Therapeutic Drug Monitoring - Humor Diagnostica
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TDM tests provide quantitative results to ensure beneficial therapeutic effects by determining the drug concentration in blood. Complete solutions for therapeutic drug monitoring Thermo Scientific TDM Assays for Therapeutic Drug Monitoring
Transcript of Therapeutic Drug Monitoring - Humor Diagnostica
TDM tests provide quantitative results to ensure beneficial therapeutic effects by determining the drug concentration in blood.
Complete solutions for therapeutic drug monitoring
Thermo Scientific TDM Assaysfor Therapeutic Drug Monitoring
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We provide a broad range of therapeutic drug monitoring (TDM) assays including full menus of Antibiotics, Antiepileptics, Antiarrhythmics, plus Theophylline. All of these assays provide outstanding performance with excellent accuracy, precision, sensitivity and specificity. Applications are available on our Thermo Scientific™ Indiko™ and Indiko Plus™ clinical and specialty chemistry analyzers and for most major laboratory instrumentation.
What are TDMs and why do they need monitoring?
TDM tests provide quantitative results to ensure beneficial therapeutic effects by determining the drug concentration in blood. Too much drug can cause toxicity and too little, a lack of efficacy. Additionally individual patient factors such as age, ethnicity, metabolism and history can affect the drug performance. TDM’s aid physicians in determining the optimal drug dosage for an individual patient by monitoring serum or plasma drug concentrations to ensure effectiveness and patient compliance.
Jain, K.K., Therapeutic Drug Monitoring Technologies, Companies and Markets, Jain PharmaBiotech, Basel, Switzerland , Tech Report, p.14. February 2012.
Plasma or Serum Concentration of the Drug Desired Effect
Toxicity
TDM
Lack of Efficacy
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Optimize patient dosages with Thermo Scientific Antibiotic Assays
Antibiotic TDMs are used in life threatening infections where serious side-effects can occur if the drug concentration exceeds the therapeutic range. Patients are often hepatically or renally impaired causing the metabolism and clearance of the drug to be unpredictable. Therefore monitoring patients for these antibiotics is extremely important.
Our menu of Antibiotics includes: Amikacin, Gentamicin, Tobramycin, Teicoplanin* and Vancomycin. Each assay provides high quality results with fast turnaround times. The assays are all robust and available on a wide variety of instrumentation. Our easy-to-use Indiko and Indiko Plus clinical and specialty chemistry analyzers are the ideal platform for running the assays. We also have applications for most major clinical laboratory systems.
ANTIBIOTICS
Antibiotics Product PerformanceTotal Precision (%CV) Method Comparison
Assay Range Low Medium HighComparison
MethodSlope Intercept
Correlation Coefficient
Amikacin 1.5-50 µg/mL 9.9 6.2 6.3 FPIA 1.00 0.25 0.992Gentamicin (CEDIA) 0.24-12 µg/mL 6.20 4.10 3.00 FPIA 1.04 -0.08 0.993Gentamicin (QMS) 0.3-10 µg/mL 3.9 3.6 2.8 FPIA 1.02 0.41 0.997Teicoplanin* 3-100 µg/mL 5.8 4.8 5.0 FPIA 0.93 0.29 0.980Tobramycin 0.4-10 µg/mL 7.60 4.20 4.30 FPIA 0.98 -0.09 0.984Vancomycin 2.5-100 µg/mL 8.8 6.2 5.1 FPIA 1.03 1.12 0.970
*Teicoplanin is not available for sale in the US.
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Ensure the highest levels of performance with Thermo Scientific Antiepileptic Assays
Antiepileptic drugs (AED) are commonly used to treat seizures. This class of TDMs is the most commonly monitored. As with all TDMs, AED’s are monitored for dosage within a narrow therapeutic range, patient compliance, and challenging pharmacokinetics. We have one of the most comprehensive menus of AED’s including many of the newer generation drugs.
Our menu includes: Carbamazepine, Lamotrigine, Phenobarbital, Phenyotin, Topiramate, Valproic Acid and Zonisamide. Multi Constituent Calibrators are available for most of our AED assays. All of our AED assays are accurate and precise to ensure the highest levels of performance. Thermo Scientific Indiko and Indiko Plus clinical and specialty chemistry bench top analyzers with bar-coded bottles make testing fast and easy. We also have applications for most of the major clinical laboratory systems.
ANTIEPILEPTICS
Antiepiletptics Product Performance
Assay RangeTotal Precision (%CV) Method Comparison
Low Medium HighComparison
MethodSlope Intercept
Correlation Coefficient
Carbamazepine 0.5-20 µg/mL 3.5 2.0 1.7 FPIA 1.00 0.87 0.986Lamotrigine 2.0-40 µg/mL 2.8 2.0 2.4 HPLC 1.03 0.11 0.960Phenobarbital 1.2-80 µg/mL 5.3 3.8 3.6 FPIA 1.08 -2.01 0.988Phenytoin* 0.6-40 µg/mL 5.1 3.1 2.3 FPIA 1.00 -0.19 0.998Topiramate 1.5-32 µg/mL 4.2 3.4 4.4 FPIA 0.96 0.23 0.986Valproic Acid 3-150 µg/mL 3.4 2.0 1.8 FPIA 1.08 -0.61 0.972Zonisamide 3-50 µg/mL 8.3 7.9 7.5 HPLC 0.92 1.67 0.910
*Run-to Run precision listed
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Reliable, sensitive and specific assays are the cornerstone of the Thermo Scientific Antiarrhythmics Assays
Antiarrhythmics drugs are used in the treatment of cardiac arrhythmias. Each is used to monitor patients to ensure they are receiving the optimal dosage to prevent any toxic adverse effects.
We are a leading supplier of antiarrhythmics assays including: Digoxin, Digitoxin, Lidocaine, N-Acetylprocainamide (NAPA), Procainamide, and Quinidine. Each assay is rigorously tested to ensure it provides the accuracy, precision, sensitivity and specificity required. Applications are available for a wide variety of laboratory instrumentation and will be available soon on the the Thermo Scientific Indiko and Indiko plus clinical and specialty chemistry systems.
Bronchodilator Product Performance
Theophylline is a bronchodilator used in the treatment of asthma, obstructive lung disease and neonatal apnea. The Thermo Scientific™ CEDIA® Theophylline II assay has a proven track record providing consistent, reliable results that you can count on.
ANTIARRHYTHMICS
Antiarrhythmics Product Performance
Assay RangeTotal Precision (%CV) Method Comparison (FPIA)
Low Medium High Slope InterceptCorrelation Coefficient
Theophylline 0.8-40 µg/mL 5.1 2.4 2.0 1.01 -0.41 0.997
Assay RangeTotal Precision (%CV) Method Comparison (FPIA)
Low Medium High Slope InterceptCorrelation Coefficient
Digoxin* 0.5-5.0 ng/mL 12.0 3.3 2.4 1.00 0.01 0.970Digitoxin* 3-50 ng/mL 11.8 8.8 3.1 1.04 -1.22 0.950Lidocaine 0.8-10 ng/mL 8.1 5.1 5.3 1.08 -0.10 0.986NAPA 0.6-30 ng/mL 7.4 4.1 2.9 1.04 0.18 0.994Procainimide 0.4-20 ng/mL 3.1 3.0 2.8 1.04 -0.01 0.991Quinidine 0.2-8.0 ng/mL 9.1 6.4 5.8 1.06 -0.21 0.978
*Run-to Run precision listed
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Thermo Scientific™ MAS™ third party quality controls are available for the TDM assays and provide an unbiased and independent assessment of the laboratory’s testing system. We are simplifying QC by providing:
• Products that are liquid, ready to use• Target levels optimized for all key analytes• Consolidated multi-consituent controls• Thermo Scientific™ MAS™ LabLink xL, an easy to use, real-time, web-based quality assurance program
MAS PAR TDM Controls
MAS Par TDM is a multi-constituent, assayed TDM control designed for use on automated analyzers. It is
liquid, ready to use and available in three distinct levels. Each level can be ordered separately.
QMS TDM Specialty Controls
These specialty controls are liquid, ready-to-use, human serum controls with low, medium and high ranges of the analytes. The controls come in kits containing three levels.
Refer to the catalog or webpage for our complete listing of controls.*Teicoplanin is not available for sale in the US.
MAS QUALITY CONTROLS
Part Number Description Kit Size PTD1-1001 Par TDM Level 1 6 x 5 mLPTD2-2002 Par TDM Level 2 6 x 5 mLPTD3-3003 Par TDM Level 3 6 x 5 mL
Part Number Description Kit Size 0374090 Lamotrigine Control Set 3 levels 1 x 2.5 mL each0374660 Teicoplanin Control Set* 3 levels 1 x 2.0 mL each0374181 Topiramate Control Set 3 levels 1 x 2.0 mL each0373373 Zonisamide Control Set 3 levels 1 x 2.0 mL each
Analytes
AcetaminophenAmikacinCaffeineCarbamazepineDigoxinDisopyramideEstriol
EthanolEthosuximideGentamicinLidocaineLithiumMethotrexateN-acetylprocainamide (NAPA)
PhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophylline
Thyroid Stimulating Hormone (TSH)Thyroxine, Total (TT4)TobramycinTricyclic AntidepressantsTriiodthyronine, Total (TT3)Valproic AcidVancomycin
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Consolidate all of your drug testing (TDM, as well as ISD and DAT, using MAS controls) on a single, compact, low volume platform. Indiko’s continually growing menu allows labs to perform on-demand specialty testing eliminating the need to send out samples or consume open channels on high throughput analyzers. The instruments have very low sample volume requirements (~12µL for most TDMs) resulting in more tests per kit. Additionally, it can use sample cups for low volume pediatric samples to full test tubes without designated racks. Vials can also be bar-coded for automatic patient result tracking. Indiko System Reagents provide the same accuracy, precision and sensitivity you can expect from all Thermo Scientific test kits.
Indiko applications are also available for Gabapentin, Levetiracetam and Methotrexate from ARK Diagnostics, Inc. Contact us for more information.
INDIKO / INDIKO PLUS
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Assay Type Assay Name TechnologyReagent Part
NumberCalibrator
Part NumberControl Part
Number
Antibiotic AmikacinQMS
Indiko QMS0373910 10017196
0374157 PTD1-1001 PTD2-2002 PTD3-3003
Antibiotic GentamicinCEDIA QMS
Indiko QMS
100016 10014390 10017107
100017
0373902
PTD1-1001 PTD2-2002 PTD3-3003
Antibiotic Teicoplanin*QMS
Indiko QMS0374645 10017211
0374652 0374660
Antibiotic Tobramycin Indiko QMS 10017109 0374116PTD1-1001 PTD2-2002 PTD3-3003
Antibiotic VancomycinQMS
Indiko QMS0373589 10017224
0373597PTD1-1001 PTD2-2002 PTD3-3003
Antiepileptic Carbamazepine CEDIA 100006 100007PTD1-1001 PTD2-2002 PTD3-3003
Antiepileptic LamotrigineQMS
Indiko QMS0373795 10017205
0373787 0374090
Antiepileptic Phenobarbital CEDIA 100003 100007PTD1-1001 PTD2-2002 PTD3-3003
Antiepileptic Phenytoin CEDIA 100002 100007PTD1-1001 PTD2-2002 PTD3-3003
Antiepileptic TopiramateQMS
Indiko QMS0374140 10017218
0374173 0374181
Antiepileptic Valproic Acid CEDIA 100013 100007PTD1-1001 PTD2-2002 PTD3-3003
Antiepileptic ZonisamideQMS
Indiko QMS0373571 10017230
0373381 0373373
Antiarrhythmics Digoxin DRI 1669 included in kitPTD1-1001 PTD2-2002 PTD3-3003
Antiarrhythmics Digitoxin CEDIA 100004 included in kit CAI-XL4
Antiarrhythmics Lidocaine QMS 0374686 0374678PTD1-1001 PTD2-2002 PTD3-3003
AntiarrhythmicsN-Acetylprocainamide
(NAPA)CEDIA 100015 100001
PTD1-1001 PTD2-2002 PTD3-3003
Antiarrhythmics Procainamide CEDIA 100014 100001PTD1-1001 PTD2-2002 PTD3-3003
Antiarrhythmics Quinidine QMS 0373936 0374165PTD1-1001 PTD2-2002 PTD3-3003
Bronchodilator Theophylline CEDIA 100008 100007PTD1-1001 PTD2-2002 PTD3-3003
Thermo Scientific Complete Solutions for Therapeutic Drug Monitoring
*Teicoplanin is not available for sale in the US.
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