, proper instrumentation selection, maintenance, internal and external quality control, and documentation.

  Point of Care Blood Glucose Meter “new FDA Guidance” Top

Sultan Mohammed Alouffi

Medical Lab Consultant & Assistant Professor (Clinical Chemistry), Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, University of Hail, Saudi Arabia

E-mail: [email protected]com

Blood glucose monitoring systems are used widely by people with diabetes to monitor and manage their blood glucose levels to prevent or delay complications associated with poor glycaemic control.

However, recently there have been reports about high rates of adverse patient events, including deaths, linked to the hospital use of glucose meters cleared for self-testing use. Consequently, the Food and Drug Administration (FDA) recognized the need for more accuracy and better performance standards for point-of-care glucose testing in hospitals, particularly in intensive care settings.

The FDA published two draft guidances on January 2014. One is called Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and the other is called Self- Monitoring Blood Glucose Test Systems for Over-the-Counter Use. This is a new distinction between glucose meters need for self-monitoring at home and those meters used in a clinical setting by healthcare professionals.

The FDA calls for higher manufacturer standards for hospital glucose meters, such that 99% of all blood glucose values ≥ 3.9 mmol/L will be within ±10% of the reference value and the other 1% must not exceed ±20%, while 99% of blood glucose less than 3.9 mmol/L need to be within ±0.4 mmol/L of the reference value and the other 1% cannot exceed ±0.8 mmol/L.

Moreover, for those hospitals now using glucose meters on the 'critically ill', that use would now be considered 'off-label'- which automatically makes the device no longer waived, but highly complex, therefore, subject to a very higher standard of validation and personnel qualifications.

  HBA1C Testing, the Benefits and Limitations Top

Mohammad Qaderi

Bio-Rad Laboratories, UAE

E-mail: [email protected]

Starting from total glycated hemoglobin in the beginning of the 1990s to HbA1c nowadays, these tests have emerged to replace conventional routine tests for diagnoses and prognosis of diabetic patients.

Since the HbA1c is evaluating the condition of the patient for a longer period of time than the fasting and random blood glucose, the HbA1c became the preferred test for both the physicians and the patients as well. The glucose tolerance test is not anymore a preferred test to diagnose diabetes or to check the susceptibility for the patient to have diabetes in the future as the HbA1c is less time consuming and a hassle free test.

Although the HbA1c is the test of choice, it is important for the lab to know the benefits from performing the test and most importantly the limitation of the test in general and when to use a specific method. This way the laboratory will report reliable result and improve the patient care.

  The Epidemiology of Vitamin D Deficiency Top

Hoda Jradi

King Saud Bin Abdulaziz University for Health Sciences

E-mail: [email protected]

Vitamin D deficiency is a major health issue affecting 30 to 50% of the world population. In middle-eastern countries, up to 80% of apparently healthy individuals have suboptimal vitamin D levels. In Saudi Arabia, prevalence is estimated at 30 -50% among women and 28-37% among men. Trends of vitamin D deficiency in Saudi Arabia are indicative of increase and ascending with age with potentially severe consequences for overall health.

Older age, female gender, higher latitude, winter season, darker skin pigmentation, limited sun exposure due to cultural practices and limited outdoor activities, dietary habits, prolonged breastfeeding, low intake of vitamin D supplementation are factors significantly associated with low vitamin D levels.

Evidence suggests an association between vitamin D insufficiency and deficiency with the leading causes of death and disability in Saudi Arabia such as cardiovascular diseases, obesity, insulin resistance, hypertension, and depression.

Prevention requires a coordinated approach to improve knowledge among healthcare practitioners and the community about screening and supplementation, promote lifestyle modifications, and foster policies that mandate food fortification and improve access to nutrition related health services.

  Vitamin D Deficiency: a Risk for Multiple Chronic Diseases Top

Yousef Mohammad

College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

Vitamin D deficiency is highly prevalent world-wide and is estimated at 25-30% in North America and Europe. The prevalence in Saudi Arabia is even three times that of the western community, approaching 80%. Lack of sun exposure and poor diet is behind the soaring rates of vitamin D deficiency in the Saudi population.

Vitamin D receptors are identified not only in skeletal tissues but non-skeletal ones as well. It is an essential factor for the structure and function of almost all the organs of the human body. Accordingly, the deficiency of vitamin D has been associated with a myriad of medical disorders including diabetes mellitus, cardiac diseases, Alzheimer, cancer, stroke, Parkinson disease, and multiple sclerosis. Furthermore, it has been linked to increased mortality.

Auspiciously, the treatment of vitamin D is simple and the awareness of this problem among the healthcare professionals has been quite adequate, especially in the areas where the prevalence is extremely high.

Currently, researchers are assessing the efficacy of vitamin D supplements in the treatment of various chronic diseases. In fact, multiple randomized clinical trials are ongoing.

  Vitamin D Quantification Top

Sobhy Yakout

College of Science, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

Recently several diagnostic manufacturers have launched a new 25-hydroxy-vitamin D (25[OH]D) assays. All these assays are used in both clinical and research settings but it is not widely appreciated that 25(OH) D assays may yield discrepant results. Inter-assay and laboratory disagreement could contribute to uncertainty when comparing results from studies investigating the prevalence or clinical consequence of vitamin D insufficiency. Several studies have indicated high variability between different assays as well as inter- laboratory disagreement. This 25(OH) D Assay variations will impact clinical decision making. Labs must carefully validate their assay of choice and make implementation. The aim of this lecture was to compare the performance of either chromatographic or immunoassay-based assays. This review of methods considers that total 25-hydroxy-vitamin D is the recommended test for vitamin D status and compares methods from published studies and recent findings to solve this issue.

  Low ALP Matters: Is Your Laboratory Looking in Both Directions? Top

Ahmed Eltayb

Alexion Pharma Middle East, Dubai, UAE

E-mail: [email protected]

Around 70% of medical decisions are based on data from laboratory reports. Alkaline phosphatase reference ranges are profoundly influenced by physiology, particularly age and gender. Children are not simply small adults, yet adult ranges are often inappropriately applied to them, which can lead to delayed or erroneous diagnoses. Hypophosphatasia (HPP) is a life-threatening, progressive, systemic, inherited metabolic disorder caused by loss-of-function mutations in the ALPL gene, which encodes the tissue nonspecific alkaline phosphatase enzyme (TNALP). The hallmark of HPP diagnoses is low-age and gender adjusted alkaline phosphatase. Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) study is addressing gaps in pediatric reference ranges including in Arab ethnic population. Implementation of alkaline phosphatase reference ranges reported in the CALIPER study is critical for accurate interpretation of ALP laboratory results and could help in diagnosing devastating diseases like HPP.

  Improving Clinical Laboratory Efficiency Through Automation & IT Top

Sepehr Seyedzadeh

Director, Portfolio Strategy Management, Automation & Diagnostics IT Siemens Healthcare Diagnostics, Inc., USA

E-mail: [email protected]

The global mega trends surrounding us are transforming the healthcare industry. Urbanization, demographic changes and growth in aging population along with global economic challenges are more than ever pressuring labs to do more with less.

The impacts of these trends are visible in our industry. Labs are consolidating and their testing volumes are growing, while at the same time, the government reimbursements are shrinking. Moreover, labs are also challenged with the shrinking clinical lab workforce. Our customers tell us that despite having well- trained and hardworking staff, in order to stay competitive, they need innovative solutions to help them achieve highest patient outcomes with lowest costs.

In this session, we will analyze the process in the clinical laboratory and identify areas of improvement. We will discuss how automation and diagnostics IT solutions can help increase process efficiencies while at the same time reduce errors. Examples of automation capabilities available in the market from pre- analytical phase to post-analytical phases will be shown. We will also discuss industry trends in the world of Healthcare IT, and provide examples of how IT systems can help labs do more with less.

  Poster Presentation Abstracts Top

  A Study on HBA1C and FPG for the Diagnosis of Diabetes Mellitus Top

Khalid S Al Grooni

Central Military Laboratory & Blood Bank, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: Glycated hemoglobin (HbA1c ≥ 6.5%) has been recommended by the American Diabetic Association as an alternate criterion to fasting plasma glucose (FPG ≥ 7.0 mmol/L) for the diagnosis of diabetes mellitus. Studies from different groups showed inconsistent results; hence, the validation of HbA1c criteria has not yet been established.

Methods: The validity of the HbA1c cut-point of 6.5% for the diagnosis of diabetes mellitus on Saudi patients with FPG of ≥7.0 mmol/L, was the focus of the study. Analysis was done on 13,668 male patients, aged 55.45 ± 14.31 years after 8 hrs. of fasting.

Results: The average values of FPG from all of the 13,668 patients were 10.535 +/- 0.030 mmol/L; while for HbA1c, values were 8.934 +/- 0.014 %. There was a significant correlation between FPG and HbA1c (R = 0.596, P < 0.001). A total of 488 patients were below the diagnostic threshold (HbA1c < 6.5%) giving 3.57 % false negative predictions. Majority of the false-negative patients belong in the 40 to 75 age bracket, and had borderline results for both FPG (7.0 - 8.0 mmol/L) and HbA1c (6.0 - 6.5%). These patients belong to the “at-risk” category on the basis of HbA1c alone.

Conclusion: The cut-point 6.5% for HbA1c is correlated with 3.57% false-negative predictions in Saudi diabetic patients. Based on the study, a combined FPG and HbA1c analysis should be done for Saudi individuals with HbA1c values between 6.0 - 6.5%.

  Detection of IL4 and IFNγ In Filarial Patients Sera: Role of TH1 & TH2 Immune Response in Lymphatic Filariasis Top

Mohammed Saeed

Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, University of Hail, Hail, Saudi Arabia

E-mail: [email protected]

Lymphatic filariasis is a chronic and debilitating disease that affects people in tropical and sub- tropical areas of Asia, Africa, Western Pacific and some areas of the United States of America. The disease is caused by the parasites Wuchereria bancrofti, Brugia malayi and Brugia timori. Lymphatic filariasis is by far the most prevalent disease of the filarial infections, commonly known as “elephantiasis,”. According to the World Health Organization, the current estimate shows that in India alone about 553 million people live in endemic areas with approximately 48 million having circulating either microfilariae or overt diseases like hydrocele, lymphoedema and elephantiasis. It is reported that the immunity in asymptomatic/microfilaremic individuals is strongly associated with a Th2-type response with high immunoglobulin E (IgE) and IgG4 levels and eosinophilia; whereas, the immune responses of the amicrofilaremic/chronic pathology group are more of the Th1 type. The aim of this study was to assess the immune responsiveness of patients with lymphatic filariasis, by studying their cytokine secretion profile. In the present study, our results showed up regulation of Th-2, producing IL-4, in chronic and acute filariasis cases, to a greater extent than in microfilaraemic and endemic controls and IFNγ in sera showed down-regulation in all the groups of filarial patients as compared to the non-endemic normal (NEN); however, it was not significant. The outcome results (which should be presented later) suggested a complex relationship between the host immune response and parasite establishment and survival.

Key words: Immune responses, filariasis, amicrofilaremic.

  Improve Compliance With Safety Requirements in Chemical Safety Checklist Top

H Almadani, S Sobki, S Bakeshawain, M Farah

Division of Clinical Chemistry, Department of Central Military Laboratory & Blood Bank, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: More than 400 workers are employed in the laboratories of PSMMC. Prioritizing workplace safety can lead to reduction in fatalities, injuries, and illnesses. This will result in cost savings in a variety of areas, such as lowering workers' compensation, costs and medical expenses, and costs to train replacement employees and conduct accident investigations. To properly address the improvement of chemical safety at PSMMC, it was necessary to gain a deeper sense of understanding of the existing chemical safety practices, policies, procedures and the ways in which such elements of chemical safety may be effectively implemented within the organization's laboratories.

Methods: By using 38 elements of checklist for different divisions and calculating the number of complaints before and after implementing the checklist.

Results: We found the complaints markedly increased as follows: A comparison of chemical safety before and after implementing the checklist was evaluated in our study in all pathology divisions using chemicals: metabolic, toxicology, microbiology, histopathology and cytogenetic

The overall performance improved, the average compliance was 66.23 %. The percent compliance ranged from 18% to 94.0%. There was an average percent variance from target of 33.77 %, which after investigation was found to be due to staff awareness of chemical safety.

Conclusion: Therefore, we have presented recommendations with implementation plans for the creation of PSMMC-wide chemical safety program. Our recommendations include creating a chemical inventory; conducting appropriate training program for all the staff; rearranging chemicals and take off unused and overstock chemicals by health and safety department and clear chemical hygiene plan process.

  Assessment of Essential & Toxic Trace Elements in Blood: Associations With Different Lifestyle Exposures among Healthy Female Medical Students Top

Rana Hasanato, Sawsan Saad Haj-Bakry, Dina Khaled Assiri, Nori Abdullah Aldosari, Deema Essam Jomar, Felwa Abdulaziz AlMarshad, Layla Mohammed Zeitouni

Department of Pathology, College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected].co

Background: Repeated exposure to both essential and toxic elements can lead to bioaccumulation and toxicity of these elements.

Objectives: To assess the life style predisposing factors and the levels of both essential elements (zinc, copper and selenium) and toxic elements (mercury, lead, cadmium and arsenic) among healthy female medical students.

Methodology: This was a cross-sectional study of 224 healthy female medical students (mean age: 22.17 ± 1.90 years) performed between December 2013 and April 2014 at King Saud University. Information about exposure to risk factors was obtained using self-administered questionnaire. Blood levels of trace and toxic elements were assessed by Inductively Coupled Plasma Mass Spectrometry (ICPMS) and results were compared with normal reference ranges of Mayo Clinic.

Results: The mean serum level of trace elements including copper (15.64 ± 3.15) µmol/l, zinc (11.43 ± 1.60 µmol/l) and selenium (1.44 ± 0.17 µmol/l) were within the expected range. Similarly, among the metals mean arsenic (0.04 ± 0.06 µmol/l), mercury (2.82 ± 1.19 nmol/l), lead (0.25 ± 0.16 µmol/l) and cadmium (16.93 ± 10.23 nmol/l) levels were also within the expected normal ranges. Eyeliner was used by 85.7%, lip-gloss was used by 70.5%, canned food was consumed by 72.8% and sea food consumed by 71% regularly. Only 6.25% were smokers. Serum lead levels in 24 and arsenic levels in 11 students were higher than the expected normal values. None of the risk factors was found to be a significant predisposition.

Conclusion: Despite exposure to predisposing factors, the female medical students had normal mean blood levels of trace and toxic elements.

  Implementation of Inr Point of Care (POC) Instrumentation in Outpatient Coagulation Clinic: Determination of Accuracy of the POC INR in Comparison to Reference Coagulation Analyzer Top

Rana Hasanato, Tasneem Fathi, Amal Elmubki, January Chad Clarin, Hind Mohamed-Ahmed

POCT Unit, Department of Pathology, King Khalid University Hospital, College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

Objectives: The need for faster turnaround time (TAT) in order to reduce patient waiting time, in addition to the need for small sample volume has led to the decision to utilize point of care testing (POCT) devices in the outpatient coagulation clinic at KKUH.

To achieve quality results, it is essential to compare results from the POC device to the main laboratory reference instrument.

Methods: The comparison study was carried out at KKUH. 43 samples were used to compare the Hemochron Jr. Signature Elite with PT/INR cuvette (J201) and STA-R analyzer. The Hemochron Jr. Signature Elite uses a mechanical endpoint clotting mechanism utilizing a highly sensitive thromboplastin. While the STA-R analyzer uses a solid state detector to measure the increase in amount of incident light scattered to signal the formation of a clot. Two different samples were drawn from each patient at the same time, capillary samples and citrated venous samples. The capillary samples were used on the Hemochron Jr. Signature Elite while the venous samples were run on the STA-R reference analyzer.

Results: The INR measurements on the STA-R instruments ranged from 0.9 to 5.2. Mean INR values were 2.09 (± 1.22). On the Hemochron Jr. Signature Elite, the mean INR values were 2.55 (± 1.56). Regression analysis between the two methods produced the equation: Hemochron Jr. Signature Elite = 1.232(STA- R) - 0.048 with a correlation coefficient of 0.954. The data showed acceptable agreement with an average bias of 0.4 INR.

Conclusion: INR results from Hemochron Jr. Signature Elite were found to be comparable to the main laboratory STA-R instrument with minimum bias and therefore suitable for the use in Coagulation clinic.

  Comparison of Cation Exchange HPLC Method of Tosoh G8 With Immunoturbidimetric Method of Dimension Xpand for the Determination of HBA1C Top

Rana Hasanato, Hassan Elfaki, Evelyn Donguines, Gamel Appeidu

Department of Pathology, College of Medicine, King Saud University, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: Accurate measurement of HbA1C is critical for management and monitoring of glycemic control in diabetes mellitus.

Objective: This study was performed to validate the Tosoh G8 HbA1C testing system by comparing its analytical performance with the immunoturbidimetric method.

Methods: This study was performed in the clinical chemistry unit at King Khalid University Hospital. A total of 55 venous blood samples from patients with diabetes mellitus were included in the study. HbA1C was analyzed simultaneously by Tosoh G8 HbA1C testing system and immunoturbidimetric method with an acceptable error of 12% (CAP 2008 quality requirement).

Results: The means of HbA1C measured by Tosoh G8 HPLC (8.064 ± 2.056) and Xpand immunoturbidimetry methods were comparable with no statistically significant difference. The interassay coefficient of variation (CV) was 0.7% for Tosoh G8 HPLC and 2.0% for immunoassay for level 1 control and 0.5% for Tosoh G8 HPLC and 2.7% for immunoassay for Level 2 control. The overall imprecisions were clinically acceptable for both the assays. The assessment of HbA1C by both the assays displayed a strong positive correlation (0.98) with an error index of within reportable range.

Conclusion: Analytical performance for assessment of HbA1C of both the methods was found to be comparable.

  Clinical Profiles of Multiple Myeloma in Saudi Arabia: a Single Institute Experience Top

Najla Al Besharah1, Samia Sobeki1, Qanita Sedick2, Ghaleb Elyamany2

1Clinical Chemistry Division, 2Hematopathology Division, Department of Central Military Laboratory, Prince Sultan Military Medical City (PSMMC), Riyadh, Saudi Arabia

E-mail: [email protected]

Aim & Background: Multiple myeloma (MM) is a B-cell malignancy characterized by clonal expansion of plasma cells within the bone marrow, as well as at extramedullary sites; accounting for 13.4% of all hematological cancers. This retrospective study aims to highlight epidemiological features, identifying initial clinical and basic laboratory features of MM.

Materials and Methods: A retrospective analysis of 121 patients of MM diagnosed at PSMMC, SA. Information on the clinical, laboratory, and radiological data was obtained at diagnosis.

Results: The study was carried out on 121 patients with MM, 75 (62%) males and 46 (38%) females. Their ages ranged between 36 and 91 years with a mean age of 66.6 years and median of 86.0 years. All the patients were stage III in the Durie-Salmon staging system. Clinical features at presentation were anemia (67.8%), osteolytic lesions on X-ray (54% ) and bone pains (45.3%), while pathological fractures found in 12%, and nephropathy in 43.5%. The average percentage of bone marrow plasma cells at diagnosis was 46%. Sixty-eight patients (56.2%) had IgG monoclonal band, 26 patients (21.5%) had IgA, 8 patients (6.6%) had IgM monoclonal band and 19 patients (15.7%) had light chain myeloma. Fifty-nine (48.8%) were lambda chain positive and 62 patients (51.2%) were kappa positive. Five cases had biclonal positivity.

Conclusion: A high index of suspicion among physicians targets investigations in order to prevent late presentation and occurrence of complications which adversely affects survival. Presence of bone pain and anemia in elderly patients should alert the clinician to investigate along the lines of MM.

  Performance Evaluation of Roche Cobas B 221 Point of Care Blood Gas Analyzers Used in Intensive Care Units Top

Nuha AlHumaidan, Samia Sobki

Clinical Chemistry Division, Department of Central Military Laboratory, Prince Sultan Military Medical City Hospital, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: Blood gas analyzers are important in assessing and monitoring critically ill patients. It is vital for the purpose of patient care to assure that all analyzers installed in the same unit give comparable results. The objective of this study was to evaluate the performance of 6 Roche cobas b221 analyzers in measuring blood gases and whole blood electrolytes in the ICU setup.

Methods: Total of 60 blood gas samples were evaluated for method comparison for analyzers that were installed in the same units using heparinized arterial and capillary blood that were collected from adult, pediatric and neonatal ICU patients. Twenty samples were analyzed at each site, correlation for blood gases and whole blood electrolytes were calculated using regression analysis and allowable systematic error. Precision study was done on quality control solutions at three different levels of concentrations and coefficients of variation (CVs) were calculated. Linearity was done using 5 different concentrations spanning the analytical range for each test.

Results: All % CVs were consistent with those claimed by the manufacturer at all three concentration levels. %CVs of level 1 for pH, PC02, P02, Na +; K +, Cl -, and Ca2+ were less than or equal to 0.08, 2.72, 8.20, 0.93, 0.95, 1.96, 0.98; level 2 were less than or equal to 0.06, 1.74, 5.38, 0.55, 0.53, 0.97, 1.20;and level 3 were less than or equal to 0.07, 2.74, 4.51, 0.53, 0.74, 0.87, 1.43 respectively. pH, PC02, PO2, Na +, K +, Cl - and Ca2+ were linear over a measured range of 6.87 - 7.70, 12 - 126 mmHg, 24 - 457 mmHg, 90 - 173 mmol/L, 2.0 - 8.8 mmol/L, 68 - 131 mmol/L, and 0.42 - 2.59 mmol/L, respectively. All analyzers located in the same unit showed satisfactory correlation between the results for all tests, the correlation coefficients were ≥ 0.975 for all tests.

Conclusion: Overall performance of cobas b 221 system was acceptable; it provided reliable results for all tests in all ICUs.

  Experimental Research Effects of Monolluma Quadrangula Hydroalcoholic Extract Against Gastric Lesions Induced by Ethanol in Rats Top

Ibrahim Abdel Aziz Ibrahim1, Mahmood Ameen Abdulla2, Maryam Hajrezaie2, Ammar Bader3, Naiyer Shahzad1, Saeed S Al-Ghamdi1, Ahmad S Gushash4, Mohadeseh Hasanpourghadi5

1Department of Pharmacology and Toxicology, 3Department of Pharmacognosy, Faculty of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia, 4College of Arts and Science in Baljurashi, Albaha University, Baljurashi, Al Baha, Saudi Arabia, 2Department of Biomedical Science, 5Department of Pharmacology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia

E-mail: [email protected]

Abstract: Monolluma quadrangula (Forssk.) Plowes is used in Saudi Arabia as a traditional medicine to treat gastric ulcers and other diseases. The hydroalcoholic extract of Monolluma quadrangula (MHAE) was used in an in vivo model to investigate its gastroprotective effects against ethanol-induced acute gastric lesions in rats. Five groups of Sprague-Dawley rats were used. The first group was treated with 10% Tween 20 as a control. The other four groups included rats treated with absolute ethanol (5 ml/kg) to induce an ulcer, rats treated with 20 mg/kg omeprazole as a reference drug, and rats treated with 150 mg/kg or 300 mg/kg MHAE. One hour later, the rats were administered absolute ethanol (5 ml/kg) orally. Animals fed with MHAE exhibited a significantly increased pH, gastric wall mucus and flattening of the gastric mucosa, as well as a decreased area of gastric mucosal damage. Histology confirmed the results, extensive destruction of the gastric mucosa was observed in the ulcer control group, and the lesions penetrated deep into the gastric mucosa with leukocyte infiltration of the submucosal layer and edema. However, gastric protection was observed in the rats pre-fed with plant extracts. Periodic acid Schiff staining of the gastric wall revealed a remarkably intense uptake of a magenta color in the experimental rats pre-treated with MHAE compared to the ulcer control group. Immunohistochemistry staining revealed an up-regulation of the HSP70 protein and a down-regulation of the Bax protein in rats pre- treated with MHAE compared with the control rats. Gastric homogenate showed significantly increased catalase (CA) and superoxide dismutase (SOD), and the level of malondialdehyde (MDA) was reduced in the rats pre-treated with MHAE compared to the control group. In conclusion, MHAE exhibited a gastroprotective effect against ethanol-induced gastric mucosal injury in rats. The mechanism of this gastro-protection included an increase in pH and gastric wall mucus, an increase in endogenous enzymes, and a decrease in the level of MDA. Moreover, protection was given through the up-regulation of HSP70 and the down-regulation of Bax proteins.

Key words:Monolluma quadrangular, gastroprotective, HSP70, superoxide dismutase, catalase, malondialdehyde, gastric ulcer.

  Preanalytical Stability of 25(Oh)-Vitamin D Using Immunoassay Testing Top

Anwar Borai1, Amal Algithami2, Amjad Bazuhair3, Alya'a Al-Ansari3, Sawsan Baatta2

1Department of Pathology, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia, 2King Abdulaziz University, Medical Laboratory Science, Jeddah, Saudi Arabia, 3Department Pathology, Umm Al Qura University, Faculty of Health and Medical Laboratory Sciences, Makkah , Saudi Arabia

E-mail: [email protected]

Introduction: Studies about preanalytical stability of 25(OH)-vitamin D using the immunoassay technique are limited but most of the outcomes showed that vitamin D is a stable analyte in spite of the various conditions of storage. The purpose of the present study was to investigate the effect of mixing serum sample on 25(OH)-vitamin D level before analysis and to assess the level of 25(OH)-vitamin D over a period of time intervals.

Subjects and methods: Blood specimens were collected from 16 volunteers. All samples were separated in 12 aliquots and stored in freezer (-20°C). Two serum aliquots from each volunteer were run for vitamin D after the blood collection as baseline. One aliquot was mixed and the second aliquot was run without mixing. The same protocol was followed in the subsequent days; 1 day, 2 days, 3 days, 4 days, 5 days and 30 days.

Results: No significant difference was found between 25(OH)-vitamin D with and without mixing. In both mixed and non-mixed samples, no significant difference was found between the baseline level (0 day) and 1 day after blood collection but the results were significantly low (average -15% to -17%) when other days (day 2, day 3, day 4 and day 5) compared to the baseline level except day 30.

Conclusions: No need for serum to be mixed before 25(OH)-vitamin D analysis. Testing serum for 25(OH)-vitamin D level using the immunoassay should be done on the same day of blood collection or maximum one day after.

  Prevalence of Coeliac Disease Autoantibodies in Saudi Children With Type 1 Diabetes Top

Shafya Al-Qahtani1, Mondher Zitouni1, Samia Sobki2

1Immunology Division, 2Biochemistry Division, Department of Pathology, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Aim: To determine the frequency of coeliac disease (CD) autoantibodies in Saudi children with type 1 diabetes mellitus (IDDM) in Prince Sultan Military Medical City (PSMMC).

Material & Methods: We studied retrospectively 64 Saudi children admitted in PSMMC with IDDM. All our patients have at least one autoantibody positive for diabetes.

The mean age of our group is 8 years (2 - 13 years) with sex ratio of 0.72 (M/F:27/37).

For coeliac disease, we detected antiendomysial antibody by indirect immunofluorescence assay on monkey esophagus (IMMCO), anti-tissue transglutaminase antibody (IgA- tTG), anti-deamidated gliadin peptide (DGP IgA and IgG) by ELISA(INOVA).

For diabetes, we detected anti-glutamic acid decarboxylase (GADA) and anti-IA-2 autoantibodies by ELISA (Eroimmun).


Conclusion: About 11% of our IDDM patients have coeliac disease autoantibodies. This prevalence is considered among the highest prevalence in Arab countries and over the world (5 to 16%).

These data suggest that CD is more common in Saudi pediatric patients with IDDM than was previously suspected.

We recommend screening coeliac disease autoantibodies in pediatric patients with IDDM.

  Assessment of Alpha Amylase Activity as a Diagnostic Tool in Emergency Room (ER) Patients in a Tertiary Hospital in Dahran, Saudi arabia Top

Zaed Ahmed Asiri

Scientific Officer, Medical Laboratory, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Objectives: This exploratory study aims to explore the following objectives:

  1. To prove the importance of the investigation of amylase as a diagnostic tool in the ER patients.
  2. To discover a new significance to the amylase for ER patients.
  3. To overcome the difficulties in diagnosing acute abdominal pains.
  4. To understand the causes and the effects of different amylase levels.
  5. To provide a new interpretation of the amylase levels found in the study.

Methods: This is a cross-sectional study. Sample data were randomly gathered from fifty patients admitted to the ER with abdominal pain complaint and were tested for both amylase and lipase levels in the last six months (April 2012), i.e., our inclusion criteria, in a tertiary Hospital in Dahran, KSA.

Results: In the sample, we noticed that the hyperamylasemia occurred in 24% of the total ER patients, both males and females (75% males, and 25% females). The 75% males with hyperamylasemia were caused by pancreatitis in 90% of the cases and 10% by acute appendicitis. The pancreatitis patients ranged between 30 to more than 60 years old, but most cases occurred between the ages of 40 to 49 years old, while the acute appendicitis occurred between the ages of 20 to 29 years old. In all abnormal cases, increased levels of both lipase and amylase were seen.

Conclusion: The study showed that the assessment of α amylase activity as a diagnostic tool in ER patients proved to be of high importance and can lead the physician to the right treatment. In the study, the amylase levels assessment to the ER patients were critical to determine the cause of the abdomen pain as a rapid, low-cost and reliable test. Amylase assessment can be specific in some cases such as pancreatitis, as well as in some non-pancreatic diseases/conditions such as appendicitis, traumas and injuries. The combination of amylase and lipase proved to be of great use and high specificity for pancreatic diseases.

  Investigation Into the Effects of Organic Osmolytes on Reactive Oxygen Species Production in Keratinocytes Top

Abdulaziz Alhasaniah

Clinical Biochemistry Science in the Faculty of Medical and Human Sciences, University of Manchester, UK

E-mail: [email protected]

Background: The epidermal layer of the skin provides an indispensable barrier that regulates water homeostasis and protects the body from the harmful effects of the external environment, such as UV radiation. Previous studies indicate that UV radiation induces water evaporation and increases osmotic pressure around these cells. In addition, UV radiation has been found to be the main source of oxidative stress for these cells, although the exact mechanism of oxidant formation because of this radiation has not been established. Organic osmolytes are small compatible solutes naturally synthesized in the body that play an important role in regulating water homeostasis and maintaining cellular volume during hyperosmotic situations. In addition, there is a wide agreement in literatures that some of these osmolytes mitigate against oxidative stress, although the mechanism of this mitigation remains controversial.

Aim: The aim of this study is to determine whether organic osmolytes mitigate against oxidative stress induced by UV radiation.

Methods: Therefore, a set of rat epidermal keratinocytes (REKs) were UV irradiated in the presence of osmolytes taurine, betaine and myo-inositol to investigate their role in the suppression of reactive oxygen species (ROS). Hydrogen peroxide (H2O2) was applied to the other set of REKs as a positive (oxidative source) control in the presence of these osmolytes, and ROS production was monitored by DCF assay.

Results and conclusion: The results revealed that UV irradiation did not cause significant ROS production during four hours of radiation, and organic osmolytes did not supress base ROS production after four hours of incubation with these osmolytes.

  Impact of Gestational Diabetes on Lipid Profiling & Indices of Oxidative Stress in Maternal & Cord Plasma Top

Samia H Sobki

Head, Division of Clinical Chemistry, Central Military Laboratory & Blood Bank, Prince Sultan Military Medical City, Riyadh, Saudi Arabia

E-mail: [email protected]

Objective: To study the effect of gestational diabetes mellitus (GDM) on indices of oxidative stress and lipid profiles in maternal and cord blood samples.

Methods: Blood samples were collected from 40 normal pregnant women and 46 women with (GDM). The GDM patients were subdivided into 2 groups: patients receiving insulin treatment (GDM-I, N = 19) and patients under control diet (GDM-D, N = 27). Plasma α and γ-tocopherols were estimated by high-performance liquid chromatography, whereas malondialdehyde (MDA) was analyzed by fluorometry. Serum lipids (low density lipoprotein, high density lipoprotein, total cholesterol, triglycerides, and total lipids) were determined by enzymatic colorimetry using automated chemistry analyzer.

Results: The Results of lipid profiles in maternal serum showed no significant differences between GDM patients and controls. However, cord serum showed significant differences between the 3 groups. Cord serum LDL, TG and total lipids in both GDM-D and GDM-I patients were significantly lower than those of control subjects (P < 0.05). A slight reduction in the levels of α-tocopherols was observed in maternal plasma of GDM-D (41.85 ± 2.33 mmo1/1) and GDM-I (40.21 ± 5.08 mmo1/1) as compared to control subjects (44.30 ± 2.67 mmo1/1). Whereas, the results of cord plasma showed a significant reduction in α-tocopherols among GDM-D (15.40 ± 2.19 mmo1/1) and GDM-I (14.90 ± 1.75 mmo1/1) versus controls (22.28 ± 1.38 mmo1/1). The levels of γ-tocopherols in maternal plasma were found to be increased in both GDM-D (2.77 ± 0.39 mmo1/1) and GDM-I (2.08 ± 0.25 mmo1/1) as compared to control (1.78 ± 0.14 mmo1/1). There was no significant difference in the cord plasma γ-tocopherols levels among the 3 groups. The level of MDA was 3-fold higher in maternal plasma as compared to cord plasma. However, neither the maternal plasma nor cord plasma showed significant differences is MDA levels between GDM patients and normal pregnant women.

Conclusion: A significant depletion of α-tocopherols in the cord blood of GDM patients is indicative of a possible oxidative stress in their fetuses. Further studies are warranted to examine a wider range of biochemical parameters to evaluate the potential risks of oxidative damage.

  The Use of Clinical Equivalence Measured at Different Allowable Total Error to Compare Enzymatic, Immunoturbidimetric & HPlC Methods for the Determination of HBA1C Levels in Patients With Normal and Abnormal Hemoglobin Top

Salam Saadeddin1, Samia Sobki1, Waleed Al-Tamimi2, G El-Yamani1, Ali Al-Othaim2, Omar Al-Sehibani1, Abdulaziz Al-Abdulaaly1

1Department of Central Military Laboratory and Blood Bank, Prince Sultan Military Medical City, Riyadh, Saudi Arabia, 2Department of Pathology & Laboratory Medicine, King Fahad National Guard Hospital, Riyadh, Saudi Arabia

E-mail: [email protected]

Background: High-performance liquid chromatography (HPLC) is considered the acceptable standard measurement procedure for hemoglobin A1c (HbA1c). The objective of this study was to compare and correlate the analytical performance by measuring clinical equivalence(CE) measured at different allowable total error (TEa) of 3 methods for measurement of HbA1c, including HPLC (Tosoh® G8), immunoturbidimetric (Cobas® 6000) and enzymatic (Architect® c4000) methods in patients with normal and abnormal Hb.

Method: Measurements of HbA1c by the three methods were made in blood from 151 patients with normal and 103 patients with abnormal Hb. Intra and inter assay precision of each method was evaluated with control specimens. Results from the Architect® c4000 and from Cobas® 6000 were compared with those of Tosoh® G8 HPLC method to determine correlation & CE at different TEa.

Results: The average HbA1c levels measured by Architect® 4000, Cobas® 6000 and Tosoh® G8 were 6.86 ± 2.16, 6.75±1.27 and 6.96±1.99% for normal Hb samples and 5.81±1.61, 5.70±1.22 and 5.74±1.37% for abnormal Hb samples, respectively. Ten abnormal Hb samples could not be read by at least one machine (6 by Tosoh® G8, 5 by Architect® 4000 and 8 by Cobas® 6000), therefore were not included in the correlation & CE studies. Comparing Architect® c4000 to Tosoh® G8 reviled r=0.9944, y=1.093x-0.720 and CE at an TEa as low as 7% in the normal Hb samples, and r=0.9710, y=1.197x-0.962 and CE at TEa as low as 13% in the abnormal Hb samples. Comparing Cobas® 6000 to Tosoh® G8 reviled r=0.9932, y=0.865x+0.740 and CE at TEa as low as 9% in the normal Hb samples, and r=0.9716, y=0.887x-0.610 and CE at TEa as low as 15% in the abnormal Hb samples. The difference in lowest TEa to achieve CE was mainly observed with HbA1c <5.7 and >6.4%.

Conclusion: Both Architect® c4000 and Cobas® 6000 showed acceptable data quality & correlation with Tosoh® G8 and achieved CE at fairly low TEa for the measurement of HbA1c in patients with normal and abnormal Hb, with Architect® c4000 achieving CE at lower TEa than Cobas® 6000 in both low and high ranges.


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