®
LEADCARE Blood Lead Test Kit
For use with LEADCARE Blood Lead Testing System to test for lead in
whole blood
For in vitro diagnostic testing (external use only)
Please read the LEADCARE User’s Guide before performing any blood
lead testing with the LEADCARE Blood Lead Testing System.
Need Help? Need Assistance?
Call the LEADCARE Product Support
toll free number 1-800-275-0102
Intended Use
The LEADCARE Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for
the quantitative measurement of lead in fresh whole blood. This product is for
professional use only. Sensors and Treatment Reagent of the Test Kit are specific for
lead only. Contents of this LEADCARE Blood Lead Test Kit must only be used with a
LEADCARE Analyzer and Blood Lead Testing System.
situations where eye contact; skin irritation or burn; or difficulty breathing occurs.
You MUST wear gloves, lab coats, and safety glasses when handling blood and
using the LeadCare II System. Consult the established policy of your organization for
proper laboratory protection.
TESTING PROCEDURE:
Refer to your LEADCARE User’s Guide for detailed test instructions.
NOTE: Properly calibrate the Analyzer with the Calibration Button that comes with each
Test Kit. Use the Calibration Button only with the Test Kit with which it came. Calibrate
the Analyzer before running any tests. The Sensor Holder MUST be attached to the
Analyzer for proper results.
MATERIALS PROVIDED IN THE TEST KIT:
Sensors
Treatment Reagent tubes
Pipette Tips
Calibration Button
48
48
96
1
MATERIALS REQUIRED BUT PROVIDED WITH THE ANALYZER:
Analyzer with Sensor Holder (using a battery or the AC Adapter)
50 µL pipette
LEADCARE User’s Guide
How the LEADCARE Blood Lead Testing System Works
MATERIALS REQUIRED BUT NOT PROVIDED:
REAGENTS:
Sensor Composition: The active electrode area in each Sensor contains a small
CALIBRATION
The LEADCARE System relies on electrochemistry and a unique sensor to detect lead in
whole blood. Most lead is carried in red blood cells. When a sample of whole blood is
mixed with Treatment Reagent, the lead in red blood cells is removed and made
available for detection. When a test is run, the analyzer causes the lead to collect on the
LEADCARE sensor. After a period of time, the Analyzer removes this lead and measures
it and converts the result into a displayed blood lead result.
amount of gold particles in an inert matrix.
Treatment Reagent Composition: The Treatment Reagent contains 250 µL of a
dilute hydrochloric acid solution in water (0.1 mol/L).
STORAGE AND HANDLING:
The Test Kit contains an expiration date. The end of the Test Kit box shows the printed
expiration date. Do NOT use the Test Kit past the expiration date as results could be in
error. NOTE: The Treatment Reagent and the Sensors have separate expiration
dates. Observe the expiration date on the kit box as this is the earliest one.
To keep the Test Kit fresh, observe the following:
• Store in a cool, dry place. Storage temperature should be between 60°-80°F (15°
27°C). Do NOT freeze or refrigerate.
• Store away from direct sunlight.
• Use Sensors immediately upon removing from the package. Repackage the
remaining unused Sensors at once to keep them fresh.
• Use the Treatment Reagent immediately after opening the tube.
• Do NOT touch the active electrode area of the Sensor (the "kidney" shaped spot).
This could damage the Sensor.
• Do NOT place any object in the Treatment Reagent other than a pipette tip.
Contamination could occur.
• Analyze the blood and Treatment Reagent mixture immediately after placing it on the
Sensor.
• Do NOT use Sensors and Treatment Reagent past their expiration date.
Specimen Collection and Handling2
• Use only fresh whole blood. Use the blood within 24 hours of collection. Store at
50°-90°F (10°-32°C).
• Do NOT use plasma or serum.
• Do NOT refrigerate the whole blood.
• A sufficient whole blood sample may be obtained from a skin puncture (for example a
finger stick) or from a venipuncture.
• Proper preparation of the puncture area is important. The puncture site should be
washed and wiped clean, for example with an alcohol wipe or equivalent.
• Use only heparin or EDTA as anticoagulants. If you use EDTA collection tubes, they
must be at least one quarter full. Otherwise you could obtain falsely lower blood lead
results.
• Make sure to properly mix the blood before obtaining the measured sample for the
blood lead test.
• Make sure the blood sample does not contain clots. Blood clots can lead to erroneous
blood lead results.
PRECAUTIONS:
Handle all products and objects containing human blood as if capable of transmitting
diseases. Follow established recommendations for prevention of blood-borne
transmissible diseases. For example, consult the "Universal Precautions" issued by the
U.S. Public Health Service, Centers for Disease Control. Your organization should have
an infectious disease control program. It should cover the storage, handling, and disposal
of blood samples.3 Do this before performing any blood lead analyses. You MUST wear
gloves. Lab coats, safety glasses, gloves, etc., should also be worn when handling blood
and using the LEADCARE System. Follow the established policy of your organization for
proper laboratory protection. CAUTION – contains 0.34M Hydrochloric Acid which
may cause eye, skin, and respiratory system irritation. Avoid contact with skin, eyes
and clothing. In case of accidental contact immediately flush skin and eyes in
running water for up to 15 minutes and move to fresh air. Seek medical assistance in
Blood collecting devices (such as lancets, blood collection tubes,
capillaries, etc.)
Alcohol wipes
Gauze pads
Gloves
High and Low Controls that span the medically relevant ranges
The LEADCARE Analyzer MUST be calibrated for each new Test Kit. Use only the
Calibration Button that comes with the Test Kit currently in use. Make sure that the
Calibration Code on the Calibration Button matches the lot number of the Test Kit and
that of the Sensors.
1. Turn on Analyzer
• Wait for SELF TEST to finish
• Press START again when display shows last blood lead result
2. Calibrate Analyzer
• Touch Calibration Button to the Calibration Button Reader on the Analyzer
• Hold Calibration Button to the reader until Analyzer "beeps"
• Display will show calibration code printed on Calibration Button
• Make sure this code matches that on Calibration Button for the Test Kit being used
• Press START button on Analyzer; it will now display READY
• Analyzer is now calibrated and ready for a blood lead test
BLOOD LEAD TEST PROCEDURE
1. Turn on Analyzer (if necessary)
• Wait for SELF TEST to finish
• Display will show last blood lead level. Press START.
• Display will show CALIBRATION and current calibration code
• Make sure this code matches that on Calibration Button for the Test Kit being used
• Press START again. Display will show READY.
2. Obtain whole blood sample1,2
• Use either a capillary or blood collection tube
• Use either heparin or EDTA as the anticoagulant. (EDTA tubes MUST be at least one
quarter full.)
3. Measure blood sample
• Thoroughly mix blood sample
• Measure a 50 µL whole blood sample
• Wipe off end of measuring device with a clean gauze pad
NOTE: The accuracy and precision of the test depend on accurately measuring a 50 µL
blood sample. Make sure to carefully measure the blood sample.
4. Mix blood sample with Treatment Reagent
• Place Treatment Reagent tube upright
• Remove cap and place it upright. Do not allow the inside part of the cap to touch
anything.
• Dispense 50 µL blood sample into Treatment Reagent tube
• Recap Treatment Reagent and mix thoroughly until it turns brown
• Stand tube upright for at least a minute
NOTE: The accuracy of the blood lead test depends on properly transferring exactly 50 µL
of blood into the Treatment Reagent.
5. Apply Treatment Reagent and blood mixture to Sensor
• Remove Sensor from package
• Place Sensor into Sensor Holder part way so that active area is outside of Sensor
Holder
• Transfer about 50 µL blood mixture to active area of Sensor with pipettor
• Carefully place the blood mixture on the Sensor using a circular motion of the
pipette.
NOTE: Be sure to cover the entire active area (the area inside the “kidney” shaped
region).
6. Run test
• Push Sensor with blood mixture rest of way into Sensor Holder
• Push START
• Blood lead test result displayed after three minutes
• After test is completed, remove used Sensor and dispose of it and other waste
properly
TEST RESULTS:
The Analyzer's display window shows the blood lead result. The result is in micrograms
(µg) of lead per deciliter (dL) of whole blood. No calculation is needed. Results are
displayed to one decimal place. The range of the test is 1.4 to 65 µg/dL. "HI" in the
display window indicates a blood lead test result greater than 65.0 µg/dL. If this occurs,
report blood lead result as greater than (>) 65 µg/dL.
IMPORTANT: Report blood lead results to the proper state or federal agency.
EXPECTED RESULTS:
In 2012, the Centers for Disease Control (CDC) established 5µg/dL as the new
"reference level" for lead in blood, a change from the previously utilized "level of
concern" of 10µg/dL. The reference level is based on the U.S. population ages 1-5
years who are in the top 2.5% of children when tested for blood lead.6 Consult your
local public health department, or the CDC, for further information on actions to be
taken for blood lead results that are greater than 5µg/dL.
Questionable Results
Incorrect high or low test results may have an adverse medical outcome. If test results
are questionable or inconsistent, follow the suggestions below:
1. Make sure the expiration date of the kit has not passed. (See end of kit box.)
2. Check that the Analyzer is properly calibrated. It must be calibrated with the
Calibration Button for the kit contents being used.
3. Check the Analyzer and kit contents using proper control material. Acceptable
performance is assured if results of the controls are within the proper range.
4. If the above steps result in unacceptable performance, see the LEADCARE User's
Guide for further steps to be taken (see section 5, CLEANING, TROUBLESHOOTING,
DISPLAY CODES).
Maintenance
The LEADCARE System needs very little maintenance. Follow the maintenance
procedures listed in your User’s Guide (see section 5, CLEANING,
TROUBLESHOOTING, DISPLAY CODES).
Quality Control
You should check the performance of the LEADCARE System using appropriate control
material:
• On each new lot of Test Kits received
• On each new shipment of Test Kits received
• If you suspect that the Test Kit may not have been stored properly
• At any time you think that the system may not be working properly
Results obtained on control samples that are within the expected ranges means that
your LEADCARE System is operating properly. Refer to the LEADCARE User's Guide for
additional important information regarding quality control.
Note for U.S. Users: CLIA regulations require laboratories to perform and document
control procedures using at least two levels of Quality Controls each day of testing.
Limitations of the Test
• Use only fresh, unrefrigerated whole blood within 24 hours stored at 50°-90°F
(10°-32°C) with the LEADCARE System. Do NOT use plasma or serum.
• After mixing the blood with the Treatment Reagent, analyze it in less than 48 hours
if stored at room temperature. If stored refrigerated analyze within 7 days. NOTE:
Allow mixture to reach room temperature before analyzing.
• Extremes in humidity may affect the blood lead results. Using the test at a relative
humidity of less than 12% could lead to falsely low results.
• Do NOT use the LEADCARE System in drafts. This could lead to falsely low results.
• Keep the LEADCARE System out of direct sunshine.
• The Analyzer will only function in the temperature range of 54° to 97°F (12° to
36°C). Otherwise the Analyzer will display the error code Er 2.
• Allow all of the LEADCARE System components to reach a steady temperature
before using (at least 1 hour) if they have been moved.
• Clinical testing demonstrates that altitudes up to 8,000 feet (2,440 meters) above
sea level do not affect results obtained with the LEADCARE System.
• Use the Sensors, the Treatment Reagent, and pipette tips only once. Do NOT
reuse. Reuse could lead to erroneous results.
• Do NOT use damaged (bent, scratched, cut, etc.) Sensors.
• Do NOT touch the active area of the Sensor (the "kidney" shaped area).
• Do NOT run a test without the Sensor Holder connected to the Analyzer.
• Use only heparin or EDTA as anticoagulants. If you use EDTA collection tubes, fill
them at least one quarter full of blood. Less than one quarter filled EDTA tubes
could result in falsely low blood lead results. Use only heparin or EDTA as
anticoagulants. If you use EDTA collection tubes, fill them at least one quarter full of
blood. Less than one quarter filled EDTA tubes could result in falsely low blood lead
results.
• In conditions where the patient’s glutathione level is elevated, blood samples should
be analyzed for lead by another method.
• High levels of the following substances at the following concentrations do NOT affect
the results of the LEADCARE system: copper (90 µmol/L), zinc (54 µmol/L), arsenic
(0.78 µmol/L), cadmium (0.27 µmol/L), aluminum (0.45 µmol/L), ascorbic acid (0.30
mmol/L), uric acid (1.5 mmol/L), acetaminophen (396 µmol/L), acetylsalicylic acid
(6.0 mmol/L), ibuprofen (396 µmol/L), heparin (80,000 units/L), calcium sodium
EDTA
(6.7
mmol/L),
succimer
(DMSA)
(78
µmol/L),
DMPS
(2,3-dimercapto-1-propane sulfonic acid) (78 µmol/L), D-penicillamine (0.17
mmol/L), BAL (2,3-dimercaptopropanol) (0.97 µmol/L).
PERFORMANCE CHARACTERISTICS:4
Consult the LEADCARE User's Guide for the complete product specifications.
The LEADCARE Blood Lead Testing System’s performance was tested in clinical
studies at four different sites. In all these studies, the LEADCARE System was calibrated
and used according to the labeling. The sites included three Physician Office
Laboratories (POLs) and one clinical laboratory.
Precision
The precision performance was obtained at the three POL sites by physician office
laboratory testing personnel and one clinical laboratory using trained personnel.
CONTROL
Normal
High
NUMBER
OF TESTS
170
169
MEAN
(µg/dL)
5.35
28.5
OVERALL
SD (µg/dL)
0.77
2.83
OVERALL
CV (%)
14.4
9.95
Accuracy
The accuracy of the LEADCARE Blood Lead Testing System was determined by
comparison with the Model 3010B Lead Analyzer (Magellan Diagnostics, Inc.) and
Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) as used in clinical
laboratories.
The following data was obtained on fresh venipuncture whole blood samples analyzed
by trained users and compared to the same samples run on a Model 3010B Lead
Analyzer:
n=97
y=1.023(x) + 2.67 µg/dL
r=0.969
range=1.6-39.3 µg/dL
The following data was obtained on fresh venipuncture whole blood samples analyzed
by trained users and compared to the same samples run on GFAAS. The data was
obtained from two different sites:
Site 1
n=112
y=1.07(x) - 0.57 µg/dL
r=0.972
range=1.8-44.6 µg/dL
Site 2
n=234
y=0.979(x) + 0.94 µg/dL
r=0.937
range=1.6-41.3 µg/dL
Accuracy was also determined in a POL clinical study using capillary blood. The range of
the blood lead results was from 1.4 to 26 µg/dL. In total LEADCARE and GFAAS results at
the 10 µg/dL lead decision point5 agreed on 170 out of 179 samples for an agreement of
95.0%.
Bibliography
1. NCCLS (National Committee for Clinical Laboratory Standards). 1991. Procedures
for the Collection of Diagnostic Blood Specimens by Skin Puncture-Third Edition.
Villanova, PA. NCCLS Document H4-A3.
2. NCCLS (National Committee for Clinical Laboratory Standards). 1991. Procedures
for the Collection of Diagnostic Blood Specimens by Venipuncture-Third Edition.
Villanova, PA. NCCLS Document H3-A3.
3. NCCLS (National Committee for Clinical Laboratory Standards). 1991. Protection of
Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids,
and Tissue. Villanova, PA. NCCLS Document M29-T2.
4. Shannon M and Rifai N, The Accuracy of a Portable Instrument for Analysis of
Blood Lead in Children, Ambulatory Child Health 1997, 3, 249-254.
5. CDC (Centers for Disease Control). 1991. Preventing Lead Poisoning in Young
Children: A Statement by the Centers for Disease Control. Atlanta: CDC, 1991.
6. CDC (Centers for Disease Control). ‘What Do Parents Need to Know to Protect
Their Children?’, 18 May 2012. Web. 26 September 2012,
www.cdc.gov/nceh/lead/ACCLPP/blood_lead_levels.htm.
Made in the USA by
Magellan Diagnostics, Inc.
101 Billerica Ave, Building 4
N. Billerica, MA 01862
Patent: www.leadcare2.com/patentmarking
LeadCare is a registered trademark of Magellan Diagnostics, Inc.
P/N 70-2234 Rev 00 (10/2012)
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN UNION:
Ichor Technologies Ltd
1 Paper Mews, 330 High Street, Dorking, Surrey, RH4 2TU, UK
Tel: +44 (0) 1372 377 754
Fax: +44 (0) 1372 388 282