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Introduction: Candida nivariensis, first described from Spain in 2005 is an emerging fungal pathogen. Malaysia has cap-tured a total of 11 cases since its first reported here in 2014. Indonesia, Thailand, and Vietnam are among South East Asia countries that reported its occurrence too. Objective(s): The occurrence and characteristics of Candida nivariensis in South East Asia are studied. We would like to highlight two cases from Selayang Hospital, Malaysia that occurred during pandemic COVID-19 in 2020 and 2022. Case Description: In July 2020, a 60-year-old lady underlying poorly controlled diabetes mellitus, CKD stage V approach-ing ESRD, congestivecardiac failure, hypertension, and dyslipidemiawas diagnosed as complicated MSSAbacteremia secondary to right gluteal carbuncle.Appropriate antibiotics were commenced.Aggressive source control including incision and drainage, cauterization of right gluteal carbuncle, and multiple wound debridement for the infected gluteal wound was performed. She underwent a trephine sigmoid loop colostomy.Tracheostomy was done following prolong ventilation.Anidulafungin as empir-ical fungal coverage was commenced in ICU as she further deteriorated. Candida nivariensis was isolated later from her blood culture. In February 2022, a 74-year-old man underlying Diabetes mellitus, chronic kidney disease, hypertension, ischemic heart disease with two vessels disease stented, post-Whipple's procedure due to necrotizing pancreatitis in 2014 complicated with chronic abdominal pain with hyperalgesia admitted to the ward for acute right lacunar infarct with failed swallowing test and neurogenic bladder.His general condition deteriorated with worsening of biochemical and septic parameters.His blood culture grew C. nivariensis following which anidulafungin was started. No distant seeding and no signs of endophthalmitis. He then required mechanical ventilatory support complicated with multiorgan failure, leading to ICU admission. Method(s): For both cases, yeast isolates were subcultured on Sabouraud dextrose agar and CHROMagar. Matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-T OF MS) with molecular testing was performed for confirmation of isolates.Phylogenetic tree among isolates from Malaysia was analyzed.Antifungal susceptibility test (AFST) to study the minimum inhibitory concentration (MIC) among treatment options was performed using the e-test method. Result(s): Wide use of MALDI-T OF MS with molecular testing increased the detection rate of the species. Isolation sites in Malaysia and South East Asia region include blood culture, peritoneal fluid, high vaginal swab, and oropharyngeal swab. Risk factors namely immunocompromised status, indwelling vascular catheter, abdominal surgeries, renal failure or on dialy-sis support, polymicrobial usage, and prolonged stay in ICU. AFST established susceptibility towards fluconazole, high MIC to itraconazole and low MIC against amphotericin B, anidulafungin and voriconazole for both patients who unfortunately succumbed to their illness. Conclusion(s): Diagnosing C. nivariensis is challenging due to its closely related phylogenetic with C. glabrata, and C. bracarensis, thus molecular testing is vital. Inadequate antifungal coverage or delay of treatment could be detrimental to pa-tient's outcome. Continuous epidemiological surveillance is crucial to address this potential invasive fungal pathogen and to observe emerging of drug resistance.
ABSTRACT
The novel coronavirus (2019-nCoV) pandemic’s global regulatory authorities are issuing provisional market authorization to current public health for timely detection of COVID-19 infections based on the analytical performance data, limited clinical performance data, and manufacturers’ declarations. Importers, local manufacturers, government procurement agencies, and other stakeholders should be made aware of the regulatory process for market authorization of COVID-19 in vitro diagnostic (IVD) kits in India. The objective is to study in detail about COVID-19 IVD guidelines. Concentrating on the recent updates in COVID-19 IVD guidelines, we analyze the necessity for India to become efficient in manufacturing SARS-CoV-2 IVDs. In India, Central Drugs Standard Control Organization (CDSCO) coordination with The Indian Council of Medical Research (ICMR) is committed to ensuring the rapid availability of diagnostic tests for COVID-19. To address the urgent need for timely detection of COVID-19 infection, it is important to scale-up the testing capacity to maximum possible levels according to the CDSCO interim licensing process. This has helped to timely expand the variety of quality diagnostic tests available in India. The regulatory tools described in this article are made based on a comparison of data available on the procedure, followed by other major countries under the health emergency without compromising on the quality of the product within the existing provisions given in the Drugs and Cosmetic Act and Medical Devices Rules 2017. © 2022
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Introduction: Nigella sativa, known for its various pharmacological activities, is under trial for COVID-19. Objectives: The objectives were to assess the efficacy of Nigella Sativa, a traditional herbal medicine, added to standard treatment in the management of uncomplicated respiratory infection in terms of reduction in severity and worsening of clinical symptoms and to assess its safety through the incidence of adverse events. Method: The study was an open-labelled, parallel-arm, randomised controlled study in 50 participants with uncomplicated respiratory infections. Patients with symptoms of respiratory infections including fever, sore throat, throat pain, rhinitis, headache, myalgia and cough with or without expectoration for 5 days or less, were enrolled in the study. They were randomly allocated to two groups: Group 1 received standard treatment for 7 days and Group 2 Nigella Sativa oil - 1000mg twice daily with standard treatment for 7 days. The patients were physically followed up on day 4 and day 7 after starting treatment. General and systemic examination, assessment of vitals including body temperature, assessment of adverse events and clinical response to treatment were carried out during each visit. Results: The two groups showed similar efficacy for improvement in clinical symptoms on day 7. But on day 4, more subjects became symptom-free in Group 2 (N. sativa + standard treatment) as compared to Group 1 (standard treatment alone). The incidence of adverse events was similar in both groups and all the adverse events were minor in nature. Conclusion: Hence it is concluded that the addition of N. sativa to standard treatment could potentially benefit the patients with uncomplicated respiratory infection with early clinical cure. Copyright (c) 2022: Author(s).
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Introduction: With the spread of COVID-19 pandemic, healthcare workers and patients look for alternate medicines including Siddha, Ayurveda, Unani and other forms of traditional medicines as we still do not have promising antiviral drugs for COVID-19. Objective: To evaluate the in-vitro antiviral activity of Fema Sakthi™ (FS) by eliciting the inhibition of cytopathic effect of Human Coronavirus (HCoV) on African Green Monkey kidney cells (VERO cells). Materials and Method: The cytopathic effect (CPE) was performed on Vero cells with Human Coronavirus 229E, a type of Coronavirus associated with respiratory infections. The Median Tissue Culture Infectious Dose (TCID50) was evaluated using Reed-Muench method. 100 TCID50 of HCoV 229E viral suspensions were added to VERO cell culture to induce the cytopathic effect. Uninfected and untreated cells were used as control and five concentrations (62.5, 125, 250, 500 & 1000 µg/mL) of Fema Sakthi™ (FS) were used to study the anti-viral activity. After incubation for 72 hours, the cell viability was observed under the inverted microscope after staining with 0.1% crystal violet. Results: Fema Sakthi™ (FS) was found to exhibit inhibition of cytopathic effect at lower concentrations (62.5, 125 and 250 µg/mL) but at higher concentrations (500 and 1000 µg/mL), the formulation itself was cytotoxic to the cells. Conclusion: This preliminary study showed that FS has antiviral activity at lower concentrations 62.5, 125 and 250 µg/mL on the VERO cells. However, further specific studies have to be carried out to confirm the anti-viral activity and clinical efficacy using other preclinical and clinical models of Human Coronavirus (HCoV) including COVID-19. Copyright (c) 2022: Author(s).
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Background: Many candidate vaccines against COVID-19 are competing for their clinical safety and efficacy but few have got approval from the competent authorities. However, people are still concerned about their use. Objectives: To assess the clinical safety of COVID-19 vaccines, Covishield and Covaxin using the incidence of self-reported and solicited local and systemic adverse events and efficacy by collecting data on the occurrence of confirmed COVID-19 infection after vaccination and to compare the clinical safety and efficacy of both the vaccines. Method: This study was conducted as an online survey using a self-administered questionnaire, among the individuals who were vaccinated in the months of February, March and April 2021. The participants were categorised into two groups, based on the type of vaccine they received as Covishield and Covaxin. The two groups did not differ in terms of age and gender. Results: The proportion of participants who had adverse events after the first dose of vaccination was significantly high with Covishield (37.2%) compared to Covaxin (17.4%). But the proportion of participants who developed adverse events after the second dose was not significantly different between Covishield and Covaxin (16.1% with Covishield and 23.8% with Covaxin). The incidence of COVID-19 infection after vaccination was similar in both the groups (4.5% in Covishield group and 5.7% in Covaxin group, p = 0.5, Chi-square test). Conclusion: The findings from this study gives real-world data that both Covishield and Covaxin are equally effective in preventing COVID-19 infection and have an acceptable safety profile. Copyright (c) 2022: Author(s).
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Background:During the ongoing COVID19 pandemic period, any new cases of acute-onset respiratory illness are likely to be treated as suspected COVID-19 by default. Methods:A 42year-old lady was admitted with a 4-week history of fever and cough, followed by a 4-days history of increasing short- ness of breath. Fever was intermittent, high grade and was associated with chills and rigor. The patient had a history of uncontrolled type II diabetes mellitus and on admission HbA1C was 15.5%. On examination she had a temperature of 102° F, blood pressure (BP) of 101/67mm Hg, heart rate of 130 beats per minute, respiratory rate (RR) of 24 breaths per minute and O2 saturations of 92% in room air. On respiratory examination, there were crackles in the left infrascapular and infraaxillary area. The patient was admitted in the COVID suspect ward with an impression of moderate COVID-19 infection and nasopharyngeal swab was sent for SARS-CoV-2 on RT-PCR. The patient underwent a CECT scan of thorax, abdomen and pelvis that revealed consolidation in bilateral lung fields with a cavity in lingular lobe with presence of air-fluid level. Mediastinal and hilar lymphadenopathy were present. [Formula presented] Results: SARS-CoV-2 RT-PCR was negative. The patient’s sputum sample revealed pure growth of purple, flat, dry, wrinkled colonies on Ashdown agar after 48 hours which was identified as Burkholderia pseudomallei. The Isolate was susceptible to ceftazidime, mero- penem, co-trimoxazole, amox-clav and chloramphenicol. The patient was started on I.V Meropenem 500mg every 8hourly for 21 days and was discharged on co-trimoxazole tablet. Conclusions: The case definitions of COVID-19 such as fever, cough and shortness of breath can be associated with other infectious etiologies. The role of the microbiology laboratory is thus very crucial in COVID-19 from overshadowing other infec- tious diseases, particularly in endemic areas, hence preventing misdiagnosis and consequent adverse outcomes for patients.
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The global COVID-19 pandemic forced society to shift to remote education and work. This shift relies on various video conference systems (VCSs) such as Zoom, Microsoft Teams, and Jitsi, consequently increasing pressure on their digital service infrastructure. Although understanding the performance of these essential cloud services could lead to better designs and improved service deployments, only limited research on this topic currently exists. Addressing this problem, in this work we propose an experimental method to analyze and compare VCSs. Our method is based on real-world experiments where the client-side is controlled, and focuses on VCS resource requirements and performance. We design and implement a tool to automatically conduct these real-world experiments, and use it to compare three platforms on the client side: Zoom, Microsoft Teams, and Jitsi. Our work exposes that there are significant differences between the systems tested in terms of resource usage and performance variability, and provides evidence for a suspected memory leak in Zoom, the system widely regarded as the industry market leader. © 2021 Association for Computing Machinery.
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Post market examination is to safeguard end users through the close watch of IVDs offered for sale or distribution in the country. Through this action product owner must aware of the problems arises with the IVD in use and analysis the risk associated with the problem reported and take appropriate action to avoid repetition and ensure quality of the IVDs in the market. Rigorous pre-market assessment of IVDs is done by the regulatory authorities;however, there is no enough system and guidance in place for the monitoring of the post-marketing phase of IVDs in most countries including India. This article has been prepared to facilitate and strengthen the reporting of Events attributable to in-vitro diagnostic medical devices in India, harmonized with WHO, National and International best practices. This article suggested the various stakeholders follow this guidance involved in the post market phase of IVDs relates to monitoring of adverse events, reporting of adverse events, reporting timeline, examination of the complaint to determine source, and the subsequent suitable action. This article also aims to create awareness among users about the importance of reporting adverse events relating to the IVDs in India. In order to monitor the quality of the IVDs available in the country and encourage the reporting, this article also urges the central government to make online portal under respective authorities for mandatory reporting, report suspected counterfeit IVDs, for voluntary reporting serious adverse event, product quality problem, product use/medication error, or /failure that is associated with the use of an IVDs.