Comparison of different rapid screening tests and ELISA for HBV, HCV, and HIV among healthy blood donors and recipients at Jibla University Hospital Yemen

Abstract

Blood transfusion is associated with many risks, especially exposure to blood transfusion-transmitted infections considered one of the main causes of death worldwide, including hepatitis B (HBV) and C virus (HCV) and human immunodeficiency virus (HIV). The threat posed by blood-borne pathogens is disproportionately high, especially in developing countries, so there is a need for continuous monitoring of blood transfusions to prevent transmitting diseases. Rapid diagnostic immunochromatographic technique (ICT) methods are the most widely used methods in developing countries, although ELISA and molecular testing are considered more accurate worldwide. Therefore, the study aimed to compare the analytical sensitivity between rapid tests and the ELISA method for detecting HBV, HCV, and HIV infection among blood donors. Four hundred (400) blood donor samples were tested using the Rapid Test Kits (INTEC, SD, ABON, and CLUN), and the ELISA method was used as a confirmatory test. Out of 400 blood samples tested for viral infection, HBV, HCV, and HIV were detected in 8, 10, and 2 samples, respectively, using the ELISA technique. This study observed that the rate of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), in addition to determining the diagnostic accuracy rate and error rate for all rapid diagnostic kits in detecting HBV, HCV and HIV are less accurate and associated with more false negatives compared to the ELISA technique. This study showed a significant difference in sensitivity between ELISA and rapid diagnostic immunochromatographic technique (ICT) groups; therefore, rapid diagnosis is not suitable for testing the quality of infectious markers for blood donors.

Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

“…A cross-sectional study was conducted by Al-Matary et al [ 84 ] to determine the analytical sensitivity of 400 blood donors and recipients attending the Laboratories of Jiblah University Hospital, Yemen, between 2018 and 2019. In the study, the analytical sensitivities and specificities of four LFA: INTEC, SD, ABON and CLUN, were evaluated and compared using the ELISA technique.…”

“…There was a significant difference in sensitivity between ELISA and all the LFA as the sensitivity for INTEC to HBV was 75% (six out of eight cases), for SD 25% (two out of eight cases), for ABON 62.5% (five out of eight cases) and for CLUN 75% (six out of eight cases), which were lower than ELISA. Based on the findings, they did not recommend LFA for blood donor screening as the sensitivity of the LFA needs to be improved [ 84 ]. A comparative assessment based on sensitivity was conducted by Navvabi et al [ 85 ] at Urmia Medical University Hospital on 140 men and 60 women using the LFA Ab Core Cassette compared with PCR.…”

An Oxford Nanopore Technology-Based Hepatitis B Virus Sequencing Protocol Suitable For Genomic Surveillance Within Clinical Diagnostic Settings

“…In such settings, serological tests are used to detect HBV surface antigen (HBsAg) in serum or plasma. However, a major concern when using serological screening tests is that these tests must possess a high degree of sensitivity and an acceptable level of specificity to reduce false results [13,14]. For more detailed characterization of HBV in patient samples, Sanger sequencing of complete or partial HBV genomes is considered the gold standard.…”

The Prevalence of Transfusion-Transmitted Diseases Among Blood Donors in the Central Blood Bank in Makkah, Saudi Arabia

“…Nucleic acid testing (NAT) allows for the direct detection of viral genomes in blood donations and is commonly used for HIV, HCV, and HBV screening [8]. Enzyme-linked immunosorbent assay (ELISA) is frequently employed to screen blood donations for antibodies or antigens related to HIV, HBV, HCV, HTLV-1, and syphilis [9]. Rapid diagnostic tests (RDTs) and serological testing are quick and cost-effective and are utilized for HIV, HCV, syphilis, and malaria screening and for detecting antibodies or antigens in the blood, respectively [9].…”

“…Enzyme-linked immunosorbent assay (ELISA) is frequently employed to screen blood donations for antibodies or antigens related to HIV, HBV, HCV, HTLV-1, and syphilis [9]. Rapid diagnostic tests (RDTs) and serological testing are quick and cost-effective and are utilized for HIV, HCV, syphilis, and malaria screening and for detecting antibodies or antigens in the blood, respectively [9]. In this study, we will rely on these techniques with the aim of studying the prevalence of infectious diseases such as HBV, HCV, HIV, malaria, HTLV-1, and syphilis among blood donors in the Central Blood Bank in Makkah, Saudi Arabia.…”