Diagnostic Efficacy of RealStar SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) in Comparison to GeneXpert System for the Detection of COVID-19.

Background and objective The coronavirus disease 2019 (COVID-19) pandemic has become a major health concern due to the rapid transmission of the virus that causes it: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To address the growing demand on healthcare systems to control this pandemic, more effective diagnostic methods need to be applied. In this study, we aimed to compare the efficacy of RealStar® SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) versus the GeneXpert® system. Methods A retrospective cross-sectional study was conducted in the central lab of King Abdulaziz Medical City (KAMC) in Riyadh, Saudi Arabia. Data from all nasopharyngeal swabs (NPS) (150,000) submitted for SARS-CoV-2 analysis from July 2020 to July 2021 were reviewed retrospectively. Furthermore, all NPS (n=384) that were analyzed on both the RealStar® SARS-CoV-2 RT-PCR and GeneXpert® systems for confirmatory purposes were included in the study. Acute respiratory illness (ARI) screening forms of the selected samples were reviewed from the electronic database (BestCare system), and they were analyzed and compared at one point in time; therefore, a cross-sectional study was found to be the best suitable study design. Using the statistical analysis software, the receiver operating characteristic (ROC) curve was obtained to compare the sensitivity (Sn), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV). The test was considered significant if the area under the curve (AUC) value was >0.5. Results The diagnostic performance of the RealStar® and GeneXpert® assays in detecting SARS-CoV-2 was evaluated using ROC curve analysis, which showed AUCs of 0.597 and 0.637, respectively. In addition, 35% of the total results fell into a substantial agreement of 0.76 (95% CI: 0.6626-0.8732). The majority of the NPS were reported negative by both RealStar® (246, 80.66%) and GeneXpert® (226, 74.10%). Most samples (210, 68.85%) were obtained from asymptomatic patients, scoring less than 4 (ARI <4) based on the ARI screening form. Conclusion Based on the AUC of ROC, there is no significant difference in the performance characteristics between the RealStar® RT-PCR and GeneXpert® in detecting COVID-19.

Impacts of Changing the Curriculum Design on the Examination Results of Anatomy and Physiology Course.

Introduction Innovating strategies have become a compulsion in all fields associated with improved outcomes. Similarly, an innovation was introduced in the curriculum design and content to be tested for the Anatomy and Physiology course at the College of Science and Health Professions (COSHP), King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), in the spring semester of 2020. Before the COVID-19 pandemic, until the spring semester of 2019, two examinations were conducted as continuous assessments (Midterm I and II), followed by a comprehensive Final examination. In the spring semester of 2020, these examinations were replaced with Block I, II, and III examinations, respectively, with modified content and weightage. The Final examination was comprehensive and included 24 Anatomy, 21 Physiology lectures, and three case-based learning (CBL) sessions, whereas Block III included only eight Anatomy, seven Physiology lectures, and 1 CBL session. Midterm I and II weighed 20% each with a comprehensive examination of 35%, while Block I, II, and III were all 25% each. This study focuses on the impact of the curriculum modifications on the results of written examinations for preprofessional students enrolled at Riyadh, Jeddah, and Al-Ahsa campuses. Methods This retrospective study included data from 2356 male and female students from Riyadh, Jeddah, and Al-Ahsa. Data included Midterm I and II grades and Final examination grades for spring semester 2019 and Block I, II, and III examination grades for spring semester 2021. The results of the spring semester 2021 examinations were compared with the spring semester 2019 examination. The spring semester of 2020 was skipped to avoid the effect of online examinations during the COVID-19 restriction period. Data were analyzed using the statistical software SPSS version 23.0 (IBM Corporation, Armonk, NY, USA). Coefficient of variation (CV) compared spring semester 2019 and spring semester 2021 examination outcomes. The findings were analyzed concerning data related to gender, student groups, and campuses. An independent t-test of proportion was used to compare the CVs for spring 2019 and 2021. Results The overall comparison showed better results in the spring semester of 2021 (p-value < 0.01). Campus-wise, the results were significantly better for Riyadh (p-value < 0.01). The gender-wise study showed better performance from male students (p-value < 0.01). Concerning campus and gender, the results of male and female students of the Riyadh campus came out to be highly significant (p-value < 0.01). Conclusions Changing from Midterms to the Block system significantly improved the Block III examination results in spring semester 2021, particularly at the Riyadh campus. Overall, the changes remained helpful to all students. Further studies are needed to investigate the long-term effect of the curriculum changes.

Correlation between ABO Blood Group Phenotype and the Risk of COVID-19 Infection and Severity of Disease in a Saudi Arabian Cohort.

BACKGROUND: Disease severity among patients infected with SARS-CoV-2 varies remarkably. Preliminary studies reported that the ABO blood group system confers differential viral susceptibility and disease severity caused by SARS-CoV-2. Thus, differences in ABO blood group phenotypes may partly explain the observed heterogeneity in COVID-19 severity patterns, and could help identify individuals at increased risk. Herein, we explored the association between ABO blood group phenotypes and COVID-19 susceptibility and severity in a Saudi Arabian cohort. METHODS: In this retrospective cohort study, we performed ABO typing on a total of 373 Saudi patients infected with SARS-CoV-2 and conducted association analysis between ABO blood group phenotype and COVID-19 infection severity. We then performed gender-stratified analysis by dividing the participating patients into two groups by gender, and classified them according to age. RESULTS: The frequencies of blood group phenotypes A, B, AB and O were 27.3, 23.6, 5.4 and 43.7%, respectively. We found that blood group phenotype O was associated with a lower risk of testing positive for COVID-19 infection (OR 0.76 95% CI 0.62-0.95, p = 0.0113), while blood group phenotype B was associated with higher odds of testing positive (OR 1.51 95% CI 1.17-1.93, p = 0.0009). However, blood group phenotype B was associated with increased risk in the mild and moderate group but not the severe COVID-19 infection group. Blood group phenotype O was protective in all severity groups. CONCLUSION: Our findings provide evidence that blood group phenotype B is a risk for COVID-19 disease while blood group phenotype O is protective from COVID-19 infection. However, further studies are necessary to validate these associations in a larger sample size and among individuals of different ethnic groups.

Association of KIR gene polymorphisms with COVID-19 disease.

BACKGROUND: Natural killer (NK) cells play an essential role against viruses. NK cells express killer cell immunoglobulin-like receptors (KIRs) which regulate their activity and function. The polymorphisms in KIR haplotypes confer differential viral susceptibility and disease severity caused by infections. We investigated the association between KIR genes and COVID-19 disease severity. METHODS: 424 COVID-19 positive patients were divided according to their disease severity into mild, moderate and severe. KIR genes were genotyped using next generation sequencing (NGS). Association between KIR genes and COVID-19 disease severity was conducted and significant correlations were reported. RESULTS: In the COVID-19 patients, KIR Bx genotype was more common than AA genotype. The Bx genotype was found more frequently in patients with mild disease, while in severe disease the AA genotype was more common than the Bx genotype. The KIR2DS4 gene carried the highest risk for severe COVID-19 infection (OR 8.48, pc= 0.0084) followed by KIR3DL1 (OR 7.61, pc= 0.0192). CONCLUSIONS: Our findings suggest that KIR2DS4 and KIR3DL1 genes carry risk for severe COVID-19 disease.

Inflammatory Response and Phenotyping in Severe Acute Respiratory Infection From the Middle East Respiratory Syndrome Coronavirus and Other Etiologies.

OBJECTIVES: In this study, we evaluated the inflammatory response in patients with severe acute respiratory infection due to the Middle East respiratory syndrome and non-Middle East respiratory syndrome and assessed the presence of distinct inflammatory subphenotypes using latent class analysis. DESIGN: Prospective cohort study. SETTING: A tertiary care ICU in Riyadh, Saudi Arabia. PATIENTS: Consecutive critically ill patients with laboratory-confirmed Middle East respiratory syndrome severe acute respiratory infection and non-Middle East respiratory syndrome severe acute respiratory infection. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: We measured cytokines on days 1, 3, 7, and 14 of ICU stay. We included 116 patients (40 with Middle East respiratory syndrome severe acute respiratory infection and 76 with non-Middle East respiratory syndrome severe acute respiratory infection). On ICU day 1, both patients with Middle East respiratory syndrome severe acute respiratory infection and non-Middle East respiratory syndrome severe acute respiratory infection had higher levels of interleukin-3, interleukin-4, interleukin-6, interleukin-8, interleukin-17A, eotaxin, and epidermal growth factor compared with healthy controls. There were no differences in cytokines over time between patients with Middle East respiratory syndrome severe acute respiratory infection and non-Middle East respiratory syndrome severe acute respiratory infection. Using day 1 cytokine levels, latent class analysis categorized patients into two subphenotypes: subphenotype 1 (n = 74 [64%]) and subphenotype 2 (n = 42 [36%]); the latter had significantly higher levels of interleukin-1ß, interleukin-1ra, interleukin-2, interleukin-6, interleukin-7, interleukin-8, interleukin-10, interleukin-12p70, interleukin-15, interleukin-17A, inducible protein-10, monocyte chemoattractant protein-1, macrophage inflammatory protein-1α, macrophage inflammatory protein-1ß, tumor necrosis factor-α, granulocyte-macrophage colony-stimulating factor, granulocyte-colony stimulating factor, interferon-α, and interferon-γ. Although baseline characteristics were not different between the two subphenotypes, patients in the subphenotype 2 had higher ICU mortality compared with the subphenotype 1 (18/42 [43%] vs 17/74 [23%]; p = 0.03). CONCLUSIONS: One third of critically ill patients with Middle East respiratory syndrome severe acute respiratory infection and non-Middle East respiratory syndrome severe acute respiratory infection demonstrated a subphenotype characterized by increased proinflammatory cytokines, consistent with cytokine storm. Further research is needed to examine whether immunomodulators have differential effects based on inflammatory subphenotypes.

Real-World Issues and Potential Solutions in Hematopoietic Cell Transplantation during the COVID-19 Pandemic: Perspectives from the Worldwide Network for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research Health Services and International Studies Committee.

The current COVID-19 pandemic, caused by SARS-CoV-2, has impacted many facets of hematopoietic cell transplantation (HCT) in both developed and developing countries. Realizing the challenges as a result of this pandemic affecting the daily practice of the HCT centers and the recognition of the variability in practice worldwide, the Worldwide Network for Blood and Marrow Transplantation (WBMT) and the Center for International Blood and Marrow Transplant Research's (CIBMTR) Health Services and International Studies Committee have jointly produced an expert opinion statement as a general guide to deal with certain aspects of HCT, including diagnostics for SARS-CoV-2 in HCT recipient, pre- and post-HCT management, donor issues, medical tourism, and facilities management. During these crucial times, which may last for months or years, the HCT community must reorganize to proceed with transplantation activity in those patients who urgently require it, albeit with extreme caution. This shared knowledge may be of value to the HCT community in the absence of high-quality evidence-based medicine. © 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.