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

NCT07701499 | Not Yet Recruiting

• 1 other identifier: UNTAR-HB-SPECTRO-2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

Anemia; Hemoglobin; Point-of-Care Testing; Hematology Analyzer; Diagnostic Validation'; Diagnostic Accuracy; Anemia Screening; Community Screening; Optical Hemoglobin Measurement; Non-Invasive Hemoglobin Measurement; optical method

Outcome Measures

Primary Outcomes (2)

• Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer

  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

  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 Outcomes (4)

• Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer

  Day 1

• Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing

  Day 1

• Area Under the ROC Curve (AUC) for Anemia Detection

  Day 1

• Agreement in Anemia Classification

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarumanagara University: lead

Study Sites (1)

Kota Bambu Subdistrict

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 23809685 BACKGROUND

• 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.

  PMID: 38495710 BACKGROUND

• 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.

  PMID: 37685800 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alexander Halim Santoso

  Tarumanagara University

  STUDY DIRECTOR

Central Study Contacts

Yohanes Firmansyah, MD

CONTACT

+6281297934375; yohanesfirmansyah28@gmail.com

Ernawati Ernawati, Dr

CONTACT

ernawati@fk.untar.ac.id

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 11, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

ID (1)