Journal of Medical Diagnostic Methods
Open Access

Abstract

Performance Characteristic of a Simple, Rapid and Cost-Effective Micro-PCR Assay for HBV DNA Quantification

Shyam Prakash*, Supriya Bharti, Priyatma and Ram Aasarey

HBV DNA detection is crucial for identifying early acute and occult HBV infections. Detection and quantification of HBV-DNA are essential to diagnose and formulate to help in the treatment of HBV infection. Micro PCR is a portable battery-operated device based on real-time PCR developed by Bigtech Bangalore, India, which is inexpensive, fast, and easily installed and can be operationalized in a remote place where diagnostic services are not easily accessible in the country. The clinical and analytical specificity of the assay was comparable i.e., 100%. Intraassay and inter-assay coefficient of variation ranged from 0.25% to 2.85% and from 0.75% to 3.25% respectively. A strong correlation (r=0.9563; p<0.001) with the in-house TaqMan HBV-DNA test (Life River Q PCR kit) v.2. Agilent System Inc. was obtained. The count of detection using the 3rd WHO International standard for HBV DNA was 5.8 Log 10 IU/ml. The test could equally detect the most prevalent HBV genotypes (A&G). Micro PCR (Bigtech Pvt Ltd) is a sensitive, specific, precise, and accurate for quantifying serum and plasma HBV-DNA assay. Thus, this simple and fast micro-PCR device can easily be used in the field as well as in remote places where the detection of HBV-DNA is not accessible thereby as an aid in diagnosing HBV infection and monitoring drug efficacy.

Published Date: 2023-10-26; Received Date: 2023-09-25