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- Title
Validation of new invasive digital hemoglobinometer for hemoglobin estimation as point-of-care device among pregnant women in a facility setting India.
- Authors
Khanam, Areeba; Chandra, Ankit; Achary, Thejas; Vohra, Kashish; M., Aravind; Singh, Archana; Yadav, Kapil
- Abstract
Background: Anemia poses a significant health challenge for pregnant women (PW), and accurate and timely diagnosis is essential for effective management. Objective: The objective was to assess the diagnostic validity of the new digital hemoglobinometer for hemoglobin against laboratory-based hematology autoanalyzer among PW. Methodology: The study was conducted at a secondary-level healthcare facility among 204 pregnant women to be sampled conveniently, their sociodemographic and iron intake data collected, and hemoglobin levels assessed using a digital hemoglobinometer (Device A) and a hematology analyzer. Specificity, sensitivity, PPV, NPV, diagnostic accuracy, and method agreement were evaluated via Bland-Altman analysis and Lin's concordance correlation coefficient. Results: The proportion of anemia using the Device A was 64.7% while the hematology analyzer reported a proportion of 52.9%. Device A showed a sensitivity of 97.22%, specificity of 80.30%, and diagnostic accuracy of 86.3%, with substantial agreement indicated by Cohen's kappa coefficient (kappa = 0.72) and the weighted kappa coefficient for different grades of anemia was 0.67. Bland-Altman analysis revealed a mean difference (bias) of -0.28 (± 0.5) between the two methods, with limits of agreement at -1.24 and 0.68. Lin's concordance correlation coefficient of absolute agreement was 0.91. Conclusion: The DH showed high sensitivity and diagnostic accuracy for anemia detection in PW, with substantial agreement with the hematology analyzer. It offers a convenient and rapid alternative for POC hemoglobin estimation in resource-constrained settings.
- Subjects
INDIA; ANEMIA diagnosis; IRON; IRON in the body; STATISTICAL correlation; AUTOANALYZERS; BODY mass index; HEMOGLOBINS; DIGITAL health; RESEARCH methodology evaluation; STATISTICAL sampling; SAMPLE size (Statistics); PREGNANT women; HEMOGLOBINOMETRY; DESCRIPTIVE statistics; HEMATOLOGY; ROUTINE diagnostic tests; STATISTICS; RESEARCH methodology; POINT-of-care testing; HEALTH facilities; SOCIODEMOGRAPHIC factors; RESOURCE-limited settings; DATA analysis software; CONFIDENCE intervals; SENSITIVITY &; specificity (Statistics); PREDICTIVE validity; PREGNANCY
- Publication
Indian Journal of Community Health, 2024, Vol 36, Issue 2, p272
- ISSN
0971-7587
- Publication type
Article
- DOI
10.47203/IJCH.2024.v36i02.018