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TECO DIAGNOSTICS

1268 N. Lakeview Ave. Anaheim, CA 92807 1-800-222-9880

TC-TROL® SERUM CONTROL LEVEL II (HUMAN)

TECO SERUM CONTROL For monitoring the accuracy and precision of assay procedures commonly used in clinical chemistry. INTRODUCTION TC-Trol contains a broad range of electrolytes, enzymes, and metabolites of interest in a general chemistry control. The human serum control is to be used in the same manner that an unknown specimen would be used in accordance with the directions of the assay procedure. This control should be run to evaluate the performance of the assay procedure. REAGENT COMPOSITION This control serum is prepared from human serum with added constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. The control is provided in lyophilized form for increased stability. PRECAUTIONS Human serum was used in the manufacture of this product. Each donor unit used was tested with licensed reagents and found negative for HBsAg and HCV and nonreactive for the HIV antibody. Because no method can offer complete assurance that HIV virus, hepatitis B virus or other infectious agents are absent, it is recommended that this product be handled with the same precautions used for patient specimens. REAGENT PREPARATION 1. Remove the metal seal and rubber stopper from each vial to be used. 2. Reconstitute each vial with 5.0 mL distilled/deionized water. 3. Replace the stopper and allow the vial to sit 20 minutes, swirling occasionally. 4. Before removing sample for testing, gently rotate or swirl the vial several times to ensure homogeneity.

STORAGE AND STABILITY 1. This product will be stable until the expiration date when stored unopened at 2 - 8°C. 2. Once the control is reconstituted, all analytes will be stable for seven (7) days when stored tightly capped at 2 - 8°C with the following exceptions: Acid phosphatase, Total and Nonprostatic, will be stable for three (3) days when stored tightly capped at 2 - 8°C. 3. This product should not be used past the expiration date. REAGENT DETERIORATION 1. Failure to obtain accurate results in the assay of control materials may indicate reagent deterioration. 2. If there is evidence of microbial contamination or excessive turbidity in the reconstituted control, discard the vial. MATERIALS PROVIDED Serum Control Level II CALCULATION Please see "Calculation" section of the package insert of the assay procedure being used. PROCEDURE LIMITATION 1. Not compatible with O-Toluidine Glucose procedures. 2. High Creatinine bias with Jaffe methods. 3. Direct Bilirubin, AST and ALT levels may gradually increase during the product shelf life. 4. Erroneous results can occur from reconstitution inaccuracies and technical errors associated with the assay procedure. For more information, refer to the "Limitations of Procedure" section of the direction insert of the assay procedure being used. EXPECTED VALUES Listed values were obtained using Teco Test reagents, in date at the time of testing, with manual and automated procedures. Any changes in reagents or instrument parameters may yield values different from those listed. The Expected Range indicates deviations from the mean value which may be expected under different laboratory conditions.

Lot#:

15272

Exp. date:

03/2012

Revision Date: 09/01/09

3 37.0 511.5 10.4 103.UV P605 Potassium (Turbidimetric) S600 Sodium (Uranyl Acetate) T528 Total Protein (Biuret) T531 Triglyceride .9 4.3 8.Liquid G572 H620 HBDH I592 Iron I592 TIBC L533 Lactate Dehydrogenase Liquid L535 Lactate Dehydrogenase .2 36.2 50.0 134.5 152. # Test A591 Acid Phosphatase.6 278.* Target Rang: Cat.6 190.Color B576 Bilirubin-Total (Walters-Gerarde) B576 Bilirubin-Direct for D&T B577 Bilirubin-Total for D&T C503 Calcium C525 Carbon Dioxide C501 Chloride C507 Cholesterol (Enzymatic) liquid C509 Cholesterol (10 minute enzymatic) C511 Cholinesterase (PTC) .9 6.0 252.1 4.5 35. Non-Pros (a-Naphthylphosphate) A591 Acid Phosphatase.0 409.0 6.0 32.0 3.3 5.0 100.0 223.0 118. Inorganic .0 59.66 7.7 75.7 6.6 69.5 228.5 68.2 268.0 356.8 90.9 4.0 20.Urease/Kinetic B551 Blood Urea Nitrogen (BUN) .0 111.0 147.3 122.0 296.4 336.8 272.Color I516 Phosphorus.0 1946.3 426.7 7.6 95.6 59.7 47.0 228.6 85.5 36.9 7.0 2.0 129.9 256. Inorganic .1 33.4 2.0 288.1 298.28 5. 03/2012 Minimum Mean Maximum 4.3 56.0 24.8 95.0 176.59 3.96 6.4 348.0 6.2 4.8 3.7 279.Jaffe kinetic C515 Creatinine – Direct G516 Glucose – Hexokinase Liquid G518 Glucose – Hexokinase G519 Glucose – Oxidase G520 Glucose – Oxidase Liquid γ-GT (modified Szasz) .0 77.9 4.9 114. M527 Magnesium (Calmagite Dye) I515 Phosphorus.1 2.7 7.6 5.0 11.9 346.7 104.7 5.5 6.9 464.3 85.0 172.9 10.9 2.9 468.0 1751.0 237.9 12.6 45.8 86.0 360.0 47.7 54.3 144.8 2140.9 5.Kinetic C512 Creatine Kinase – NAC/kinetic-37°C C514 Creatinine .1 340.0 102.6 42.8 102.Urease/Kinetic liquid B550 Blood Urea Nitrogen (BUN) .Modified Wacker/Tris.7 403.8 94.Soluble G571 γ-GT (modified Szasz) .3 328.0 90.0 10.5 1.4 39.6 Unit U/L U/L g/dl U/L U/L U/L U/L U/L U/L U/L U/L mg/dl mg/dl mg/dl mg/dl mg/dl mg/dl mg/dl mg/dl mg/dl mEq/L mg/dl mg/dl U/L U/L mg/dl mg/dl U/L U/L mg/dl mg/dl mg/dl mg/dl U/L µg/dl µg/dl U/L U/L mEq/L mg/dl mg/dl mEq/L mEq/L g/dl mg/dl mg/dl mg/dl mg/dl Revision Date: 09/01/09 .4 228.1 146.0 186.9 3.9 371.3 334. Total (a-Naphthylphosphate) A502 Albumin (BCG) A505 Alkaline Phosphatase – Kinetic (37°C) A504 Alkaline Phosphatase – Kinetic (37°C) liquid A506 Alkaline Phosphatase – Color A524 Alanine Aminotransferase – Kinetic Liquid A525 Alanine Aminotransferase – Optimized Kinetic A533 Amylase – Kinetic A560 Aspartate Aminotransferase – Optimized Kinetic A561 Aspartate Aminotransferase – Color B538 Bilirubin-Direct (Diazo) B549 Blood Urea Nitrogen (BUN) .0 78.6 6.GPO T532 Triglyceride – GPO liquid U580 Uric Acid (uricase) U582 Uric Acid (uricase) liquid Lot #15272 Exp.6 9.0 32.0 268.2 3.9 56.27 333.91 9.3 97.9 7.4 1.6 29.4 301.9 8.4 208.4 8.7 5.5 2.0 23.9 1.3 6.0 16.0 222.0 340.0 557.1 96.