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1.
PLoS One ; 17(3): e0265519, 2022.
Article in English | MEDLINE | ID: covidwho-1753198

ABSTRACT

Alcohol-based hand sanitizers (ABHS) have been an important hand hygiene tool during the COVID-19 pandemic. Recently, ABHS from non-traditional drug manufacturers have entered the market, triggered by a lack of ABHS availability. Some of these ABHS contain high levels of chemical impurities that may be harmful with frequent exposure. Additionally, the use of refillable dispensers designed to accept ABHS from bulk containers allows for mixing and evaporation that may compromise ABHS integrity. To understand the risks associated with low quality ABHS and bulk refilling practices, we collected 77 ABHS samples sourced from community settings (restaurants, grocery stores, etc.) and 40 samples from a single school district. All samples were obtained from bulk refillable dispensers that were in use. Samples were analyzed for alcohol content, chemical impurities, aesthetic qualities, and presence of drug labeling information. Additionally, we performed laboratory-based experiments to determine the impact of dispenser design on alcohol evaporation rates. Over 70% of samples for which photos were available showed lack of essential labeling information, including missing "Drug Facts Labels". For ABHS samples acquired from community settings, nearly 14% of samples had visible impurities, and over 30% of samples had concentrations of acetal and acetaldehyde in excess of FDA interim limits. Subpotent ethanol concentrations were observed in 9.09% and 82.05% of samples from community settings and the school district, respectively, with the school district sample results being associated with dispenser misuse. Laboratory-based experiments show dispenser design significantly impacts the rate of ethanol evaporation of ABHS products, especially if stored in open refillable dispensers without an internal reservoir. This study demonstrates risks associated with use of inferior ABHS and bulk refilling practices. Regulatory agencies should issue guidance on best practices in community settings to ensure the integrity of ABHS as an essential public health tool to prevent the spread of COVID-19 and other transmissible diseases.


Subject(s)
COVID-19/prevention & control , Ethanol/analysis , Hand Sanitizers/analysis , Drug Contamination/statistics & numerical data , Drug Storage , Hand Sanitizers/standards , Humans , Product Labeling/standards , Product Labeling/statistics & numerical data , Quality Control
2.
Sci Rep ; 12(1): 4231, 2022 03 10.
Article in English | MEDLINE | ID: covidwho-1740477

ABSTRACT

Since the outbreak of the Coronavirus Disease 2019 (CoViD-19), the World Health Organization has recommended that, in absence of soap and water, alcohol-based hand sanitizer can be used to prevent the transmission of coronaviruses. Unfortunately, many media and anecdotal reports indicate that many alcohol-based hand sanitizers sold in South Africa are substandard and some contain potentially toxic ingredients. The study aimed to identify hand sanitizers used in the Johannesburg area during the CoViD-19 pandemic that do not contain the recommended alcohol concentration of at least 70% propanol or 60% ethanol, and contain traces of toxic ingredients. Hand sanitizers randomly collected from various traders around Johannesburg were analyzed using Agilent auto sampler coupled to a gas chromatograph utilizing flame ionisation detection. Of the 94 hand sanitizer samples collected, three preparations contained no alcohol, whereas the rest contained either ethanol, 2-propanol or 1-propanol or a combination of two alcohols. Of the alcohol-containing hand sanitizers, 37 (41%) contained less than 60% alcohol. Ethyl acetate, isobutanol and other non-recommended alcohols (methanol and 3-methyl-butanol) were also identified. Consumers are therefore warned that among the many brands of hand sanitizers found around Johannesburg, there are some substandard preparations and some that contain traces of toxic ingredients.


Subject(s)
COVID-19 , Hand Sanitizers/chemistry , Quality Control , Alcohols/analysis , Alcohols/isolation & purification , COVID-19/prevention & control , Chromatography, Gas , Hand Sanitizers/analysis , South Africa
3.
J Forensic Nurs ; 17(1): 61-64, 2021.
Article in English | MEDLINE | ID: covidwho-1722672

ABSTRACT

ABSTRACT: Standard operating procedures drive everyday practice within any organization, including those within a forensic setting. In the event of unusual circumstances, organizations must respond rapidly to address the impact on operations while ensuring that the quality and safety outcomes of routine services are not affected. This case study illustrates how standard operating procedures can be newly developed or modified, and rapidly deployed and quickly revised, to address unusual circumstances. The response to the COVID-19 pandemic is used as an example in this case report.


Subject(s)
Forensic Sciences/organization & administration , Organizational Case Studies , Organizational Policy , Quality Control , COVID-19/epidemiology , Humans , Texas/epidemiology
4.
Front Immunol ; 12: 681636, 2021.
Article in English | MEDLINE | ID: covidwho-1714997

ABSTRACT

The emergence of COVID-19 has emphasised that biological assay data must be analysed quickly to develop safe, effective and timely vaccines/therapeutics. For viruses such as SARS-CoV-2, the primary way of measuring immune correlates of protection is through assays such as the pseudotype microneutralisation (pMN) assay, thanks to its safety and versatility. However, despite the presence of existing tools for data analysis such as PRISM and R the analysis of these assays remains cumbersome and time-consuming. We introduce an open-source R Shiny web application and R library (AutoPlate) to accelerate data analysis of dose-response curve immunoassays. Using example data from influenza studies, we show that AutoPlate improves on available analysis software in terms of ease of use, flexibility and speed. AutoPlate (https://philpalmer.shinyapps.io/AutoPlate/) is a tool for the use of laboratories and wider scientific community to accelerate the analysis of biological assays in the development of viral vaccines and therapeutics.


Subject(s)
COVID-19/diagnosis , Immunoassay/statistics & numerical data , Influenza A virus/physiology , Influenza, Human/diagnosis , SARS-CoV-2/physiology , Antibodies, Neutralizing/metabolism , Antibodies, Viral/metabolism , Data Interpretation, Statistical , Dose-Response Relationship, Drug , Humans , Immunoassay/standards , Quality Control , Software
6.
PLoS One ; 17(2): e0263736, 2022.
Article in English | MEDLINE | ID: covidwho-1674020

ABSTRACT

Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.


Subject(s)
COVID-19 Testing/standards , COVID-19/diagnosis , Clinical Laboratory Techniques/standards , Laboratories/standards , Mass Screening/standards , Quality Assurance, Health Care/standards , Reverse Transcriptase Polymerase Chain Reaction/standards , COVID-19/epidemiology , COVID-19/genetics , COVID-19/virology , Humans , India/epidemiology , Quality Control , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Specimen Handling/methods
7.
Medicine (Baltimore) ; 100(47): e27950, 2021 Nov 24.
Article in English | MEDLINE | ID: covidwho-1604259

ABSTRACT

ABSTRACT: During the coronavirus disease 2019 (COVID-19) pandemic, convenient accessibility and rapid publication of studies related to the ongoing pandemic prompted shorter preparation time for studies. Whether the methodological quality and reporting characteristics of published systematic reviews (SRs)/meta-analyses are affected during the specific pandemic condition is yet to be clarified. This study aimed to evaluate the epidemiology, methodological quality, and reporting characteristics of published SRs/meta-analyses related to COVID-19.The Ovid Medline, Ovid Embase, Cochrane Library, and Web of Science electronic databases were searched to identify published SRs/meta-analyses related to the COVID-19 pandemic. Study screening, data extraction, and methodology quality assessment were performed independently by 2 authors. The methodology quality of included SRs/meta-analyses was evaluated using revised version of a measurement tool to assess SRs, and the reporting characteristics were assessed based on the preferred reporting items for SRs and meta-analyses guidelines.A total of 47 SRs/meta-analyses were included with a low to critically low methodological quality. The median number of days from the date of literature retrieval to the date that the study was first available online was 21 days; due to the limited time, only 7 studies had study protocols, and the studies focused on a wide range of COVID-19 topics. The rate of compliance to the preferred reporting items for SRs and meta-analyses checklists of reporting characteristics ranged from 14.9% to 100%. The rate of compliance to the items of protocol and registration, detailed search strategy, and assessment of publication bias was less than 50%.SRs/meta-analyses on COVID-19 were poorly conducted and reported, and thus, need to be substantially improved.


Subject(s)
COVID-19 , Meta-Analysis as Topic , Periodicals as Topic/standards , Publishing/standards , Systematic Reviews as Topic , Cross-Sectional Studies , Humans , Pandemics , Quality Control , SARS-CoV-2
8.
Sci Rep ; 11(1): 24490, 2021 12 29.
Article in English | MEDLINE | ID: covidwho-1594104

ABSTRACT

During the first wave of Covid-19 infections in Germany in April 2020, clinics reported a shortage of filtering face masks with aerosol retention> 94% (FFP2 & 3, KN95, N95). Companies all over the world increased their production capacities, but quality control of once-certified materials and masks came up short. To help identify falsely labeled masks and ensure safe protection equipment, we tested 101 different batches of masks in 993 measurements with a self-made setup based on DIN standards. An aerosol generator provided a NaCl test aerosol which was applied to the mask. A laser aerosol spectrometer measured the aerosol concentration in a range from 90 to 500 nm to quantify the masks' retention. Of 101 tested mask batches, only 31 batches kept what their label promised. Especially in the initial phase of the pandemic in Germany, we observed fluctuating mask qualities. Many batches show very high variability in aerosol retention. In addition, by measuring with a laser aerosol spectrometer, we were able to show that not all masks filter small and large particles equally well. In this study we demonstrate how important internal and independent quality controls are, especially in times of need and shortage of personal protection equipment.


Subject(s)
COVID-19/prevention & control , COVID-19/transmission , Masks/statistics & numerical data , Aerosols , Filtration/instrumentation , Germany , Humans , Masks/standards , Masks/trends , N95 Respirators/standards , N95 Respirators/statistics & numerical data , Occupational Exposure/prevention & control , Pandemics/prevention & control , Personal Protective Equipment/standards , Quality Control , Respiratory Protective Devices/standards , SARS-CoV-2/pathogenicity
9.
J Clin Lab Anal ; 36(2): e24211, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1589067

ABSTRACT

BACKGROUND: Presently, the global spread of COVID-19 is still going on, with more than 0.6 million new cases confirmed per day (as of November 20, 2021). However, since China entered a post-epidemic phase in mid-March 2020, the daily number of new domestic infections in the Chinese mainland has been maintained at almost zero or single digits, which was attributed to a series of effective measures for COVID-19 prevention and control adopted by the Chinese government. Among these measures, SARS-CoV-2 nucleic acid testing holds key role for the timely confirmation and isolation of the infections to prevent further transmission. METHODS: Referring to the national policy requirements, since April 30, 2020, The Affiliated Hospital of Qingdao University has conducted SARS-CoV-2 nucleic acid testing in its PCR laboratory for patients and social workers, as well as for environmental monitoring and employee screening. As of mid-November 2020, the daily amount of single-tube samples for nucleic acid testing rose above 4,000. RESULTS: In this article, a rapid and highly effective approach for SARS-CoV-2 nucleic acid daily testing is presented, allowing five technicians to complete nucleic acid testing in 6,500 single-tube samples in one day with a high level of quality. Using this approach, since the samples entered the PCR laboratory, all testing results were reported in 2.5-3 h with satisfactory quality control and precise reporting criterion as prerequisites. CONCLUSION: This testing approach provides a referable workflow for other testing institutions and is expected to play an important role in COVID-19 prevention and control.


Subject(s)
COVID-19 , Nucleic Acid Amplification Techniques , SARS-CoV-2 , COVID-19/diagnosis , COVID-19/prevention & control , China , High-Throughput Nucleotide Sequencing , Humans , Nucleic Acid Amplification Techniques/methods , Nucleic Acid Amplification Techniques/standards , Nucleic Acid Amplification Techniques/statistics & numerical data , Quality Control , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Time Factors
10.
Nat Microbiol ; 7(1): 108-119, 2022 01.
Article in English | MEDLINE | ID: covidwho-1574813

ABSTRACT

The global spread and continued evolution of SARS-CoV-2 has driven an unprecedented surge in viral genomic surveillance. Amplicon-based sequencing methods provide a sensitive, low-cost and rapid approach but suffer a high potential for contamination, which can undermine laboratory processes and results. This challenge will increase with the expanding global production of sequences across a variety of laboratories for epidemiological and clinical interpretation, as well as for genomic surveillance of emerging diseases in future outbreaks. We present SDSI + AmpSeq, an approach that uses 96 synthetic DNA spike-ins (SDSIs) to track samples and detect inter-sample contamination throughout the sequencing workflow. We apply SDSIs to the ARTIC Consortium's amplicon design, demonstrate their utility and efficiency in a real-time investigation of a suspected hospital cluster of SARS-CoV-2 cases and validate them across 6,676 diagnostic samples at multiple laboratories. We establish that SDSI + AmpSeq provides increased confidence in genomic data by detecting and correcting for relatively common, yet previously unobserved modes of error, including spillover and sample swaps, without impacting genome recovery.


Subject(s)
DNA Primers/standards , SARS-CoV-2/genetics , Sequence Analysis/standards , COVID-19/diagnosis , DNA Primers/chemical synthesis , Genome, Viral/genetics , Humans , Quality Control , RNA, Viral/genetics , Reproducibility of Results , Sequence Analysis/methods , Whole Genome Sequencing , Workflow
12.
Am J Emerg Med ; 51: 22-25, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1561095

ABSTRACT

BACKGROUND: The use of personal protective equipment for respiratory infection control during cardiopulmonary resuscitation (CPR) is a physical burden to healthcare providers. The duration for which CPR quality according to recommended guidelines can be maintained under these circumstances is important. We investigated whether a 2-min shift was appropriate for chest compression and determined the duration for which chest compression was maintained in accordance with the recommended guidelines while wearing personal protective equipment. METHODS: This prospective crossover simulation study was performed at a single center from September 2020 to October 2020. Five indicators of CPR quality were measured during the first and second sessions of the study period. All participants wore a Level D powered air-purifying respirator (PAPR), and the experiment was conducted using a Resusci Anne manikin, which can measure the quality of chest compressions. Each participant conducted two sessions. In Session 1, the sequence of 2 min of chest compressions, followed by a 2-min rest, was repeated twice; in Session 2, the sequence of 1-min chest compressions followed by a 1-min rest was repeated four times. RESULTS: All 34 participants completed the study. The sufficiently deep compression rate was 65.9 ± 31.1% in the 1-min shift group and 61.5 ± 30.5% in the 2-min shift group. The mean compression depth was 52.8 ± 4.3 mm in the 1-min shift group and 51.0 ± 6.1 mm in the 2-min shift group. These two parameters were significantly different between the two groups. There was no significant difference in the other values related to CPR quality. CONCLUSIONS: Our findings indicated that 1 min of chest compressions with a 1-min rest maintained a better quality of CPR while wearing a PAPR.


Subject(s)
Cardiopulmonary Resuscitation/education , Health Personnel/education , Heart Massage/methods , Respiratory Protective Devices , Adult , Clinical Competence , Cross-Over Studies , Female , Humans , Infection Control , Male , Manikins , Prospective Studies , Quality Control , Republic of Korea , Rest
13.
J Sep Sci ; 44(22): 4064-4081, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1525471

ABSTRACT

Coronil is a tri-herbal medicine consisting of immunomodulatory herbs, Withania somnifera, Tinospora cordifolia, and Ocimum sanctum. The formulation has been developed specifically as the supporting measure for COVID-19. Current investigation is aimed to identify the phytoconstituents in Coronil utilizing ultra-performance liquid chromatography-mass spectrometry coupled with quadrapole time of flight and to establish its quality standardization using high-performance liquid chromatography and high performance thin layer chromatography. Out of 52 identified compounds, cordifolioside A, magnoflorine, rosmarinic acid, palmatine, withanoside IV, withanoside V, withanone, betulinic acid, and ursolic acid were quantified in 15 different batches of Coronil on validated high-performance liquid chromatography method. Similarly, withanoside IV, withaferin A, magnoflorine, palmatine, rosmarinic acid, and ursolic acid were analyzed on high performance thin layer chromatography. Methods were validated as per the International Council for Harmonization guidelines. These methods were specific, reproducible, accurate, precise, linear (r2 > 0.99), and percent recoveries were within the prescribed limits. The content uniformity of Coronil was ascertained using Fourier transform infrared spectroscopy. Results indicated that, validated methods were fit for their intended use and the analytical quality of Coronil was consistent across the batches. Taken together, these developed methods could drive the analytical quality control of herbal medicines such as Coronil, and other formulations containing similar chemical profiles.


Subject(s)
COVID-19/drug therapy , Chromatography, High Pressure Liquid/methods , Herbal Medicine , Mass Spectrometry/methods , Phytochemicals/analysis , COVID-19/virology , Chromatography, Thin Layer/methods , Humans , Quality Control , SARS-CoV-2/isolation & purification , Spectroscopy, Fourier Transform Infrared/methods
14.
J Clin Lab Anal ; 35(11): e23998, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1525445

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the coronavirus disease 2019 (COVID-19), is detected using real-time RT-PCR. However, there are limitations pertaining to quality control, particularly with respect to establishing quality control measures for extraction of viral nucleic acids. Here, we investigated the quality control measures for the various processes using an extrinsic quality control substance and quality control charts. METHODS: An extrinsic quality control substance was added to the sample, and then, real-time RT-PCR was performed. Samples with negative test results and the corresponding data were analyzed; a quality control chart was created and examined. RESULTS: Data analysis and the quality control charts indicated that SARS-CoV-2 could be reliably detected using real-time RT-PCR, even when different nucleic acid extraction methods were used or when different technicians were employed. CONCLUSION: With the use of quality control substances, it is possible to achieve quality control throughout the process-from nucleic acid extraction to nucleic acid detection-even upon using varying extraction methods. Further, generating quality control charts would guarantee the stable detection of SARS-CoV-2.


Subject(s)
COVID-19 Nucleic Acid Testing/standards , COVID-19/diagnosis , Nucleic Acids/isolation & purification , Quality Control , SARS-CoV-2/genetics , Humans , Retrospective Studies , SARS-CoV-2/isolation & purification
15.
J Ethnopharmacol ; 284: 114760, 2022 Feb 10.
Article in English | MEDLINE | ID: covidwho-1525847

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese medicines (TCMs) have made great contributions to the prevention and treatment of human diseases in China, and especially in cases of COVID-19. However, due to quality problems, the lack of standards, and the diversity of dosage forms, adverse reactions to TCMs often occur. Moreover, the composition of TCMs makes them extremely challenging to extract and isolate, complicating studies of toxicity mechanisms. AIM OF THE REVIEW: The aim of this paper is therefore to summarize the advanced applications of mass spectrometry imaging (MSI) technology in the quality control, safety evaluations, and determination of toxicity mechanisms of TCMs. MATERIALS AND METHODS: Relevant studies from the literature have been collected from scientific databases, such as "PubMed", "Scifinder", "Elsevier", "Google Scholar" using the keywords "MSI", "traditional Chinese medicines", "quality control", "metabolomics", and "mechanism". RESULTS: MSI is a new analytical imaging technology that can detect and image the metabolic changes of multiple components of TCMs in plants and animals in a high throughput manner. Compared to other chemical analysis methods, such as liquid chromatography-mass spectrometry (LC-MS), this method does not require the complex extraction and separation of TCMs, and is fast, has high sensitivity, is label-free, and can be performed in high-throughput. Combined with chemometrics methods, MSI can be quickly and easily used for quality screening of TCMs. In addition, this technology can be used to further focus on potential biomarkers and explore the therapeutic/toxic mechanisms of TCMs. CONCLUSIONS: As a new type of analysis method, MSI has unique advantages to metabolic analysis, quality control, and mechanisms of action explorations of TCMs, and contributes to the establishment of quality standards to explore the safety and toxicology of TCMs.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/chemistry , Mass Spectrometry/methods , Medicine, Chinese Traditional/standards , SARS-CoV-2 , Biomarkers, Pharmacological , Drugs, Chinese Herbal/adverse effects , Drugs, Chinese Herbal/standards , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional/instrumentation , Quality Control
17.
J Med Syst ; 45(12): 105, 2021 Nov 02.
Article in English | MEDLINE | ID: covidwho-1491288

ABSTRACT

Developers proposing new machine learning for health (ML4H) tools often pledge to match or even surpass the performance of existing tools, yet the reality is usually more complicated. Reliable deployment of ML4H to the real world is challenging as examples from diabetic retinopathy or Covid-19 screening show. We envision an integrated framework of algorithm auditing and quality control that provides a path towards the effective and reliable application of ML systems in healthcare. In this editorial, we give a summary of ongoing work towards that vision and announce a call for participation to the special issue  Machine Learning for Health: Algorithm Auditing & Quality Control in this journal to advance the practice of ML4H auditing.


Subject(s)
Algorithms , Machine Learning , Quality Control , Humans
20.
AAPS J ; 23(6): 112, 2021 10 15.
Article in English | MEDLINE | ID: covidwho-1470633

ABSTRACT

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.


Subject(s)
COVID-19/epidemiology , Drug Industry/standards , Pharmaceutical Preparations/supply & distribution , Pharmaceutical Preparations/standards , Pharmacopoeias as Topic/standards , Quality Control , COVID-19/prevention & control , Drug Industry/methods , Humans , Technology, Pharmaceutical/methods , Technology, Pharmaceutical/standards , United States/epidemiology
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