ESA LeadCare II Quick Reference Manual

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LeadCare®II

BLOOD LEAD ANALYZER

Quick Reference Guide

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Precautions

• The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that

• Any modifications by the laboratory to the test system or the manufacturer’s

• All laboratories eligible for a CLIA Certificate of Waiver must follow the manu-

• Observe universal precautions for handling blood samples as defined by the

• The LeadCare treatment reagent contains dilute hydrochloric acid solution.

• Do not mix components from different lots of test kits.

• Test kit components (kit box, sensors, controls, and treatment reagent tubes) are

• Proper sample preparation is essential for accurate results. Take precautions to

• Use only fresh, whole blood. Mix the blood with treatment reagent within

Caution

perform tests with the LeadCare II System must have a CLIA Certificate of Waiver as issued under the authority of the Public Health Service Act (PHSA) (42 U.S.C. 263(a). In addition to a waiver certificate, laboratories performing this test must comply with all applicable state and local laws.

instructions will result in the test no longer meeting the requirements of the waived category.

facturer's instructions as specified in the LeadCare II User's Guide, LeadCare II Quick Reference Guide and LeadCare II Test Kit package insert.

U.S. Public Health Service, Centers for Disease Control. Refer to the LeadCare II User's Guide for information about where to find this document.

The reagent is harmful if swallowed. Keep out of reach of children. If swallowed, consult a physician. If the reagent contacts eyes, flush immediately with water and consult a physician.

labeled with expiration dates. Using any item with an expired date may produce inaccurate results. Do not use any component with an expiration date that has passed. Check the expiration on the kit box as this is the earliest date.

ensure that the sample collection area is not contaminated by environmental sources of lead. Refer to Collecting and Handling Blood Lead Samples—2004 published by the Department of Health and Human Services, Centers for Disease Control.

24 hours of collection. Follow sample collection instructions exactly.

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Wear protective gloves, safety glasses and lab coats.

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Dispose of materials in appropriate biohazard containers.

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Allow analyzer, test kit and samples to reach room temperature before testing.

97°F

54°F

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Required Materials

LeadCare II

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LeadCare II

Blood Lead T

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Blood Testing

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LeadCare II

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Analyzer Kit Contents

User's guide Calibration button reader LeadCare II Blood

Lead Analyzer Sensor retainer

Materials

Required

AC power cord

Instructional CD-ROM

Quick reference guide AA batteries

Test Kit Contents

Droppers

Treatment reagent tubes

Capillary tubes and plungers

Calibration button

Control solutions

Blood lead sensors Labels Package insert LeadCare II worksheet

Power on the Analyzer

POWER

Connect the analyzer to an outlet using the AC power cord or install batteries as shown below.

POWER

To turn ON the analyzer, move the switch to the left.

To turn the analyzer OFF, move the switch to the right.

POWER

Battery Installation (Optional)

POWER

IOIO

Push white tab up and pull blue cover off.

Insert batteries as shown and replace cover.

POWER

IOIOI

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Analyzer Calibration and Quality Control

Perform this calibration procedure each time you open a new Test Kit.

The first time you turn on the analyzer, you will see the PLEASE CALIBRATE message.

CALIBRATION

SUCCESSFUL

LeadCare II

Hold the calibration button to the button reader until you hear a beep.

NOTE: Button must touch both the center contact and metal side of button reader.

Remove the calibration button from the Test Kit.

LeadCare II

Make sure the number on the button matches the display.

The analyzer is ready when the PREPARE SAMPLE message appears.

Quality Control

LeadCare II Blood Lead Controls are intended to monitor the accuracy and precision of your blood lead testing using the LeadCare II Blood Lead Testing System.

How Often to Test with Controls

Test two levels of quality control:

• on each new lot of test kits received

• on each new shipment of test kits received

• to test the technique of new users

• 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 II System is operating properly. Refer to the LeadCare II User's Guide for additional important information on quality control.

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Using the Controls (See Prepare the Sample for Additional Information)

Treat the controls as you would a patient blood sample. Refer to the LeadCare II User's Guide for detailed instructions on how to perform blood lead testing.

Label a fresh treatment reagent tube “Level 1

Control”.

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After thorough mixing, remove the cap from the Level 1 control vial and place it top down on a clean laboratory wipe.

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Wipe the outside of the capillary to remove any excess control.

Inspect the capillary tube to confirm that it is properly filled.

Place the capillary tube into the treatment reagent tube. Insert a plunger into the top of the capillary tube. Dispense the entire volume of control into the reagent.

Holding the capillary tube almost horizontally with the green band on top, fill the tube to the 50 µL black line. Replace the cap on the control vial.

Replace the tube cap. Invert the tube 8 to 10 times to mix the sample completely. Control material in treatment reagent tube will appear red.

Quality Control

Calibration &

Analyze the control sample according to the instructions provided in the Analyze the

Sample

section. Repeat this process for the Level 2 control.

Lead Control Test Results: Expected Results

Control target values and acceptable ranges are provided on the control vial label. The blood lead result you obtain for a control should be within the acceptable range. If the results are not within the listed range, refer to the Troubleshooting section of the User's Guide. If, after following the instructions, the controls are still out of range, call ESA Technical Support at 1-800-275-0102.

CAUTION: Do NOT proceed to patient samples unless both Level 1 and Level 2 control results are within the acceptable ranges.

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Prepare the Sample

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Label the tube with the patient ID using the labels provided.

If using blood from a tube, make sure the blood is well mixed by inverting the tube 8 to 10 times before sampling.

Hold the capillary tube almost horizontally with the green band on top, fill the tube to the 50 µL black line.

Holding the capillary tube almost horizontally with the green band on top, fill the capillary to the 50 µL black line.

Note: The CDC’s Steps for Collecting Fingerstick Blood Samples for Lead Testing is provided in Appendix C of the User’s Guide.

Remove excess blood from the outside of the tube with a clean wipe or gauze.

Use caution not to drain the blood from the end of the capillary tube.

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5 6

Correct Underfilled Bubbles Blood

Wrong Air Excess

Wrong Wrong

Inspect the capillary tube for proper filling. Make sure there are no gaps or bubbles, or any excess blood on the outside of the capillary.

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Replace the tube cap. Invert the tube 8 to 10 times to mix the sample completely.

Place the capillary tube into the treatment reagent tube. Insert a plunger into the top of the capillary tube. Dispense the entire volume into the bottom of the tube.

The sample is ready when the mixture turns brown. Samples may be stored up to one week if refrigerated.

CAUTION: Any visual impairment, such as color blindness may affect the operator's ability to detect the sample color change. Operators with vision deficiencies should invert the tube 8 to 10 times to ensure that the sample is properly mixed.

the Sample

Prepare

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Analyze the Sample

Remove a sensor from the sensor container. Close the container.

LeadCare II

Insert the sensor (with black bars facing up) completely into the analyzer until you hear a beep.

Make sure the sensor lot number matches the display.

Remove the cap from the tube. Squeeze the walls of the dropper and insert into the sample. Release the pressure to draw some sample into the dropper.

Make sure the sample is thoroughly mixed. Allow samples that were stored refrigerated to reach room temperature before use.

dCare II

Touch the dropper tip to the X on the sensor and squeeze the walls to dispense the sample.

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Wait 3 minutes until the test is done. The analyzer will beep and display the lead result in

µg/dL Pb.

Record the test results on the LeadCare II worksheet provided.

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Remove the used sensor. Discard materials in appropriate

containers.

the Sample

Analyze

The analyzer is ready for the next sample.

The analyzer displays “Low” when it detects a blood lead level below

3.3 ug/dL. “Low” results should be recorded as “< 3.3 majority of your patient samples should produce “Low” results.

µg/dL”. The

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Interpreting Patient 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 reportable range of the test is 3.3 to 65 µg/dL.

“Low” in the display window indicates a blood lead test result less than 3.3 µg/dL. When this occurs, report the blood lead result as less than (<) 3.3 µg/dL.

“High” in the display windows indicates a blood lead test result greater than

65.0 µg/dL. When this occurs, report the blood lead result as greater than (>) 65 µg/dL.

Blood lead test results should be shared with the patient’s physician for interpretation and to determine when retesting and follow-up care are necessary.

Blood lead levels less than 10 µg/dL are below the “level of concern”.

Blood lead levels above 10 µg/dL indicate possible lead poisoning, which is a serious medical condition. Patients with blood lead levels above 10 µg/dL must be confirmed with a venous sample. The following table shows when to test patients again if the result is above 10 µg/dL.

Retesting Guidelines

If blood lead result of Perform diagnostic test on screening test is: venous blood within:

10 – 19 µg/dL 3 months

20 – 44 µg/dL 1 month to 1 week

45 – 59 µg/dL 48 hours

60 – 69 µg/dL 24 hours

Greater than or equal to 70 µg/dL Immediately as an emergency lab test

(the higher the result, the more urgent the need for follow-up testing)

When the LeadCare II display reads “High”, the analyzer has detected a blood lead level greater than 65 µg/dL. “High” results on LeadCare II should be followed up

immediately as an emergency laboratory test.

Venous confirmation samples can be tested on the LeadCare II System to rule out contamination in the first sample. However, if the result of the venous sample is also above 10 µg/dL, ESA recommends that you send the venous sample to a reference laboratory for confirmation by another method.

NOTE: If you are concerned about the accuracy of results near the 10 µg/dL threshold, ESA recommends that you set the confirmation threshold at 8 µg/dL, and have venous samples sent out for confirmation by a reference laboratory.

Report all blood lead test results to the appropriate state or federal agency.

Contact your State Childhood Lead Poisoning Prevention Program for the specific case management guidelines that apply to your patients.

CDC (Centers for Disease Control). Screening Young Children for Lead Poisoning: Guidance for State

and Local Public Health Officials. Atlanta: CDC, 1997.

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Maintenance

Maintaining the Analyzer

• Clean the analyzer with a damp cloth and warm, soapy water. Do not immerse in water.

• Disinfect with dilute (10%) bleach solution.

• Do not leave any soap film on the analyzer.

• Do not allow liquid of any kind into the sensor connector.

• Do not wash the inside of the calibration button reader.

• Remove the sensor retainer to clean. Dry thoroughly before reinstalling.

ESA Biosciences Technical Support Number 1-800-275-0102

Interpreting Results

Maintenance

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Troubleshooting

STARTUP MESSAGES DEFINITION WHAT TO DO

PLEASE CALIBRATE Analyzer must be calibrated the first Calibrate the analyzer. Refer to the

ANALYZER WITH BUTTON time you use it. calibration instructions in this guide.

TEMP IS TOO HOT The temperature is too hot for testing. Wait until the screen displays

PLEASE WAIT UNTIL the PREPARE SAMPLE message.

ANALYZER IS IN

TEMP RANGE

TEMP IS TOO COLD The temperature is too cold for testing. Wait until the screen displays PLEASE WAIT UNTIL the PREPARE SAMPLE message.

ANALYZER IS IN

TEMP RANGE

ELECTRONIC The internal quality control check Call ESA Biosciences Technical

QC CHECK FAILED failed. Support at 1-800-275-0102.

CALL TECH SERVICE

ERROR X

PROCESSING MESSAGES DEFINITION WHAT TO DO

WARNING The temperature is changing rapidly. Allow system temperature to stabilize.

TEMP IS UNSTABLE This message flashes for 2 seconds.

TEST MAY FAIL

THIS IS A USED SENSOR The sensor in the analyzer is wet Remove the used sensor or adjust the

PLEASE REMOVE SENSOR or previously used. new sensor until the screen displays

PLEASE REMOVE SENSOR A sensor was left in the analyzer. Remove the sensor.

SENSOR OUT OF VIAL The sensor in the analyzer has been Remove the sensor and insert a new

TOO LONG out of the container too long and sensor.

PLEASE REMOVE SENSOR cannot be used.

TEST FAILED There is not enough sample on the Remove the sensor, discard it and

PLEASE REMOVE SENSOR sensor or the sensor failed. insert a new sensor. When adding the

SENSOR REMOVED TOO SOON The sensor was removed from the Remove the sensor, discard it, insert a

analyzer before the end of the test. new sensor and add another drop of

TEMP IS UNSTABLE The temperature in the room is too Move the analyzer to an area where

RESULT DISCARDED unstable to yield accurate test results. there are fewer temperature changes

PLEASE REMOVE SENSOR (away from sources of cold or heat).

PLEASE RECALIBRATE There was a problem with transferring Repeat the calibration procedure.

the calibration data to the analyzer Refer to the calibration procedure from the calibration button. in this guide.

SYSTEM FAILURE One of the main system Call ESA Biosciences Technical

CALL TECH SERVICE components failed. Service at 1-800-275-0102.

PLEASE CALIBRATE The analyzer must be calibrated Calibrate the analyzer. Refer to the

ANALYZER WITH BUTTON before you can use it. calibration instructions in this guide.

SENSOR LOT TOO OLD The sensor is from a lot that has Discard the sensor and the expired

PLEASE RECALIBRATE expired. lot. Use a sensor from a new lot and

CHANGE BATTERIES SOON Message flashes before or after a Change the batteries. Use four 1.5 V

test. Voltage is too low for the AA alkaline batteries. analyzer to run a test.

the PREPARE SAMPLE message.

sample to the sensor, make sure the sample covers the X area.

sample. Wait 180 seconds (3 minutes) for the test to finish.

The temperature is stable enough when the PREPARE SAMPLE message indicates that the Analyzer is ready.

The PREPARE SAMPLE message indicates that the analyzer is ready to use.

recalibrate the analyzer.

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Troubleshooting of Inaccurate Results

Scenario 1: Troubleshooting results below the target or expected value

• Make sure the analyzer is calibrated to the sensor lot in use.

• Check the expiration date on the test kit box. Do NOT use a test kit that is beyond the expiration date. Note: the analyzer will not perform a test when it is calibrated for a sensor lot that has expired.

• Use only fresh, whole blood from patients. Do NOT use plasma or serum.

• Less than 50 µL in the capillary tube will tend to produce lower blood lead results.

• Make sure that there are no clots or bubbles in the capillary tube.

• Always mix the blood sample with treatment reagent. Results generated with untreated blood are not accurate.

• Do NOT use clotted blood. If there are clots in the blood, obtain a new sample.

• Operate the analyzer only within the specified humidity range – 12 to 80% relative humidity.

• Make sure that the analyzer, test kit, and sample are all at the same temperature before testing. Note: The analyzer will not initiate a test if the temperature is changing too rapidly, or if the temperature is outside of the operating range.

• Avoid operating the LeadCare II System in drafts.

• Make sure the blood and treatment reagent is thoroughly mixed before placing onto the sensor.

• Keep the lid on the sensor container closed to protect unused sensors.

• Do NOT touch the sensor while running a test.

Scenario 2: Troubleshooting results above the target or expected value

• Make sure the analyzer is calibrated to the sensor lot in use.

• Check the expiration date on the test kit box. Do NOT use a test kit that is beyond the expiration date.

• To avoid contamination, thoroughly clean the sample site prior to puncture. Use clean gloves during testing and keep your gloved hands clean.

• Make sure you are using lead-free collection devices.

• Do NOT touch the ends of the capillary tubes or the plungers. This could cause contamination.

• Excess blood on capillary tube. Be sure to wipe excess blood from the tube with a downward motion. The accuracy of the test depends on filling the capillary tube with 50 µL. Excess blood on the outside of the tube will tend to produce higher blood lead results.

• Do NOT use clotted blood. If there are clots in the blood, obtain a new sample.

• Do NOT leave the treatment reagent tube uncapped other than to add the blood sample and remove the blood sample/treatment reagent mixture.

• Make sure to thoroughly mix blood with the treatment reagent. The mixture should turn brown before you place it on the sensor.

Operate the analyzer only within the specified humidity range – 12 to 80% relative humidity.

•

• Make sure that the analyzer, test kit, and sample are all at the same temperature before testing.

• Do NOT use a sensor that has been dropped on the floor or exposed to contaminants.

• Do NOT touch the sensor while running a test.

Troubleshooting

If you have any doubt about the accuracy of your results, refer to the Troubleshooting section of the User's Guide. If, after following the instructions, the problem persists, call ESA Biosciences Technical Support at 1-800-275-0102.

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To place an order, call 1-800-959-5095.

Analyzer:

LeadCare®II Analyzer Kit 70-6760

Reagents:

LeadCare®II Test Kit 70-6762

Parts and Accessories:

Label Printer (U.S. only) 70-3447

Printer Labels 70-3443

AA Batteries (4 Pack) 50-0005

Sensor Retainer 70-6543

Quick Reference Guide 70-6552

User’s Guide 70-6551

Instructional CD-ROM 70-6554

AC Power Cord 70-6692

International Power Plug Set 70-6693

ESA Biosciences Technical Support Number 1-800-275-0102

LeadCare II Serial Number: _______________________

ESA Biosciences, Inc. 22 Alpha Road, Chelmsford, MA 01824 USA (800) 275-0102 www.esainc.com