Abstract
In this study, we describe and compare a simple, rapid, low cost, point-of-care diagnostic paper-based test for screening of sickle cell disease, which is based on principle of haemoglobin solubility. This observational study was carried out in 384 cases advised for screening of haemoglobin disorders by HPLC. All the cases were subjected to both HPLC and modified sickle cell paper solubility test simultaneously. The results of both the test were compared accordingly. Further to check the minimum level of HbS that can be identified by paper solubility test, a sample dilution method was used and analyzed. Out of 384 cases, 131 cases were found to have an HbS window in the HPLC report and rest 263 cases were found to have either normal or other haemoglobin variants. The paper solubility test also showed the similar results with 100% of sensitivity and specificity. Further, a > 5% of HbS can be traced and identified by paper solubility test. The paper-based haemoglobin solubility test was seen to be capable of distinguishing sickle cell patients from non sickle cell blood samples with a high degree of accuracy. It is a very rapid test that can be performed by a person with minimal training at community level (field study). The paper based Hb Solubility test is a low cost, easy, rapid, accurate, point of care and reproducible screening test for sickle cell patients.