Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among Adults in Jakarta (SPECTRO-Hb)
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
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ernawati Ernawati, Dr
- Email: ernawati@fk.untar.ac.id
Study Contact Backup
- Name: Yohanes Firmansyah, MD
- Phone Number: +6281297934375
- Email: yohanesfirmansyah28@gmail.com
Study Locations
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 11420
- Kota Bambu Subdistrict
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Contact:
- Ernawati Ernawati, Dr
- Email: ernawati@fk.untar.ac.id
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Contact:
- Yohanes Firmansyah
- Phone Number: 081297934375
- Email: yohanes@fk.untar.ac.id
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time Frame: Day 1
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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).
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Day 1
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Diagnostic Accuracy for Anemia Detection
Time Frame: Day 1
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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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time Frame: Day 1
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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.
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Day 1
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Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing
Time Frame: Day 1
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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.
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Day 1
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Area Under the ROC Curve (AUC) for Anemia Detection
Time Frame: Day 1
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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.
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Day 1
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Agreement in Anemia Classification
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alexander Halim Santoso, Tarumanagara University
Publications and helpful links
General Publications
- Shah N, Osea EA, Martinez GJ. Accuracy of noninvasive hemoglobin and invasive point-of-care hemoglobin testing compared with a laboratory analyzer. Int J Lab Hematol. 2014 Feb;36(1):56-61. doi: 10.1111/ijlh.12118. Epub 2013 Jun 27.
- Chen YY, Lai GH, Chen CT, Cheng HC, Tseng SH. Noninvasive hemoglobin quantification across different cohorts using a wearable diffuse reflectance spectroscopy system. Biomed Opt Express. 2024 Feb 20;15(3):1739-1749. doi: 10.1364/BOE.517645. eCollection 2024 Mar 1.
- Alwabari M, Alhamad F, Alsahaf F, Al Amer F, Alniniya F, Alherz I, Omer N, Bushehab A, Yassen K. Can Non-Invasive Spectrophotometric Hemoglobin Replace Laboratory Hemoglobin Concentrations for Preoperative Anemia Screening? A Diagnostic Test Accuracy Study. J Clin Med. 2023 Sep 3;12(17):5733. doi: 10.3390/jcm12175733.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNTAR-HB-SPECTRO-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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