Magellan LeadCare II Quick Reference Manual

®

Quick Reference Guide

Note: For use with Analyzer Firmware Version 1.09 or higher.

Please check the label on the bottom of your analyzer

to determine rmware version.

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• The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that
perform tests with the LeadCare II System must have a CLIA Certicate 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 certicate, laboratories performing this
test must comply with all applicable state and local laws.

• Any modications by the laboratory to the test system or the manufacturer’s
instructions will result in the test no longer meeting the requirements of the
waived category.

• All laboratories eligible for a CLIA Certicate of Waiver must follow the manu­facturer's instructions as specied in the LeadCare II User's Guide, LeadCare II
Quick Reference Guide and LeadCare II Test Kit Package Insert.

• Observe universal precautions for handling blood samples as dened by the
U.S. Public Health Service, Centers for Disease Control. Refer to the LeadCare II
User's Guide for information about where to nd this document.

• The LeadCare treatment reagent contains dilute hydrochloric acid solution
which may cause eye, skin, and respiratory system irritation. In case of acci­dental contact immediately ush skin and eyes with running water for up to 15
minutes and move to fresh air. Seek medical assistance in situations where eye
contact; skin irritation or burn; or difculty breathing occurs.

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

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

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

• Use only fresh, whole blood. Mix the blood with treatment reagent within 24
hours of collection. Follow sample collection instructions exactly.

Wear protective gloves,
safety glasses and lab
coats.

Dispose of materials in

appropriate biohazard

containers.

Allow analyzer, test kit

and samples to reach
room temperature

before testing.

Precautions

Precautions

Caution

!

P P P

15°C

27

°

C

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Analyzer Kit Contents

Calibration Button Reader

LeadCare II Blood
Lead Analyzer

AC Adapter and Plug Set

LeadCare II Flash Drive
containing User’s Guide

& Instructional Videos

(not pictured)

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 &

Assay Control Sheet

Power on the Analyzer

Connect the analyzer to

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

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

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

Battery Installation (Optional)

Insert batteries as shown and replace cover.

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Push white tab up and pull blue cover off.

Required Materials

Required

Materials

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PLEASE CALIBRAT E

ANALYZER WITH BUTTON

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

Remove the calibration
button from the test kit.

Analyzer Calibration and Quality Control

Perform this calibration procedure each time you open a new test kit.

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IF N E W L OT

TEST CO N T R O L S

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LeadCare II

CAL IB RAT IO N

SUC CE SSFUL

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LeadCare II

Record Result

&

PR EPA RE S AM PLE

US E SE NS OR LO T 0 01 8A

OR R EC AL IB RAT E

TH EN I NS ER T S EN SO R

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Test two levels of quality
control on each new kit
lot. Refer to the ‘Quality
Control’ section for further
instructions on when to
run controls.

Make sure the number on

the button matches the

display.

The analyzer is ready

when the PREPARE SAMPLE
message appears.

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.

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:

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• on each new lot, or on each new shipment of materials

• with each new operator

• monthly, as a check on continued storage condition

• when problems (storage, operator, instrument, or other) are suspected

or identied

• if required by your laboratory’s standard QC procedure

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.

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of in Vitro Diagnostic Devices, Guidance for Industry and FDA Staff:, p. 34, viewed 17 August 2017,
<https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm070890.pdf>.

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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 Product Support.

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

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.

Wipe the outside of the

capillary tube to remove
any excess control.

Inspect the capillary tube

to conrm that it is properly
lled (see step 5 on page 7).

Place the capillary tube

into the treatment reagent
tube. Insert a plunger into

the top of the capillary tube

and push down, ensuring
the entire volume of control

is dispensed into the

treatment reagent.

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.

Label a fresh treatment

reagent tube “Level 1
Control”.

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

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

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Calibration &

Quality Control

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