الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
 |  | from | 63 |  |  |
| | | from | 63 | | |
Abstract
HCV infection is the most common cause of chronic liver diseases where Over 170
million people worldwide are infected with HCV and more than 70%of infected people
may develop chronic hepatitis, cirrhosis and hepatocellular carcinoma (HCC). HCV
infection has emerged as major public health problem in Egypt where the overall predicted
number of truly infected individuals is more than five million.
Laboratory diagnostic tests for HCV infection include serological assays for
antibodies detection and molecular techniques for detecting viral RNA. The main
screening tests for anti-HCV is ELISA technique which shows high sensitivity.
Despite the excellent sensitivity and specificity of third-generationEIAs, the
turnaround time for reporting test results is at least 1day, thereby making it difficult to
deliver the result to tested individuals at first visit. In settings where few blood donations
are collected and equipment is unavailable or even when money is available to purchase
the necessary equipment, the fluctuation of the power supply and the difficulties in
maintaining and repairing equipment present yet. Rapid tests are formatted such that they
do not require complicated instrumentation or testing by skilled technical staff. They
potentially generate results within an hour and therefore may be used for point of-care
testing. Rapid tests can represent a solution for blood screening in resource-poor settings
where EIAs are not feasible or practical and in geographic areas with limited laboratory
infrastructure. Rapid tests may be appropriate for hard-to-reach populations (e.g IDU) or
geographically remote populations, for whom HCV test results may need to be provided on
site on the same day as specimen collection. In most countries in West Africa, testing by
EIA occurs in major or national blood centres, whereas rapid tests are used in small blood
banks .In resource-challenged countries, the expense of currently available ELISA for
blood screening results in a lack of or inconsistent testing of blood donations. These
constraints carry us to identify diagnostic test kits that are rapid, sensitive, specific and
affordable.
Rapid test provides a flexible, practical, technically undemanding, relatively
inexpensive approach to ensuring a safer blood supply and suitable in geographic areas
with limited laboratory infrastructure.
The aim of the present study was to evaluate the effectiveness of rapid tests for the
detection of HCV antibodies. This study was carried out through the period from December
2011to May 2013. It included 500blood donors (100anti-HCV positive and 400anti-HCV
negative according to ELISA results) who attended the Blood Bank of the Medical Research
Institute in Alexandria. The anti-HCV results of attendees were taken from blood bank records,
and the samples were tested by ELISA technique to obtain the absorbance values. After taking
the donor’s consent a thorough history taking was done including the important personal data
(e.g. age, sex ,surgery...) (Appendix ) and were subjected to collection of blood sample which
was tested for:
1- HCV antibodies by third-generation ELISA ( MUREX vrsion 4).
2- HCV antibodies by rapid diagnostic test ;Immuno-chromatographic HCV test
(ACON® HCV one step test device)
Summary and Conclusion
61
3- HCV RNA by RT PCR technique.
The study revealed the following results:
1. The sensitivity of 98% and specificity of 100% were found with ACON HCV one step
test device.
2. The sensitivity of 67% and specificity of 100% of third generation ELISA to detect the
HCV antibodies compared to RT-PCR results.
3. By simple logistic regression analysis among blood donors: Parenteral treatment for
schistosoma, male, age, surgery, Anti- HCV-positive family member, marital status
were risk factors associated with HCV seropositivily and are statistically significant
(p< 0.05)
4. By stepwise logistic regression analysis among blood donors: Accidental exposure to
blood, parenteral treatment and needle stick were not risk factors and are statistically
insignificant.
from the study it could be concluded that:
1. The performance of the investigated rapid test is comparable to the third generation
ELISA with regards to sensitivity(98%) and specificity(100%).
2. Age, surgery and contact with anti-HCV positive family member are statistically
significant risk factors associated with anti-HCV seropositivity.