LeadCare II Blood Lead Analyzer: Complete Guide to Point-of-Care Blood Lead Testing
Lead exposure remains an important public health concern, particularly for children and other at-risk populations. For healthcare providers who need convenient access to blood lead testing, the LeadCare® II Blood Lead Analyzer provides quantitative blood lead results at the point of care without sending every sample to an outside laboratory.
The LeadCare II is a CLIA-waived point-of-care blood lead testing system designed for testing capillary whole blood. With a small sample requirement, portable analyzer and results in approximately three minutes, LeadCare II can help physician offices, pediatric practices, clinics and public health programs incorporate blood lead testing directly into their workflow.
What Is the LeadCare II Blood Lead Analyzer?
The LeadCare II Blood Lead Testing System is an FDA-cleared, CLIA-waived system used for the quantitative determination of lead in capillary whole blood.
Unlike testing workflows that require samples to be sent to an outside laboratory, LeadCare II allows testing to be performed at the point of care, with results displayed by the analyzer in approximately three minutes.
The LeadCare II system uses an electrochemical testing method with disposable sensors. A prepared blood sample is placed onto a sensor, and the analyzer measures the amount of lead present and reports the result in micrograms per deciliter (µg/dL).
LeadCare II Key Specifications
| Specification | LeadCare II |
|---|---|
| Manufacturer | Magellan Diagnostics / Meridian Bioscience |
| Analyzer Catalog Number | 70-6760 |
| Test Kit Catalog Number | 70-6762 |
| CLIA Classification | Waived |
| Sample Type | Capillary whole blood |
| Sample Volume | 50 µL |
| Test Time | Approximately 3 minutes |
| Reportable Range | 3.3–65 µg/dL |
| Test Method | Electrochemical with disposable sensors |
| Calibration | Electronic calibration button |
| Quality Control | Two levels included with test kit |
| Analyzer Dimensions | Approx. 9" × 6.5" × 3.5" |
| Analyzer Weight | Approx. 2.4–2.5 lb. |
| Power | AC power or four AA batteries |
| FDA 510(k) | K052549 |
How Does LeadCare II Work?
LeadCare II uses electrochemistry to measure lead in whole blood.
The blood sample is first mixed with the treatment reagent supplied with the LeadCare II Test Kit. This preparation makes the lead available for measurement. A portion of the prepared sample is then placed onto a disposable LeadCare II sensor.
The analyzer applies an electrical potential to the sensor. Lead from the prepared sample collects on the sensor and is measured by the analyzer. After approximately three minutes, the quantitative blood lead result is displayed in µg/dL.
Because the testing process occurs directly at the point of care, providers can obtain a result during the patient visit rather than waiting for an outside laboratory result.
How Much Blood Does LeadCare II Require?
LeadCare II requires a 50 µL capillary whole blood sample.
The relatively small sample requirement can be particularly useful in pediatric settings, where blood lead screening is commonly performed.
Healthcare professionals should always follow the current LeadCare II User's Guide, Blood Lead Test Kit package insert and applicable blood collection procedures when collecting and preparing samples.
How Quickly Does LeadCare II Provide Results?
A LeadCare II test takes approximately three minutes once the prepared sample is placed on the sensor.
The ability to obtain a quantitative result during the patient visit is one of the primary advantages of point-of-care blood lead testing.
Is LeadCare II CLIA Waived?
Yes. LeadCare II is classified as a CLIA-waived test system.
Testing facilities must have the appropriate CLIA Certificate of Waiver or higher and must follow the manufacturer's instructions. State or local requirements may also apply.
The manufacturer notes that modifying the test system or manufacturer's testing instructions can cause the test to no longer meet the requirements for waived testing.
Who Can Perform LeadCare II Testing?
According to the manufacturer, employees of an office or laboratory operating under a CLIA Certificate of Waiver or higher may perform LeadCare II testing when the manufacturer's instructions are followed.
However, individual states may impose additional laboratory licensing or testing requirements. Healthcare facilities should verify the requirements that apply in their jurisdiction before beginning point-of-care blood lead testing.
What Comes With the LeadCare II Analyzer?
The LeadCare II Analyzer Kit, Catalog #70-6760, includes the portable blood lead analyzer and supporting materials needed to set up the instrument.
The manufacturer's current listing includes:
- LeadCare II Analyzer
- AC power supply/cord
- AA batteries
- Quick Reference Guide
- Digital training and instructional resources
LeadCare II Blood Lead Test Kits are ordered separately.
Shop the LeadCare II Blood Lead Analyzer – 70-6760
What Test Kit Does LeadCare II Use?
LeadCare II uses the LeadCare II Blood Lead Test Kit, Catalog #70-6762.
Each test kit provides materials for 48 blood lead tests and includes the testing materials, sensors and quality-control materials required for use with the LeadCare II system.
Practices purchasing a LeadCare II Analyzer should therefore plan for an ongoing supply of LeadCare II 70-6762 test kits based on their expected testing volume.
Shop LeadCare II Blood Lead Test Kits – 70-6762
Does the LeadCare II Analyzer Need Calibration?
LeadCare II uses an electronic calibration button supplied with each test kit.
The calibration information is specific to the test-kit lot, so users should follow the current manufacturer's instructions whenever opening and using a new LeadCare II Test Kit.
Does LeadCare II Include Quality Controls?
Yes. The LeadCare II Test Kit includes two levels of quality-control material.
The manufacturer provides specific procedures for running and documenting quality controls. Practices should follow the current LeadCare II instructions and their applicable laboratory policies when establishing their quality-control procedures.
What Is the LeadCare II Measurement Range?
The LeadCare II reportable range is:
3.3 to 65 µg/dL
The analyzer displays “Low” for results below its reportable range and “High” for results above the reportable range.
Healthcare providers should follow current manufacturer instructions, CDC recommendations and applicable clinical protocols regarding interpretation, confirmatory testing and patient management.
Do LeadCare II Results Need to Be Reported?
Blood lead reporting requirements vary by state.
The office or laboratory performing blood lead testing is responsible for complying with applicable reporting requirements. Providers should consult their state or local lead poisoning prevention program to determine current reporting procedures.
Who Commonly Uses LeadCare II?
LeadCare II may be appropriate for healthcare environments that perform blood lead testing and want testing available at the point of care, including:
- Pediatric practices
- Primary care practices
- Community health centers
- Public health departments
- Family medicine practices
- Clinics serving populations at increased risk for lead exposure
- Other qualified point-of-care testing facilities
Whether LeadCare II is appropriate for a particular facility depends on testing volume, applicable regulations, workflow and clinical needs.
LeadCare II Analyzer vs. LeadCare II Test Kit: What's the Difference?
These are two separate products that work together.
The LeadCare II Analyzer #70-6760 is the reusable instrument that measures the prepared blood sample.
The LeadCare II Blood Lead Test Kit #70-6762 contains consumable materials used to perform testing. Each kit provides materials for 48 tests.
If you're establishing a new LeadCare II testing program, you generally need both the analyzer and a test kit.
Existing LeadCare II users can purchase additional 70-6762 test kits as their testing supplies are consumed.
Frequently Asked Questions About LeadCare II
How long does a LeadCare II test take?
The LeadCare II analyzer provides a quantitative blood lead result in approximately three minutes after the prepared sample is placed on the sensor.
How much blood is required?
LeadCare II requires a 50 µL capillary whole blood sample.
Is LeadCare II CLIA waived?
Yes. LeadCare II is a CLIA-waived blood lead testing system. Facilities must meet applicable CLIA and state requirements and follow the manufacturer's instructions.
What is the LeadCare II testing range?
The analyzer's reportable range is 3.3–65 µg/dL.
How many tests are in a LeadCare II test kit?
The LeadCare II Blood Lead Test Kit #70-6762 provides materials for 48 tests.
Are test kits included with the LeadCare II analyzer?
The LeadCare II Analyzer and LeadCare II Blood Lead Test Kits are separate products. Test kits should be ordered based on the facility's expected testing needs.
Can LeadCare II test for anything besides lead?
No. LeadCare II is specifically designed for blood lead testing.
Can LeadCare II be used at the point of care?
Yes. LeadCare II is designed as a portable, CLIA-waived point-of-care blood lead testing system.
Shop LeadCare II Blood Lead Testing Products
Mohawk Medical Mall supplies LeadCare II blood lead testing equipment and supplies for qualified healthcare facilities.
LeadCare II Analyzer Kit – 70-6760
The reusable LeadCare II point-of-care analyzer provides quantitative blood lead results in approximately three minutes.
Shop LeadCare II Analyzer 70-6760
LeadCare II Blood Lead Test Kit – 70-6762
Designed specifically for the LeadCare II Analyzer, each kit provides materials for 48 blood lead tests.
Shop LeadCare II Blood Lead Test Kit 70-6762
For facilities establishing a new LeadCare II testing program, Mohawk Medical Mall can help identify the analyzer, test kits and related supplies needed to get started.
LeadCare® is a registered trademark of Meridian Bioscience. Product specifications are based on current manufacturer information and are subject to change. Healthcare facilities should refer to the current manufacturer instructions for use and applicable federal, state and local requirements before performing patient testing. This article is provided for general product information and is not a substitute for manufacturer instructions or clinical guidance.
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