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ABSTRACT Introduction: Approximately 55.52% of the Indian population had been fully vaccinated by Jan. 2022, since its first roll out on January 16, 2021. A few concerns were raised concerning the Covishield vaccination related to thrombotic thrombocytopenia. Apheresis-derived platelet concentrates are frequently required in a plethora of clinical situations and post-vaccination decrement of platelet counts might lead to increased deferral of the plateletpheresis donors. Objectives. The aim of the study was to discover the effect of the Covishield vaccination on deferral rates of plateletpheresis donors. Methods: Blood samples were collected from the potential platelet donors for the completion of the standard questionnaire for the complete blood count. The data collected were tabulated in the MS Excel spreadsheet and the biostatistical analysis was performed with the SPSS v23. A p-value of < 0.05 was taken as significant. We compared this data with age-and sex-matched controls. Results: The mean age of cases and controls was 29.69 ± 8.57 and 30.15 ± 7.11, respectively. There was a significant difference in platelet counts of cases (188496.35 ± 72065.66/cumm) and controls (269524.50 ± 53981.60/cumm). Furthermore, donors who received one dose had higher platelet counts of 248676.47 ± 80075.24/cumm than those who received both doses of vaccine (179970.83 ± 66773.73/cumm). The difference in deferral rates between the two groups was remarkable (34.7% vs. 0.9%, with the p-value < 0.001). Conclusion: Vaccination certainly increased the deferral rates of plateletpheresis donors due to low platelet counts. Average platelet counts were low in fully vaccinated individuals, however, the platelets returned to normal counts as the post-vaccination days progressed.
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【Objective】 To discuss the reliability and applicability of the current blood deferral strategy concerning anti-TPreactive blood donors (by ELISA). 【Methods】 TPPA confirmatory test was performed on the samples routinely detected by two different anti-TP ELISA reagents(reagent 1 and reagent 2), and the test data of dual reagent reactive and one reagent reactive blood donors were analyzed to determine the possibility of true positivity. 【Results】 1 624 anti-TP reactive samples(by ELISA) were collected, among which 1 467 were dual reagent reactive, 77 were reagent 1 reactive, and 80 were reagent 2 reactive. TPPA results showed that the positive predictive value (PPV) of dual reactive samples was 85.48%. Samples with high S/CO value (reagent 1≥13 and/or reagent 2 >17) were more likely to be true positive, with the PPV at 98.56% (reagent 1) and 99.13% (reagent 2), respectively, which were significantly higher than that when the S/CO value was≥1. Among the samples reactive to one reagent, 2 were confirmed positive in reagent 1 and 3 in reagent 2, with the PPV at 2.60% and 3.75% respectively, and had no correlation with high S/CO value. 【Conclusion】 Dual-reagent reactive donors with high S/CO value showed high possibility of true positivity, therefore should be deferred. TPPA test is helpful to identify true positivity in one-reagent reactive donors. Confirmatory test and follow-up should be a supplement to the current blood donor deferral strategy to ensure blood safety.
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【Objective】 To establish deferral criterion of HIV ELISA (enzyme-linked immunosorbent assay) and electrochemiluminescence immunoassay(ECLIA) by using receiver operating characteristic curve(ROC) method to screen HIV reactive blood donors suitable for entering the re-entry process and improve the management efficiency of reactive blood donors. 【Methods】 The test results of 92 001 blood donors from February to September 2019 were analyzed, and 177 reactive samples were screened by conventional screening mode (twice ELISA and once nucleic acid), supplemented with electrochemiluminescence immunoassay assay (ECLIA), and confirmed by Western blotting (WB). Screening reactive samples were divided into three groups: group A was both serological and nucleic acid reactivity, group B was only serological reactive, and group C was only nucleic acid reactivity. Its efficacy in blood donor classification was assessed by drawing ROC curves with 99% specific corresponding S/CO low values as the deferral criterion of the corresponding serological method. 【Results】 1) A total of 177 HIV reactive samples were detected in conventional mode, including 34 in group A, 142 in Group B and 1 in Group C. The positive predictive value (PPV) was 100%, 0.75% and 100%, respectively. ECLIA detection mode (once ECLIA and once NAT), a total of 67 HIV reactive samples including 34 in group A, 32 in group B and 1 in group C, with positive predictive values of 100%, 3.7% and 100%, respectively.2) The HIV test results showed diversity, with 36 true positive samples including 1 HIV elite controller and 3 early HIV infections (1 HIV ELISA antigen/antibody window and 2 ELISA HIV antibody window), and 32 serological and NAT cases were reactive infections.3) The deferral limit of ELISA 1 and ELISA 2 in conventional screening mode were 20.25 and 9.85, respectively, can screen 97.14% (34/35) of all true positive samples in group A and B, except for one ELISA HIV antibody window (ELISA 2 reactivity). The positive predictive values were 93.94% and 92.85%, respectively. The ECLIA deferral limit of 7.83 can screens all true positive samples in Groups A and B (35/35)in ECLIA mode. The positive predictive value was 94.59%. 【Conclusion】 The establishment of deferral limits in this study can effectively screen HIV-positive blood donors, and the number of screened blood donors is greatly reduced, which is helpful to fine and scientific management of HIV-reactive blood donors. The deferral limit values of different testing reagents are quite different, so each laboratory should choose appropriate testing methods to establish the deferral limit values suitable for the laboratory according to its own testing ability, so as to provide technical support for optimizing the process of returning blood donors to the team.
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Introduction: Acquired bleeding disorders are a major causeof mortality, both in the developed and developing countries.An acute haemorrhage should be managed immediately withblood products, factor concentrates or anti-fibrinolytics.Investigations to detect coagulopathies typically includebaseline screening tests like prothrombin time, activatedpartial thromboplastin time, platelet count and fibrinogenlevel. These tests have a long turn around time whichfrequently lead to a blinded approach towards blood productsupport leading to under or over transfusion. In contrast,rotational thromboelastometry (ROTEM) which assesseshaemostasis from the start of clot formation to fibrinolysisgives earliest results within ten minutes. This study wasdone to establish a correlation between ROTEM parametersand standard coagulation profile in the context of acquiredbleeding disorders.Material and Methods: A total of 138 subjects - 70 patientswho presented with acquired bleeding disorders and 68 subjectsdiagnosed to be normal on the basis of a complete coagulationwork up were included as the cases and controls respectively.All samples were subjected to standard coagulation profileand ROTEM analysis which included Clotting Time, ClotFormation Time, Alpha Angle, Maximum Clot Firmness andMaximum Lysis.Results: The Maximum Clot Firmness had a very goodco relation with serum fibrinogen levels (k value - 0.807;p<0.000; Sensitivity - 88%; Specificity - 92%), and goodcorrelation with platelet count (k value - 0.793; p< 0.000;Sensitivity - 86%, Specificity-92%), whereas Clot FormationTime showed moderate correlation with aPTT. Clotting timehad a poor correlation with prothrombin time and activatedpartial thromboplastin time.Conclusion: The achievement of haemostasis is a crucialfactor for determining patient outcomes in acquired bleedingdisorders. The gold standard test to diagnose coagulopathy is thestandard coagulation profile. Rotational thromboelastometrycorrelates well with standard coagulation parameters. Thistest which is performed on whole blood showed interpretableresults within 10 minutes, whereas standard coagulationprofile required an average of 45 – 75 minutes. In view of thegood correlation to the standard coagulation profile, it appearsthat Rotational Thromboelastometry results can be safely usedto implement early transfusion therapy for haemorrhage.
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Objective To establish and confirm the hepatitis B surface antigen(HBsAg) enzyme linked immunosorbent assay(ELISA) high specificity S/CO limit as blood donor deferral criterion.Methods A total of 783 HBsAg ELISA reactive and 588 non-reactive samples were collected, and confirmed by HBsAg electrochemiluminescence detection and neutralization test.Receiver operating characteristic curve (ROC curve) was used to evaluate the S/CO limit under 95% and 99% specificity.Another 124 HBsAg ELSIA reactive samples were tested for five kinds of hepatitis B virus(HBV) markers by using electrochemiluminescence detection to verify the blood donor deferral limit.The blood donor deferral limits of 3 laboratories, using the same reagents, were compared.Results The 95% specificity S/CO limit of two reagents were 0.24 and 0.65, the 99% specificity S/CO limit of two reagents were 3.89 and 3.62.The 99% specificity S/CO limit was set as the blood donor deferral criterion.Verify test indicated that the samples, with S/CO higher than the blood donor reentry limit of reagent 1 and 2, were all from HBV infected donor.The 99% specificity S/CO limits of reagent 1 in the other three laboratories were 3.77, 3.60 and 13.42 respectively.And the 99% specificity S/CO limits of reagent 2 in the other three laboratories were 27.73, 31.75 and 1.17.Conclusion The blood donor deferral limit of HBsAg ELISA could identify the true positive blood donor, and reduce the number of blood donor, entering the reentry process.It might not suit to adopt a unified donor deferral limit in different laboratories, even using the same reagents.
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BACKGROUND: Electronic Donor Health Questionnaire (e-DHQ) could prevent omissions in filling in the questionnaire. Compared with the paper Donor Health Questionnaire (p-DHQ), it can expect honest answers from donors to the questions relating to high risk behaviors. The aim of this study is to evaluate the effect of e-DHQ on the answers from donors by analyzing variations of the reasons for deferral after the introduction of e-DHQ to the Korean Red Cross (KRC). METHODS: The reasons for deferral determined by p-DHQ in 2008~2011 and by e-DHQ in 2011~2014, which have been accumulated in the database of the Blood Information Management System in KRC, were analyzed and compared. RESULTS: The results showed that the deferral rates for the general health status and medication taken were 0.47% (P=0.0100) and 0.16% (P=0.0103) higher in e-DHQ than in p-DHQ. In particular, for questions including hunger, lack of sleep, fatigue, endoscopy, dental treatment, surgery, tattoo, and acupuncture, the proportion of answers was higher in e-DHQ than in p-DHQ. CONCLUSION: The deferral rates for general health status and medication taken increased after the implementation of e-DHQ. The rate of deferral by some details of general health status, medical treatment for recent one month, and history for recent one year also increased because e-DHQ induced donors to give straightforward answers. e-DHQ is expected to contribute to the strengthening of health protection of blood donors and recipients. However the questions relating to high risk behaviors should be reformed so that honest answers can be induced from donors.
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Humans , Acupuncture , Blood Donors , Endoscopy , Fatigue , Hunger , Information Management , Red Cross , Risk-Taking , Tissue DonorsABSTRACT
BACKGROUND: The donor deferral registry (DDR) program has been operating since 2004. The donors who registered in the DDR are prohibited from donating blood. But some of them can enter the eligible donor group if they pass a reentry test. We analyzed the results of the reentry tests for the HCV deferred donors. METHODS: A total of 587 donor samples were tested during 18 months (July. 2007~December. 2008). Anti-HCV (ARCHITECT HCV, Abbott, Wiesbaden, Germany), RIBA (LG HCD confirm, LG Life Sciences, Daejeon, Korea), and HCV RNA (PCR with COBAS AMPLICOR HCV, Roche, Molecular Systems, Inc. Branchburg, USA) were used for detection. The donors showing negativity for all the test items were released from the DDR. RESULTS: Among the 587 subjects, 466 (79.4%) of the donors who showed negative results on the tests were released from DDR. The donors who showed variable positive results for the tests were not released. Only 15 donors of 121 donors showed positive or indeterminate (ID) results according to the anti-HCV, RIBA and the PCR results. CONCLUSION: Those people with RIBA ID with negative results in anti-HCV and PCR results were unnecessarily kept on the retained in DDR unnecessarily. The algorithm of the reentry test for HCV deferred donors seems to needs to be reevaluated to for the saveing eligible donors.