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1.
Sci Rep ; 12(1): 20282, 2022 Nov 24.
Article in English | MEDLINE | ID: covidwho-2133623

ABSTRACT

Since Coronavirus Disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Tests (NAAT) have been developed all over the world, and it has been the standard method. Even though several assays were rapidly developed and applied to laboratory diagnostic testing, the performance of these assays was not evaluated in different contexts. Thus, this study aimed to assess the performance of Abbott SARS-CoV-2, Daan Gene, BGI and Sansure Biotech assays by using Composite Reference Standard (CRS). The study was conducted at the Ethiopian Public Health Institute (EPHI) from December 1 to 30/2020. Of the 164 nasopharyngeal samples were extracted by using a QIAamp RNA mini kit and Abbott DNA sample preparation system. Out of 164 samples, 59.1% were positive and 40.9% were negative by CRS. Sansure Biotech positivity was significantly low compared to CRS (p < 0.05). The overall agreement of the four assays compared to CRS was 96.3-100%. The performance of the four assays had almost comparable diagnostic performance, except for a low positive rate of Sansure Biotech assay. Hence, Sansure Biotech assay [Research Use Only (RUO)] needs further verification on its use in Ethiopia. Finally an additional study should be considered for evaluating assays with respective manufacturer claims.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , SARS-CoV-2/genetics , Ethiopia/epidemiology , COVID-19/diagnosis , COVID-19/epidemiology , Nucleic Acid Amplification Techniques , Reference Standards
2.
Am J Health Syst Pharm ; 79(21): 1885-1886, 2022 10 21.
Article in English | MEDLINE | ID: covidwho-2097307
3.
Diabetes Technol Ther ; 24(11): 789-796, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2097242

ABSTRACT

Background: The COVID-19 pandemic and the rapid expansion of telemedicine have increased the need for accurate and reliable capillary hemoglobin A1c (HbA1c) testing. Nevertheless, validation studies of commercially available products suitable for home use have been in short supply. Methods: Three commercial home-use capillary blood sample HbA1c tests (Home Access, CoreMedica, and A1cNow+) were evaluated in 219 participants with type 1 or type 2 diabetes (4-80 years years of age, HbA1c 5.1%-13.4% [32-123 mmol/mol]) at four clinical sites. Comparisons were made between HbA1c measurements from the commercial tests and paired venous samples for which HbA1c was measured at two central reference laboratories. The primary outcome was percentage of commercial HbA1c values within 5% of the corresponding reference values. Results: HbA1c values were within 5% (relative difference) of paired reference values for 82% of Home Access samples, 29% of CoreMedica samples, and 46% of A1cNow+ samples. Absolute differences were within 0.3% of the reference value for 75% of Home Access samples, 28% of CoreMedica samples, and 44% of A1cNow+ samples and exceeded 0.5% for 8%, 55%, and 37%, respectively. Conclusions: None of the commercial home-use HbA1c tests produced the National Glycohemoglobin Standardization Program goal of ≥90% measurements within 5% of a DCCT venous reference. However, the Home Access product performed substantially better than the CoreMedica or A1cNow+ products. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home-based HbA1c assessment represents an urgent need for the diabetes community.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , Humans , Glycated Hemoglobin A/analysis , Pandemics , Reference Standards
5.
Infection ; 50(4): 959-963, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1971878

ABSTRACT

PURPOSE: Since 2020, a SARS-COV2 epidemic has been raging worldwide. The cycle of the PCR test in which the virus is detected is called cycle threshold (CT). The method of obtaining the sample is not detailed in any published study and is based on general guidelines of the CDC. Our contention is that the manner in which the sample is obtained has a dramatic effect on CT values. METHODS: For each person suspected of having Covid-19 who arrives at the emergency room, two swabs are taken in succession, one according to CDC guidelines and the other according to "Ziv" guidelines. The Ziv method sample collection guidelines determine the depth of penetration, the number of rotations of the swab, and their direction. Each double sample was sent for analysis. RESULTS: Analysis of the CT results of the sample to results methods and of the Seegene platform clearly found (p = 0.003 and p = 0.001, respectively) that more rigorous sample collection yielded lower CT values. CONCLUSION: The method of obtaining the samples had a dramatic effect on CT results. Any publication that includes CT results, and certainly studies that discuss CT kinetics, must describe in detail the method by which the samples were obtained. In places where it is also important to detect the onset of illness (airports, hospitals, schools, etc.), it is important to use the Ziv method to reduce the risk of false negatives.


Subject(s)
COVID-19 , COVID-19/diagnosis , COVID-19 Testing , Humans , Polymerase Chain Reaction , RNA, Viral , Reference Standards , SARS-CoV-2/genetics
6.
Respiration ; 100(12): 1208-1217, 2021.
Article in English | MEDLINE | ID: covidwho-1956956

ABSTRACT

Bronchoscopy is a commonly performed procedure within thoracic and critical care medicine. Modern bronchoscopes are technologically advanced tools made of fragile electronic components. Their design is catered to allow maximum maneuverability within the semi-rigid tracheobronchial tree. Effective cleaning and reprocessing of these tools can be a challenge. Although highly functional, the design poses several challenges when it comes to reprocessing. It is a very important step, and lapses in the procedure have been tied to nosocomial infections. The process lacks universal standardization; several organizations have developed their own recommendations. Data have shown that key stakeholders are not fully versed in the essentials of endoscope reprocessing. A significant knowledge gap exists between those performing bronchoscopy and those who are stewards of effective endoscope reprocessing. To service as a resource for bronchoscopists, this study summarizes the steps of effective reprocessing, details the important elements within a health-care facility that houses this process, and reviews some of the current data regarding the use of disposable endoscopes.


Subject(s)
Disinfection , Equipment Contamination , Bronchoscopes , Disinfection/methods , Endoscopes , Equipment Contamination/prevention & control , Humans , Reference Standards
7.
Int J Tuberc Lung Dis ; 26(6): 481-482, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1957554
8.
Aging Clin Exp Res ; 34(7): 1635-1644, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1920347

ABSTRACT

BACKGROUND: Despite the relevance of telephone-based cognitive screening tests in clinical practice and research, no specific test assessing executive functioning is available. The present study aimed at standardizing and providing evidence of clinical usability for the Italian telephone-based Frontal Assessment Battery (t-FAB). METHODS: The t-FAB (ranging 0-12), comprising two subtests, has two versions: one requiring motor responses (t-FAB-M) and the other verbal responses (t-FAB-V). Three hundred and forty-six Italian healthy adults (HPs; 143 males; age range = 18-96 years; education range = 4-23 years) and 40 participants with neurological diseases were recruited. To HPs, the t-FAB was administered along with a set of telephone-based tests: MMSE, verbal fluency (VF), backward digit span (BDS). The in-person version of the FAB was administered to both HPs and clinical groups. Factorial structure, construct validity, inter-rater and test-retest reliability, t-FAB-M vs. t-FAB-V equivalence and diagnostic accuracy were assessed. Norms were derived via Equivalent Scores. RESULTS: In HPs, t-FAB measures yielded high inter-rater/test-retest reliability (ICC = .78-.94), were internally related (p ≤ .005) and underpinned by a single component, converging with the telephone-based MMSE, VF, BDS (p ≤ .0013). The two t-FAB versions were statistically equivalent in clinical groups (ps of both equivalence bounds < .001). Education predicted all t-FAB scores (p < .001), whereas age only the t-FAB-M score (p ≤ .004). t-FAB scores converge with the in-person FAB in HPs and clinical groups (rs = .43-.78). Both t-FAB versions were accurate in discriminating HPs from the clinical cohort (AUC = .73-.76). DISCUSSION: The t-FAB is a normed, valid, reliable and clinically usable telephone-based cognitive screening test to adopt in both clinical and research practice.


Subject(s)
Executive Function , Nervous System Diseases , Aged , Aged, 80 and over , Humans , Male , Nervous System Diseases/diagnosis , Neuropsychological Tests , Reference Standards , Reproducibility of Results , Telephone
9.
BMC Med Educ ; 22(1): 512, 2022 Jun 30.
Article in English | MEDLINE | ID: covidwho-1910311

ABSTRACT

OBJECTIVE: To study the effect of the problem-based learning (PBL) method in ultrasonography (US) resident standardization training during the COVID-19 pandemic. METHODS: Fifty residents were divided into two groups to participate in a 30-day US training program. The residents in the observation group underwent PBL combined with the lecture-based learning (LBL) method, while the residents in the control group experienced the LBL method alone, with 25 residents in each group. A basic theoretical test, practical examination, and questionnaire were used to evaluate the teaching effect of the PBL + LBL method and the LBL method alone. RESULTS: The basic theoretical pretest score of the observation group was not significantly different from that of the control group. However, the posttest theoretical score and practical score were significantly higher in the observation group than in the control group (P < 0.01). The results of the questionnaire showed that the resident satisfaction level in the observation group with PBL combined with the LBL method was 96%, which was significantly higher than that of the control group with the LBL method alone (80%) (P < 0.05). CONCLUSION: The combination of PBL with the LBL method has obvious advantages over the LBL method alone in regard to the training of US residents during the COVID-19 pandemic.


Subject(s)
COVID-19 , Problem-Based Learning , Humans , Pandemics , Problem-Based Learning/methods , Reference Standards , Teaching , Ultrasonography
10.
Am J Health Syst Pharm ; 79(Supplement_4): S115-S122, 2022 Nov 22.
Article in English | MEDLINE | ID: covidwho-1890864

ABSTRACT

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic provided an opportunity to change how health-system specialty pharmacy (HSSP) call center operations are organized. This article describes the steps taken to virtualize the current operations of a specialty pharmacy services call center and evaluate the impact. SUMMARY: The onset of the COVID-19 pandemic and its impact on the normal provision of healthcare necessitated that HSSPs drastically modify existing procedures to both accommodate the expectations of staff and overcome the many barriers to care being experienced by patients. To fully understand and improve upon the workflow processes of an HSSP call center, a combination of qualitative feedback from patients, quantitative claims data, and quality metrics was evaluated. This project was divided into 3 phases: phase 1 (baseline) from July 2020 through August 2020, phase 2 (implementation) from September 2020 through December 2020, and phase 3 (analysis) from January 2021 through March 2021. Phase 1 included baseline review of workflow. Phase 2 encompassed development of new standard operating procedures (SOPs), making critical decisions to promote virtual capabilities of staff, and collaboration with team members to increase efficiency of current workflow. During phase 3, an evaluation of operational and service-related metrics was conducted to determine the impact of phase 2 workflow changes. Optimization of the specialty pharmacy call center allowed for staff members to transition to remote work to minimize exposure risk and prioritize the safety of patients and team members. CONCLUSION: The call center team was able to transition to fully remote operations, implement new SOPs, and undergo significant workflow changes to optimize performance while still maintaining all call center metric goals and without increased complaints from patients or errors. This approach allowed for added staff value and safety and improved organization during the COVID-19 pandemic.


Subject(s)
COVID-19 , Call Centers , Pharmaceutical Services , Pharmacy , Humans , Pandemics , COVID-19/epidemiology , Reference Standards
11.
Clin Chem Lab Med ; 60(7): 959-960, 2022 May 03.
Article in English | MEDLINE | ID: covidwho-1875156
13.
Yonsei Med J ; 63(5): 480-489, 2022 May.
Article in English | MEDLINE | ID: covidwho-1834349

ABSTRACT

PURPOSE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen of coronavirus disease 2019. Diagnostic methods based on the clustered regularly interspaced short palindromic repeats (CRISPR) have been developed to detect SARS-CoV-2 rapidly. Therefore, a systematic review and meta-analysis were performed to assess the diagnostic accuracy of CRISPR for detecting SARS-CoV-2 infection. MATERIALS AND METHODS: Studies published before August 2021 were retrieved from four databases, using the keywords "SARS-CoV-2" and "CRISPR." Data were collected from these publications, and the sensitivity, specificity, negative likelihood ratio (NLR), positive likelihood ratio (PLR), and diagnostic odds ratio (DOR) were calculated. The summary receiver operating characteristic curve was plotted for analysis with MetaDiSc 1.4. The Stata 15.0 software was used to draw Deeks' funnel plots to evaluate publication bias. RESULTS: We performed a pooled analysis of 38 independent studies shown in 30 publications. The reference standard was reverse transcription-quantitative PCR. The results indicated that the sensitivity of CRISPR-based methods for diagnosis was 0.94 (95% CI 0.93-0.95), the specificity was 0.98 (95% CI 0.97-0.99), the PLR was 34.03 (95% CI 20.81-55.66), the NLR was 0.08 (95% CI 0.06-0.10), and the DOR was 575.74 (95% CI 382.36-866.95). The area under the curve was 0.9894. CONCLUSION: Studies indicate that a diagnostic method based on CRISPR has high sensitivity and specificity. Therefore, this would be a potential diagnostic tool to improve the accuracy of SARS-CoV-2 detection.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , Humans , ROC Curve , Reference Standards , SARS-CoV-2/genetics , Sensitivity and Specificity
14.
J Med Primatol ; 51(4): 234-245, 2022 08.
Article in English | MEDLINE | ID: covidwho-1794630

ABSTRACT

In efforts to increase rigor and reproducibility, the USA National Primate Research Centers (NPRCs) have focused on qualification of reagents, cross-laboratory validations, and proficiency testing for methods to detect infectious agents and accompanying immune responses in nonhuman primates. The pathogen detection working group, comprised of laboratory scientists, colony managers, and leaders from the NPRCs, has championed the effort to produce testing that is reliable and consistent across laboratories. Through multi-year efforts with shared proficiency samples, testing percent agreement has increased from as low as 67.1% for SRV testing in 2010 to 92.1% in 2019. The 2019 average agreement for the four basic SPF agents improved to >96% (86.5% BV, 98.9 SIV, 92.1 SRV, and 97.0 STLV). As new pathogens such as SARS coronavirus type 2 emerge, these steps can now be quickly replicated to develop and implement new assays that ensure rigor, reproducibly, and quality for NHP pathogen detection.


Subject(s)
Simian T-lymphotropic virus 1 , Animals , Primates , Reference Standards , Reproducibility of Results , Specific Pathogen-Free Organisms
15.
Hum Vaccin Immunother ; 18(5): 2059307, 2022 11 30.
Article in English | MEDLINE | ID: covidwho-1795427

ABSTRACT

Given the ongoing COVID-19 vaccination drive across the globe, a significant amount of confusion, mistrust, misunderstanding, and hesitancy had surfaced regarding the vaccine. A standardized tool to understand the possible reasons of COVID-19 vaccination anxiety and hesitancy would be valuable in this context. The current study aimed at developing a standardized tool to measure COVID-19 Vaccination Anxiety among Urban Indian adults. A 19-item scale was administered to an Urban adult Indian population (N = 760) between the period of February 2021- May 2021 to obtain factors associated with COVID-19 Vaccination Anxiety and establish reliability estimates of the scale. Infection-related anxiety, information-related anxiety and vaccine side-effect-related anxiety were the three factors determined through Factor Analysis. The scale was validated with Convergent and Discriminant Validity by finding correlation between the three factors of the scale and five factors of the Brief version of the Big-Five personality Inventory (extraversion, agreeableness, openness to experience, conscientiousness, and neuroticism). It is expected that a tool such as CVAS-A would help in understanding and managing COVID-19-related vaccination hesitancy.


Subject(s)
COVID-19 , Vaccines , Adult , Anxiety , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Personality Inventory , Reference Standards , Reproducibility of Results , Vaccination
17.
BMJ ; 377: o954, 2022 04 14.
Article in English | MEDLINE | ID: covidwho-1788941
18.
Vaccine ; 40(14): 2233-2239, 2022 03 25.
Article in English | MEDLINE | ID: covidwho-1757910

ABSTRACT

A reference standard is needed for quality control of protein subunit SARS-CoV-2 vaccines to meet urgent domestic needs. The Chinese National Institutes for Food and Drug Control (NIFDC) launched a project to establish the first reference material for the protein subunit SARS-CoV-2 vaccine to be used for calibration of antigen testing. The potency and stability of the national candidate standard (CS) were determined by collaborative calibration, and accelerated and freeze-thaw degradation studies. Moreover, a suitability study of the CS was performed. Eight laboratories in mainland China were asked to detect antigen content of CS using a common validated enzyme-linked immunosorbent assay (ELISA) kit established by NIFDC and in-house kits in the collaborative study. Six laboratories returned valid results, which established that the antigen content of the CS was 876,938 YU/mL, with good agreement across laboratories. In the suitability study, the CS exhibited excellent parallelism and a linear relationship with four samples produced by different expression systems and target proteins. In addition, good stability in the accelerated and freeze-thaw degradation study was observed. In conclusion, the CS was approved by the Biological Product Reference Standards Sub-Committee of the National Drug Reference Standards Committee as the first Chinese national standard for determining antigen content of protein subunit SARS-CoV-2 vaccines, with an assigned antigen content of 877,000 U/mL (Lot. 300050-202101). This standard will contribute to a standardized assessment of protein subunit SARS-CoV-2 vaccine in China and may provide experience for developing reference materials for antigen content detection of SARS-CoV-2 vaccine in other countries.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/prevention & control , Humans , Protein Subunits , Reference Standards , SARS-CoV-2
19.
Health Aff (Millwood) ; 41(3): 322-323, 2022 03.
Article in English | MEDLINE | ID: covidwho-1742027

ABSTRACT

Marketplace enrollment rose significantly, and the Biden administration proposed sweeping new standards for 2023.


Subject(s)
Insurance Coverage , Patient Protection and Affordable Care Act , Humans , Reference Standards , United States
20.
Anal Bioanal Chem ; 414(12): 3561-3569, 2022 May.
Article in English | MEDLINE | ID: covidwho-1733964

ABSTRACT

Development of diagnostic testing capability has advanced with unprecedented pace in response to the COVID-19 pandemic. An undesirable effect of such speed is a lack of standardization, often leading to unreliable test results. To assist the research community surmount this challenge, the National Research Council Canada has prepared a SARS-CoV-2 spike protein reference material, SMT1-1, as a buffered solution. Value assignment was achieved by amino acid analysis (AAA) by double isotope dilution liquid chromatography-tandem mass spectrometry (LC-ID-MS/MS) following acid hydrolysis of the protein, in combination with ultraviolet-visible spectrophotometry (UV-Vis) based on tryptophan and tyrosine absorbance at 280 nm. Homogeneity of the material was established through spectrophotometric absorbance readings at 280 nm. Transportation and long-term storage stabilities were assessed by monitoring relative changes in oligomeric state by size-exclusion liquid chromatography (LC-SEC) with UV detection. The molar concentration of the spike protein in SMT1-1 was 5.68 ± 0.22 µmol L-1 (k = 2, 95% CI), with the native trimeric form accounting for ~ 94% of the relative abundance. Reference mass concentration and mass fraction values were calculated using the protein molecular weight and density of the SMT1-1 solution. The spike protein is highly glycosylated which leads to analyte ambiguity when reporting the more commonly used mass concentration. After glycoprotein molar mass determination by LC-SEC with multi-angle light scattering detection, we thus reported mass concentration values for both the protein-only portion and intact glycoprotein as 0.813 ± 0.030 and 1.050 ± 0.068 mg mL-1 (k = 2), respectively.


Subject(s)
COVID-19 , Spike Glycoprotein, Coronavirus , Glycoproteins , Humans , Pandemics , Reference Standards , SARS-CoV-2 , Tandem Mass Spectrometry/methods
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