Manuscript Title:

COMPARATIVE ANALYSIS OF SENSITIVITY AND SPECIFICITY OF ANTI-HCV RAPID DIAGNOSTIC TEST (RDT) WITH HCV QUANTITATIVE POLYMERASE CHAIN REACTION (PCR): A LONGITUDINAL STUDY OF PUNJAB, PAKISTAN

Author:

MUHAMMAD IQBAL RANA, BASIT JABBAR, Dr. MUHAMMAD ILYAS, Dr. NAEEM ASIM

DOI Number:

DOI:10.17605/OSF.IO/9PXQ2

Published : 2023-04-10

About the author(s)

1. MUHAMMAD IQBAL RANA - Hepatitis & Infection Control Program, Punjab ; Institute of Business Administration, University of the Punjab, Lahore.
2. BASIT JABBAR - Program Officer, Hepatitis & Infection Control Program, Punjab; Hepatitis Reference cum Public Health Lab and Research Centre, Punjab, Lahore.
3. Dr. MUHAMMAD ILYAS - Hepatitis & Infection Control Program, Punjab.
4. Dr. NAEEM ASIM - Department of Public Health, The Islamia University of Bahawalpur, Pakistan.

Full Text : PDF

Abstract

With an extensive burden of chronic viral Hepatitis C, Pakistan is ranked second in the World in terms of disease burden after China and second in prevalence after Egypt. The Punjab Hepatitis & Infection Control Program has established a network of Hepatitis Clinics across the province in district, tehsil, teaching and partner organizations hospitals with provision of services in a standardized manner. Anti-HCV Rapid diagnostic test kits (RDTs) are convenient method of serological testing for screening for Hepatitis C. In this study, the sensitivity, specificity and diagnostic practicality of SD Bioline anti-HCV RTDs are assessed and compared with Quantitative HCV Polymerase Chain Reaction (PCR) for the detection of HCV through analysis of year-wise screening vs PCR data extracted from the electronic medical record (EMR) of the Hepatitis and Infection Control Program, Punjab from 2017-2022. After analyzing the complete data of 2,181,212 people who visited the Hepatitis Clinics and were screened for HCV on anti-HCV RDTs from August 2017 to December 2022, a total of 699,705 were screened positive for anti-HCV RDTs. Out of 699,705 individuals, only 376,467 were confirmed through HCV PCR meaning thereby confirmation rate for HCV RDT screened positive individuals stand at 50-60%. The data also indicated that 1,481,507 people were detected as negative. Based on the accuracy of HCV RDTs versus HCV PCR tests, there is a probability that the screened negative individuals might be carrying HCV and could not be detected. This is because of the low accuracy rate of HCV RDTs which might be a symptomless and silent source of HCV spread among the population. Keeping in view the findings of the study, it is recommended that manufacturers manufacturing anti-HCV RDTs should improve sensitivity by 95%. Secondly, the widespread use of anti-HCV RDTs may be curtailed and more sensitive methods of screening may be adopted at mass level. Thirdly, data health facility level data indicates that anti-HCV positivity at 17%, therefore, a fresh population level prevalence survey may be conducted or the Egyptian model may be replicated in order to eliminate Hepatitis C from Pakistan by 2030.


Keywords

COMPARATIVE ANALYSIS OF SENSITIVITY AND SPECIFICITY OF ANTI-HCV RAPID DIAGNOSTIC TEST (RDT) WITH HCV QUANTITATIVE POLYMERASE CHAIN REACTION (PCR): A LONGITUDINAL STUDY OF PUNJAB, PAKISTAN