Evaluation of Impact of Nucleic Acid Testing in Transfusion Transmitted Infections (TTIs) Screening in Egyptian Blood Donors
Shereen Mostafa Mohy El-Din;
Abstract
Summary
he safety of blood products is one of the major issues in the area of transfusion medicine. Screening of blood donors for transmissible agents play a major role to decrease the risk of transfusion of infected units. Firstly, testing of antibody/or antigen markers of blood borne pathogens was established. However, limitation of these serological techniques including window period between infection time and detection time, and antigenic variability enhance implementation of NAT.
NAT is a highly sensitive and advanced molecular technique. It is based on amplification of target regions of viral RNA or DNA and detects them earlier than other screening methods which thus reducing the window period for HBV, HCV and HIV to 8, 7 and 9 days respectively. NAT blood screening system was originally intended to complement serological screening for detection of donations infectious for those viruses.
This study was conducted at NBTC, blood donation collected from 20000 voluntary donors January 2014 to June 2014 and tested with both ID NAT and ELISA assays for HBV, HCV and HIV. Using the PROCLEIX® TIGRIS® System, ID-NAT depending on (TMA) Technology. TMA assay involves three main steps utilizing three proprietary technologies:
T
Summary and Conclusion
90
(a) Target capture based sample preparation,
(b) Transcription-mediated amplification,
(c) Hybridization protection assay.
Data collected and analysis done for serological and NAT results to detect seronegative, reactive NAT yield and residual risk of TTIs.
We identified 12 samples (0. 06%) as NAT yield (seronegative samples and NAT reactive) of total 20000 tested samples. The NAT yield of 12 samples in 20000 samples assumes more significance when one considers the fact that single donation is used for generating 3 components (packed RBCs, plasma, platelet) that can be used by 3 recipients.
In our study, the prevalence of transfusion transmitted viruses among the studied donors were 4.6% for HCV and 1.56% for HBV, total number of false positive tested samples with were 257 samples (1.2%) of total tested samples. The need for NAT depends on the prevalence and incidence rate of infections in blood donor population, available resources and the evidence of benefit added when combined with serology tests. Hence the decision of starting NAT should be considered when basic quality assured blood transfusion system is already in place such as volunteer base for blood donation, provision of donor self-deferral, donor notification and counseling along with quality assured sensitive serological methods for testing TTIs.
he safety of blood products is one of the major issues in the area of transfusion medicine. Screening of blood donors for transmissible agents play a major role to decrease the risk of transfusion of infected units. Firstly, testing of antibody/or antigen markers of blood borne pathogens was established. However, limitation of these serological techniques including window period between infection time and detection time, and antigenic variability enhance implementation of NAT.
NAT is a highly sensitive and advanced molecular technique. It is based on amplification of target regions of viral RNA or DNA and detects them earlier than other screening methods which thus reducing the window period for HBV, HCV and HIV to 8, 7 and 9 days respectively. NAT blood screening system was originally intended to complement serological screening for detection of donations infectious for those viruses.
This study was conducted at NBTC, blood donation collected from 20000 voluntary donors January 2014 to June 2014 and tested with both ID NAT and ELISA assays for HBV, HCV and HIV. Using the PROCLEIX® TIGRIS® System, ID-NAT depending on (TMA) Technology. TMA assay involves three main steps utilizing three proprietary technologies:
T
Summary and Conclusion
90
(a) Target capture based sample preparation,
(b) Transcription-mediated amplification,
(c) Hybridization protection assay.
Data collected and analysis done for serological and NAT results to detect seronegative, reactive NAT yield and residual risk of TTIs.
We identified 12 samples (0. 06%) as NAT yield (seronegative samples and NAT reactive) of total 20000 tested samples. The NAT yield of 12 samples in 20000 samples assumes more significance when one considers the fact that single donation is used for generating 3 components (packed RBCs, plasma, platelet) that can be used by 3 recipients.
In our study, the prevalence of transfusion transmitted viruses among the studied donors were 4.6% for HCV and 1.56% for HBV, total number of false positive tested samples with were 257 samples (1.2%) of total tested samples. The need for NAT depends on the prevalence and incidence rate of infections in blood donor population, available resources and the evidence of benefit added when combined with serology tests. Hence the decision of starting NAT should be considered when basic quality assured blood transfusion system is already in place such as volunteer base for blood donation, provision of donor self-deferral, donor notification and counseling along with quality assured sensitive serological methods for testing TTIs.
Other data
| Title | Evaluation of Impact of Nucleic Acid Testing in Transfusion Transmitted Infections (TTIs) Screening in Egyptian Blood Donors | Other Titles | تقييم تأثير اختبار الأحماض النووية فى الكشف عن عدوى نقل الدم فى المتبرعين المصريين | Authors | Shereen Mostafa Mohy El-Din | Issue Date | 2015 |
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