Biochemistry is the branch of science that examines the normal functions of living organisms at the cell level, metabolism events in the ultramicroscopic field, and structural changes at the molecular level in theoretical and laboratory environment. In biochemistry laboratories, the analysis of many parameters used in the protection of health, diagnosis and follow-up of diseases are carried out in all body fluids, fully automatically and with reliable methods in systems using advanced technology. It is clinically important that the test results of laboratories have diagnostic value as well as accuracy and precision.
Today, the test menus of clinical biochemistry laboratories are very wide and many medical decisions are made according to their results. These include carbohydrate, lipid, protein, enzyme, hormone, hormone, mineral, vitamin panels and cardiac and tumor markers, liver and kidney function tests, urine and hemotology tests. These tests are routinely and widely used in almost every advanced biochemistry laboratory.
Unlike these tests, which are commonly performed in almost all biochemistry laboratories, the Clinical Pharmacogenetics Laboratory of our University aims to be the first clinical biochemistry laboratory specific to the field of neuropsychiatry in our country and to pioneer the formation of a "field-specific laboratory". With this in mind, blood levels of drugs commonly used in neuropsychiatry are analyzed in our laboratory. Nearly 70 drug analyses in the test menu are performed with LC-MS-MS device in accordance with the accuracy and precision limits specified in FDA-EMA guidance and analyzes are performed daily.
As it is known, drug blood level, Therapeutic Drug Monitoring (TDM) measurement and Drug Concentration Measurement (DCM) are of great importance in psycho-neuro-pharmacology with their cost-reducing aspect. It is a method that will shorten the patient's long hospitalizations and minimize the use of drugs through trial and error. Another benefit of patient follow-up with TDM is for patients who use maximal doses of medication but have inadequate response to treatment (decreased effect). Patients whose drug is detected to be metabolized rapidly by blood levels are given the chance to use the drug by adhering to the principles of "Right Drug, Right Dose, Right Route, Right Duration". Another benefit of TDM is that it helps us to identify slowly metabolized drugs in patients who cannot comply with the drug, that is, patients who take minimal doses of medication but experience toxic effects. While it is useful in identifying unexpected toxicity at the normal treatment dose, high doses and abuse of drugs are also prevented. TDM in treatment-resistant cases is expected to be a routine practice in the future and our laboratory is the only and pioneering laboratory in Turkey that provides this service using a very large test panel and advanced technology.
In addition to TDM, scientific developments in DNA sequence imaging techniques, gene polymorphism and genotyping seem to be revolutionary options for psychiatrists and neurologists, although they are far from being specific enough to make a diagnosis yet. As a result of the development of analysis methods and technology, clinicians in neuro-psychiatry have gradually abandoned traditional treatment habits in recent years.
Three main goals are pursued in drug blood level monitoring, in which drug blood levels are monitored in the desired biological matrix thanks to highly sensitive measurements:
1. Is the person following the pharmacotherapy prescribed to him/her? Is he/she taking his/her medication?
2. Is the drug reaching the effective concentration thanks to the dose regimen applied?
3. Is there any drug ineffectiveness or drug toxicity?
Thus, in order to prevent deaths due to drug dosage errors, it is attempted to measure the Cytochrome P450 enzyme activities of people in a practical way and to adjust drug dosage accordingly or to examine the genetic structures of people and adjust drug dosages according to the structures of existing genes and to establish the concept of "PERSONALIZED TREATMENT".
It is known that addictive substance analysis is one of the tests with clinical decision-making features. For this reason, there have been significant developments in the approach of clinicians to substance addicted patients. Experts working in the field of addiction control now insist on the method of laboratory tests they want to be performed while following their patients. In order to make a difference in this field, the infrastructure of our laboratory was prepared with a project. Our university's project titled "Establishment of an Evidence-Based Toxic and Addictive Substances Detection-Screening and Counseling Center" was supported by the Istanbul Development Agency (ISTKA) with a budget of 977,303.-TL in 2014. Istanbul Chief Public Prosecutor's Office, Beykoz Municipality and Istanbul Provincial Directorate of National Education also participated in the project. Within the scope of the project, seminars and conferences on addiction were given to the people of Beykoz and other districts and various secondary education institutions in Istanbul. Our project was successfully completed with the closing meeting on September 29, 2015. After the end of the project, this laboratory of our University continued its activities in order to ensure the employment of trained personnel and the institutional sustainability of machinery and equipment with high technological qualities. In this process, it is an important added value of the project that some institutions and organizations prefer to have similar analyzes performed at our University, which they have done abroad.
Clinical Pharmacogenetics Laboratory;
Our laboratory, whose ultimate goal is "Verification Laboratory" within the scope of the fight against addiction, applied to the Turkish Accreditation Agency on 24.06.2016: TS EN ISO/IEC 17025 Standard was accredited with the competence of testing and calibration laboratories (Ethyl Glucuronide, Benzoylecgonine, Morphine). Our laboratory successfully completed the surveillance audit in May 2017.
Our laboratory, which performs the analysis of illicit and abused drugs and substances in urine samples using an advanced technology LC-MS/MS device, performs the validation of its methods by using the highest technology in this field according to the rules specified in the "Guideline on Bioanalytical Method Validation", which was put into operation by the European Medicines Agency (EMA) in 2011. Currently in our laboratory; Alcohol (ethylglucuronide), Amphetamine, MDMA, Marijuana, Cocaine (benzoylecgonine), Morphine, around 20 Bonzai, Buprenorphine and metabolite, Pethidine and metabolite and VitD analyzes are performed.
In the fight against addiction, the analysis results must be safe enough not to require verification. Our laboratory has the most advanced technology for analytical quantification. Analyses are performed with High Pressure Liquid Chromatography sequential Mass Spectrometry device with high specificity, selectivity and sensitivity, whose measurements are accepted as gold standard. In sample measurements in biological matrix (blood, urine, etc.), there are many endogenous substances that affect the measurements from the matrix and are called interferences. Due to these effects (sensitivity and selectivity), the smallest concentration that can be measured is very high in devices such as autoanalyzers used in routine Biochemistry Laboratories. Tandem Mass devices used in our laboratory can measure up to one hundred millionth of a milligram (pg/ml). Our laboratory, which is accredited in its field, also participates in international proficiency tests (College of American Pathologist (CAP) proficiency) three times a year and obtains successful results. The Clinical Pharmacogenetics Laboratory was licensed on 12.12.2017 with the approval of the Ministerial Authority, number 546/01.
