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      How safe is safe, and where are we in the journey toward safest of safe?

      editorial
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      Indian Journal of Ophthalmology
      Medknow Publications & Media Pvt Ltd

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          Abstract

          It is nice to have yet another issue of IJO, the official publication of AIOS out in print with a bevy of interesting articles packed with new information. This issue of the journal carries a paper investigating serology results in cornea donors, comparing the reports from donors who died in hospital whose corneas were retrieved under the Hospital Cornea Recovery Program (HCRP) with those recovered from voluntary home deaths. The article has raised the specter of donor transmission of dreaded diseases. Irrespective of the outcomes of comparison of the two pools of donors, the paper unquestionably reaffirms what we know already – there is a silent presence of sinister diseases which patients, relatives, or caregivers are not aware of and the condition is unveiled only by routine serological screening of asymptomatic individuals. In short, it is a sober reminder that serological testing of eye donors is mandatory and we hope that there are no longer any eye banks in the country not following National Programme for Control of Blindness guidelines. The Eye Bank Association of India has played a key role in assisting in the process of dissemination of information to all stakeholders, further substantiated and reinforced by the requirement as per the Transplantation of Human Organs and Tissues Act checklist for legal registration. Another aspect the paper uncovers is that in this particular patient population, there was a difference in seroprevalence of blood- and tissue-borne infections between HCRP and voluntary home donors with a higher likelihood among those who were admitted and died in hospital. Consequently, it highlights that the well-placed enthusiastic emphasis on hospital recovery motivated by better efficiency and utilization rates must be tempered by the ground reality that these cases may harbor higher than the expected transmission risks. Hence, more vigilance is required in screening the blood samples, using reliable testing methods, and extra care must be exercised in interpreting the findings before clearing the tissue as safe for transplantation. In the study reported in this issue, enzyme immunoassay (EIA)-based rapid diagnostic test (RDT) kits have been used for the HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) serologies. The manuscript states that test results (of the specified rapid EIA-based government-approved kits) were double checked by ELISA, but the names and manufacturers of the ELISA kits used for verification are not mentioned. For HIV and HCV, RDTs are considered to have acceptable sensitivity and specificity. These tests are included in national guidelines for HIV testing (NACO, 2015);[1] and for HCV antibody testing, some RDTs are also WHO prequalified.[2] However, many RDTs are unable to detect low levels of HBV surface antigen, particularly in asymptomatic individuals.[2] In view of time constraints, good quality rapid tests would be a particularly useful option for screening cadaveric corneal donors. An issue which needs to be considered while screening cadaveric (postmortem) samples is that a very small percentage of false-positive and even more rarely, false-negative results, have been reported on comparison with premortem samples.[3] It is probably better to err on the side of caution, and corneas from all serologically positive donors, including the false-positive ones, should not be transplanted, treating this as acceptable wastage in the interest of preventing transmission of infection. This is of relevance, because in the rare case of an adverse event of the recipient ever acquiring one of the blood- and tissue-borne diseases after corneal transplantation, the decision to use the tissue despite a positive result can be questionable. In an attempt to eliminate false-negative results, in many developed countries, screening by nucleic acid tests (NAT) is also recommended. However, given the known prevalence of HIV, and the low-to-intermediate endemicity of HBV and HCV in India[2 4] the probability of donors being in the window period (negative serology with a positive NAT) at the time of screening is quite negligible, and these expensive tests are unlikely to provide any real benefit in terms of additional “yield” of infected donors. Of course, the local and regional variations will impact the practical implications, but a strong emphasis of reliance on serological tests to support the mandatory screening for medical history, social and behavioral risk factors, and physical examination of the donor to ensure full safety of recipients demands a relook at the quality of testing techniques and the reliability of their interpretation. A shift to processing of blood samples by professional facilities with reporting by experts, a transition many eye banks in India have already made, rather than simply depending on underqualified eye bank technicians, may have to be considered. Finally, some food for thought, are we to believe that safety standards[5 6 7 8 9 10] should be equivalent globally? Ethical concerns would recommend so, but economic and technical constraints may play an unseemly role in searching for a safe-enough acceptable alternative. The point of the matter is, what some perceive as increasing costs and complexities in eye banking, others may view as a valid price to pay to ensure safety and eliminate risks. As the country has progressed from gloveless, drapeless eye surgeries to near state-of-the-art protective measures, so must the eye banking and corneal transplantation community rise to the occasion by driving for change in mindsets that quality does come for a price and we must find ways to make it affordably available. About the author Prof. Radhika Tandon currently heads the clinical unit providing Cornea and External Disease, Cataract and Refractive Surgery, Ocular Oncology and Low Vision Services at the Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi. She is also the Co-chairperson of the National Eye Bank, Chairperson of Low Vision Services and Chairperson of the Medical Board Ophthalmology. Her extramural positions include Chairperson Visual Disabilities Sub-committee of Ministry of Social Justice and Empowerment, Ophthalmology Expert for Medical Council of India, Technical Expert for Directorate for Health Research, Member of Advisory Board for National Program for Control of Blindness, Task Force member for Department of Biotechnology and Indian Council for Medical Research, Member of Apex Technical Committee for National Organ and Tissue Transplant Organization, and elected President of Eye Bank Association of India. Endowed with a sharp, analytical mind and high intellectual capabilities, coupled with a brilliant academic record, Professor Tandon is a graduate and post graduate from AIIMS, and is devoted to an academic career balancing patient care, teaching and research with numerous publications to her credit. She is well known as co-editor of the renowned textbook Parsons’ Diseases of the Eye. Her work on standardization of eye banking in India has resulted in a paradigm change.

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          Seroprevalence of infectious markers & their trends in blood donors in a hospital based blood bank in north india

          Background & objectives: Hepatitis B virus (HBV), human immunodeficiency virus (HIV), hepatitis C virus (HCV) and syphilis infections pose a great threat to blood safety. This study was undertaken to investigate the seroprevalence of serologic markers for transfusion transmitted infections (TTIs) among blood donors at a hospital based blood centre in north India over a period of nine years. Methods: The results of serologic markers for TTIs (HBsAg, anti-HCV, anti-HIV and syphilis) of all blood donations (both voluntary and replacement) at our hospital from January 2005 to December 2013 were screened. Additional analysis was conducted to examine the prevalence trends associated with each of the positive marker. Results: The data of 180,477 donors [173,019 (95.86%) males and 7,458 (4.13%) females] were analyzed. Replacement donations [174,939 (96.93%)] represented the majority whereas, only 5,538 (3.06%) donations were from the voluntary donors. The risk of blood being reactive was three times higher in male donors when compared with the female donors. The risk of blood being reactive for one or more infectious markers was 2.1 times higher in replacement donors when compared with the voluntary donors. Seropositivity of HIV, HBsAg, HBcAb, syphilis showed a significant decreasing trend (P<0.05) while there was an increasing trend in HCV infection which was insignificant. Interpretation & conclusions: This study reflects that the risk of TTIs has been decreased over time with respect to HIV, HBV and syphilis, but the trends for HCV remains almost the same in blood donors. Blood transfusion remains a risk factor for the spread of blood-borne infections. Therefore, improvements are needed to strengthen both safety and availability of blood.
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            Evaluation of serological screening of cadaveric sera for donor selection for cornea transplantation.

            Human corneas are explanted for grafting as late as 72 h after death, for example, from medical examiner cases. Currently, infection of the donor with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is excluded in most cornea banks by serological testing of the cadaveric serum only. The reliability of this strategy was investigated by testing paired cadaveric and premortem sera of 33 potential donors. Results were discordant in 17 of 33 donors by at least one assay. Most frequently, HBsAg enzyme-linked immunosorbent assay (ELISA) yielded false-positive results with the cadaveric serum (16 of 33 serum pairs). Virus safety of the graft was affected in a single case, which was HCV antibody negative in the cadaveric serum, but positive in the premortem serum (confirmed by HCV-RIBA strip immunoassay). Forensic DNA profiling by polymerase chain reaction (PCR) of both serum samples confirmed that these were derived from the same individual. In conclusion, the results indicate that serological testing of cadaveric sera is not a reliable method for screening of potential cornea donors, and may not be sufficient for the virus safety of cornea grafts. Therefore, other screening strategies such as detection of viral nucleic acids by PCR should be evaluated.
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              Comparative infectious serology testing of pre- and post-mortem blood samples from cornea donors.

              Defined serological blood tests of deceased cornea donors are required to minimize the risk of viral infections of a transplant recipient as much as possible. Haemolysis, autolysis and bacterial contamination, may produce significant changes of post-mortem blood samples, which may lead to false serological test results. Pre- and post-mortem findings from the same cornea donors of the University Tissue Bank of the Charité in the years 2004-2009 (n = 487) were retrospectively analyzed and compared. The test results from pre-mortem blood samples were defined as the reference for the post-mortem blood test. Of 487 cornea donors, there were a total of 21 cases (4.3%) with discrepancies between serological test results from pre- and post-mortem blood samples. Of these, 7 values referred to the HBsAg-testing, 3 to the anti-HBs-, 1 to the anti-HBcIgG + IgM-, 1 to the anti-HCV-, 4 to the anti-HIV 1/2- and 5 to the TPLA-findings. False negative results within post-mortem serology occurred in 4 of 487 cases (0.8%). False positive results within the post-mortem blood samples occurred at a much more frequent rate, with 17 of 487 cases (3.5%). Discrepancies between serological pre- and post-mortem blood tests occur mainly due to the use of non-validated test systems. Therefore, it seems reasonable to test pre- and post-mortem blood samples serologically, whenever possible, at the same time, regardless of the sample age. Positive results, regardless of the sample type, should always be retested with validated confirmation tests (e.g. NAT), in order to differentiate between false and true positive results.
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                Author and article information

                Journal
                Indian J Ophthalmol
                Indian J Ophthalmol
                IJO
                Indian Journal of Ophthalmology
                Medknow Publications & Media Pvt Ltd (India )
                0301-4738
                1998-3689
                November 2017
                : 65
                : 11
                : 1075-1076
                Affiliations
                [1]Professor In-charge Virology Section, Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India
                [1 ]Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. E-mail: radhika_tan@ 123456yahoo.com
                Article
                IJO-65-1075
                10.4103/ijo.IJO_1054_17
                5700570
                29133628
                cfa2d5c7-9f3a-4c4a-bd88-0fad8ee3d952
                Copyright: © 2017 Indian Journal of Ophthalmology

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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                Ophthalmology & Optometry

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