Comparison of Blood Sampling Methods for Hemoglobin Measurement

ICF Macro

Status: Completed

Conditions: Anemia

Treatments: Device: Blood source: pooled capillary and venous blood; Device: Blood source: single capillary and venous blood; Device: Blood source: single and pooled capillary and venous blood

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05059457

720-OAA-18C-00083

Details and patient eligibility

About

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.

Enrollment: 1,082 patients

Sex: All

Ages: 6 months to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,082 participants in 3 patient groups

Controlled setting: single capillary and pooled capillary and venous blood

Description:

Single drop capillary blood, pooled capillary blood, and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a controlled setting.

Treatment:

Device: Blood source: single and pooled capillary and venous blood

Field setting: single capillary and venous blood

Description:

Single drop capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.

Treatment:

Device: Blood source: single capillary and venous blood

Field setting: pooled capillary and venous blood

Description:

Pooled capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.

Treatment:

Device: Blood source: pooled capillary and venous blood