Biosecurity and Biosafety concerns of Research and diagnostic Laboratory under International Guidelines

Currently, academic research labs and diagnostic laboratories are facing a serious issue of biosecurity and biosafety globally. The high rate of mutations and continuous new emerging infectious diseases with the risk of bioterrorism demands that each lab personnel share equal responsibility for biosecurity & biosafety at their work. The primary job of government authorities is to implement a well-organized detection system and limit the spread of hazardous biological agents by providing a biologically safe setting for lab scientists and for the common man in communities and institutes. The safety of lab personnel, lab environment, and pathogens depends on effective and safe laboratory working and pathogen handling which determines the reliable and accurate results of laboratory experiments. The aim of this article is to address the basic components of laboratory biosafety, laboratory biosecurity, and laboratory management. Further DURC (dual-use research of concern) deals with the commencement of lawful reasons to generate information, knowledge, technology, and products that are used for either harmful or beneficial purposes. The precautions are taken to ensure laboratory biosecurity and biosafety should be a part of the laboratory safety policy manual for guidance and implementation for a safe laboratory environment.Keywords: Antioxidants; tomato; lycopene; β-carotene; reactive oxygen species (ROS)

Secondary analysis of the WOMAN trial to explore the risk of sepsis after invasive treatments for postpartum hemorrhage.

OBJECTIVE: To examine the association between the use of invasive treatments for postpartum hemorrhage and the risk of sepsis and severe sepsis. METHODS: Secondary data analysis of the WOMAN randomized controlled trial, including 20 060 women with postpartum hemorrhage in 21 countries. Logistic regression with random effects was used. RESULTS: The cumulative incidence was 1.8% for sepsis and 0.5% for severe sepsis. All-cause mortality was 40.4% in women with severe sepsis versus 2.2% for women without. After adjusting for bleeding severity and other confounders, intrauterine tamponade, hysterectomy, and laparotomy increased the risk of sepsis (aOR 1.77 [95% CI 1.21-2.59], P=0.004; aOR 1.97 [95% CI 1.49-2.65], P<0.001; and aOR 6.63 [95% CI 4.29-10.24], P<0.001, respectively) and severe sepsis (aOR 2.60 [95% CI 1.47-4.59], P=0.002; aOR 1.97 [95% CI 0.83-2.46], P=0.033; and aOR 5.35 [95% CI 2.61-10.98], P<0.001, respectively). CONCLUSION: In this secondary data analysis, certain invasive treatments for postpartum hemorrhage appear to increase the risk of sepsis. Further research is needed to confirm this finding and investigate the role of prophylactic antibiotics during these procedures. The harms and benefits of such interventions must be carefully weighed, both in treatment guidelines and during individual patient management. TRIAL REGISTRATION: ISRCTN76912190

Maternal anaemia and the risk of postpartum haemorrhage: a cohort analysis of data from the WOMAN-2 trial

Background: Worldwide, more than half a billion women of reproductive age are anaemic. Each year, about 70 000 women who give birth die from postpartum haemorrhage. Almost all deaths are in low-income or middle-income countries. We examined the association between anaemia and the risk of postpartum haemorrhage. Methods: We did a prospective cohort analysis of data from the World Maternal Antifibrinolytic-2 (WOMAN-2) trial. This trial enrols women with moderate or severe anaemia giving birth vaginally in hospitals in Pakistan, Nigeria, Tanzania, and Zambia. Hospitals in each country where anaemia in pregnancy is common were identified from a network established during previous obstetric trials. Women who were younger than 18 years without permission provided by a guardian, had a known tranexamic acid allergy, or developed postpartum haemorrhage before the umbilical cord was cut or clamped were excluded from the study. Prebirth haemoglobin, the exposure, was measured after hospital arrival and just before giving birth. Postpartum haemorrhage, the outcome, was defined in three ways: (1) clinical postpartum haemorrhage (estimated blood loss ≥500 mL or any blood loss sufficient to compromise haemodynamic stability); (2) WHO-defined postpartum haemorrhage (estimated blood loss of at least 500 mL); and (3) calculated postpartum haemorrhage (calculated estimated blood loss of ≥1000 mL). Calculated postpartum haemorrhage was estimated from the peripartum change in haemoglobin concentration and bodyweight. We used multivariable logistic regression to examine the association between haemoglobin and postpartum haemorrhage, adjusting for confounding factors. Findings: Of the 10 620 women recruited to the WOMAN-2 trial between Aug 24, 2019, and Nov 1, 2022, 10 561 (99·4%) had complete outcome data. 8751 (82·9%) of 10 561 women were recruited from hospitals in Pakistan, 837 (7·9%) from hospitals in Nigeria, 525 (5·0%) from hospitals in Tanzania, and 448 (4·2%) from hospitals in Zambia. The mean age was 27·1 years (SD 5·5) and mean prebirth haemoglobin was 80·7 g/L (11·8). Mean estimated blood loss was 301 mL (SD 183) for the 8791 (83·2%) women with moderate anaemia and 340 mL (288) for the 1770 (16·8%) women with severe anaemia. 742 (7·0%) women had clinical postpartum haemorrhage. The risk of clinical postpartum haemorrhage was 6·2% in women with moderate anaemia and 11·2% in women with severe anaemia. A 10 g/L reduction in prebirth haemoglobin increased the odds of clinical postpartum haemorrhage (adjusted odds ratio [aOR] 1·29 [95% CI 1·21–1·38]), WHO-defined postpartum haemorrhage (aOR 1·25 [1·16–1·36]), and calculated postpartum haemorrhage (aOR 1·23 [1·14–1·32]). 14 women died and 68 either died or had a near miss. Severe anaemia was associated with seven times higher odds of death or near miss (OR 7·25 [95% CI 4·45–11·80]) than was moderate anaemia. Interpretation: Anaemia is strongly associated with postpartum haemorrhage and the risk of death or near miss. Attention should be given to the prevention and treatment of anaemia in women of reproductive age. Funding: The WOMAN-2 trial is funded by Wellcome and the Bill & Melinda Gates Foundation

Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation

Association of Depression, Anxiety and Stress in Medical Students Studying in Modular, Semester and Annual Examination System

Background: When there are high demands besides less resources, a person experiences a feeling of fear that is known as “Stress”. Students of professional schools/colleges and universities are encounter more stress than the general population as they are in a transitory phase from adolescence to adulthood. It has been highlighted that medical education has greater association with stress. There are three examination systems that are been followed by medical colleges of Pakistan (modular, semester and annual systems). However, to the best of our knowledge, no data is available to show the association of stress with current examination systems in our country. Aims: The objectives of our study were to find out the association of stress with different examination systems and to identify the frequency of stress causing and coping factors adopted by 1st, 2nd and 3rd year medical students studying in colleges having different examination systems i.e. modular, semester and annual. Study Design: Comparative cross-sectional study. Place &amp; Duration of Study: This study was conducted from December 2018 to April 2019 in three medical colleges of Sindh having above mentioned examination systems. Study Population: Medical students of 1st 2nd and 3rd year. Methodology: To assess depression, anxiety and stress among study population, DASS Scale was used. To identify the stress causing and coping factors in the students Likert scale based proforma with 19 factors were given to the selected participants Results: There was no significant association of examination system with depression, anxiety and stress, however various stress causing and coping factors were found significant in altering medical student`s life. Conclusion: According to our study, the frequency of stress in the medial students has no association with the examination systems (modular, semester and annual), currently followed by the medical colleges in Sindh, Pakistan

Diet in Pregnancy and Preeclampsia: Is There An Association?A Hospital Based Matched Case Control Study

Introduction: Preeclampsia has been rated amongst leading causes of feto-maternal morbidity and mortality but its etiology still remains not very clear. Aims & Objectives: To study the association of intake of certain food items with preeclampsia. Place and duration of study: This was a matched case-control study, carried out in tertiary care hospitals of Lahore during February 2019 to March 2020. Material & Methods: One hunded and thirty-two subjects were recruited based on predetermined inclusion and exclusion criteria. Matching was done for age, gestational period, parity, education status, and income status. Information on consumption of various food items was recorded on food frequency questionnaire and results were analyzed to determine risk of developing preeclampsia by computing Odds Ratio. Data entry and analysis was done using SPSS version 20., p value ? 0.05 was taken as significant. Results: Milk, meat and fruits consumption in study group did not show statistically significant association with preeclampsia (OR 0.51, 0.69, 1.75 and p-value=0.194, 0.211, 0.114 respectively), while consumption of green leafy vegetables shows statistically significant difference between Cases and Control. Higher risk of developing preeclampsia was seen in Cases with deficient intake of green leafy vegetables than in Controls with regular intake (Odds ratio=3.51 and p-value=0.001). Conclusion: Deficient consumption of green leafy vegetables is associated with higher risk of preeclampsia in pregnant women

Inter Simple Sequence Repeat-Based Genetic Divergence and Varietal Identification of Banana in Pakistan

Banana is one of the major cash and fruit crops of Pakistan. The lack of information concerning genetic diversity and purity within locally cultivated banana varieties is a major bottleneck in improving its genetics. Due to the existence of a narrow genetic background, it’s quite important to find genomic variations in banana varieties. DNA marker-based techniques have been used to effectively characterize banana varieties. In the current study, Inter Simple Sequence Repeat (ISSR) markers were used to characterize banana cultivars and to assess the genetic diversity of 14 local banana varieties grown in Pakistan. Out of the 45 primers used, 40 primers revealed reproducible results and produced 121 polymorphic bands, which contributed a ratio of 47.87 polymorphism. The ISSR UBC-835 and UBC-834 possessed the highest PIC ranged between (86–88%) in banana varieties, while the lowest PIC (46%) was detected in the case of UBC−857 marker with (100–1500 bp) PCR product size. Pairwise Jaccard’s similarity coefficient values were also calculated, and these were ranged from 0.56–0.88. Multivariate analysis divided 14 banana varieties into two distinct groups—A and B respectively—and furthermore into subgroups, clusters, and sub−clusters. Our results indicated that at the molecular level, the banana varieties in group—A were found to be 66% similar whereas in group B were 88% similar. Nei’s genetic diversity, PCA analysis, and a minimum spanning tree depicted Fenjiao, Dajiao, and NIGAB-2 as the most diverse members as compared to all other varieties of the three populations. Out of 14 varieties used, 11 varieties were uniquely identified by 54 polymorphic ISSR bands of different sizes. Some varieties like NIGAB-2 and NIGAB-3 were uniquely identified only with one band while others were tagged by multiple unique bands. In future, this study will be utilized to establish a molecular-based protocol for the identification of banana varieties