Clinical Trial

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

Study acronym: SPECTRO-Hb
Not Yet Recruiting
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-16
Trial Details
NCT Number NCT07701499
Lead Sponsor Tarumanagara University
Conditions Anemia
Enrollment 200 participants
Start Date 2026-07-11
Primary Completion 2027-07-30 (estimated)
Study Completion 2028-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-15