Since the pandemic occurred due to the emergence of SARS-CoV-2, there has always been a demand for a simple and sensitive diagnostic kit for detection of SARS-Cov-2 infection. In January 2020, WHO approved the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for detecting the presence of Covid-19 genetic material in individuals. Till date many diagnostic kits have arrived in the market for quantification of SARS-CoV-2 antibodies. In spite of being the gold standard method of Covid-19 detection, there are some drawbacks associated with RT-PCR which leads to false-negative results. Hence, in order to fulfil the need for an antibody testing kit for evaluating seroconversion and immunity acquisition in the population, an efficient, highly specific and sensitive assay, Chimera Soochak, an enzyme-linked immunoassay (ELISA) Kit has been developed. It works on the principle of detecting IgG antibodies developed specifically against the S1-RBD by employing a recombinant strain of S1-RBD produced in the HEK293 cell line. The developed kit was validated using different modes and methods to attain the utmost confidence on the samples collected from patients. The validation methodology included, validation with known samples, blind study, third-party validation, validation using WHO Reference Panel and comparison with FDA approved Surrogate virus neutralization kit. The kit was found successful in detecting IgG against the S1-RBD of SARS-CoV-2. The kit had been validated on multiple parameters. A total of 900 samples had been tested by using this kit and it has exhibited the sensitivity, specificity and accuracy for all the above-mentioned parameters.
Background: Timeline is a key factor for hematopoietic stem cell transplant (HSCT) recipient. HSCT by matched unrelated donor (MUD) is a standard definitive therapeutic approach for many hematological disorders which are not amenable to chemotherapy and other conventional treatment. Aims and Objectives: The aim of the present study was to compare the turnaround time (TAT) involved in completion of MUD HSCT workup from an Indian registry (Genebandhu) with international registries. Materials and Methods: On receipt of pre-transplant matching request through a transplant physician, patient's human leukocyte antigen (HLA) type was entered in both Genebandhu and World Marrow Donor Association search tool for initiating a “search.” The software gave the descending order of the best possible matches by performing computational analysis. The search result was considered a “match” when potential 10/10 HLA match was found. The average TAT was calculated in the middle of search request and HLA confirmatory typing (CT) and infectious disease marker (IDM). Further, TAT was also determined between the infusion of harvested stem cell product and CT and IDM. At last, the total time engaged in completion of each MUD HSCT workup was determined and compared in national versus international registries. Results: The average TAT involved in between search request and CT and IDM was 71 days in case of global registry and 67 days in case of Genebandhu. Similarly, the average TAT involved between infusion of harvested cell product and CT and IDM testing in case of donor identified in global stem cell registry was 65 days whereas 45 days in case of Genebandhu. At last, the average time associated with the finishing of a MUD workup was 136 days in case of global registry, whereas 112 days in the case of Genebandhu at P ≤ 0.05 with a 95% confidence interval. Conclusion: To conclude, the average TAT obtained through this study clearly demonstrates the advantages in terms of donor availability for MUD HSCT through the national registry.
Background: With only 25% chances of finding a human leukocyte antigen matched stem cell donor within the family, in case of minimal residual disease, the dependence on matched unrelated donor (MUD) is inevitable. With increasing awareness about the MUD stem cell registries, the numbers of registrations for voluntary stem cell donations are also increasing each day. A workup coordinator is a strong and the most crucial link in the MUD hematopoietic stem cell transplantation (HSCT) workup. The coordination between the stem cell registry and transplant center TC in need of a MUD HSCT workup is handled by a workup coordinator. Aims and Objectives: The aim here is to highlight key roles and responsibilities of workup coordinators, without whom it can be impossible to complete a MUD HSCT. Materials and Methods: We accessed the roles and responsibilities of workup coordinators via the MUSD HSCT workup assisted by Genebandhu from May 2012 to August 2020. The methodology mainly involved was electronic communication between stem cell registry/transplant center (TC)/donor center/collection center/patient/donor. All these activities of coordinators were closely observed to understand their roles, requirements, and responsibilities in detail. Results: The workup coordinator has been successfully involved in 33 MUD HSCT workups since its inception. Out of these, 18 were from international stem cell registries and 15 with TC s from India. Discussion: Workup coordinator acts like a catalyst during a MUD HSCT. Appropriate and timely exchange of information between the registry and the TC is managed by a coordinator. Conclusion: This study showed the crucial role, requirements, and responsibilities of the coordinators and their importance in MUD HSCT workups.
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