Efficacy of Nucleic Acid Amplification Test (NAT) over Enzyme Linked Immuno Sorbent Assay (ELISA) in Detecting Transfusion Transmissible Infections (TTI) among Blood Donors at a Tertiary Care Centre

Aramani, Shakuntala S; Bommanahalli, Basavaraj P.; Kammar, Sourabh Mouneshwar

doi:10.21276/apalm.2453

Cited by 5 publications

(4 citation statements)

References 6 publications

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“…10,12 In a previous study, ELISA, and NAT results of 6,000 donor samples showed that 60 samples were seroreactive while only 52 samples were NAT positive and ELISA negative with one in 113 NAT yield. 14 In another study, ELISA positive, NAT negative (seroyield) samples were as follows, 9 samples seroyield HBV (0.9 %), 9 samples HCV (0.9 %) and 3 samples seroyield HIV (0.3 %). 12 The study by Hans et al, 2019, observed a combined NAT yield for all 3 viruses of 0.09 % (1 in 1,031).…”

Section: Discussionmentioning

confidence: 94%

Clinical significance of viral markers testing by ELISA and Individual Donation Nucleic Acid Testing (ID-NAT) for blood screening in blood bank: Single center study in Egypt

Abdelhady

2024

EJI

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Prevention of transfusion-transmitted viral infections and insurance of safe blood transfusion are the main goals of all blood banks worldwide. Despite the high sensitivity and specificity of currently used enzyme linked immunosorbent assay (ELISA) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) testing, viral transmission could still occur during the window period. Introducing viral individual donation nucleic acid testing (ID-NAT) can greatly decrease such risk providing an additional layer in securing blood transfusion. We aimed to assess the clinical significance of viral markers testing by ELISA and ID-NAT for blood screening in the Blood Bank of Suez Canal University Hospital. We studied all donations (2132) collected during a two-months period. Blood donor samples were screened by ELISA and ID-NAT tests for HBV, HCV, and HIV. Serological testing results for HCV by ELISA revealed 2,122 (99.5 %) negative donations compared to 2,131 (99.95 %) negative donations by ID-NAT testing. Of the positive ELISA samples, only one was NAT positive. For HBV ELISA testing, 2,115 (99.2 %) donations were negative, also by ID-NAT testing 2,115 (99.2 %) donations were HBV DNA negative. Out of the negative ELISA samples, two samples were ID-NAT reactive donors which were missed by serology assay being in the window period. HIV ELISA testing revealed negative 2,130 (99.9 %) donations while ID-NAT testing showed 2,131 (99.95 %) negative donations and one positive donation. In conclusion, this is the first study carried out in the Suez Canal and Sinai region, Egypt to assess the importance of ID-NAT implementation. The introduction of ID-NAT in blood banks is an effective method for increasing safety of the blood transfusion.

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Section: Discussionmentioning

confidence: 94%

Clinical significance of viral markers testing by ELISA and Individual Donation Nucleic Acid Testing (ID-NAT) for blood screening in blood bank: Single center study in Egypt

Abdelhady

2024

EJI

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“…This observation would become a necessity for the implementation of the nucleic acid test (NAT), especially in large transfusion centers in countries with limited resources. And it is preferable for the detection of infectious agents in blood banks to use a NAT with a lower detection threshold (for example 13.2 copies/ml) [ 38 – 41 ]. HIV-1 strains circulate daily in blood banks, more precisely at the NBTC in Gabon.…”

Section: Discussionmentioning

confidence: 99%

Genetic diversity of the human immunodeficiency virus of type 1 in Gabonese transfusional settings

et al. 2023

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Background The high endemicity of transfusion-transmissible infections (TTIs) in sub-Saharan Africa is a real public health problem. To reduce the risk of HIV transmission through blood donation, the NBTC of Gabon has launched in recent years a reorganization of its blood transfusion system. This study aims to characterize the molecular strains of HIV-1 circulating in donors and to estimate the risk of viral transmission. Materials and methods A cross-sectional study was carried out during the period from August 2020 to August 2021 among 381 donors who had agreed to donate blood at the National Blood Transfusion Center (NBTC). Viral load was determined by Abbott Real-Time (Abbott m2000®, Abbott) and sequencing by the Sanger method (ABI 3500 Hitachi®). The phylogenetic tree was constructed by MEGA X software. Data were checked, entered, and analyzed using SPSS version 21.0 software, with p ≤ 0.05 considered statistically significant. Results A total of 381 donors were enrolled in the study. Among the 359 seronegative donors, five (5) seronegative donors were detected positive for HIV-1 using Real-Time PCR. The residual risk was 648 per 1,000,000 donations. The prevalence of residual infection was 1.4% [0,01; 0,03]. Sixteen (16) samples were sequenced. The strains obtained were CRF02_AG (50%), subtype A1 (18.8%), subtype G (12.5%), CRF45_cpx (12.5%) and subtype F2 (6.2%). Six sequences clustered with A1, G, CRF02_AG, and CRF45_cpx subtypes. Conclusion The residual risk of HIV-1 transmission by blood transfusion remains a concern in the Gabonese transfusional settings. A policy based on improving the current screening strategy would involve the implementation of the nucleic acid test (NAT) in order to optimize the safety of the donation by detecting the HIV-1 subtypes in circulation in the donors.

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“…Several authors have shown that the consequence of passive blood safety is exposure to infectious agents transmissible by transfusion. To estimate the efficiency of the transfusion chain, it is necessary a priori determine the transfusion risk [41][42][43][44][45]. Today much has been done with the aim of improving the diagnostic tests used in blood banks, but this does not exclude that these tests have limits (existence of the detection threshold) that could be caused by the genetic diversity of HIV-1 whose mutations are seen every day in infected patients.…”

Section: Discussionmentioning

confidence: 99%

Genetic Diversity of HIV-1 and Transfusion Safety : Systematic Review and Concepts Analysis

Mangala

Fokam

Maulot-Bangola

et al. 2021

I-SRR

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Background: The genetic diversity of human immunodeficiency virus type 1 (HIV-1) is a real problem facing blood banks. This genetic diversity has a negative impact on diagnostic strategies within the transfusion chain by weakening the security of the donation. The objective of this study is to clarify the concepts emanating from the research project entitled : «Genetic diversity of HIV-1 and its effect on the residual risk in blood transfusion in Gabon». Methods: This study was the result of a systematic review and a conceptual analysis of several studies that were systematically searched for in databases (PubMed, Google Scholar, and Medline), and whose object was focused on the genetic diversity of HIV -1 and its impact on transfusion safety. Indeed, the information relating to the concepts coming from the full articles was used. These were obtained by reading the most relevant articles. All relevant studies reporting data on HIV-1 genetic diversity and blood safety published in English between January 2012 and December 2020 have been identified for context. The method of conceptual analysis of « Walker and Avant (2005) » was used to clarify the different concepts of our study. The correlation test was used to show the relationship between the concepts. Results: This systematic review and conceptual analysis study made it possible to determine the variables and to clarify the different concepts (HIV-1, Genetic diversity, Blood transfusion, Residual risk) essential for carrying out our research project entitled: "Genetic diversity of HIV-1 and its effect on the residual risk in blood transfusion". This model made it possible to show the effect of the genetic diversity of HIV-1 on the residual risk in blood transfusion using as model variables : viral load and serological markers (Antibodies and P24 Antigen). Knowledge of molecular strains (URF, CRF, subtypes) during this study made it possible to better identify the molecular strains most involved in the residual risk. Despite its complexity, this conceptual analysis contributed enormously to the understanding of the activities and the quantifiable and non-quantifiable components that participated in our study. Statistical analysis showed that the HIV-1 concept was significantly related to the other three concepts with P = 0.001. Likewise for the concept of genetic diversity was also significantly linked to the two other concepts with P = 0.003. Conclusion: The genetic diversity of HIV-1 in the blood transfusion environment contributes significantly to the transmission of HIV from donor to recipient. The mastery of these molecular strains is essential for the various blood banks to ensure a safe blood supply.

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Efficacy of Nucleic Acid Amplification Test (NAT) over Enzyme Linked Immuno Sorbent Assay (ELISA) in Detecting Transfusion Transmissible Infections (TTI) among Blood Donors at a Tertiary Care Centre

Cited by 5 publications

References 6 publications

Clinical significance of viral markers testing by ELISA and Individual Donation Nucleic Acid Testing (ID-NAT) for blood screening in blood bank: Single center study in Egypt

Clinical significance of viral markers testing by ELISA and Individual Donation Nucleic Acid Testing (ID-NAT) for blood screening in blood bank: Single center study in Egypt

Genetic diversity of the human immunodeficiency virus of type 1 in Gabonese transfusional settings

Genetic Diversity of HIV-1 and Transfusion Safety : Systematic Review and Concepts Analysis

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