Point-of-Care Blood Lead Testing

Point-of-care blood lead testing allows qualified healthcare professionals to perform quantitative blood lead measurements within the clinical setting.

The LeadCare II Blood Lead Testing System uses an electrochemical testing method with disposable sensors and requires a 50 µL whole-blood sample. Results are available in approximately three minutes, with a reportable range of 3.3–65 µg/dL. The system is CLIA waived when used according to the manufacturer's instructions.

Its compact design and rapid testing process make LeadCare II an option for healthcare environments that want to incorporate blood lead testing into a point-of-care workflow.

Why Choose the LeadCare II Blood Lead Testing System?

LeadCare II combines a portable analyzer with disposable testing supplies to provide quantitative blood lead results without requiring a large laboratory analyzer.

Key features include:

• Results in approximately 3 minutes
• Requires only a 50 µL whole-blood sample
• Reportable range of 3.3–65 µg/dL
• Electrochemical testing method
• Disposable test sensors
• Electronic calibration
• Two levels of quality control included with the test kit
• Battery or AC operation
• Compact, portable analyzer
• CLIA-waived testing system
• FDA 510(k) K052549

These specifications are published by the manufacturer for the LeadCare II system.

LeadCare II Specifications

Who Uses Point-of-Care Blood Lead Testing?

Blood lead testing equipment may be used by qualified healthcare professionals in appropriate testing environments, including:

• Pediatric practices
• Family medicine offices
• Primary care practices
• Community health centers
• Public health programs
• Occupational health facilities
• Clinics
• Other qualified point-of-care testing locations

Facilities should select a testing system based on patient population, testing volume, regulatory requirements and applicable manufacturer instructions.

LeadCare II Test Kits & Supplies

The LeadCare II analyzer uses dedicated LeadCare II Blood Lead Test Kits containing the components required to perform testing with the system.

When ordering replacement testing supplies, always verify that the test kit is intended for your specific LeadCare analyzer and follow the manufacturer's current storage, collection and testing instructions.

Important LeadCare II Sample Collection Information

For capillary blood samples tested with LeadCare II, use only the capillary collection tubes supplied with the LeadCare II Blood Lead Test Kit.

The FDA and manufacturer issued a 2026 field correction following reports of unexpectedly elevated results associated with certain third-party micro-collection devices. The FDA states that this action does not require removal of LeadCare II Blood lead Analyzer systems from the field, product supply remains uninterrupted, and the system continues to perform as intended when used according to its labeling and Instructions for Use.

Healthcare professionals should follow the current LeadCare II Instructions for Use and applicable recommendations for confirmatory testing.

CLIA-Waived Blood Lead Testing

The LeadCare II Blood Lead Testing System is classified as CLIA waived when used according to the manufacturer's instructions.

CLIA-waived status can make point-of-care testing more accessible to eligible healthcare facilities, but waived does not mean requirements can be ignored. Facilities must follow the manufacturer's instructions and applicable federal, state and local requirements.

Modifying the test system or deviating from the manufacturer's instructions may affect its waived status.

Choosing Blood Lead Testing Equipment

When selecting a blood lead analyzer and testing supplies, consider:

• Testing volume
• Sample volume
• Time to result
• Reportable testing range
• Portability requirements
• Quality-control procedures
• CLIA classification
• Test kit compatibility
• Collection-device requirements
• Storage requirements

For facilities performing point-of-care testing, the combination of a small sample, approximately three-minute results and CLIA-waived classification makes LeadCare II worth considering.

Why Buy Lead Testing Supplies from Mohawk Medical Mall?

Mohawk Medical Mall is backed by Mohawk Healthcare, a medical supply and equipment distributor serving healthcare organizations since 1946.

Healthcare customers can count on:

• Professional medical testing products
• Knowledgeable medical supply support
• Secure online ordering
• Nationwide shipping
• Decades of experience serving healthcare organizations

Frequently Asked Questions About Blood Lead Testing

What is the LeadCare II system?

LeadCare II is a portable blood lead testing system designed to quantitatively measure lead in whole blood using an electrochemical testing method.

How quickly does LeadCare II provide a result?

The LeadCare II system provides a blood lead result in approximately three minutes.

How much blood does a LeadCare II test require?

LeadCare II requires approximately 50 µL of whole blood.

What is the LeadCare II testing range?

The manufacturer specifies a reportable range of 3.3–65 µg/dL.

Is LeadCare II CLIA waived?

Yes. LeadCare II is classified as a CLIA-waived testing system when used according to the manufacturer's instructions.

Can third-party capillary tubes be used with LeadCare II?

For capillary samples, no third-party collection device should be used with LeadCare II. The FDA states that the only capillary tubes validated for use with the LeadCare II Blood Lead Test Kit are those supplied with the kit.

What supplies are needed for LeadCare II testing?

LeadCare II uses dedicated blood lead test kits containing compatible sensors, treatment reagent and other testing components. For capillary testing, use the collection devices supplied with the LeadCare II kit and follow the current manufacturer Instructions for Use.