Microsoft word - tdm linearity insert azer

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 ampules must 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

Source: http://www.azerscientific.com/Product%20Inserts/TDM%20Linearity%20Insert%20Azer.pdf