Improving Hepatitis B diagnosis by implementing statistical quality controls

Hepatitis B is a viral infection that causes major health problems worldwide. The hepatitis B virus (HBV) and 1.2 million deaths per year globally infect more than two billion people. Hepatitis B mainly affects the liver and causes liver cirrhosis and hypocellularity carcinoma. This study investigates diagnostic quality parameters of quantitative polymerase Chain Reaction (qPCR) and enzyme-linked Immunosorbent Assay (ELISA) called enzyme immunoassay (EIA) for HBV Diagnosis. The research was conducted at the Molecular Biochemistry Laboratory (MBL) in the Department of Biochemistry at the University of Agriculture, Faisalabad, Pakistan. The samples for the randomized study containing 977 male and female samples who had pre-diagnosis HBV infection were selected for this comparative study and collected from the Punjab Institute of Nuclear Medicine (PINUM) Hospital and Allied Hospital Faisalabad, Pakistan. This study compared the sensitivity and specificity of the ELISA assay with the HBV qPCR assay to diagnose HBV infection. The cut-off value < 1.00 was considered non-reactive, whereas ≥ 1.00 was reactive patients for ELISA. Similarly, HBV viral load was measured on qPCR < 101 IU/mL was considered a negative result, and > 101 IU/mL showed positive results. Statistical data analysis was conducted using Statistical Package for Social Sciences (SPSS 22) software. These tests were used to diagnose HBV infection on a large scale to calculate the percentage value of sensitivity, specificity, and other parameters. With a 95% confidence interval, the qPCR's positive predictive value (PPV) was 46%, whereas 52% for ELISA. The negative predictive value (NPV) for qPCR was 98%, but it was the same for ELISA. The specificity for qPCR was 91% and 92% for ELISA. The sensitivity value for qPCR was 83%, and 87% for ELISA was observed from the samples. Accuracy for both methods varied, which showed their proficiency and size. The results obtained from qPCR were more accurate and authentic than those obtained from ELISA.