SAMPLE CALCULATION:
If the Mean Recovered value for Level 4 = 10.1, you can calculate Theoretical Values by multiplying 10.1 by the “Linearity Factor” associated with each level. For example
189 Twin County Rd. Morgantown, PA 19543
Therapeutic Drug Monitoring Linearity Test Set
INTENDED USE:
Therapeutic Drug Monitoring Test Sets are for in vitro diagnostic use in verifying
Level 4 = 10.1 X 1.0 10.10 9.87
reportable ranges and determining linearity in automated, semi-automated and manual
chemistry systems. The analytes included are Acetaminophen, Amikacin,
Carbamazepine, Digoxin, Disopyramide, Ethosuxmide, Gentamicin, Lidocaine, Lithium,
Methotrexate, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone,
In order to assess the linearity of a specific test method, plot results on standard linear
Procainamide, Qunidine, Salicylate, Theophyilline, Tobramycin, Valproic Acid, and
graph paper using “Theoretical” as X-axis and “Recovered” as Y-axis.
EXPECTED VALUES:
Therapeutic Drug Monitoring Linearity Test Sets are designed to be compatible with all
Each lot of product is manufactured in such a way that a linear relationship exists
popular chemistry analyzers, providing clinicians with 6 dilution levels, and 3 ampules of
between all levels. Actual results obtained may vary depending upon instrumentation
1ml each per level. They are manufactured such that a linear relationship exists
and methodology used, as well as assay temperature. Results may also depend upon
the accuracy of the instrument and reagent calibration. The degree of acceptable non-
linearity is an individual judgment based upon a test analyte’s methodology, clinical
significance and medical decision levels.
SUMMARY:
Therapeutic Drug Monitoring Linearity Test Sets are used to establish the relationship
Technicians are advised to consult the analytical limits defined by the Clinical
between theoretical and actual performance of specified analytes. This control set will
Laboratory Improvement Act of 1988 (CLIA ’88). These criteria specify the total error
assist in the documentation of linearity, calibration verification and verification of linear
allowed for most analytes in question, and they can be referenced at the following web
range required by many inspection agencies. The control solutions can also be used to
troubleshoot problems with chemistry systems, reagents, and / or calibration anomalies.
http://www.phppo.cdc.gov/clia/regs/subpart_i.aspx#493.931
INGREDIENTS:
Purified materials for Acetaminophen, Amikacin, Carbamazepine, Digoxin,
Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, Methotrexate, N-
Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Qunidine, Salicylate, Theophyilline, Tobramycin, Valproic Acid, and Vancomycin are stabilized and
STORAGE AND STABILITY:
When stored and refrigerated at 2 to 8° C, Therapeutic Drug Monitoring Linearity Test
Sets are stable until the expiration date printed on the ampule or vial. Opened ampulesmust be used within the same working day or else discarded. Dispose if gross INSTRUCTIONS FOR USE:
Therapeutic Drug Monitoring Linearity Test Sets are ready-to-use, and require no
reconstitution. Depending upon the range and sensitivity of your instrument’s test
method, you will be able to run a minimum of 4 prediluted levels, and a maximum of 6 for
a specific analyte. Materials contained herein should be treated in the same manner as patient samples. If additional dilutions or pre-treatment are required as part of your
testing procedure, please consult the user manual of your instrument’s manufacturer.
Before actual use, hold ampule by the top and shake gently. Then with light tapping,
restore all liquid to the bottom. Break open carefully to avoid cutting of fingers – using
the complementary ampule snapper provided with this test set. With pipette, aspirate
liquid from ampule and transfer to one or more sample cups.
Duplicate or triplicate runs are advised when performing calibration verification.
CALCULATION OF RESULTS:
Users of our Linearity Test Sets are strongly advised to calculate their results via Azer
REORDERING INFORMATION:
Scientific’s free data reduction service. The computational method and graphical
analyses deployed in our reports are far more rigorous than the manual procedures
Therapeutic Drug Monitoring Linearity Test Set
outlined below. In addition, we can save clinicians considerable time by performing all of
their calculations for them at no cost. Simply enter data into our customized MS Excel
spreadsheets, and email them to the address provided. Spreadsheets can be obtained
by emailing us at the following address:
For technical assistance or to place an order, please
If performing calculations manually, however, the following considerations will apply.
After sampling each level in duplicate or triplicate, calculate a Mean Recovered Value for each, and record in the worksheet space provided. Theoretical Values for each level
can be obtained by multiplying the Mean Recovered Value of Level 4 with the “Linearity Linearity Factors
189 Twin County Rd. Morgantown, PA 19543
Azer Scientific Therapeutic Drug Monitoring Linearity Test Set Free Data-Reduction Service: For more info, please contact us at info@azersci.com ANALYTE – Procainamide ANALYTE – Gentamicin Cat. No.: ES5030 Lot#: _________________ Expiration Date: ________________________ Documentation Date: ___________________ ANALYTE – Quinidine ANALYTE – Lidocaine THERAPEUTIC DRUG LINEARITY FACTORS ALL OTHER ANALYTES ANALYTE – Salicylate ANALYTE – Lithium ANALYTE – Acetaminophen ANALYTE – Theophyilline ANALYTE – Methotrexate ANALYTE – Amikacin ANALYTE – Tobramycin ANALYTE – N-Acetylprocainamide ANALYTE – Carbamazepine ANALYTE – Valproic Acid ANALYTE – Phenobarbital ANALYTE – Digoxin ANALYTE - Vancomycin ANALYTE – Phenytoin ANALYTE – Disopyramide ANALYTE – ____________________ ANALYTE – Primidone ANALYTE – Ethosuximide Azer Scientific Therapeutic Drug Monitoring Linearity Test Set Free Data-Reduction Service: For more info, please contact us at info@azersci.com
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SAMPLE CALCULATION: