Need for Nucleic Acid Testing in Countries with High Prevalence of Transfusion-Transmitted Infections

Abstract

Introduction. In India, family/replacement donors still provide more than 45% of the collected blood. With increasing voluntary blood donation and the still-prevalent infectious diseases in donors, we need to augment transfusion-transmitted infections (TTIs) testing before use. Our study was aimed to know the seroprevalence of TTIs among the donors of Rajasthan and the need for newer technologies like nucleic acid testing (NAT). Materials and Methods. Enhanced chemiluminescence immunoassay (ECi) was used for detection of HBsAg, anti-HIV, and anti-HCV in donor serum. 50% of the blood units which were negative on ECi were randomly selected and subjected to NAT testing for HBV, HCV, and HIV. Results. The total seroprevalence of TTIs is 2.62%. Of the randomly selected donor units negative by ECi, 8 turned out to be reactive on NAT testing: 4 were voluntary and 4 were family/replacement donors. Combined NAT yield (NAT reactive/seronegative) for HIV, HCV, and HBV was 0.034% (1 in 2972 donations). All the 8 reactive samples were positive for HBV DNA. Conclusion. In countries with a high prevalence of TTIs like India there are likely to be a significant number of window period donations that can be identified by NAT which may be implemented in blood centers allover India with serological testing to provide safe blood and cost alone should not be a deterrent to the government and implementing agencies.

A Cross-Sectional Study on Burden of Hepatitis C, Hepatitis B, HIV and Syphilis in Multi-Transfused Thalassemia Major Patients Reporting to a Government Hospital of Central India

“…These were individually tested by procleix ultrio assay for HIV 1, HCV and HBV. Another study from Jaipur reported a combined NAT yield (NAT reactive/seronegative) for HIV, HCV and HBV of 0.034 % in 23,779 donors [25] which is high compared to that reported from other developed countries. In another study conducted in north India, 18,354 donors were tested by both ID-NAT and fourth generation enzyme-linked immunosorbent assay (ELISA), 7 were found to be NAT-positive but ELISAnegative (NAT yield) for HBV and HCV.…”

Significance of nucleic acid testing in window period donations: Revisiting transfusion safety in high prevalence-low resource settings

“…The NAT yield rate from other blood Centers in India is 1 in 753, 16 1 in 610, 17 1 in 1528, 18 1 in 2622, 19 1 in 2000, 20 and 1 in 2972. 15 The higher NAT yield compared to other studies 15,18,19,20 is probably on account of higher prevalence in the population reaching to this tertiary care hospital.…”

“…Most populations in resource limited countries suffer from high prevalence of transfusion transmitted infections and are expected to have more frequent incident and occult cases. 15 Of the 16551 seronegative donor's samples subjected to NAT testing, there were 17 NAT yields (1 in 974). The NAT yield rate from other blood Centers in India is 1 in 753, 16 1 in 610, 17 1 in 1528, 18 1 in 2622, 19 1 in 2000, 20 and 1 in 2972.…”

Into the occult: Strategies for preventing transfusion-transmissible infections

“…The highest yield was for HBV infection (6/8) [9]. There are a few other reports from India [10][11][12][13][14][15] which also show that the addition of tests to detect nucleic acids (NAT or PCR) increased the yield of donors who are hepatitis B positive. In China and Taiwan, with a high endemicity of hepatitis B, the addition of NAT increased the detection of occult carriers [16,17].…”

“…In countries where the prevalence of HBV infection is low, minipool strategy is adequate while in high-prevalence countries to which India belongs, individual donor testing is recommended [10,18]. There has been considerable debate regarding the necessity to make NAT mandatory in all blood banks but the significant increase in the cost of NAT tested blood is possibly the major factor which has prevented implementation across all sectors.…”