DIAGNOSTIC ACCURACY OF DIGITAL HEMOGLOBINOMETERS: EVIDENCE SYNTHESIS AND RECOMMENDATIONS
Author(s)
Jasmine Samal, PhD1, Tulika Seth, MD2, Perumal Vivekanandan, PhD3, Mohan S Kamath, MS4.
1Scientist, Indian Institute of Technology Delhi, New Delhi, India, 2All India Institute of Medical Sciences, New Delhi, New Delhi, India, 3Indian Institute of Technology Delhi, New Delhi, India, 4Christian Medical College, Vellore, India.
1Scientist, Indian Institute of Technology Delhi, New Delhi, India, 2All India Institute of Medical Sciences, New Delhi, New Delhi, India, 3Indian Institute of Technology Delhi, New Delhi, India, 4Christian Medical College, Vellore, India.
OBJECTIVES: Objectives: Anemia, a public health issue in India, requires mass screening for hemoglobin levels without delay. Conventional hemoglobin testing has limitations, including sample collection, accessibility and lab-based setup. Digital hemoglobinometers as point-of-care screening tools are quick, portable and user-friendly alternatives, enabling real-time and repeated assessments. Many digital hemoglobinometers are commercially available, but their diagnostic accuracy has not been systematically evaluated.
METHODS: Methods: We undertook a systematic review and meta-analysis to review the diagnostic accuracy of digital hemoglobinometers across the globe. We searched in PubMed, CINAHL, Embase, Web of Science, and Scopus databases. Full-text articles reporting the sensitivity and specificity of digital hemoglobinometers compared to automated analysers (the gold standard) were included. Two independent reviewers screened, extracted data and assessed the methodological quality using the QUADAS-2 tool. We pooled sensitivity and specificity using a random-effects meta-analysis and calculated I² heterogeneity. Certainty of evidence was evaluated by GRADE. The review was registered in PROSPERO (CRD42024600500).
RESULTS: Results: Out of 5248 studies screened, a total of 72 studies (40 invasive; 33 non-invasive) representing 64,945 participants, were included. Compared with the laboratory gold standard, invasive hemoglobinometers showed a pooled sensitivity of 85% (95% CI: 77 - 91%) and specificity of 90% (95% CI: 83 - 95%). For non-invasive hemoglobinometers, the pooled sensitivity was 65% (95% CI: 51 - 76%), and specificity 88% (95% CI: 79 - 93%). In a subgroup analysis for community settings, Invasive devices exhibited better performance.
CONCLUSIONS: Conclusion: Taken together, digital hemoglobinometers demonstrated lower sensitivity compared with the gold-standard. Invasive digital hemoglobinometers showed better performance for anemia screening compared with non-invasive ones. Nevertheless, non-invasive devices, despite systematic bias, enable better acceptability and operational feasibility. However, further investigation is needed to evaluate the effectiveness and accuracy of both invasive and non-invasive digital hemoglobinometers in community settings, particularly for at-risk groups, including pregnant women.
METHODS: Methods: We undertook a systematic review and meta-analysis to review the diagnostic accuracy of digital hemoglobinometers across the globe. We searched in PubMed, CINAHL, Embase, Web of Science, and Scopus databases. Full-text articles reporting the sensitivity and specificity of digital hemoglobinometers compared to automated analysers (the gold standard) were included. Two independent reviewers screened, extracted data and assessed the methodological quality using the QUADAS-2 tool. We pooled sensitivity and specificity using a random-effects meta-analysis and calculated I² heterogeneity. Certainty of evidence was evaluated by GRADE. The review was registered in PROSPERO (CRD42024600500).
RESULTS: Results: Out of 5248 studies screened, a total of 72 studies (40 invasive; 33 non-invasive) representing 64,945 participants, were included. Compared with the laboratory gold standard, invasive hemoglobinometers showed a pooled sensitivity of 85% (95% CI: 77 - 91%) and specificity of 90% (95% CI: 83 - 95%). For non-invasive hemoglobinometers, the pooled sensitivity was 65% (95% CI: 51 - 76%), and specificity 88% (95% CI: 79 - 93%). In a subgroup analysis for community settings, Invasive devices exhibited better performance.
CONCLUSIONS: Conclusion: Taken together, digital hemoglobinometers demonstrated lower sensitivity compared with the gold-standard. Invasive digital hemoglobinometers showed better performance for anemia screening compared with non-invasive ones. Nevertheless, non-invasive devices, despite systematic bias, enable better acceptability and operational feasibility. However, further investigation is needed to evaluate the effectiveness and accuracy of both invasive and non-invasive digital hemoglobinometers in community settings, particularly for at-risk groups, including pregnant women.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
EPH22
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health
Disease
SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain), STA: Nutrition