A Pilot to Asses Hemoglobin Concentration Obtained From Capillary and Venous Blood Measured Using the HemoCue 201+ Hemoglobin Analyzer in a Controlled and Field Setting

ICF Macro, Inc.2 sites in 1 country1,082 target enrollmentAugust 23, 2021

ConditionsAnemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anemia
Sponsor: ICF Macro, Inc.
Enrollment: 1082
Locations: 2
Primary Endpoint: Hemoglobin measurement
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to inform The DHS Program on whether there are variations in hemoglobin concentration using the DHS standard technique of a single drop of capillary blood and alternative blood sources (pooled capillary and venous blood) using the HemoCue 201+ analyzer compared to venous blood using a clinical hematology autoanalyzer.

Research Objectives:

To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) and a pooled drop of capillary blood measured on the HemoCue 201+ analyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled setting (i.e., blood specimens are collected in a laboratory setting).
To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
To determine if there are differences in the hemoglobin concentration between a pooled drop of capillary blood measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
To compare results of hemoglobin distribution and estimates of anemia prevalence using two types of capillary blood (single drop and pooled) and venous blood measured on the HemoCue 201+ analyzer and a clinical autoanalyzer using venous blood in a controlled and field setting.

Registry

clinicaltrials.gov

Start Date

August 23, 2021

End Date

September 26, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ICF Macro, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children 6-59 months or non-pregnant women 15-49
•Apparently healthy individuals
•Consent to participate in the study

Exclusion Criteria

•Children less than 6 months or over 59 months
•Women less than 15 years of age or greater than 49 years of age
•Pregnant women

Outcomes

Primary Outcomes

Hemoglobin measurement

Time Frame: Day 1

Difference (correlation, concordance, paired t-test) in hemoglobin concentration between each blood source measured with the HemoCue 201+ compared to venous blood measured with a clinical autoanalyzer.