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.
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).
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.
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.
Case-only
Cross-sectional
Not listed
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).
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.
Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
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.
Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing
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.
Area Under the ROC Curve (AUC) for Anemia Detection
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.
Agreement in Anemia Classification
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
