Validation of Point-of-Care Testing Device for Serum Ferritin Estimation in an Outpatient Facility in India

Iron deficiency anaemia is the most common cause of anemia among pregnant and lactating women. Personalised management and precision in anemia diagnosis requires ferritin estimation. The current laboratory-based serum ferritin tests are a bottleneck for further management of anemia. The study aimed to assess the diagnostic accuracy of the point-of-care testing (POCT) device for serum ferritin estimation among people in different age groups in a secondary care health facility in India, compared to the gold standard laboratory-based enhanced chemiluminescence-based immunoassay. A sample of 40 participants attending the 50-bed secondary healthcare facility in Faridabad, Haryana, was included. Venous blood samples were collected to estimate serum ferritin levels using the POCT device and the laboratory-based enhanced chemiluminescence-based immunoassay (gold standard). Sensitivity, specificity, positive and negative predictive values, accuracy, and Lin's concordance correlation coefficient were calculated to assess diagnostic accuracy. This study enrolled 40 participants between the ages of 5 and 45 years, with the majority being females (67.5%). Based on hemoglobin estimation using the Hemocue 301, 50% were anemic. The POCT device demonstrated a sensitivity of 73.3% (95% CI: 49.9-92.2), specificity of 96.0% (95% CI: 79.6-99.9), and diagnostic accuracy of 87.5% (95% CI: 72.1-93.3) compared to the laboratory-based enhanced chemiluminescence-based immunoassay. The mean percent difference (S.D.) based on Bland Altman analysis was 35.9% (37.8) (95% C.I. 23.9-48.1%), with lower and upper limits of agreement as -38.0%, and 109.9% respectively. Lin's concordance correlation coefficient was 0.95 (95% CI: 0.92 to 0.98). The ferritin POCT device's high specificity and moderate sensitivity make it suitable for diagnosing iron deficiency. Its ability to provide rapid turnaround of test results can facilitate the early initiation of appropriate treatment, leading to improved clinical outcomes. Further research, including validation studies, should be undertaken.

The online version contains supplementary material available at 10.1007/s12288-024-01943-3.