Comparison of Blood Sampling Methods for Hemoglobin Measurement

Completed

• Conditions: Anemia

• Registration Number: NCT05059457
• Lead Sponsor: ICF Macro, Inc.

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:

1. 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).

2. 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.

3. 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.

4. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Primary Completion: 2021-09-26
• Study Completion: 2021-09-26
• Study First Posted: 2021-09-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1082

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin measurement	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.

Trial Locations

Locations (2)

Ebenezer Lab; 🇺🇬 Kampala, Uganda

Uganda Bureau of Statistics; 🇺🇬 Kampala, Uganda