for therapeutic drug monitoring

Thermo Scientific TDM Assays
for Therapeutic Drug Monitoring
Complete solutions
for therapeutic drug monitoring
TDM tests provide quantitative results to ensure beneficial therapeutic
effects by determining the drug concentration in blood.
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.
Toxicity
Plasma or Serum
Concentration of the Drug
TDM
Desired Effect
Lack of Efficacy
Jain, K.K., Therapeutic Drug Monitoring Technologies, Companies and Markets, Jain PharmaBiotech, Basel, Switzerland ,
Tech Report, p.14. February 2012.
2
ANTIBIOTICS
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 Product Performance
Total Precision (%CV)
Amikacin
Gentamicin (CEDIA)
Gentamicin (QMS)
Teicoplanin*
Tobramycin
Vancomycin
Assay Range
Low
Medium
High
1.5-50 µg/mL
0.24-12 µg/mL
0.3-10 µg/mL
3-100 µg/mL
0.4-10 µg/mL
2.5-100 µg/mL
9.9
6.20
3.9
5.8
7.60
8.8
6.2
4.10
3.6
4.8
4.20
6.2
6.3
3.00
2.8
5.0
4.30
5.1
Method Comparison
Comparison
Method
FPIA
FPIA
FPIA
FPIA
FPIA
FPIA
Slope
Intercept
1.00
1.04
1.02
0.93
0.98
1.03
0.25
-0.08
0.41
0.29
-0.09
1.12
Correlation
Coefficient
0.992
0.993
0.997
0.980
0.984
0.970
*Teicoplanin is not available for sale in the US.
3
ANTIEPILEPTICS
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.
Antiepiletptics Product Performance
Total Precision (%CV)
Assay Range
Carbamazepine
Lamotrigine
Phenobarbital
Phenytoin*
Topiramate
Valproic Acid
Zonisamide
0.5-20 µg/mL
2.0-40 µg/mL
1.2-80 µg/mL
0.6-40 µg/mL
1.5-32 µg/mL
3-150 µg/mL
3-50 µg/mL
Low
Medium
High
3.5
2.8
5.3
5.1
4.2
3.4
8.3
2.0
2.0
3.8
3.1
3.4
2.0
7.9
1.7
2.4
3.6
2.3
4.4
1.8
7.5
Method Comparison
Comparison
Method
FPIA
HPLC
FPIA
FPIA
FPIA
FPIA
HPLC
Slope
Intercept
1.00
1.03
1.08
1.00
0.96
1.08
0.92
0.87
0.11
-2.01
-0.19
0.23
-0.61
1.67
Correlation
Coefficient
0.986
0.960
0.988
0.998
0.986
0.972
0.910
*Run-to Run precision listed
4
ANTIARRHYTHMICS
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.
Antiarrhythmics Product Performance
Total Precision (%CV)
Assay Range
Digoxin*
Digitoxin*
Lidocaine
NAPA
Procainimide
Quinidine
0.5-5.0 ng/mL
3-50 ng/mL
0.8-10 ng/mL
0.6-30 ng/mL
0.4-20 ng/mL
0.2-8.0 ng/mL
Low
Medium
High
12.0
11.8
8.1
7.4
3.1
9.1
3.3
8.8
5.1
4.1
3.0
6.4
2.4
3.1
5.3
2.9
2.8
5.8
Method Comparison (FPIA)
Correlation
Slope Intercept
Coefficient
1.00
0.01
0.970
1.04
-1.22
0.950
1.08
-0.10
0.986
1.04
0.18
0.994
1.04
-0.01
0.991
1.06
-0.21
0.978
*Run-to Run precision listed
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.
Total Precision (%CV)
Assay Range
Theophylline
0.8-40 µg/mL
Low
Medium
High
5.1
2.4
2.0
Method Comparison (FPIA)
Correlation
Slope Intercept
Coefficient
1.01
-0.41
0.997
5
MAS QUALITY CONTROLS
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.
Part Number
PTD1-1001
PTD2-2002
PTD3-3003
Description
Par TDM Level 1
Par TDM Level 2
Par TDM Level 3
Kit Size
6 x 5 mL
6 x 5 mL
6 x 5 mL
Analytes
Acetaminophen
Amikacin
Caffeine
Carbamazepine
Digoxin
Disopyramide
Estriol
Ethanol
Ethosuximide
Gentamicin
Lidocaine
Lithium
Methotrexate
N-acetylprocainamide (NAPA)
Phenobarbital
Phenytoin
Primidone
Procainamide
Quinidine
Salicylate
Theophylline
Thyroid Stimulating Hormone (TSH)
Thyroxine, Total (TT4)
Tobramycin
Tricyclic Antidepressants
Triiodthyronine, Total (TT3)
Valproic Acid
Vancomycin
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.
Part Number
0374090
0374660
0374181
0373373
Description
Lamotrigine Control Set
Teicoplanin Control Set*
Topiramate Control Set
Zonisamide Control Set
Kit Size
3 levels 1 x 2.5 mL each
3 levels 1 x 2.0 mL each
3 levels 1 x 2.0 mL each
3 levels 1 x 2.0 mL each
Refer to the catalog or webpage for our complete listing of controls.
*Teicoplanin is not available for sale in the US.
6
INDIKO / INDIKO PLUS
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.
7
Thermo Scientific Complete Solutions for Therapeutic Drug Monitoring
Reagent Part Calibrator
Number
Part Number
Control Part
Number
PTD1-1001
PTD2-2002
PTD3-3003
Assay Type
Assay Name
Technology
Antibiotic
Amikacin
QMS
Indiko QMS
0373910
10017196
Antibiotic
Gentamicin
CEDIA
QMS
Indiko QMS
100016
10014390
10017107
0373902
PTD1-1001
PTD2-2002
PTD3-3003
Antibiotic
Teicoplanin*
QMS
Indiko QMS
0374645
10017211
0374652
0374660
Antibiotic
Tobramycin
Indiko QMS
10017109
0374116
Antibiotic
Vancomycin
QMS
Indiko QMS
0373589
10017224
0373597
Antiepileptic
Carbamazepine
CEDIA
100006
100007
Antiepileptic
Lamotrigine
QMS
Indiko QMS
0373795
10017205
0373787
Antiepileptic
Phenobarbital
CEDIA
100003
100007
Antiepileptic
Phenytoin
CEDIA
100002
100007
Antiepileptic
Topiramate
QMS
Indiko QMS
0374140
10017218
0374173
0374181
Antiepileptic
Valproic Acid
CEDIA
100013
100007
PTD1-1001
PTD2-2002
PTD3-3003
Antiepileptic
Zonisamide
QMS
Indiko QMS
0373571
10017230
0373381
0373373
Antiarrhythmics
Digoxin
DRI
1669
included in kit
Antiarrhythmics
Digitoxin
CEDIA
100004
included in kit
Antiarrhythmics
Lidocaine
QMS
0374686
0374678
Antiarrhythmics
N-Acetylprocainamide
(NAPA)
CEDIA
100015
100001
Antiarrhythmics
Procainamide
CEDIA
100014
100001
Antiarrhythmics
Quinidine
QMS
0373936
0374165
Bronchodilator
Theophylline
CEDIA
100008
100007
0374157
100017
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
0374090
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
CAI-XL4
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
PTD1-1001
PTD2-2002
PTD3-3003
*Teicoplanin is not available for sale in the US.
8
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