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COVID-19 laboratory diagnosis primarily relies on molecular tests, highly sensitive during early infection stages with high viral loads. As the disease progresses, sensitivity decreases, requiring antibody detection. Since the beginning of the pandemic, serological tests have been developed and made available in Brazil, but their diagnostic performance varies. This study evaluated the IBMP ELISA IgA/IgM/IgG COVID-19 kit performance in detecting SARS-CoV-2 antibodies. A total of 90 samples, including 64 from COVID-19 patients and 26 pre-pandemic donors, were assessed based on time post symptom onset (0-7, 8-14, and 15-21 days). The kit showed 61% sensitivity, 100% specificity, and 72% accuracy overall. Sensitivity varied with time, being 25%, 57%, and 96% for 0-7, 8-14, and 15-21 days, respectively. Similar variations were noted in other commercial tests. The Gold ELISA COVID-19 (IgG/IgM) had sensitivities of 31%, 71%, and 100%, while the Anti-SARS-CoV-2 NCP ELISA (IgG) and Anti-SARS-CoV-2 NCP ELISA (IgM) showed varying sensitivities. The IBMP ELISA kit displayed high diagnostic capability, especially as the disease progressed, complementing COVID-19 diagnosis. Reproducibility assessment revealed minimal systematic and analytical errors. In conclusion, the IBMP ELISA IgA/IgM/IgG COVID-19 kit is a robust tool for detecting anti-SARS-CoV-2 antibodies, increasing in efficacy over the disease course, and minimizing false negatives in RT-PCR COVID-19 diagnosis.

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INTRODUCTION: Research quality within the neurosurgical field remains suboptimal. Therefore, many studies published in the neurosurgical literature lack enough statistical power to establish the presence or absence of clinically important differences between treatment arms. The field of neurotrauma deals with additional challenges, with fewer financial incentives and restricted resources in low-income and middle-income countries with the highest burden of neurotrauma diseases. In this systematic review, we aim to estimate the prevalence of false claims of equivalence in the neurosurgical trauma literature and identify its predictive factors. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Review and Meta-Analyses recommendations were followed. Randomised clinical trials that enrolled only traumatic brain injury patients and investigated any type of intervention (surgical or non-surgical) will be eligible for inclusion. The MEDLINE/PubMed database will be searched for articles in English published from January 1960 to July 2020 in 15 top-ranked journals. A false claim of equivalence will be identified by insufficient power to detect a clinically meaningful effect: for categorical outcomes, a difference of at least 25% and 50%, and for continuous outcomes, a Cohen's d of at least 0.5 and 0.8. Using the number of patients in each treatment arm and the minimum effect sizes to be detected, the power of each study will be calculated with the assumption of a two-tailed alpha that equals 0.05. Standardised differences between the groups with and without a false claim of equivalence will be calculated, and the variables with a standardised difference equal or above 0.2 and 0.5 will be considered weakly and strongly associated with false claims of equivalence, respectively. The data analysis will be blinded to the authors and institutions of the studies. ETHICS AND DISSEMINATION: This study will not involve primary data collection. Therefore, formal ethical approval will not be required. The final systematic review will be published in a peer-reviewed journal and presented at appropriate conferences.

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OBJECTIVE: Spin is characterized as a misinterpretation of results that, whether deliberate or unintentional, culminates in misleading conclusions and steers readers toward an excessively optimistic perspective of the data. The primary objective of this systematic review was to estimate the prevalence and nature of spin within the traumatic brain injury (TBI) literature. Additionally, the identification of associated factors is intended to provide guidance for future research practices. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations were followed. A search of the MEDLINE/PubMed database was conducted to identify English-language articles published between January 1960 and July 2020. Inclusion criteria encompassed randomized controlled trials (RCTs) that exclusively enrolled TBI patients, investigating various interventions, whether surgical or nonsurgical, and that were published in high-impact journals. Spin was defined as 1) a focus on statistically significant results not based on the primary outcome; 2) interpreting statistically nonsignificant results for a superiority analysis of the primary outcome; 3) claiming or emphasizing the beneficial effect of the treatment despite statistically nonsignificant results; 4) conclusion focused in the per-protocol or as-treated analysis instead of the intention-to-treat (ITT) results; 5) incorrect statistical analysis; or 6) republication of a significant secondary analysis without proper acknowledgment of the primary outcome analysis result. Primary outcomes were those explicitly reported as such in the published article. Studies without a clear primary outcome were excluded. The study characteristics were described using traditional descriptive statistics and an exploratory inferential analysis was performed to identify those associated with spin. The studies' risk of bias was evaluated by the Cochrane Risk of Bias Tool. RESULTS: A total of 150 RCTs were included and 22% (n = 33) had spin, most commonly spin types 1 and 3. The overall risk of bias (p < 0.001), a neurosurgery department member as the first author (p = 0.009), absence of a statistician among authors (p = 0.042), and smaller sample sizes (p = 0.033) were associated with spin. CONCLUSIONS: The prevalence of spin in the TBI literature is high, even at leading medical journals. Studies with higher risks of bias are more frequently associated with spin. Critical interpretation of results and authors' conclusions is advisable regardless of the study design and published journal.

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Objectives: This study evaluated the performance of recombinant receptor binding domain (RBD) protein-based enzyme-linked immunosorbent assays (RBD-ELISAs) for detecting anti-SARS-CoV-2 immunoglobulin (Ig) G and IgM antibodies. Methods: In this study, 705 sera from SARS-CoV-2-infected individuals and 315 sera from healthy individuals were analyzed. Results: The RBD-ELISA IgG exhibited high specificity (99.1%) and moderate sensitivity (48.0%), with an overall diagnostic accuracy of 73.5%. RBD-ELISA IgM demonstrated specificity at 94.6% and sensitivity at 51.1%, with an accuracy of 72.8%. Both assays displayed improved performance when analyzing samples collected 15-21 days post-symptom onset, achieving sensitivity and accuracy exceeding 88% and 90%, respectively. Combining RBD-ELISA IgG and IgM in parallel analysis enhanced sensitivity to 98.6% and accuracy to 96.2%. Comparing these RBD-ELISAs with commercially available tests, the study found overlapping sensitivity and similar specificity values. Notably, the combined RBD-ELISA IgG and IgM showed superior performance. Cross-reactivity analysis revealed low false-positive rates (4.4% for IgG, 3.7% for IgM), primarily with viral infections. Conclusion: This research underscores the potential of RBD-based ELISAs for COVID-19 diagnosis, especially when assessing samples collected 15-21 days post-symptom onset and utilizing a parallel testing approach. The RBD protein's immunogenicity and specificity make it a valuable tool for serodiagnosis, offering an alternative to polymerase chain reaction-based methods, particularly in resource-limited settings.

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INTRODUCTION: Spin is defined as an inaccurate interpretation of results, intentionally or not, leading to equivocal conclusions and misdirecting readers to look at the data in an overly optimistic way. Previous studies have shown a high prevalence of spin in scientific papers and this systematic review aims to investigate the nature and prevalence of spin in the neurosurgical trauma literature. Any associated factors will be identified to guide future research practice recommendations. METHODS AND ANALYSIS: The Preferred Reporting Item for Systematic Reviews and Meta-Analyses recommendations will be followed. Randomised clinical trials (RCTs) that enrolled only patients with traumatic brain injury and investigated any type of intervention (surgical or non-surgical) will be eligible for inclusion. The MEDLINE/PubMed database will be searched for articles in English published in 15 top-ranked journals. Spin will be defined as (1) a focus on statistically significant results not based on the primary outcome; (2) interpreting statistically non-significant results for a superiority analysis of the primary outcome; (3) claiming or emphasising the beneficial effect of the treatment despite statistically non-significant results; (4) conclusion focused in the per-protocol or as-treated analysis instead of the intention-to-treat results; (5) incorrect statistical analysis; (6) republication of a significant secondary analysis without proper acknowledgement of the primary outcome analysis result. Traditional descriptive statistics will be used to present RCT characteristics. Standardised differences between the groups with or without spin will be calculated. The variables with a standardised difference equal or above 0.2 and 0.5 will be considered weakly and strongly associated with spin, respectively. ETHICS AND DISSEMINATION: This study will not involve primary data collection and patients will not be involved. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/H3FGY.

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