Comparison of Blood Sampling Methods for Hemoglobin Measurement

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 month–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ebenezer Lab, Kampala, Uganda

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood source: single and pooled capillary and venous blood

Device

A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+.
Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+.
Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Blood source: single capillary and venous blood

Device

A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+ .
Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Blood source: pooled capillary and venous blood

Device

Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+.
Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

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.

Sponsors and collaborators

Lead sponsor

ICF Macro, Inc.

Other

Collaborators

Uganda Bureau of Statistics
United States Agency for International Development (USAID)

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Sep 28, 2021
Registry last updated: Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed