Safety, immunogenecity and effectiveness of ChAdOx1 nCoV-19 vaccine during the second wave of pandemic in India: a real-world study.

OBJECTIVES: This real-world study was conducted to assess the adverse effects following immunization (AEFI) and immunogenicity of ChAdO×1 nCoV-19 vaccine in terms of neutralising antibody titers and to study the effects of covariates such as age, sex, comorbidities and prior COVID status on these outcomes. Also, the effectiveness of the vaccine based on interval between the two doses was also investigated. METHODS: A total of 512 participants (M/F=274/238) aged 35(18-87) years comprising a mixed population of healthcare workers, other frontline workers and general public were enrolled between March and May 2021. Records for adverse events if any were collected telephonically by following up with participants up to 6 months post first dose and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5. Blood samples for measuring antibody titers against the receptor binding domain (RBD) were collected serially using a convenient sampling strategy up to 6 months after the first dose. Data on breakthrough COVID infection was collected telephonically till December 2021. RESULTS: Incidence of local reactions was higher after first dose at 33.4 % (171/512) compared to those after second dose at 12.9 % (66/512). Commonest side effect observed was injection site pain after the first (87.1 %; 149/171) and second (87.9 %; 56/66) dose respectively. Among systemic reactions, fever was the most common manifestation followed by myalgia and headache. Female sex (p<0⸱001) and age less than 60 years (p<0⸱001) had significantly higher predilection for systemic toxicities. Age ≤60 years (p=0.024) and prior-COVID (p<0.001) were found to be significantly associated with higher antibody titers, however, no association was found between these variables and breakthrough COVID infection. Longer spacing between the doses (≥6 weeks) was found to offer better protection against breakthrough infection compared to a spacing of 4 weeks. All breakthroughs were mild-moderate in severity, not requiring hospitalization. CONCLUSIONS: The ChAdOx1 nCov-19 vaccine is apparently safe and effective against SARS-CoV-2 virus infection. Prior COVID infection and younger age group achieve higher antibody titers, but no additional protection. Delaying the second dose up to at least 6 weeks is more effective compared to shorter spacing between doses.

Reduction in sample rejections at the preanalytical phase - Impact of training in a tertiary care oncology center.

CONTEXT: Major clinical decisions are based on the laboratory test results where preanalytical errors are an important cause of repeat collections in patients. Identification of problem areas and continuous training of phlebotomy staff are important tools in reducing these errors. AIMS: In this study, we looked at the most common causes of sample rejection in our setting and the efficacy of the corrective measures and training processes for staff in reducing preanalytical errors. SETTINGS AND DESIGNS: This prospective study was conducted at the laboratory diagnostic services of a tertiary care oncology center, with a hematopoietic stem cell transplant unit during the period of 2012-2017 in two phases. Sample rejections from various wards were analyzed for types of rejections. MATERIALS AND METHODS: In the first phase, we analyzed the problem areas (year 2012). Following a root cause analysis, current practices of training were altered. In the second phase (2013-2017), we studied the effects of these measures. STATISTICAL ANALYSIS USED: The percent variation and P value for significance in sample rejections were calculated. RESULTS: During the year 2012, 0.36% samples were rejected by laboratory. Following interventions in the period from 2013 to 2017, samples rejected dropped to 0.19% (P < 0.0001), 0.09% (P < 0.0001), 0.09% (P = 0.8387), 0.05% (P = 0.0004), and 0.05% (P = 0.329), respectively. The reduction was significant from surgical oncology ward (P = 0.0107) and intensive care unit (P = 0.0007). From 2013 to 2017, errors significantly reduced to 0.015% for hemolyzed samples (P = 0.0001), 0.005% for contaminated samples, 0.036% for clotted samples, and 0.019% for labeling errors. CONCLUSION: Intervention in the form of targeted training helps reduce errors and improves the quality of results generated and contributes to better clinical outcomes.

The External Quality Assessment Scheme (EQAS): Experiences of a medium sized accredited laboratory.

INTRODUCTION: We put forth our experiences of EQAS, analyzed the result discrepancies, reviewed the corrective actions and also put forth strategies for risk identification and prevention of potential errors in a medical laboratory. METHODS: For hematology, EQAS samples - blood, peripheral and reticulocyte smears - were received quarterly every year. All the blood samples were processed on HMX hematology analyzer by Beckman-Coulter. For clinical chemistry, lyophilized samples were received and were processed on Siemens Dimension Xpand and RXL analyzers. For microbiology, EQAS samples were received quarterly every year as lyophilized strains along with smears and serological samples. RESULTS: In hematology no outliers were noted for reticulocyte and peripheral smear examination. Only one outlier was noted for CBC. In clinical chemistry outliers (SDI ≥ 2) were noted in 7 samples (23 parameters) out of total 36 samples (756 parameters) processed. Thirteen of these parameters were analyzed as random errors, 3 as transcriptional errors and seven instances of systemic error were noted. In microbiology, one discrepancy was noted in isolate identification and in the grading of smears for AFB by Ziehl Neelsen stain. CONCLUSION: EQAS along with IQC is a very important tool for maintaining optimal quality of services.