COMPARISON BETWEEN ELISA AND ICT TECHNIQUES FOR THE

DETECTION OF ANTI-HCV ANTIBODIES AMONG BLOOD DONORS

ABSTRACT Background and Objective: 

The most important marker for HCV infection is the detection of anti-HCV antibodies. Although
HCV detection by immunochromatography (ICT) method is one of the most popular methods,
enzyme-linked immunosorbent assay (ELISA) and nucleic acid testing methods are considered
more reliable.

This is a cross-sectional study. This study aims to compare the performance of ICT and Elisa
techniques' performance for detecting anti-HCV antibodies among blood donors in Children's
Hospital Lahore.
Methods: Blood samples from 130 male blood donors were randomly collected according to
WHO criteria of donor selection at the blood bank of children's hospital Lahore. Blood samples
were taken from 1 September 2015 to 28 November 2015. All samples were subjected to the
detection of HCV by ICT and ELISA. 

Results: 100 samples of blood donors showing negative results for HCV were retested with
ELISA. Out of these 100 samples, only 1 (1%) sample showed positive results for HCV with
ELISA. Similarly, 30 blood donor samples showing positive results by the ICT technique were
also analyzed by ELISA, and only 1 sample (3.3%) showed negative results with the ELISA
technique. Using the ELISA technique as the gold standard for HCV infection showed 99%
specificity and 96.66% sensitivity to the ICT technique. 
Conclusion: ICT results for blood donor screening are acceptable, just like ELISA, due to its
comparable sensitivity and specificity. It can be used in blood banks with limited facilities
because it is rapid and cost-effective.

INTRODUCTION

Hepatitis C is a major health problem worldwide, especially in developing countries like

The prevalence rate of HCV in the Asia Pacific region is from 4% to 12%.1 Seroprevalence of
HCV is reported from 0.4% to 13.3% in different countries.2 6% of the total population, or more
than 10 million people in Pakistan, are infected with HCV, leading to a high mortality rate and
morbidity rate.1 HCV mainly affects the liver to cause hepatitis C.

It is a single standard RNA virus belonging to the family Flaviviridae. The major source of
hepatitis C virus (HCV) infection includes the infected blood, its products, and other body fluids.
Risk factors like intravenous drug injecting, reuse of syringes, dental procedures, use of infected
razors, pricking by sharp objects, infected sexual partners, and tattooing also play an important
role in the occurrence of HCV infection.
Now a day's, different lab techniques are used for screening and diagnostic purposes for HCV,
including rapid kit, ELISA, chemiluminescence (CLIA), and PCR. 6 Blood donation screening
tests have a major concern with cost-effectiveness and sensitivity. They should provide the
results in a short duration of time. We can detect HCV antigens, anti-HCV antibodies, or both by
serological assays. 2 In developing countries, many blood banks have limited facilities such as
electric supply, trained workforce, and instrumentation. Alternative screening methodology to
EIAs and PCR is rapid tests in such situations. These tests are easy to perform without
instruments or an electric supply and can be read visually within a few minutes. They are based
upon the following principles; agglutination, immunofixation, or immuno-chromatography. 5
ELISA tests are expensive as the instruments and chemicals are required to perform the test, but
it has shortened the window period of HCV.4 For detecting two infectious markers (antigen and
antibody), the combination EIA of HCV, also known as 4th generation EIA, is used nowadays. 

HCV-RNA can also be amplified using (NAT) nucleic acid amplification technology. It shortens
the window period to 4 days and is more sensitive.2 Polymerase chain reaction (PCR) can be
used to detect HCV RNA to detect acute infection with hepatitis C virus (HCV). PCR involves a
high cost of testing because it requires trained staff and specialized expertise. 
6 Blood banks use rapid screening kits because they are rapid, cost-effective, user-friendly, and
do not require sophisticated equipment and elaborate training.7 Antigen that is mostly the same
as in 3rd generation ELISA is also used in these tests. The sensitivities of these tests are reported
from 98% to 100%. Due to their cost-effectiveness and user-friendly attributes, rapid kits are
practically used in all Pakistan primary and secondary healthcare facilities.2 Early generations of
ELISA had a long incubation period that has been reduced in new generations. 

3rd generation ELISA has a non-structural antigen (NS5), an additional antigen showing a
reduced window period of 66 days. Monalisa anti-HCV, 3rd generation ELISA used in this
study, has been reported (as 100%) sensitive and (98%) specific in different studies.2,11 Hence
rapid tests and ELISA are the most common and popular methods for detecting HCV infections.
The major problem that we face is the discordance between the results of these two assays,
which can be solved by using the availability of suitable kits. Therefore, kit evaluation gains
importance for determining the diagnostic kits of better performance.8

 This study was conducted to analyze the effectiveness of these testing kits for screening blood
donors and compare ICT results with ELISA. In the present study, we used ICT to detect HCV
infection. For the reconfirmation of ICT results, we used 3rd generation ELISA as the gold
standard due to its performance improvements in terms of "generations" of the assay.
SUBJECTS AND METHODS This cross-sectional study was conducted in the Immunology
department of Children's Hospital Lahore. It was a hospital-based study from 1 September 2015
to 8 November 2015e. The sample size of this study was calculated by using the WHO software
for sample size determination in health studies (Wanga and Lemeshow, 2001). A convenient
sampling technique was used.

ZAMEER M., 1 SHAZAD F., 2 SAEED M., 3 AZIZ S., 4 NAZISH5 AND HUSSAIN S.

Departments Pathology, Children’s Hospital,