Anaheim, CA 928071-800-222-9880

1268 N. Lakeview Ave.TECO DIAGNOSTICS

TC-TROL®

SERUM CONTROL LEVEL I (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 Non-prostatic, 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#: 15271 Exp. date: 03/2012 TCTROL-N: 08/09

Revision Date: 09/01/2009

Revision Date: 09/01/2009

The Target Range: Cat. # Test Minimum Mean Maximum Unit A591 Acid Phosphatase, Non-Pros (a-Naphthylphosphate) 1.4 2.0 2.8 U/L A591 Acid Phosphatase, Total (a-Naphthylphosphate) 3.6 4.6 5.5 U/L A502 Albumin (BCG) 3.0 3.7 4.4 g/dl A505 Alkaline Phosphatase – Kinetic (37°C) 59.3 85.0 110.2 U/L A504 Alkaline Phosphatase – Kinetic (37°C) liquid 68.0 85.0 102.0 U/L A506 Alkaline Phosphatase – Color 9.0 11.4 13.7 U/L A524 Alanine Aminotransferase – Kinetic Liquid 23.0 29.0 35.0 U/L A525 Alanine Aminotransferase – Optimized Kinetic 24.8 31.0 38.0 U/L A533 Amylase – Kinetic 51.7 57.0 63.2 U/L A560 Aspartate Aminotransferase – Optimized Kinetic 26.4 39.0 52.0 U/L A561 Aspartate Aminotransferase – Color 77.4 86.0 95.0 U/L B538 Bilirubin-Direct (Diazo) 0.0 0.4 0.8 mg/dl B549 Blood Urea Nitrogen (BUN) - Urease/Kinetic liquid 11.3 14.1 17.0 mg/dl B550 Blood Urea Nitrogen (BUN) - Urease/Kinetic 11.2 14.0 16.8 mg/dl B551 Blood Urea Nitrogen (BUN) - Color 7.9 8.7 9.5 mg/dl B576 Bilirubin-Total (Walters-Gerarde) 0.4 1.2 1.9 mg/dl B576 Bilirubin-Direct for D&T 0.2 0.6 1.2 mg/dl B577 Bilirubin-Total for D&T 0.2 1.5 2.8 mg/dl C503 Calcium 7.2 8.0 8.8 mg/dl C525 Carbon Dioxide 24.6 30.8 36.9 mg/dl C501 Chloride 77.2 99.0 110.9 mEq/L C507 Cholesterol (Enzymatic) liquid 220.9 245.5 270.0 mg/dl C509 Cholesterol (10 minute enzymatic) 210.0 234.0 257.4 mg/dl C511 Cholinesterase (PTC) - Kinetic 1448.0 1607.0 1767.0 U/L C512 Creatine Kinase – NAC/kinetic-37°C 105.5 131.9 158.2 U/L C514 Creatinine - Jaffe kinetic 0.97 1.63 2.28 mg/dl C515 Creatinine – Direct 2.73 4.05 5.37 mg/dl G516 Glucose – Hexokinase Liquid 75.0 94.0 112.4 U/L G518 Glucose – Hexokinase 75.0 99.0 124.0 U/L G519 Glucose – Oxidase 71.0 88.9 106.7 mg/dl G520 Glucose – Oxidase Liquid 69.7 87.2 104.6 mg/dl G571 γ-GT (modified Szasz) - Soluble 23.7 29.6 35.5 mg/dl G572 γ-GT (modified Szasz) - Liquid 22.6 28.2 33.9 mg/dl H620 HBDH 100.4 118.1 135.8 U/L I592 Iron 127.0 167.0 207.0 µg/dl I592 TIBC 233.0 291.0 349.0 µg/dl L533 Lactate Dehydrogenase Liquid 115.0 143.8 172.5 U/L L535 Lactate Dehydrogenase - Modified Wacker/Tris. 114.8 143.5 172.2 U/L M527 Magnesium (Calmagite Dye) 1.0 1.4 1.7 mEq/L I515 Phosphorus, Inorganic - Color 3.0 3.7 4.4 mg/dl I516 Phosphorus, Inorganic - UV 2.6 3.0 3.4 mg/dl P605 Potassium (Turbidimetric) 3.7 4.3 4.7 mEq/L S600 Sodium (Uranyl Acetate) 103.0 115.0 126.0 mEq/LT528 Total Protein (Biuret) 4.7 5.9 7.0 g/dl T531 Triglyceride - GPO 137.7 172.0 206.5 mg/dl T532 Triglyceride – GPO liquid 121.6 162.2 202.7 mg/dl U580 Uric Acid (uricase) 4.0 5.0 6.1 mg/dl U582 Uric Acid (uricase) liquid 4.3 5.4 6.4 mg/dl Lot #15271 Exp. 03/2012