Plan for Testing Fingerstick Bloods on Magellan Systems

Magellan Diagnostics

Status: Unknown

Conditions: Lead Poisoning

Treatments: Device: Lead testing

Study type: Observational

Funder types: Industry

Identifiers

NCT03256383

276

Details and patient eligibility

About

This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.

Enrollment: 190 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy subjects who consent to a capillary blood collection

Exclusion criteria

• Patients are not currently taking chelating agents, e.g., penicillamine, succimer

Trial design

190 participants in 3 patient groups

Adult

Description:

Patients aged 18+ years

Treatment:

Device: Lead testing

Children 7 - 17

Description:

Patients aged 7 - 17 years

Treatment:

Device: Lead testing

Children <7

Description:

Patients aged under 7 years

Treatment:

Device: Lead testing