BI – LEVEL URINE METALS
URINE TOXICOLOGY CONTROL
I.
INTENDED USE:
Many metals can be measured or detected in patients by using analytical test methods. The UTAK Bi – Level Urine Metals Control is for
use as a quality control material for measuring metal levels in urine. It is intended for use on a continuous basis so that a statistical
evaluation of testing performance can be obtained.
II.
VIII. EXPECTED VALUES:
1. Listed in the table below are the Reference Value and the Expected Range; the Reference Value is derived from replicate analysis
performed by independent laboratory testing.
2. The Reference Value is determined by Ion Selective Electrode (ISE), Inductively Coupled Plasma / Mass Spectrometry (ICP/MS),
Inductively Coupled Plasma / Optical Emission Spectroscopy (ICP/OES), and Calorimetric Method (JAFFE).
3. Laboratories should establish their own mean values; an individual laboratory's mean of several determinations may not duplicate
the values listed below, but should fall within the Expected Range.
SUMMARY AND PRINCIPLES:
URINE METALS
Several different techniques are used for evaluating or estimating the variance of results. The three subjects summarized below must be
considered with any test method.
12111
Normal Range
1. PREVENTIVE MEASURES:
These measures are usually contained in the design of the test method and include consideration for reagents, equipment, and
operator errors. These measures are designed to minimize variance.
2. QUALITY CONTROL MEASURES:
When a quality control sample is analyzed at the same time and in the same manner as a patient specimen, an estimate of
variance is obtained for the test method. This estimate of variance can be compared to the acceptable limits of variance of the
test method.
3. STATISTICAL ANALYSIS OF PATIENT RESULTS:
As an aid in evaluating overall test results, the past experience of expected results can be compared to the results of any given
test run. For example, it would not be expected that all results of a given test run be in an elevated range.
Quality control materials are widely used as a means to aid in the evaluation of test results. The following subjects are to be considered
in the use of any control material.
1.
2.
3.
4.
5.
Multi-Level
Matrix
Availability
Form
Variety
(NORMAL / ELEVATED)
(HUMAN / ANIMAL / CHEMICAL)
(SUFFICIENT FOR STATISTICS)
(LIQUID / FROZEN / DRIED)
(DIFFERENT THAN CALIBRATORS)
The UTAK Bi – Level Urine Metals Control is prepared from normal human urine and will generate data that checks and evaluates the
results of a test method over the normal and elevated ranges. The principles of statistics require that the same material be available for
comparison for any given time period. Dried control materials both extend the usable time period and allow larger quantities to be
available. Statistical accuracy requires that a test method be defined for variance and be calibrated with a suitable standard. The quality
control materials that are used must be of a sufficient variety so that the measurements and the data that are obtained are independent
of the calibration standards. By using a variety of materials, the entire test method can be continuously evaluated to insure reliable
results.
III.
PRODUCT DESCRIPTION:
The matrix for the UTAK Bi – Level Urine Metals Control is prepared from normal human urine. The metal concentrations are adjusted to
the desired concentration range for each lot prepared. Quality control before, during, and after the preparation of the control material
ensures that each lot is of the same quality. The listed values are obtained by quantitative analytical methods.
IV.
PRECAUTIONS:
1. Although the urine donors have been tested and found negative for HBsAg by RIA and HIV by EIA, the control material should be
treated as any other potentially infectious agent.
2. For in vitro diagnostic use only.
Lot Number : A5883
Expiration Date : 08/18
Analyte
Method
Aluminum
ICP/MS
Arsenic
ICP/MS
Cadmium
ICP/MS
Calcium
ICP/OES
Chromium
ICP/MS
Cobalt
ICP/MS
Copper
ICP/MS
Creatinine
JAFFE
Fluoride
STORAGE AND STABILITY:
1. Store dried control material at 2-8C (35-46F). Stable to expiration date printed on the insert and label.
PROCEDURE:
1. Remove cap from each vial to be used.
2. Reconstitute control material by adding exactly 5.0 mL of a 1% Hydrochloric Acid Solution, using a 5 mL volumetric pipette or
equivalent. Avoid contamination of control material by using metal-free pipettes and dilutors.
3. Replace cap and let sit 10-15 minutes.
4. Swirl gently 3-4 minutes to ensure a homogeneous mixture.
Reference Value Expected Range Reference Value Expected Range
5.75 g/L
4.9-6.6
35.15 g/L
29.9-40.4
(0.21 mol/L)
9.43 g/L
(0.13 mol/L)
0.024 g/L
(0.21 nmol/L)
(0.18-0.25)
8.0-10.8
(0.11-0.14)
(1.30 mol/L)
107.4 g/L
(1.43 mol/L)
0.02-0.03
4.62 g/L
(0.18-0.25)
(41.1 nmol/L)
(1.11-1.50)
91.3-123.5
(1.22-1.65)
3.9-5.3
(34.9-47.3)
79.3 mg/L
67.4-91.2
432 mg/L
367-497
(2.0 mmol/L)
(1.68-2.28)
(10.8 mmol/L)
2.5-3.38
9.42 g/L
(9.2-12.4)
(56.5 nmol/L)
(48.1-65.0)
(181.2 nmol/L)
0.89-1.21
7.50 g/L
(154-208)
(17.8 nmol/L)
(15.1-20.5)
(127.3 nmol/L)
(108.2-146.4)
2.94 g/L
1.05 g/L
123.3 g/L
104.8-141.8
164.8 g/L
6.4-8.6
140.1-189.5
1.21 g/L
1.03-1.39
2.25 g/L
1.9-2.6
(10.7 mmol/L)
(9.1-12.3)
(19.9 mmol/L)
(16.9-22.9)
ISE
(22.1 mol/L)
(18.8-25.4)
(39 mol/L)
(33.1-44.8)
Iron
ICP/OES
(0.14 mol/L)
(0.12-0.16)
Lead
ICP/MS
Manganese
ICP/MS
Mercury
ICP/MS
Molybdenum
ICP/MS
Nickel
ICP/MS
Selenium
ICP/MS
Vanadium
ICP/MS
Zinc
ICP/MS
5. Swirl gently each time an aliquot is removed to ensure a homogeneous mixture.
(1.94 mol/L)
8.0-10.8
(2.59mol/L)
2. Store reconstituted control material at 2-8C (35-46F). Stable for 30 days after reconstitution.
VI.
Lot Number : A5882
Expiration Date : 08/18
(1.65-2.23)
3. For analytical use only.
V.
12110
High Range
420 g/L
8.0 g/L
357-483
6.8-9.2
740 g/L
(2.20-2.98)
629-851
470 g/L
400-541
(8.42 mol/L)
(7.2-9.7)
0.26 g/L
0.22-0.30
126.1 g/L
107-145
(1.25 nmol/L)
(1.07-1.44)
(608.8nmol/L)
2.21 g/L
(517.5-700.1)
1.01-1.37
(21.7 nmol/L)
(18.4-24.9)
(40.2 nmol/L)
0.07-0.10
49.2 g/L
(34.2-46.3)
(0.41 nmol/L)
(0.35-0.48)
(245.2 nmol/L)
(208.4-282.0)
(0.81 mol/L)
(0.69-0.93)
(1.06 mol/L)
4.14 g/L
3.52-4.76
35.7 g/L
30.3-41.0
(70.5 nmol/L)
(60.0-81.1)
(607.8 nmol/L)
(516.6-698.9)
1.19 g/L
0.083 g/L
77.8 g/L
55.2 g/L
(0.70 mol/L)
0.12 g/L
66.1-89.5
46.9-63.4
(0.59-0.80)
101.8 g/L
78 g/L
86.5-117.0
(0.90-1.22)
66.3-89.7
(0.84-1.14)
(143.0-193.5)
0.10-0.14
8.57 g/L
(2.0-2.7)
(168.2 nmol/L)
535g/L
455-616
(7.0-9.4)
41.8-56.6
(0.99 mol/L)
(2.4 nmol/L)
(8.2 mol/L)
1.88-2.54
1082 g/L
(16.5 mol/L)
7.3-9.9
920-1244
(14.1-19.0)
6. Assay control material in same manner as patient specimens, following the exact same instructions from the entire test method.
UTAK's express and implied warranties (including merchantability and fitness) are conditioned on the observance of UTAK's insert directions with respect to the use of UTAK's
products.
7. Record the results obtained on a quality control chart that describes the statistical limits for the test method and the particular lot of
control material.
UTAK LABORATORIES, INC.
PRODUCT NUMBER:
EC AUTHORIZED REPRESENTATIVE
25020 AVENUE TIBBITTS
VALENCIA, CA 91355
TEL: (661) 294-3935
FAX: (661) 294-9272
E-MAIL: [email protected]
12110, HIGH RANGE
12111, NORMAL RANGE
DFID: LUTE
5X5ML VIALS, DRIED
EMERGO EUROPE
MOLENSTRAAT 15
2513 BH, THE HAGUE
THE NETHERLANDS
VII. LIMITATIONS:
1. Control material is for use in quality control programs only; it is not intended for use as a calibration standard.
For technical assistance call: UTAK Technical Service (800) 235-3442
2. Check the lot number on each vial to be sure it corresponds to the lot number printed on the insert.
3. Results are dependent upon proper storage, reconstitution accuracy, and adequate mixing.
4. Control material approximates a patient specimen; it has not been assayed for any analytes not listed in the table below.
FM-75-05-07.36
Revision B
04/14