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

Shyam Prakash, Supriya Bharti, Priyatma, 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.