Natural infection versus hybrid (natural and vaccination) humoral immune response to SARS-CoV-2: a comparative paired analysis.

Objectives: There is substantial immunological evidence that vaccination following natural infection increases protection. We compare the humoral immune response developed in initially seropositive individuals (naturally infected) to humoral hybrid immune response (developed after infection and vaccination) in the same population group after one year. Methods: The study included 197 male individuals who were naturally infected with SARS-CoV-2 and then vaccinated with SARS-CoV-2 vaccine. Trimeric spike, nucleocapsid, and ACE2-RBD blocking antibodies for SARS-CoV-2 were measured. Nasal swabs were collected for SARS-CoV-2 PCR testing. Information on vaccination against SARS-CoV-2 and PCR verified infection was retrieved from official databases (Abu Dhabi Health Data Services- SP LLC. ("Malaffi"), including number of vaccine doses received, date of vaccination, and type of the received vaccine. Results: All the study population were tested PCR-Negative at the time of sample collection. Our results showed that there was a significant rise in the mean (SD) and median (IQR) titers of trimeric spike, nucleocapsid and ACE2-RBD blocking antibodies in the post-vaccination stage. The mean (± SD) and median (IQR) concentration of the anti-S antibody rose by 3.3-fold (+230% ± 197% SD) and 2.8-fold (+185%, 220-390%, p<0.001), respectively. There was an observed positive dose-response relationship between number of the received vaccine doses and having higher proportion of study participants with higher than median concentration in the difference between the measured anti-S and ACE2-RBD blocking antibodies in the post-vaccination compared to pre-vaccination. Conclusion: Our study demonstrates that COVID-19 vaccination post natural infection elicits a robust immunological response with an impressive rise of SARS-CoV-2 antibodies, especially the ACE2-RBD blocking antibodies.

Susceptibility to reinfection with SARS-CoV-2 virus relative to existing antibody concentrations and T cell response.

OBJECTIVES: We investigated the reinfection rate of vaccinated or convalescent immunized SARS-CoV-2 in 952 expatriate workers with SARS-CoV-2 serological antibody (Ab) patterns and surrogate T cell memory at recruitment and follow-up. METHODS: Trimeric spike, nucleocapsid, and neutralizing Abs were measured, along with a T cell stimulation assay, targeting SARS-CoV-2 memory in clusters of differentiation (CD) 4+ and CD8+ T cells. The subjects were then followed up for reinfection for up to 6 months. RESULTS: The seroprevalence positivity at enrollment was greater than 99%. The T cell reactivity in this population was 38.2%. Of the 149 (15.9%) participants that were reinfected during the follow-up period (74.3%) had nonreactive T cells at enrollment. Those who had greater than 100 binding Ab units/ml increase from the median concentration of antispike immunoglobulin G Abs had a 6% reduction in the risk of infection. Those who were below the median concentration had a 78% greater risk of infection. CONCLUSION: Significant immune protection from reinfection was observed in those who retained T cell activation memory. Additional protection was observed when the antispike was greater than the median value.

Evaluation of post-vaccination immunoglobulin G antibodies and T-cell immune response after inoculation with different types and doses of SARS-CoV-2 vaccines: A retrospective cohort study.

Introduction: The induction and speed of production of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) immune biomarkers may vary by type and number of inoculated vaccine doses. This study aimed to explore variations in SARS-CoV-2 anti-spike (anti-S), anti-nucleocapsid (anti-N), and neutralizing immunoglobulin G (IgG) antibodies, and T-cell response by type and number of SARS-CoV-2 vaccine doses received. Methods: In a naturally exposed and SARS-CoV-2-vaccinated population, we quantified the anti-S, anti-N, and neutralizing IgG antibody concentration and assessed T-cell response. Data on socio-demographics, medical history, and history of SARS-CoV-2 infection and vaccination were collected. Furthermore, nasal swabs were collected to test for SARS-CoV-2 infection. Confounder-adjusted association between having equal or more than a median concentration of the three IgG antibodies and T-cell response by number and type of the inoculated vaccines was quantified. Results: We surveyed 952 male participants with a mean age of 35.5 years ± 8.4 standard deviations. Of them, 52.6% were overweight/obese, and 11.7% had at least one chronic comorbidity. Of the participants, 1.4, 0.9, 20.2, 75.2, and 2.2% were never vaccinated, primed with only one dose, primed with two doses, boosted with only one dose, and boosted with two doses, respectively. All were polymerase chain reaction-negative to SARS-CoV-2. BBIBP-CorV (Sinopharm) was the most commonly used vaccine (92.1%), followed by rAd26-S + rAd5-S (Sputnik V Gam-COVID-Vac) (1.5%) and BNT162b2 (Pfizer-BioNTech) (0.3%). Seropositivity to anti-S, anti-N, and neutralizing IgG antibodies was detected in 99.7, 99.9, and 99.3% of the study participants, respectively. The T-cell response was detected in 38.2% of 925 study participants. Every additional vaccine dose was significantly associated with increased odds of having ≥median concentration of anti-S [adjusted odds ratio (aOR), 1.34; 95% confidence interval (CI): 1.02-1.76], anti-N (aOR, 1.35; 95% CI: 1.03-1.75), neutralizing IgG antibodies (aOR, 1.29; 95% CI: 1.00-1.66), and a T-cell response (aOR, 1.48; 95% CI: 1.12-1.95). Compared with boosting with only one dose, boosting with two doses was significantly associated with increased odds of having ≥median concentration of anti-S (aOR, 13.8; 95% CI: 1.78-106.5), neutralizing IgG antibodies (aOR, 13.2; 95% CI: 1.71-101.9), and T-cell response (aOR, 7.22; 95% CI: 1.99-26.5) although not with anti-N (aOR, 0.41; 95% CI: 0.16-1.08). Compared with priming and subsequently boosting with BBIBP-CorV, all participants who were primed with BBIBP-CorV and subsequently boosted with BNT162b2 had ≥median concentration of anti-S and neutralizing IgG antibodies and 14.6-time increased odds of having a T-cell response (aOR, 14.63; 95% CI: 1.78-120.5). Compared with priming with two doses, boosting with the third dose was not associated, whereas boosting with two doses was significantly associated with having ≥median concentration of anti-S (aOR, 14.20; 95% CI: 1.85-109.4), neutralizing IgG (aOR, 13.6; 95% CI: 1.77-104.3), and T-cell response (aOR, 7.62; 95% CI: 2.09-27.8). Conclusion: Achieving and maintaining a high blood concentration of protective immune biomarkers that predict vaccine effectiveness is very critical to limit transmission and contain outbreaks. In this study, boosting with only one dose or with only BBIBP-CorV after priming with BBIBP-CorV was insufficient, whereas boosting with two doses, particularly boosting with the mRNA-based vaccine, was shown to be associated with having a high concentration of anti-S, anti-N, and neutralizing IgG antibodies and producing an efficient T-cell response.

Levothyroxine Administration during Ramadan: A Prospective Randomized Controlled Trial.

BACKGROUND AND AIM: We have previously shown in a retrospective analysis that the plasma thyroid-stimulating hormone (TSH) rises significantly post-Ramadan in levothyroxine-treated hypothyroid patients, possibly as a result of lifestyle alterations and time restrictions during the nonfasting period from dusk until dawn. The aim of this study is to determine the best time to instruct patients to take levothyroxine during Ramadan so as to minimize changes in thyroid function tests during this period. METHODS: In a randomized prospective design, hypothyroid patients taking levothyroxine were randomized to receive instructions to take levothyroxine at one of the following 3 times during Ramadan: (group 1) at dusk 30-min before Iftar meal, (group 2) 3 or more hours after Iftar meal, or (group 3) at dawn 30-min before Suhur meal. Thyroid function tests were performed within 3 months before Ramadan and within 6 weeks post-Ramadan. Data from patients with at least 1 blood test before or after Ramadan were analyzed using mixed-effects regression models. RESULTS: Plasma TSH levels were available at one or more time points for 148 patients, group 1 (n = 50), group 2 (n = 46), and group 3 (n = 52). A statistically significant within-patient increase in plasma TSH was seen in patients at the 25th percentile pre-Ramadan in groups 2 and 3 (p values <0.001), but not in group 1. A statistically significant within-patient decrease in plasma TSH was found in patients at the 75th percentile in group 1 only. For patients at the 50th percentile pre-Ramadan, no statically significant within-patient changes were found, though descriptively, increases in plasma TSH were observed for groups 2 and 3, while a decrease was observed in group 1. CONCLUSIONS: Our data suggest that instructing patients to take levothyroxine at the time of breaking the fast 30 min before the Iftar meal minimizes unfavorable changes in plasma TSH post-Ramadan. In contrast, instructing patients to take levothyroxine 3 h post-Iftar or 30 min before Suhur led to a greater rise in post-Ramadan TSH.

Challenges in Establishing a Coronavirus Disease 2019 (COVID-19) Convalescent Plasma Donation Program in a Multicultural Environment.

CONTEXT.­: In the face of the coronavirus disease 2019 (COVID-19) pandemic response, it was worthwhile to test the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion. OBJECTIVE.­: To establish a CCP donation program based on the availability of recovered COVID-19 patients and the practical limitations in recruiting clinically valid donors in a multicultural setting. DESIGN.­: From March to June 2020, we developed a program for collection of COVID-19 CCP as part of the treatment options for patients affected with COVID-19. From an initial population of 3746 candidates, only those with positive polymerase chain reaction results in at least 2 separate tests were considered. This filter reduced the eligible donor pool to 488 patients. After other exclusions were applied, such as language barrier, age, accessibility to donation, and comorbidities, the final count was 267 potentially eligible donors, which represented only 54.7% (267 of 488) of preselected candidates. RESULTS.­: Eighty donors were called. Approximately a third of the calls provided additional challenges as outlined by the following 4 reasons: limited functional understanding of English; schedule availability due to rotating work timetables; transportation restrictions since public transport services were severely restricted during lockdown; and lost to follow-up. Finally, a total of 38 valid donors participated, upon whom 45 apheresis procedures were performed. CONCLUSIONS.­: As a summary of our experience, we can conclude that despite the limitations we were able to establish an effective program. A total of 90 units of CCP were collected before the pandemic curve began to flatten toward the end of June 2020.

Evaluation of three commercial SARS-CoV-2 serology assays in a tertiary care hospital in the United Arab Emirates.

BACKGROUND: Serology assays have the potential to support RT-PCR in the diagnosis of SARS-CoV-2 infection. We studied three commercially available immunoassays for their diagnostic accuracy from blood specimens collected from 93 patients. METHODS: Blood samples from patients with confirmed COVID-19 infection were analysed using three different Immunoassays (Roche total antibody assay, Abbott IgG assay and Euroimmun IgG assay). Sensitivity, specificity, precision and time of seroconversion were evaluated. RESULTS: The sensitivity of Roche, Abbott and Euroimmun assays was 38.7%, 35.5% and 25.0% respectively for specimens collected <10 days and 84.4%, 84.4% and 70.0% respectively for specimens collected ≥10 days after the first positive RT-PCR. The specificity of all the three assays in this study was 100%. The timing of seroconversion occurred at day 1, 7 or 14. CONCLUSIONS: The assays evaluated in this study have different sensitivities for detecting antibodies in SARS-CoV-2 infection. Sensitivity for detecting antibodies for all three assays was higher for specimens collected ≥10 days after first positive PCR compared with specimens collected <10 days. Time of seroconversion is variable and assay-dependent.

Convalescent Plasma Efficacy in Life-Threatening COVID-19 Patients Admitted to the ICU: A Retrospective Cohort Study.

(1) Background: There are limited data regarding the efficacy of convalescent plasma (CP) in critically ill patients admitted to the intensive care unit (ICU) due to coronavirus disease 2019 (COVID-19). We aimed to determine whether CP is associated with better clinical outcome among these patients. (2) Methods: A retrospective single-center study including adult patients with laboratory-confirmed SARS-CoV-2 infection admitted to the ICU for acute respiratory failure. The primary outcome was time to clinical improvement, within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale. (3) Results: Overall, 110 COVID-19 patients were admitted. Thirty-two patients (29%) received CP; among them, 62.5% received at least one CP with high neutralizing antibody titers (≥1:160). Clinical improvement occurred within 28 days in 14 patients (43.7%) of the CP group vs. 48 patients (61.5%) in the non-CP group (hazard ratio (HR): 0.75 (95% CI: 0.41-1.37), p = 0.35). After adjusting for potential confounding factors, CP was not independently associated with time to clinical improvement (HR: 0.53 (95% CI: 0.23-1.22), p = 0.14). Additionally, the average treatment effects of CP, calculated using the inverse probability weights (IPW), was not associated with the primary outcome (-0.14 days (95% CI: -3.19-2.91 days), p = 0.93). Hospital mortality did not differ between CP and non-CP groups (31.2% vs. 19.2%, p = 0.17, respectively). Comparing CP with high neutralizing antibody titers to the other group yielded the same findings. (4) Conclusions: In this study of life-threatening COVID-19 patients, CP was not associated with time to clinical improvement within 28 days, or hospital mortality.

Saliva as an Alternative Specimen for Molecular COVID-19 Testing in Community Settings and Population-Based Screening.

PURPOSE: With the easing of restriction measures, repeated community-based sampling for tracking new COVID-19 infections is anticipated for the next 6 to 12 months. A non-invasive, self-collected specimen like saliva will be useful for such public health surveillance. Investigations on the use of saliva for SARS-CoV-2 RT-PCR have largely been among COVID-19 in-pa\tients and symptomatic ambulatory patients with limited work in a community-based screening setting. This study was carried out to address this paucity of data and reported discrepancies in diagnostic accuracy for saliva samples. PATIENTS AND METHODS: From 29th June to 14th July 2020, adults presenting for COVID-19 testing at a community-based screening facility in Dubai, United Arab Emirates were recruited. Clinical data, nasopharyngeal swab in universal transport media and drooling saliva in sterile containers were obtained. Reverse transcriptase PCR amplification of SARS-CoV-2 RdRp and N genes was used to detect the presence of the SARS-CoV-2 virus. RESULTS: Of the 401 participants, 35 (8.7%) had viral detection in at least one specimen type and the majority (n=20/35; 57.1%) were asymptomatic. Both swab and saliva were positive in 19 (54.2%) patients, while 7 (20.0%) patients had swab positive/saliva negative results. There were 9 (25.7%) patients with saliva positive/swab negative result and this included 5 asymptomatic COVID-19 patients undergoing repeat screening. Using the swab as the reference gold standard, the sensitivity and specificity of saliva were 73.1% (95% CI 52.2-88.4%) and 97.6% (95% CI 95.5-98.9%) while the positive and negative predictive values were 67.9% (95% CI 51.5-80.8%) and 98.1% (95% CI 96.5-99.0%), respectively. CONCLUSION: The findings suggest good diagnostic accuracy for saliva and feasibility of utilization of specimen without transport media for SARS-CoV-2 RT-PCR. Saliva represents a potential specimen of choice in community settings and population-based screening.

Thrombotic events following tocilizumab therapy in critically ill COVID-19 patients: a Façade for prognostic markers.

BACKGROUND: Hospitals in the Middle East Gulf region have experienced an influx of COVID-19 patients to their medical wards and intensive care units. The hypercoagulability of these patients has been widely reported on a global scale. However, many of the experimental treatments used to manage the various complications of COVID-19 have not been widely studied in this context. The effect of the current treatment protocols on patients' diagnostic and prognostic biomarkers may thus impact the validity of the algorithms adopted. CASE PRESENTATION: In this case series, we report four cases of venous thromboembolism and 1 case of arterial thrombotic event, in patients treated with standard or intensified prophylactic doses of unfractionated heparin or low molecular weight heparin at our institution. Tocilizumab has been utilized as an add-on therapy to the standard of care to treat patients with SARS-CoV-2 associated acute respiratory distress syndrome, in order to dampen the hyperinflammatory response. It is imperative to be aware that this drug may be masking the inflammatory markers (e.g. IL6, CRP, fibrinogen, and ferritin), without reducing the risk of thrombotic events in this population, creating instead a façade of an improved prognostic outcome. However, the D-dimer levels remained prognostically reliable in these cases, as they were not affected by the drug and continued to be at the highest level until event occurrence. CONCLUSIONS: In the setting of tocilizumab therapy, traditional prognostic markers of worsening infection and inflammation, and thus potential risk of acute thrombosis, should be weighed carefully as they may not be reliable for prognosis and may create a façade of an improved prognostic outcome insteasd. Additionally, the fact that thrombotic events continued to be observed despite decrease in inflammatory markers and the proactive anticoagulative approach adopted, raises more questions about the coagulative mechanisms at play in COVID-19, and the appropriate management strategy.

The Asia-Pacific Society of Cardiology (APSC) Expert Committee Consensus Recommendations for Assessment of Suspected Acute Coronary Syndrome Using High-Sensitivity Cardiac Troponin T in the Emergency Department.

The Asia-Pacific Society of Cardiology (APSC) high-sensitivity troponin T (hs-TnT) consensus recommendations and rapid algorithm were developed to provide guidance for healthcare professionals in the Asia-Pacific region on assessing patients with suspected acute coronary syndrome (ACS) using a hs-TnT assay. Experts from Asia-Pacific convened in 2 meetings to develop evidence-based consensus recommendations and an algorithm for appropriate use of the hs-TnT assay. The Expert Committee defined a cardiac troponin assay as a high-sensitivity assay if the total imprecision is ≤10% at the 99th percentile of the upper reference limit and measurable concentrations below the 99th percentile are attainable with an assay at a concentration value above the assay's limit of detection for at least 50% of healthy individuals. Recommendations for single-measurement rule-out/rule-in cutoff values, as well as for serial measurements, were also developed. The Expert Committee also adopted similar hs-TnT cutoff values for men and women, recommended serial hs-TnT measurements for special populations, and provided guidance on the use of point-of-care troponin T devices in individuals suspected of ACS. These recommendations should be used in conjunction with all available clinical evidence when making the diagnosis of ACS.

Metabolic dysfunction in Emirati subjects in Abu Dhabi: Relationship to levels of soluble RAGEs.

BACKGROUND: The United Arab Emirates is experiencing increasing rates of type 2 diabetes (T2D) and its complications. As soluble levels of the receptor for advanced glycation end products, (sRAGE), and endogenous secretory RAGE (esRAGE), the latter an alternatively spliced form of AGER (the gene encoding RAGE), have been reported to be associated with T2D and its complications, we tested for potential relationships between these factors and T2D status in Emirati subjects. METHODS: In a case-control study, we recruited Emirati subjects with T2D and controls from the Sheikh Khalifa Medical City in Abu Dhabi. Anthropomorphic characteristics, levels of plasma sRAGE and esRAGE, and routine chemistry variables were measured. RESULTS: Two hundred and sixteen T2D subjects and 215 control subjects (mean age, 57.4 ±â€¯12.1 vs. 50.7 ±â€¯15.4 years; P < 0.0001, respectively) were enrolled. Univariate analyses showed that levels of sRAGE were significantly lower in the T2D vs. control subjects (1033.9 ±â€¯545.3 vs. 1169.2 ±â€¯664.1 pg/ml, respectively; P = 0.02). Multivariate analyses adjusting for age, sex, systolic blood pressure, pulse, body mass index, Waist/Hip circumference ratio, fasting blood glucose, HDL, LDL, insulin, triglycerides, Vitamin D and urea levels revealed that the difference in sRAGE levels between T2D and control subjects remained statistically-significant, P = 0.03, but not after including estimated glomerular filtration rate in the model, P = 0.14. There were no significant differences in levels of esRAGE. Levels of plasma insulin were significantly higher in the control vs. the T2D subjects (133.6 ±â€¯149.9 vs. 107.6 ±â€¯93.3 pg/L. respectively; P = 0.01, after adjustment for age and sex). CONCLUSION/DISCUSSION: Levels of sRAGE, but not esRAGE, were associated with T2D status in Abu Dhabi, but not after correction for eGFR. Elevated levels of plasma insulin in both control and T2D subjects suggests the presence of metabolic dysfunction, even in subjects without diabetes.

Setting Up a Point-of-Care Testing Service in a Greenfield, Quaternary Hospital: An Implementation Review.

CONTEXT.­: The health care industry is growing rapidly and is continually seeking more-innovative ways to deliver patient care. The growing demands of clinicians seeking faster and more-efficient ways of providing care to their patients presents challenges to clinical laboratory services. Point-of-care testing (POCT) is frequently seen as a viable solution to address this dilemma. The role of POCT is widely established and accepted in many circumstances provided certain criteria are met. OBJECTIVES.­: To discuss the Cleveland Clinic Abu Dhabi experience-the challenges faced and the solutions found-during the process of establishing a POCT service in a greenfield hospital, and to share this experience to support health care professionals wishing to establish or expand POCT services. DATA SOURCE.­: First-hand expert opinion relating to setting up a POCT service, which was guided and informed by national and international standards and regulatory bodies, provide the basis for this review. CONCLUSIONS.­: Point-of-care testing is a fast growing and unique discipline of pathology. The establishment of a new POCT service creates distinctive and unique challenges compared with traditional laboratory services. The difficulties experienced are compounded in a greenfield hospital but the process of multidisciplinary collaboration and information exchange among peer groups allows the efficient development of a highly effective POCT department.

Challenges in Establishing a Transfusion Medicine Service: The Cleveland Clinic Abu Dhabi Experience.

CONTEXT.­: Opening a new hospital is a once in a lifetime experience and can be very inspiring for those involved in its activation. However, establishing a safe transfusion practice in a greenfield environment comes with unique challenges and opportunities. OBJECTIVE.­: To highlight critical activation components such as on-boarding of new personnel, establishing clinical practices, and integrating critical laboratory software. DESIGN.­: Our staff initially faced challenges in standardizing transfusion medicine clinical practice inside the laboratory. Our efforts were mainly focused on the appropriate use of various transfusion orders, creating comprehensive policies for type and screening, cost effective utilization of blood products, and establishment of the maximum surgical blood order schedule. The transfusion service was launched with 2 information technology programs that separately facilitated steps in the transfusion process, but did not provide centralized access to the entire process. In these circumstances, we partnered with the laboratory information system team to create a series of interfaces that streamlined each system's functionality and implemented the existing infrastructure with upgrades that enable remote location and management of blood products. RESULTS.­: The transfusion medicine team spent more than a year training and monitoring workflows to avoid individual variations between technologists and to adopt our own standards of practice. Participation in a structured training plan was also necessary between clinical caregivers to know the safe and efficient use of these standards. CONCLUSIONS.­: Although laboratory and clinical staff are knowledgeable in care delivery, it is always a learning experience to establish a new system because of the natural tendency of resorting to previous practices and resistance to new approaches.

Establishing an Anatomic Pathology Laboratory at Cleveland Clinic Abu Dhabi.

CONTEXT: - The Department of Anatomic Pathology is a division of the Pathology & Laboratory Medicine Institute at Cleveland Clinic Abu Dhabi. The hospital offers the same model of care as its US-based counterpart the Cleveland Clinic, established in 1921 in Cleveland, Ohio. Pathology services at Cleveland Clinic are internationally acclaimed: the endeavor for Cleveland Clinic Abu Dhabi was to create a parallel facility, with the same standards in a greenfield start-up environment. OBJECTIVE: - To narrate how we addressed challenges customary in any laboratory start-up and issues distinctive to our setting with the aim to provide a model for others involved in a similar undertaking. DATA SOURCES: - All information in this article is based on published literature obtained by search on internet-based search engines, Clinical and Laboratory Standards Institute, and the authors' firsthand experience. CONCLUSIONS: - Key considerations in establishing an anatomic pathology laboratory are careful planning and design, adherence to local and international regulatory standards, selection of equipment and supplies, appropriate staffing, development of a laboratory information system, and sound test validation. In addition to meeting our clinical needs, alliance with the US Cleveland Clinic had an integral role in establishing our laboratory and regional reputation.

Establishing a Clinical Laboratory in a Tertiary/Quaternary Care Greenfield Hospital in the Middle East: Recounting the Cleveland Clinic Abu Dhabi Experience.

CONTEXT: - This review chronicles the establishment of a clinical laboratory in Cleveland Clinic Abu Dhabi, a greenfield tertiary/quaternary care hospital in the United Arab Emirates. It discusses the challenges faced, solutions sought, and lessons learned and shares insights and pitfalls that may be encountered in such an undertaking. OBJECTIVES: - To share our experience in building a clinical laboratory in a start-up, multispecialty hospital and how we provided support and managed people, processes, and technology for building and making operational the Cleveland Clinic Abu Dhabi. DATA SOURCES: - The Medline (PubMed, National Center for Biotechnology Information, Bethesda, Maryland) database was used to review this topic as well as other journals, books, and Google (Mountain View, California) search engine. CONCLUSIONS: - To deliver on the promise of quality healthcare in a culturally appropriate setting close to home, Cleveland Clinic Abu Dhabi proved to be an unprecedented and ambitious project, jointly carried out by Mubadala Investment Corporation and the Cleveland Clinic Foundation. Cognizant of the scale of this task, hospital leadership engaged closely with staff and stakeholders through motivational techniques and effective communication. Excellent project planning and execution of complex tasks were required for initiation of services. Establishing the clinical laboratory served as an instructive model in fostering multidisciplinary teamwork by highlighting ways to manage operational roadblocks and opportunities in the planning, commissioning, and activation phases. Throughout the activation process, all efforts were directed to create a patient-safety culture within an intentional-learning organization.

Persistent candidemia despite appropriate fungal therapy: First case of Candida auris from the United Arab Emirates.

In this case, we report an elderly patient with multiple chronic conditions and prolonged intensive care unit (ICU) stays who had recurrent Candida auris (C. auris) in blood despite antifungal therapy. C. auris was misidentified using conventional automated identification system as Candida haemulonii resulting in delayed diagnosis. The isolate showed increasing minimum inhibitory concentrations (MICs) to different antifungal drugs and persisted in the patient's blood before the patient deceased. This is the first case of C. auris reported from the United Arab Emirates (UAE); laboratories should be aware of this Candida species and should confirm suspected cases since it is an emerging multi-drug resistant and health-care associated Candida.

Fast Track to Accreditation: An Implementation Review of College of American Pathologists and International Organization for Standardization 15189 Accreditation.

CONTEXT: - This review examines challenges and opportunities in preparing laboratories in a startup phase for accreditation by both the College of American Pathologists (CAP) and International Organization for Standardization (ISO) 15189 in an international setting as it relates to our experience at Cleveland Clinic Abu Dhabi Laboratory. It also discusses some of the strategies used in executing those projects and the added advantages in pursuing both types of accreditations. OBJECTIVES: - To share our experience with CAP and ISO 15189 accreditations in a startup international operation in relation to the challenges encountered and implementation strategy success factors. DATA SOURCES: - MEDLINE (PubMed) database was used to review this topic as well as peer-reviewed articles and World Health Organization publications on the topic. CONCLUSIONS: - Accreditation is a perfect means toward building quality medical laboratories in a diverse workforce environment and improving patient safety. Further, it establishes a strong foundation on which any new operation can build a sustainable quality improvement culture. Accreditations by CAP and/or ISO are among the most reputable and well-established accreditation systems that clinical laboratories could aim for. As a result of both accreditations offering synergistic and complementing features, we recommend that any laboratory seeking excellence in quality and performance should consider exploring both. Key elements to success include having dedicated project management and change management support while preparing for accreditation. Laboratories seeking accreditation in early operational stages may face a number of challenges; however, significant opportunities will also be present to optimize various operational components from the beginning.

Comparison of antimicrobial activity between ceftolozane-tazobactam and ceftazidime-avibactam against multidrug-resistant isolates of Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

OBJECTIVE: This study compared the activity of ceftolozane-tazobactam and ceftazidime-avibactam against 120 bacterial strains, including extended-spectrum beta-lactamase (ESBL) producers, carbapenem-resistant Enterobacteriaceae (CRE), and Pseudomonas aeruginosa, isolated from patients admitted to Cleveland Clinic Abu Dhabi, United Arab Emirates. METHODS: In vitro susceptibility was tested using the Etest strip minimum inhibitory concentration (MIC) method, and PCR was used to characterize the carbapenemase enzymes produced by CRE strains. RESULTS: All 29 ESBL isolates were susceptible to ceftazidime-avibactam (MIC50 0.125µg/ml), whereas all but one were susceptible to ceftolozane-tazobactam (MIC50 0.38µg/ml). Twenty-seven (45%) CRE isolates were susceptible to ceftazidime-avibactam (MIC50 ≥256µg/ml), whereas only six (10%) isolates were susceptible to ceftolozane-tazobactam (MIC50 ≥256µg/ml). Very few NDM-1 isolates were susceptible to ceftazidime-avibactam, whereas the majority of OXA-48 isolates were susceptible. Twenty-nine (94%) P. aeruginosa isolates were susceptible to ceftazidime-avibactam (MIC50 1.5µg/ml), whereas 30 (97%) isolates were susceptible to ceftolozane-tazobactam (MIC50 0.75µg/ml). CONCLUSIONS: Ceftolozane-tazobactam and ceftazidime-avibactam showed comparable activity against ESBL and P. aeruginosa, with ceftazidime-avibactam having lower MICs against ESBL isolates and ceftolozane-tazobactam having lower MICs against P. aeruginosa. Ceftazidime-avibactam showed better activity against all CRE isolates except for those carrying the NDM-1 enzyme.