Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among Adults in Jakarta (SPECTRO-Hb)

July 13, 2026 updated by: Yohanes Firmansyah, dr, MH, MM, Tarumanagara University

Validation of Non-Invasive Hemoglobin Measurement (Using Optical Method) Compared With Point-of-Care Testing and Hematology Analyzer Among Adult in Jakarta

Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Non-invasive spectrophotometric technology has emerged as a potential alternative for rapid hemoglobin assessment without blood sampling.

This study aims to evaluate the validity and diagnostic performance of a non-invasive hemoglobin using optical method compared with capillary point-of-care testing (POCT) and venous blood hemoglobin measured using an automated hematology analyzer as the reference standard. A total of 150 adults from Kelurahan Kota Bambu, Jakarta, will undergo non-invasive hemoglobin measurement, capillary blood testing, and venous blood testing during a single study visit.

The study will assess agreement between methods, diagnostic accuracy for anemia detection, and factors that may influence measurement performance. Findings from this study are expected to support the development of convenient, community-based anemia screening strategies and provide evidence for future implementation of non-invasive hemoglobin assessment technologies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background

Anemia affects billions of people worldwide and remains an important public health challenge, particularly in low- and middle-income countries. Undiagnosed anemia is associated with impaired physical performance, reduced productivity, cognitive dysfunction, poor maternal outcomes, and increased morbidity. Early detection of anemia is therefore essential for timely intervention and prevention of complications.

Conventional hemoglobin measurement relies on venous blood analysis using automated hematology analyzers or capillary blood testing using point-of-care devices. While these methods provide reliable results, they require blood collection, trained healthcare personnel, consumable materials, and appropriate laboratory infrastructure. In addition, invasive sampling may cause pain, anxiety, and reluctance to participate in large-scale screening programs.

Recent advances in optical and spectrophotometric technologies have enabled the development of non-invasive methods for estimating hemoglobin concentration without blood collection. These systems utilize light absorption and reflection characteristics of peripheral tissues to estimate hemoglobin levels rapidly and painlessly. Non-invasive approaches may improve participant acceptance, facilitate repeated measurements, and support large-scale community screening initiatives. However, their accuracy and agreement with established laboratory methods remain variable across populations and settings. Therefore, local validation studies are necessary before widespread implementation.

Objectives

Primary Objective

To evaluate the validity and agreement of a non-invasive hemoglobin measurement method compared with capillary POCT hemoglobin measurement and venous blood hemoglobin measured using an automated hematology analyzer.

Secondary Objectives

To determine the correlation between non-invasive hemoglobin measurements and hematology analyzer results.

To assess agreement between non-invasive measurements, POCT results, and hematology analyzer measurements using Bland-Altman analysis.

To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and diagnostic accuracy for anemia detection.

To explore the feasibility of implementing non-invasive hemoglobin measurement in community-based screening programs.

Study Design

This study is a community-based cross-sectional diagnostic validation study.

Study Population

The study population consists of adults aged 18 years and older participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.

Sample Size

A total of 150 participants will be recruited using consecutive sampling. Sample size calculation was based on an expected diagnostic accuracy of 90%, a confidence level of 95%, and a margin of error of 5%, with additional participants included to compensate for incomplete data.

Study Procedures

Each participant will undergo three hemoglobin measurements during a single study visit:

Non-Invasive Hemoglobin Measurement Performed on the thumb using a using optical method device. No blood collection is required. Capillary Hemoglobin Measurement Obtained through finger-prick blood sampling. Measured using a point-of-care testing (POCT) device. Venous Hemoglobin Measurement Venous blood collected by trained healthcare personnel. Analyzed using an automated hematology analyzer as the reference standard.

Demographic information, medical history, smoking status, anthropometric measurements, and factors potentially affecting measurement accuracy will also be collected.

Outcome Measures

Primary Outcome

Agreement between non-invasive hemoglobin measurements and venous hemoglobin measured using a hematology analyzer.

Secondary Outcomes

Correlation coefficients between methods. Mean measurement bias and limits of agreement. Sensitivity and specificity for anemia detection. Positive and negative predictive values. Likelihood ratios. Area under the receiver operating characteristic (ROC) curve. Cohen's kappa coefficient for anemia classification agreement. Statistical Analysis

Descriptive statistics will summarize participant characteristics and hemoglobin measurements. Agreement between methods will be assessed using Bland-Altman analysis and Intraclass Correlation Coefficients (ICC). Correlation analyses will be conducted using Pearson or Spearman tests as appropriate. Diagnostic performance will be evaluated through sensitivity, specificity, predictive values, likelihood ratios, ROC analysis, and area under the curve (AUC). Cohen's kappa coefficient will assess agreement in anemia classification. Subgroup analyses may be performed according to age, sex, and measurement conditions.

Expected Impact

The study is expected to provide evidence regarding the accuracy and screening capability of non-invasive hemoglobin measurement in community settings. Results may contribute to the development of accessible, rapid, and patient-friendly anemia screening programs and support future research involving pediatric and other vulnerable populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years and older participating in community-based health screening activities in Jakarta. Participants include both healthy individuals and individuals with potential anemia or other underlying medical conditions. All participants undergo non-invasive hemoglobin measurement, capillary hemoglobin testing using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer during a single study visit.

Description

Inclusion Criteria:

  • Adults aged 18 years and older.
  • Residents or community members participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
  • Willing to undergo non-invasive hemoglobin measurement.
  • Willing to undergo capillary blood hemoglobin testing using point-of-care testing (POCT).
  • Willing to undergo venous blood collection for hematology analyzer examination.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Active bleeding at the time of examination.
  • Severe acute illness requiring urgent medical attention.
  • Refusal to undergo finger-prick or venous blood sampling.
  • History of severe anxiety, syncope, or adverse reactions related to blood collection procedures.
  • Visible infection, wound, or skin lesion at the measurement site.
  • Severe hand deformity preventing proper non-invasive measurement.
  • Nail polish or artificial nails that cannot be removed before examination.
  • Markedly cold hands or poor peripheral perfusion that may interfere with optical measurements.
  • Incomplete hemoglobin measurement data from any of the study methods.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Diagnostic Validation Cohort
A cohort of 200 adults recruited from community screening activities. Each participant undergoes three hemoglobin assessments: non-invasive hemoglobin measurement, capillary blood hemoglobin measurement using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer as the reference standard. Data are used to evaluate agreement, diagnostic accuracy, and anemia classification performance of the non-invasive measurement method.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time Frame: Day 1
Assessment of agreement between non-invasive hemoglobin values and venous hemoglobin values measured using an automated hematology analyzer using Bland-Altman analysis, mean bias, 95% limits of agreement, and intraclass correlation coefficient (ICC).
Day 1
Diagnostic Accuracy for Anemia Detection
Time Frame: Day 1
Diagnostic performance of non-invasive hemoglobin measurement for identifying anemia compared with hematology analyzer results, including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time Frame: Day 1
Hemoglobin concentration obtained from the non-invasive device will be compared with venous hemoglobin concentration measured using a laboratory hematology analyzer. The strength and direction of the relationship will be quantified using Pearson's correlation coefficient for normally distributed data or Spearman's rank correlation coefficient for non-normally distributed data. Correlation coefficients (r), 95% confidence intervals, and p-values will be reported.
Day 1
Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing
Time Frame: Day 1
Hemoglobin concentration obtained from the non-invasive device will be compared with capillary hemoglobin concentration measured using a point-of-care testing (POCT) device. Agreement will be evaluated using Bland-Altman analysis, including mean bias and 95% limits of agreement. Intraclass correlation coefficients (ICC) with 95% confidence intervals will also be calculated to assess measurement reliability between methods.
Day 1
Area Under the ROC Curve (AUC) for Anemia Detection
Time Frame: Day 1
The diagnostic performance of the non-invasive hemoglobin measurement device for identifying anemia will be evaluated using receiver operating characteristic (ROC) curve analysis, with venous hemoglobin concentration measured by a hematology analyzer serving as the reference standard. The area under the ROC curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value will be reported.
Day 1
Agreement in Anemia Classification
Time Frame: Day 1
Participants will be classified as anemic or non-anemic based on established hemoglobin thresholds. Agreement between anemia classifications derived from non-invasive hemoglobin measurements and venous hemoglobin measurements obtained using a hematology analyzer will be assessed using Cohen's kappa coefficient. Kappa values and corresponding 95% confidence intervals will be reported.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarumanagara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alexander Halim Santoso, Tarumanagara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNTAR-HB-SPECTRO-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD Sharing Description De-identified individual participant data underlying the results reported in publications may be shared upon reasonable request to the principal investigator, following approval by the institutional ethics committee and execution of an appropriate data-sharing agreement.

Supporting Information Study protocol, statistical analysis plan, and data dictionary.

Time Frame Beginning 6 months after publication and ending 5 years after publication.

Access Criteria Access will be granted to qualified researchers for scientifically sound research proposals, subject to ethical approval and institutional review.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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