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TM

Liquichek Therapeutic Drug Monitoring Control (TDM)


Levels 1, 2 and 3
724 Trilevel 12 x 5 mL
Level 1 27721
725 Level 1 12 x 5 mL
2019-11-30 27720 Level 2 27722
726 Level 2 12 x 5 mL
Level 3 27723
727 Level 3 12 x 5 mL
724X MiniPak 3 x 5 mL

http://www.myeinserts.com/27720

INTENDED USE LIMITATIONS


Liquichek Therapeutic Drug Monitoring Control (TDM) is intended for use as an 1. This product should not be used past the expiration date.
assayed quality control serum to monitor the precision of laboratory testing 2. If there is evidence of microbial contamination or excessive turbidity in the
procedures for the analytes listed in this package insert. product, discard the vial.
SUMMARY AND PRINCIPLE 3. This product is not intended for use as a standard.
The use of quality control materials is indicated as an objective assessment of 4. Dispenser Tips for Screw Caps are not approved for use with Desipramine.
the precision of methods and techniques in use and is an integral part of good WARNING
laboratory practices. Multiple levels of control are available to allow monitoring
of the test system’s reliability. Biological source material. Treat as potentially infectious.
For customers in Germany: Quality control materials are required for assessment Each human donor unit used to manufacture this product was tested by FDA
of laboratory performance as described in the “Guideline for Quality Assurance accepted methods and found non-reactive for Hepatitis B Surface Antigen
of Medical Laboratory Examinations following the German Medical Association” (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product
(Rili-BÄK regulation). may also contain other human source materials for which there are no approved
REAGENT tests. In accordance with good laboratory practice, all human source material
This product is prepared from human serum with added constituents of human should be considered potentially infectious and handled with the same
and animal origin, drugs, stabilizers and preservatives. This product is provided precautions used with patient specimens.
in liquid form for convenience. Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
STORAGE AND STABILITY SPECIFIC PERFORMANCE CHARACTERISTICS
This product will be stable until the expiration date when stored This product is a stabilized liquid product manufactured under rigid quality
unopened at -20 to -70°C. control standards. To obtain consistent assay values, the control requires proper
Thawed Unopened: When thawed and stored unopened at 2 to 8°C, this storage and handling as described.
product will be stable as follows: OPTIONAL SUPPLIES
- All Analytes: 180 days Item No. 987000 Dispenser Tips for Screw Caps (100/package).
Except: ASSIGNMENT OF VALUES
- Cortisol and Desipramine: 30 days The mean values and corresponding ±3SD ranges in the Assignment of Values
Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8°C, Data Charts (available separately) were derived from replicate analyses and are
this product will be stable as follows: specific for this lot of product. Data from Unity™ Interlaboratory Program are
- All analytes: 30 days included in the determination of some ranges. The tests listed were performed
Except: by the manufacturer and/or independent laboratories using manufacturer
- T3 (Free) and T3 (Total): 15 days supported reagents and a representative sampling of this lot of product. It is
- Diazepam: 24 hours recommended that each laboratory establish its own acceptable ranges and use
Avoid repeated freezing and thawing of this product. those provided only as guides. Laboratory established ranges may vary from
This product is shipped under frozen conditions. those listed during the life of this control. [Customers in Germany have to follow
PROCEDURE the requirements as described in the Rili-BÄK regulation.] Variations over time
This product should be treated the same as patient specimens and run in and between laboratories may be caused by differences in laboratory technique,
accordance with the instructions accompanying the instrument, kit, or reagent instrumentation and reagents, or by manufacturer test method modifications.
being used.
If the product has been stored frozen, allow it to stand at room temperature Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
(18 to 25°C) until it is completely thawed. Gently swirl the vial several times to holding more than 2 billion QC data points from thousands of laboratories.
ensure homogeneity. INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
If the product has been stored refrigerated, allow it to reach room temperature The Data Charts are available through the Internet, at
(18 to 25°C) before use. Before sampling, gently swirl the vial several times to www.myeinserts.com/27720. Follow the directions at the website to receive
ensure homogeneity. After each use promptly replace the stopper and return to email notifications of insert updates. Alternate methods for receiving data charts
2 to 8°C storage. are available by contacting your local Bio-Rad Laboratories Office.
Dispose of any discarded materials in accordance with the requirements of your
local waste management authorities. In the event of damage to packaging,
contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories
Technical Services.

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TM

Liquichek Therapeutic Drug Monitoring Control (TDM), Levels 1, 2 and 3


ANALYTES
Acetaminophen Digoxin Nortriptyline ❑ T4 (Free) ❑
Amikacin Disopyramide Phenobarbital T4 (Total)
Amitriptyline ❑ Estriol (Total) ❑ Phenytoin TCA Screen
Caffeine Ethosuximide Phenytoin (Free) Theophylline
Carbamazepine Flecainide ❑ Primidone Thyroid Stimulating Hormone (TSH)
Carbamazepine (Free) Gentamicin Procainamide Tobramycin
Chloramphenicol Haloperidol ❑ Propranolol Valproic Acid
Clonazepam ❑ Imipramine ❑ Quinidine Valproic Acid (Free)
Cortisol Lidocaine Salicylate Vancomycin
Cyclosporine ❑ Lithium T3 (Free)
Desipramine Methotrexate T3 (Total)
Diazepam N-Acetyl Procainamide (NAPA) T3 Uptake/T Uptake

NOTES
❑ No claim is made for expected value or stability of this analyte.

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© 2017 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2017-02 • 5176-00
TM

Liquichek Therapeutic Drug Monitoring Control (TDM), Levels 1, 2 and 3

Revision Date 2017-12-22 Indicates Revised Information

INSTRUMENT (1)
Level 1 - 27721 (2) Level 2 - 27722 (2) Level 3 - 27723 (2)
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (Enzymatic) (ACET) mg/dL 1.67 1.09 – 2.25 4.33 3.51 – 5.14 14.4 12.7 – 16.1
Carbamazepine (EIA) (CARB_2) µg/mL 3.86 2.59 – 5.13 8.83 6.58 – 11.1 12.3 8.75 – 15.9
Digoxin (Immunoturbidimetric) (DIG) ng/mL 0.507 <0.100 – 0.964 1.41 0.923 – 1.90 3.05 2.48 – 3.62
Gentamicin (EIA) (GENT_2) µg/mL 1.38 0.974 – 1.79 3.80 3.10 – 4.50 6.05 4.20 – 7.90
Lithium (Colorimetric) (LITH) mEq/L 0.840 0.595 – 1.09 1.72 1.38 – 2.07 2.67 2.21 – 3.13
Phenobarbital (EIA) (PHNB_2) µg/mL 10.9 6.71 – 15.1 31.4 22.2 – 40.5 54.8 40.1 – 69.4
Phenytoin (EIA) (PHNY_2) µg/mL 4.22 2.06 – 6.38 12.8 9.08 – 16.5 24.4 14.0 – 34.7
Salicylate (Enzymatic) (SAL) mg/dL 6.27 3.12 – 9.41 21.2 17.2 – 25.3 47.8 41.8 – 53.9
Theophylline (EIA) (THEO_2) µg/mL 5.62 3.67 – 7.57 14.0 9.60 – 18.4 27.1 17.9 – 36.3
Tobramycin (EIA) (TOB_2) µg/mL 1.38 0.917 – 1.85 3.32 2.82 – 3.81 5.48 4.62 – 6.35
Valproic Acid (EIA) (VPA_2) µg/mL 33.6 24.8 – 42.4 82.3 65.6 – 99.0 128 101 – 156
Vancomycin (EIA) (VANC_2) µg/mL § § §

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) A dilution should be made prior to running those tests where the value listed exceeds the highest standard.
(3) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
Data is not available at this time. Please inquire.
§ The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is
interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.

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