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Experimental research with animals can help the prevention, cure, and alleviation of human ailments. Animal research facilities are critical for scientific advancement, but they can also pose a higher risk than other biomedical laboratories. Zoonosis, allergic reactions, bites, cuts, and scratches by animals are all substantial concerns that can occur in animal facilities. Furthermore, human error and unexpected animal behavior pose a risk not just to humans, but also to the environment and the animals themselves. The majority of biosafety and biosecurity training programs focus on clinical and biomedical laboratories dealing with human safety factors, with little emphasis on animal biosafety. The current virtual training was designed to improve biosafety and biosecurity capabilities of animal laboratory personnel, researchers, and veterinarians from different regions of Pakistan. The results revealed that understanding was improved regarding triggers for risk assessment in addition to annual and regular reviews (56% to 69%), biosecurity (21% to 50%), decontamination (17% to 35%), safe handling of sharps (21% to 35%), Dual Use Research of Concern (DURC) (17% to 40%), Personal Protective Equipment (PPE) usage by waste handlers (60.9% to 75%), waste management (56% to 85%), animal biosafety levels (40.57% to 45%), and good microbiological practices and procedures (17% to 35%). To bring human and animal laboratories up to the same level in terms of biosafety and biosecurity, it is critical to focus on areas that have been overlooked in the past. Training programs focusing on animal biosafety should be conducted more frequently to strengthen bio risk management systems in animal research facilities.Copyright © 2021
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The COVID-19 pandemic has severely affected public health system and surveillance of other communicable diseases across the globe. The lockdown, travel constraints and COVID phobia turned down the number of people with illness visiting to the clinics or hospitals. Besides this, the heavy workload of SARS-CoV-2 diagnosis has led to the reduction in differential diagnosis of other diseases. Consequently, it added to the underlying burden of many diseases which remained under-diagnosed. Amidst the pandemic, the rise of emerging and re-emerging infectious diseases was observed worldwide and reported to the World Health Organization i.e., Crimean Congo Hemorrhagic Fever (2022, Iraq;2021 India), Nipah virus (2021, India), Zika virus (2021, India), and H5N1 influenza (2021, India), Monkeypox (2022, multicountry outbreak), Ebola virus disease (2022, DRC, Uganda;2021, DRC, Guinea;2020, DRC), Marburg (2022, Ghana;2021, Guinea), Yellow fever (2022, Uganda, Kenya, West and Central Africa;2021, Ghana, Venezuela, Nigeria;2020, Senegal, Guinea, Nigeria, Gabon;2020, Ethiopia, Sudan, Uganda), Dengue (2022, Nepal, Pakistan, Sao Tome, Temor-Leste;2021, Pakistan), Middle east respiratory syndrome coronavirus (2022, Oman, Qatar;2021, Saudi Arabia, UAE;2020, Saudi Arabia, UAE), Rift valley fever (2021, Kenya;2020, Mauritania), wild poliovirus type 1 (2022, Mozambique), Lassa fever (2022, Guinea, Togo, Nigeria;2020, Nigeria), Avian Influenza (H3N8) (2022, China), Avian Influenza (H5N1) (2022, USA), H10N3 influenza (2021, China), Hepatitis E virus (2022, Sudan), Measles (2022, Malawi, Afghanistan;2020, Burundi, Mexico), Mayaro virus disease (2020, French Guiana), Oropouche virus disease (2020, French Guiana). All these diseases were associated with high morbidity and burdened the public health system during the COVID-19 pandemic. During this critical public health menace, majority of the laboratory workforce was mobilized to the SARS-CoV-2 diagnosis. This has limited the surveillance efforts that likely led to under diagnosis and under-detection of many infectious pathogens. Lockdowns and travel limitations also put a hold on human and animal surveillance studies to assess the prevalence of these zoonotic viruses. In addition, lack of supplies and laboratory personnel and an overburdened workforce negatively impacted differential diagnosis of the diseases. This is especially critical given the common symptoms between COVID-19 and other pathogens causing respiratory illnesses. Additionally, the vaccination programs against various vaccine preventable diseases were also hampered which might have added to the disease burden. Despite these challenges, the world is better prepared to detect and respond to emerging/re-emerging pathogens. India now has more than 3000 COVID-19 diagnostic laboratories and an enhanced hospital infrastructure. In addition, mobile BSL-3 facilities are being validated for onsite sampling and testing in remote areas during outbreak situations and surveillance activities. This will undoubtedly be valuable as the COVID-19 pandemic evolves as well as during future outbreaks and epidemics. In conclusion, an increase in the emergence and re-emergence of viruses demonstrates that other infectious diseases have been neglected during the COVID-19 pandemic. Lessons learned from the infrastructure strengthening, collaborations with multiple stakeholders, increased laboratory and manufacturing capacity, large-scale COVID-19 surveillance, extensive network for laboratory diagnosis, and intervention strategies can be implemented to provide quick, concerted responses against the future threats associated with other zoonotic pathogens.
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The interaction between clinic and laboratory is crucial for the diagnostic process of neurological disorders, in particular in patients with autoimmune/inflammatory conditions. In these conditions, different diagnostic assays with specific sensitivity and specificity are available. Many laboratories use commercial assays based on line-blot techniques (for the detection of antibodies to intracellular antigens, such as Hu and Yo) or fixed cell-based-assays (for the detection of antibodies to surface antigens such as NMDAR or LGI1 or to oligodendrocytes-MOG- or astrocytes-AQP4). However, assays with higher sensitivity, such as live CBA or immunohistochemistry on rat brain/cerebellum are available and allow the detection of additional antibodies, also to unknown antigens, by evaluating specific patterns of positivity. In this context, the continuous interaction between clinicians and laboratory physicians is necessary to guide antibody testing and select those cases which need additional advanced investigations. This concept was even more relevant during the COVID-19 pandemic, which led to an increase of samples referred to reference laboratories, in particular from patients with encephalitis or myelitis, for whom the differential diagnosis between an infectious vs. postinfectious vs. inflammatory vs. autoimmune process was challenging. The interaction between clinicians and laboratory physicians in this area focused on solving some important questions, and in particular: 1) to understand whether SARS-CoV-2 infection could cause autoimmune neurological diseases;2) to clarify the course of SARS-CoV-2 infection in patients with autoimmune neurological diseases;3) to understand if vaccines could induce autoimmune neurological diseases;and 4) to understand the effect of vaccination in patients with autoimmune neurological diseases. The constant scientific exchange between the various professional figures led to an improvement of the diagnostic process of these neurological disorders, with a significant impact on patients' prognosis and quality of life.Copyright © 2022 EDIZIONI MINERVA MEDICA.
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Introduction: Stress and the ability to cope with stress can influence the health and performance of laboratory technicians. This is especially true in the current circumstances of a global pandemic which has placed a tremendous amount of stress on healthcare professionals, including laboratory technicians. However, there is little to no research in India about the relationship between stress and coping abilities and its influence on health and work performance. Objective(s): To assess the self-reported stress levels, perceived coping effectiveness, coping techniques & health behaviours of lab technicians. Material(s) and Method(s): A cross-sectional observational study was done using a structured questionnaire among 152 lab technicians working in a lab chain across 3 states in Western India. Result(s): The responses indicated that the lab technicians had less than ideal stress levels. 80.3% reported moderate-to-very high stress levels;51.3% slept less than 8 hours of sleep per night;53.3 to 61.2% did not exercise regularly;30.9% consumed less than 2 servings of fruits and vegetables per day;and 9.2% were classified as binge drinkers. When confronted with workplace stress, 34.1% reported that they consumed more food than usual (28.3% reported that they consumed more junk food), 48.1% reported a loss of appetite and eating less food than usual, 45.4% reported losing sleep. Lab technicians in the "high stress and poor coping" group reported a statistically significant higher number of days feeling worried, tense or anxious, sad or depressed. The attitudes of lab technicians to preventive health in the COVID-19 pandemic (especially considering the increased risk of co-morbidities during the COVID-19 pandemic) were also less than ideal: 83.6% did not undergo a preventive health check-up package in the past year, 55.9% had not visited a doctor for a general physical exam in the past year. Conclusion(s): Given the amount of stress and work that has been placed on the diagnostic industry over the past 2 years, it is imperative that we understand the stress levels, coping adequacy and health behaviours of lab technicians who form the backbone of the industry. As the results of this pilot study show, there is an immediate need to implement worksite health promotion programmes focusing on stress reduction, stress management and the development of healthy coping skills.
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Introduction: With the rapid spreading of the coronavirus (COVID-19) pandemic and the limited capacities of realtime reverse transcriptase-PCR (RT-PCR) at the laboratory level, there is an emerging need for rapid, point-of-care (POC), molecular testing in the Emergency Department (ED). Aims and objectives: To compare the diagnostic performance of ID NOW COVID-19 assay (Abbott, Chicago, Il, USA) performed by ED doctors with a gold standard reference RT-PCR test (GeneXpert assay developed by Cepheid). Method(s): Paired nasopharyngeal swabs were collected from consecutive adult patients suspected of having COVID-19 in the ED of a tertiary hospital in Athens (Greece);the first swab was directly used for the ID NOW COVID-19 assay in POC by an emergency physician and the second was analyzed with reference RT-PCR by a central laboratory technician. Cohen's kappa was run to determine if there was sufficient agreement between the two diagnostic methods. Result(s): Seventy one consecutive patients (36 female, mean age 64.6) were enrolled in the present study from 15th January to 21th February, 2022. The two tests agreed on 20 positive and 50 negative results. On the contrary, ID NOW COVID-19 assay was found positive in one patient with a negative reference RT-PCR test. There was very good agreement between the two diagnostic methods [kappa = 0.966 (95% CI, 0.900 to 1.032), p < 0.0001]. Conclusion(s): Comparison of a POC and a standard laboratory RT-PCR test in an ED patient population yielded high positive (95%) and negative percent agreement (100%). ID NOW COVID-19 assay seems to be a highly reliable POC test for early screening and triage of suspected COVID-19 patients.
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Introduction: Healthcare Professionals (HCPs) involved in managing Coronavirus Disease 2019 (COVID-19) pandemic were instructed to wear Personal Protective Equipment (PPE) to protect themselves from contracting virus. However, PPE use can sometimes lead to adverse events which create greater impact on health status of HCPs. Thus, the prevalence of adverse events and associated risk factors should be estimated for taking necessary preventive measures. Aim(s): To evaluate the prevalence of adverse events in HCPs due to PPE use during second wave of COVID-19 in Tamil Nadu, India. Material(s) and Method(s): A cross-sectional study was conducted in different levels of healthcare centres in Tamil Nadu, India, from April to May 2021. Data were collected using a pre-validated questionnaire from HCPs of any discipline who were directly involved in managing COVID-19 patients. A total of 282 responses were collected through Google forms and proportion of HCPs who experienced adverse events due to PPE and percentage of different adverse events associated with PPE wearing were assessed. Data were analysed using Chi-square test. Result(s): Out of 282 respondents of the survey included 224 doctors, 34 nurses and 24 lab technicians with a mean age of 30 years. There were 164 females and 118 males. A total of 177 (62.76%) participants experienced adverse events which included dehydration, thirst and heat, headaches, inability to go to restroom and other urinary/respiratory problems. With respect to duration of exposure to PPE, 163 (57.8%) HCPs had >6 hours/day and 102 (36.2%) had 4-6 hours/day. It was observed that factors such as age, gender, profession, various wards posted for COVID-19 duty and duration of PPE worn daily were significantly associated with adverse events to PPE (p-value<0.05). Conclusion(s): The results of the study concluded that higher prevalence of adverse events with PPE was seen among doctors and nurses. Most common encountered adverse events were dehydration, headache and skin problems, which have been associated with prolonged use of PPE.Copyright © 2023 Journal of Clinical and Diagnostic Research. All rights reserved.
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Polymerase chain reaction (PCR) invented by Kary Mullis (1983), has become the centrepiece of molecular detection of various infectious diseases including coronavirus disease 2019 (COVID-19). Many developing countries like Nepal faces various challenges and grab many future opportunities during and after establishment of molecular PCR laboratories throughout the country. This viewpoint describes the involvement of laboratory employees, development and adoption of new protocols or framework, deliberate partnership with national and international community is very efficient for the establishment of PCR laboratories. Beside this, continued alliance and nation leadership is crucial to generate a unified and sustainable PCR laboratory network in the country like Nepal. In future the established PCR laboratories can be utilized for the diagnosis of others pandemic diseases and can be used for multipurpose like in verification of infectious diseases;Oncology;Blood test;Genetic testing. Copyright © 2020, Kathmandu University. All rights reserved.
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Introduction: The COVID-19 pandemic led educators to adopt non-traditional methods for delivery of education materials. In hematology laboratory, training in morphologic assessment of blood smears is an important skill that entry-level staff needs to show competency CellaVision DM 96 and its proficiency testing features have benefits that extend far beyond its use in clinical practice. For hematology laboratory training programs, the use of Cellavision Proficiency Software can be used in training laboratory staff and medical laboratory program students, assess competency and to ensure standardization in result reporting when evaluating peripheral blood smear reviews CellaVision Proficiency Software can be used as a simulation-based learning tool in pathology and laboratory science education. Method(s): Pilot, crosssectional study. Students matriculated at Rose State College's Medical Laboratory Technician Program in the Fall of 2021 enrolled in Hematology. The laboratory component of Hematology trains the students in the proper evaluation of peripheral blood smears The RSC MLT Class of 2022 cohort was introduced to the traditional microscopic evaluation of peripheral blood smears in the laboratory component of RSC MLT's Introduction to Medical Laboratory class and digital cell morphology assessment is the method used to train students in peripheral blood smear evaluations in the Hematology class. Laboratory component of Hematology follows the educational methodology that includes: Instructive, Self-study, Formative assessment , and Summative assessment Effectiveness in learning was measured by comparing the assessment scores of students who were taught peripheral blood smear evaluations using traditional microscopy. A comparison of student surveys was used to measure the effectiveness of student learning. Result(s): The use of the digital cell morphology software in the Medical Laboratory Technician Program has resulted in: Increased student participation. Improved student learning because of real-time feedback to students. Improved performance in morphological assessment and peripheral blood smear evaluations. 100% student satisfaction with the course. 100% of respondents stated the use of digital microscopy increased their knowledge of subject matter. Conclusion(s): In the delivery of content for hematology laboratory training, the use of Cellavision Proficiency Software improved morphology skill set in evaluation of peripheral blood smears. The digital morphology software provides a system that caters to different learner skills because of its asynchronous delivery and complements the didactic portion of the class to fully understand the materials discussed The use of digital morphology software to train entrylevel medical laboratory staff is an excellent option to supplement traditional microscopy and leads to improved competency, improved technical knowledge and improved learner participation.
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Introduction: Mononucleosis is an infectious disease caused by Epstein-Barr virus (EBV, human herpes virus type 4, HHV-4) and is characterized by asthenia, fever pharyngitis, and lymphadenopathy. In our laboratory diagnosis is made by rapid test and Epstein-Barr virus antibody assay. The presence of Epstein-Barr virus (VCA) specific IgM antibodies indicates primary infection. A marked lymphocytosis with inversion of the formula can be seen on the blood count. The smear shows numerous activated lymphocytic elements By examining the complete scattergram of patients with confirmed primary infection we noticed a peculiar arch arrangement of the lymphocytes in the FL1 x ALL specific leukocyte scatters. Method(s): In this study Vircell's Virapid mono M&G is used, an immunotest for the qualitative determination of 4 serological markers of EBV: two IgM, VCA and heterophile, and two IgG, VCA and EBNA. The presence of anti-VCA IgM antibodies and the absence of anti-EBNA antibodies are indicative of primary infection. CBC was performed on Abbott Alinity hq, which uses a combination of photometry optical counting and fluorescence analysis in order to enumerate cells and cellular constituens. The instrument utilizes eight light scatter detectors which include ALL (axial light loss), IAS (intermediate angles of light scatter), PSS (polarized side scatter), DSS (depolarized side scatter) and FL1 ( fluorescent channel). Result(s): The sixteen cases examined, all of which resulted positive for primary infection on the rapid test, showed a peculiar FL1 x ALL scattergram (see Fig.1). In the lymphocytes' scattergram cloud, we observed an archshaped trend going upwards and rightwards, thus highlighting cells with greater fluorescence and size Often these lymphocytes are identified as monocytes In cases of lymphocytosis from other causes (CLL lymphomas) we can see how the lymphocytes' scattergram cloud is totally different. In such a case the cloud seems like a short bar due to lymphocytes with increased fluorescence signal though with small size (see Fig.2). Conclusion(s): In the 16 cases of primary EBV infection examined, the blood count shows a peculiar FL1 x ALL scattergram, which compared with the scattergram of other causes of lymphocytosis highlights a substantial difference that could support the laboratory technician in the diagnostic differentiation of a lymphocytosis: lymphocytic response to viral infection (EBV, SARS-Cov19, ecc) or monoclonal lymphocyte proliferation.
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Introduction: Improper waste management has a negative impact on the health of medical professionals, sanitary staff, general public and the environment in general. Objective(s): To assess the Knowledge and Practice regarding COVID-19 biomedical waste management (BMWM) among healthcare workers (HCW) of government health facilities of rural Ghaziabad. Methodology: A cross-sectional study was conducted to assess the knowledge and practices regarding Bio-Medical waste, in rural blocks of the district Ghaziabad at C.H.C, P.H.C and Sub-centres. Health care worker (HCW) like Doctor, Nursing Staff, Laboratory technician and Sanitary staff working in the Health care facilities were selected for the Study. A total number of 122 HCW were selected, which included 27 Doctors, 75 Nurse, 06 Lab technician and 14 sanitary staff, using Proportional allocation scheme respectively. Result(s): The Knowledge regarding Biomedical waste management of COVID-19 was 62.2% and practice was 50.8% among the HCW. Multinomial regression between socio-demographic features of HCW and their practice regarding COVID-19 Biomedical waste revealed that the practice was three times better 3.859 (1.378-10.811) in graduate and four times 4.062 (1.030-16.024) in post graduate than diploma holders. Doctors had three time better 3.595 (1.304-9.908) practice of COVID-19 biomedical waste management than nurses. Similarly, the CHC's COVID 19 biomedical waste management practices were more than four time 4.440 (1.482-13.974) better than sub centers. Conclusion(s): Level of knowledge and practice scores were unsatisfactory. Healthcare facilities should provide periodic training and adequate supplies for the waste handlers. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
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The importance of co-ordinated, robust sample collection for medical research has been highlighted during the COVID pandemic with the need for rapid, well curated samples and data. The knowledge and skills present within biobanks expedited such collections and the value of expert repository staff was recognised. Investing in staff is one of the most important activities a biobank can undertake as part of social sustainability. Biobank personnel are core to the success of the repository and a valued and engaged team is key to provide a solid foundation for the biobank to evolve and flourish. Supporting education gives the individual the opportunity for career development, the biobank a more stable workforce and has impact and value to both the biobank and host institution. Personnel come to biobanking via many varied routes, and it can be difficult when recruiting to benchmark an individual's knowledge of biobanking and associated processes. The Qualification in Biorepository Science (QBRS) is a new education tool that was jointly developed by the International Society for Biological and Environmental Repositories (ISBER) and the American Society of Clinical Pathology's Board of Certification (ASCP BOC). It provides a biobanking specific, international exam that 'professionalises' biobanking and allows remote learning to fit around daily tasks. All aspects of the biobanking pathway are covered in the syllabus and the exam is taken online, giving wide accessibility. The Wales Cancer Biobank sponsored a laboratory technician to take the test in 2021 and we present the impact and value of the QBRS qualification from a biobank's perspective. Funding(s): The Wales Cancer Biobank is funded by Health and Care Research Wales Conflict of Interest: None to disclose Copyright © 2022
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Introduction We all know that the most important task in combating COVID-19 pandemic is to produce enough effective vaccines and the greatest number of vaccinated subjects within a time frame. Nevertheless, the goal of this worldwide effort should be aligned to raise protective level of neutralizing antibodies (NAb) in vaccinees. It is clear that the NAb can block a viral invasion at the initial access to human receptors. Some methods for NAb measurement are commercially available.In this study, we evaluate the immune response of all employees receiving the III dose of BNT162b2 mRNA vaccine at November 2021. Serological NAb determination was performed before the administration of the III dose of vaccine (T0) and then 1 (T1) and 3 months (T2). Methods We collected serum samples of 46 laboratory workers at T0, T1 and T2. We determined the concentration of Anti-S IgG with SARS-CoV-2 IgG II Quant kit by chemiluminescence method on Alinity i Abbott (cutoff 50 AU/mL) in all samples and of NAb in 11 laboratory workers at T0, T1, T2 using SARS-CoV-2 Anticorpi Neutralizzanti kit (SGM Italia), an immunoturbidimetric method (high concentration >30 AU/mL, high % inibition >56%) on Alinity i Abbott platform. This method is able to detect NAb which bind specifically to the binding domain of the RBD receptor blocking the human ACE2 receptor. Statistical analysis was performed using MedCalc Software Ltd. Results At T0, T1 and T2, the mean+/-standard deviation concentration for anti-S IgG is 1016+/-1462, 22239+/-22480, 41777+/-30778 AU/mL and for NAb is 33+/-24, 100+/-100, 95+/-12, and the mean inibition percentage (%NAb) is 66+/-51, 309+/-105 and 320+/-164, respectively. Comparison between anti-S IgG and NAb at T0 showed a good correlation (R2=0.88);the NAb concentration was upper of linearity an all subjects at T1 and T2. Comparison between anti-S IgG and %NAb showed the same trend. Discussion The anti-S IgG are significantly reduced after 6 months from II dose of vaccine and increased about 30 times at T1. Concentration become half at T2 in all subjects who not affected by SARS-CoV-2 between T1 and T2. Although all subjects had a high %NAb at T0 that becomes 5 times higher at T1 and remains high at T2, 7 out of 11 subjects have been infected by SARS-CoV-2. Further studies are needed to define better the SARSCoV-2 neutralizing activity and the suitable routine test to measure them.
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Introduction At november 2021 in our public hospital, all employees have been received the III dose of SARS-CoV-2 vaccine with BNT162b2 mRNA. To evaluate the immune response to the vaccine, the antibodies measurement directed against the S protein or, more specifically, against the RBD domain stimulated by vaccination, was performed. The aim of this study is to evaluate SARS-CoV-2 antibody dinamics over 6 months after vaccine (at T0, T1, T2, T3: before III dose, at 1, 3 and 6 months, respectively). Methods We collected serum samples from 46 laboratory workers at T0, T1, T2, T3 (between november 2021 and may 2022). Serologic testing for specific SARS-CoV-2 anti-RBD IgG were performed by chemiluminescence method on Alinity Abbott instrument;according to manifacturer, the cut-off is 50 AU/mL. All samples were tested also for anti-N IgG with chemiluminescence assay on Alinity Abbott instrument (cutoff is 1.4 AU/mL) to evaluate subjects affected by COVID-19. Results At T0, the mean concentration of anti-S IgG is 581+/-303 AU/mL for 42 subjects (91%) that received II dosis until to April 2021 whereas the mean concentration is 3963+/-1386 AU/mL for 4 workers (9%) affected by SARS-CoV-2 between I dosis and november 2021. At T1, the mean concentration of anti-S IgG is 23326+/- 15905 AU/mL (min/ max value 4766 and 69816 AU/mL) without difference among subjects that had the upper concentration at T0. At T2, the mean concentration of anti-S IgG is 27374+/-27057 AU/mL (min/max value 1038 and 80000 AU/mL) with mean concentration of 60561+/-22281 AU/mL in 6 subjects affected by SARS-CoV-2 between T1 and T2.At T3, the mean concentration of anti-S IgG is 20610+/-12403 AU/mL (min/max value 1825 and 39796 AU/mL) with mean concentration of 22525+/-10121 AU/mL in 5 subjects affected by SARS-CoV-2 between T2 and T3. Discussion We found that booster dose of the vaccine triggers robust immune responses in healthy recipients, COVID-19 triggers an earlier and more intense immune response even after 2-3 months from III dose;in all cases, however, antibody titers remain at high levels in COVID-19 recovered patients. Although virus infection among vaccinated subjects is rare, this would seem to promote a more intense immune response after boosting dose, inducing antibody titers significantly higher and likely more durable.
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Introduction: The increase in the number of cases of COVID-19 in Cuba demanded of new capacities for the molecular diagnosis of the infection. A Laboratory of Molecular Biology for the molecular diagnosis of this disease was installed at the Base Business Unit LIORAD-AICA+ Laboratories in Havana. Objective(s): To analyze a one-year work experience in the molecular diagnosis of COVID-19 at the Laboratory of Molecular Biology, LIORAD-AICA+. Method(s): To begin with the molecular diagnosis of SARS-CoV-2 at LIORAD-AICA+, a group of actions were carried out aimed at evaluating the risks, establishing the working areas and flow, and training the work team. Personnel were trained, and procedures and guidelines were drawn up and modified. Result(s): Risk assessment allowed identifying several risks associated with the diagnostic activity, and measures were established to mitigate them. The laboratory personnel received 23 training sessions;and eight procedures and guidelines, and two registers were drawn up. The laboratory processed a total of 125 154 samples in a year. Conclusion(s): During the work year, the accurate diagnosis of the disease was conducted at the Laboratory of Molecular Biology, LIORAD-AICA+. This evidences the importance of personnel training and the compliance with good practices and biosafety measures when working with potentially infectious samples. Copyright © 2022, Editorial Ciencias Medicas. All rights reserved.
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The almost relentless worldwide diffusion of severe acute respiratory syndrome coronavirus (SARS-CoV-2) is deeply engaging the minds of many scientists, clinicians and laboratory professionals, who struggle to identify the possible short- and long-term consequences of coronavirus disease 2019 (COVID-19) in the general population, as well as in specific cohorts of individuals, who may display peculiar features of infection. Pregnant women represent one of these categories, since the biological implications of SARS-CoV-2 infection extend far beyond those caused to the mother, involving also the fetus. Several lines of evidence now attest that although mother-to-child SARS-CoV-2 transmission is relatively rare (<2% of all pregnancies), the consequences on maternal-fetal-neonatal interface of COVID-19 can be very serious. To this end, some important questions raise, such as "is COVID-19 a risk factor for complications in pregnancy?", "which laboratory tests are more predictable of unfavorable pregnancy outcomes?", "how efficacious is COVID-19 vaccination in pregnancy?" and, last but not least, "what evidence supports laboratory monitoring of COVID-19 vaccination immunogenicity in pregnancy?". In this opinion paper, we will attempt to provide an overview of the current biological, clinical and laboratory evidence of SARS-CoV-2 infection in pregnancy, trying also to provide reliable answers to the aforementioned questions. Copyright © 2022 Biomedia. All rights reserved.
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Background: Taking annual mycobacterial sputum cultures (MSCx) is a best practice standard for surveillance of nontuberculous mycobacterium (NTM) infection. MSCx collection among sputum-producing people with CF (PwCF) is essential for early identification and management of NTM. Initiation of highly effective modulator therapy (HEMT), elexacaftor/ tezacaftor/ivacaftor in 2019, resulted in a reduction in sputum production in PwCF. The concurrent emergence of the COVID-19 pandemic led to a shift from in-person to virtual clinic visits. These two events led to a dramatic decline in the rate of MSCx collection at our center-from 52.7% (2019) to 26.5% (2020) based on our CF Patient Registry report. We used a multidisciplinary approach to evaluate and implement continuous quality improvement (CQI) measures with the aim of increasing MSCx collection from 52.7% to 65% in 12 months. Eligibility was defined as producing 1 mL or more of sputum and no MSCx within the past 12 months. Method(s): The Minnesota CF Center care team consists of multidisciplinary specialties and approximately 450 PwCF. The CQI team generated the aim and developed a process map highlighting key stakeholders and barriers to MSCx collection. The team used a plan-do-study-act (PDSA) model to optimize key steps involved in MSCx collection. The first PDSA model included microbiology lab leadership identifying optimal (5-10 mL) and acceptable (>=1 mL) sputum volumes to avoid rejected specimens. Next, providers approved a new protocol to prioritize first sputum collection for MSCx and subsequent collection for CF bacterial cultures in eligible PwCF. Development of a certified medical assistant flowchart guided determination of eligibility for MSCx collection (Figure 1). Certified medical assistant then used a paper tool to document eligibility, specimen type, and lab orders placed for PwCF in clinic during the 4-week PDSA cycle. The paper tool was adapted using electronic health record (EHR) capabilities to generate date of last MSCx and allow electronic documentation of specimen collection type and orders placed. Result(s):With the use of HEMT, the percentage of sputum-producing PwCF declined from 74% to 40%. Use of process mapping and paper tool identified barriers to collecting MSCx in our clinic. Workflows were established through recurrent PDSA cycles to identify actionable interventions (education of lab personnel, paper tool, EHR documentation), which has led to collection of 53% of eligible samples-up from 26.5% in 2020 and on Figure 1 : Certified medical assistant (CMA) flowchart for mycobacterial sputum culture (MSCx) collection to determine patient eligibility and order placement(Figure Presented) track for 65% MSCx collection for the year. The paper tool revealed that the greatest barrier to obtaining MSCx was lab cancellation. By November, the team will complete another PDSA cycle after further lab education with the aim of decreasing the number of MSCx that the lab erroneously rejects. Conclusion(s): Despite the reduction in sputum production after use of HEMT, approximately 40% of PwCF still produce sufficient sputum for MSCx monitoring. Applying effective CQI tools including process mapping, PDSA cycles, pareto charts, and run charts to implement an improved, standardized workflow can increase the rate of MSCx, which will aid in detection and management of NTM infections and inform the epidemiology of NTM in the era of HEMT Copyright © 2022, European Cystic Fibrosis Society. All rights reserved
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Automated detection of highly communicable diseases such as COVID-19 will reduce the risk of the disease spreading. Detection of such disease requires a great amount of accuracy to ensure the safety of the patient and doctor as well. To provide an efficient solution to the problem, this model has proposed a robust solution to detect and classify diseases such as Covid-19 and Pneumonia for testing personnel which include doctors, different pathology laboratory personnel, etc. The work is divided into 2 parts, first is image classification into the above mentioned categories using deep neural networks and the second is adding the obtained model for the said deep neural network to an android application using Android Studio. This algorithm classifies the given image into 3 categories namely Covid-19, Pneumonia, and normal. The classifier architecture is created using CNN (Convolutional Neural Network) and it is trained on 10725 images, each of size 128 x 128. This dataset is a collection of datasets taken from Kaggle repositories in their open challenges.
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The article discusses periodical's third "State of the Industry" survey on topic, Disease Management. It mentions that survey findings has revealed higher testing volumes at a time when most labs have been struggling with staff shortages. It discusses the changes made in diagnostic processes in response to the Covid-19 pandemic, such as supplier diversification and increased space for molecular testing.
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Study question: Do the Merck family of fertility pen injectors (follitropinalfa, follitropin-alfa/lutropin-alfa, choriogonadotropin-alfa) meet the International Organization for Standardization (ISO 11608-1:2000/2012/ 2014) product-validation requirements? Summary answer: Each presentation of the family of fertility pen injectors performed as per the state-of-the-art product-validation specifications for dose accuracy in ISO 11608-1:2000/2012/2014 under atmospheric conditions. What is known already: Pen injectors for medically assisted reproduction must comply with ISO 11608-1:2000/2012/2014, which specifies essential performance requirements, including dose accuracy, and represent a benchmark for product reliability. Product-validation studies of the follitropin-alfa pen injector showed that three presentations (300 IU, 450 IU, and 900 IU) reliably dispensed accurate doses under a range of conditions, but no information was available for the follitropin-alfa/lutropin-alfa and choriogonadotropinalfa pen injectors. This study was done to confirm that the incremental dose/ clicks system was accurate for equivalence of volume (dose) delivered at standard atmospheric conditions for the complete Merck family of fertility pen injectors (follitropin-alfa, follitropin-alfa/lutropin-alfa, choriogonadotropin-alfa). Study design, size, duration: Laboratory-based dose accuracy measurement testing was carried out under standard atmospheric conditions, as specified in ISO 11608-1:2000/2012/2014, between 2015 and 2020. Participants/materials, setting, methods: Set doses (Vset) for three dose dial settings (minimum dose [Vmin], midpoint dose [Vmid] and maximum dose [Vmax] [follitropin-alfa, choriogonadotropin-alfa, and follitropinalfa/ lutropin-alfa]) or a single Vset (choriogonadotropin-alfa) were assessed, as appropriate. The last dose administered by the multi-dose device and cartridge and total extractable dose were assessed on the 900 IU and 300 IU follitropin- alfa and the 900 IU/450IU and 300/150 IU follitropin-alfa/lutropinalfa- pen presentations. Sixty measurements per assessment were made for each Vset. Main results and the role of chance: Measurements were performed at two manufacturing sites. Dose accuracy tests for Vmin, Vmid and Vmax (dose dial settings of 12.5 IU, 87.5 IU and 150 IU, respectively, for the 150 IU pen [n=2,226 (one site)];dose dial settings of 12.5 IU, 162.5 IU and 300 IU, respectively, for the 300 IU pen [n=742 per site];and dose dial settings of 12.5 IU, 237.5 IU and 450 IU, respectively, for the 450 IU [n=180 per site] and 900 IU pens [n=410 per site]) for the follitropin-alfa and the follitropinalfa/ lutropin-alfa pen injectors were within the acceptable limits defined in ISO 11608-1:2000/2012/2014. The results of further assessments of last dose and total extracted volume for each presentation of these devices were also within acceptable limits. Dose accuracy tests for the single use/single dose device classification (D1) of the choriogonadotropin-alfa pen injector (n=210 [one site]) showed that the Vset (6,500 IU) was within the acceptable limits according to ISO 11608-1:2000/2012/2014. Furthermore, dose accuracy tests for the single use/variable dose device classification (D2) of the choriogonadotropin-alfa pen injector (n=180 [one site]) showed that the Vmin (260 IU), Vmid (3,380 IU) and Vmax (6,500 IU) values were also the within acceptable limits. Limitations, reasons for caution: These assessments were carried out by laboratory scientists, who are not the intended users of the pen injectors, and were not delivered into human tissue;therefore, although these conditions meet the international standards, they do not reflect the real-world use of the pen injectors by patients. Wider implications of the findings: The Merck family of fertility pen injectors functions reliably and the incremental dose/clicks system dispenses accurate doses, providing users with confidence that they can accurately administer the prescribed dose and minimize drug wastage outside of a clinic environment, which is ore important than ever in light of the COVID pandemic.
ABSTRACT
Introduction/ Background: The COVID-19 pandemic has brought multifaceted impact including on health systems. In Ethiopia limited data is available how the response to the pandemic is shaping at sub-national level. This study explored the response to COVID-19 at subnational level and its impact on essential health services. Methods: We conducted a qualitative study using key informant interviews. A total of 59 health leaders across Ethiopia's 10 regions and 2 administrative cities were purposively selected. Data were collected using a semi-structured interview guide in October 2020. Transcripts were coded, categorized and thematic analysis was conducted. Twenty-four experts with graduate level training conducted the interviews and supervised the data collection. The respondents included regional and zonal managers, directors and health workers at primary health facilities. Results: Local government took the lead in responding to COVID-19 by organizing multisectoral committees. Health officials organized incident management teams. The management reassigned the health workforce to COVID-19 surveillance and case management and took other measures. Training was prioritized for members of rapid response teams, laboratory technicians, clinicians assigned to treatment centers and health extension workers. Personal protective equipment was difficult to obtain at the beginning of the pandemic. Rapid response teams conducted case investigation, contact tracing, and sample collection. Essential health services declined in the first few months of the pandemic, affecting maternal and child health, HIV/AIDS, and tuberculosis services. Impact: There is a need to learn from the multisectoral actions that were effective at beginning of the SARS-COV-2 pandemic. it also underscores multisectoral actions are critical for minimizing the impact of pandemics such as COVID-19. In addition, investing to build resilient health systems at grassroots is a priority issue. Conclusion: Multisectoral support was intensive at beginning and helped in directing human, material, and financial resources toward the response. But the intensity of the response faded away and essential services suffered in the first few months of the pandemic.