Inter-Observer Variability in the Assessment of the 4Ts Score for the Diagnosis of Heparin Induced Thrombocytopenia (HIT) in Patients Undergoing Cardiac Surgery (CS).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4467-4467 ◽  
Author(s):  
Fareen Din ◽  
Michael J. Kovacs ◽  
Ron Butler ◽  
Alejandro Lazo-Langner

Abstract Abstract 4467 Background HIT is a potentially serious complication of heparin therapy. Because of the multiple conditions potentially causing thrombocytopenia, particularly in clinical scenarios such as patients undergoing CS or admitted to intensive care units, its diagnosis is frequently not straightforward and depends on a combination of clinical suspicion and laboratory tests. The 4Ts score has been proposed as a tool to assess the pretest probability of a HIT diagnosis (as low, intermediate or high) and it comprises 4 clinical parameters: severity and timing of onset of thrombocytopenia, development of thrombosis, and the presence of alternate causes for thrombocytopenia. This score has several handicaps including the fact that the temporal profile of thrombocytopenia onset is frequently unclear, the history of previous heparin exposure is not always available, the diagnosis of new thrombosis (including extensions of previous ones) is often difficult, and the judgment about the likelihood of an alternate cause for the thrombocytopenia is entirely subjective. The clinical usefulness of a scoring system depends mainly on its robustness and reproducibility and therefore inclusion of difficult to evaluate or subjective components might compromise its clinical performance. Objectives We evaluated the inter-observer agreement for classifying the probability of HIT in a population of patients undergoing CS. Methods We conducted a retrospective study of patients admitted for cardiac surgery to our institution between January 2006 and December 2008 and in whom HIT was suspected. Clinical information including all necessary data for calculating the 4 components of the 4Ts score was collected in a standardized database which was used by 2 independent observers (blinded to serological tests results) to calculate the score and the pretest probability for HIT as low (≤3 points), intermediate (4-5 points), or high (≥6 points). Scores assigned by both observers were compared using a Wilcoxon signed ranks test and the inter-observer agreement for scores and pretest probabilities was evaluated using a Kappa statistic. 95% confidence intervals for proportions were estimated using the Wilson score method. Results 73 patients were included in the analysis. The score assigned by both observers differed in 40 cases (54.8%; 95% CI 43.4, 65.7; p=0.001). The value of the Kappa statistic for the inter-observer agreement for scores was 0.266 (95% CI 0.111, 0.421) and for pretest probabilities was 0.400 (95% CI 0.218, 0.582). Conclusions In this study, we found that the 4Ts score has an inter-observer agreement ranging between slight and moderate when applied to patients undergoing CS. The variability observed in the assessment of the score raises doubts about its usefulness when evaluating the possibility of HIT in this patient population. Limitations of this study include a relatively small sample size, inclusion of a single clinical setting, and its retrospective nature. Further studies in this and other populations are needed to assess the reproducibility of the 4Ts score. Disclosures: No relevant conflicts of interest to declare.

Pathobiology ◽  
2021 ◽  
Vol 88 (2) ◽  
pp. 156-169
Author(s):  
Williams Fernandes Barra ◽  
Dionison Pereira Sarquis ◽  
André Salim Khayat ◽  
Bruna Cláudia Meireles Khayat ◽  
Samia Demachki ◽  
...  

Identifying a microbiome pattern in gastric cancer (GC) is hugely debatable due to the variation resulting from the diversity of the studied populations, clinical scenarios, and metagenomic approach. <i>H. pylori</i> remains the main microorganism impacting gastric carcinogenesis and seems necessary for the initial steps of the process. Nevertheless, an additional non-<i>H. pylori</i> microbiome pattern is also described, mainly at the final steps of the carcinogenesis. Unfortunately, most of the presented results are not reproducible, and there are no consensual candidates to share the <i>H. pylori</i> protagonists. Limitations to reach a consistent interpretation of metagenomic data include contamination along every step of the process, which might cause relevant misinterpretations. In addition, the functional consequences of an altered microbiome might be addressed. Aiming to minimize methodological bias and limitations due to small sample size and the lack of standardization of bioinformatics assessment and interpretation, we carried out a comprehensive analysis of the publicly available metagenomic data from various conditions relevant to gastric carcinogenesis. Mainly, instead of just analyzing the results of each available publication, a new approach was launched, allowing the comprehensive analysis of the total sample amount, aiming to produce a reliable interpretation due to using a significant number of samples, from different origins, in a standard protocol. Among the main results, <i>Helicobacter</i> and <i>Prevotella</i> figured in the “top 6” genera of every group. <i>Helicobacter</i> was the first one in chronic gastritis (CG), gastric cancer (GC), and adjacent (ADJ) groups, while <i>Prevotella</i> was the leader among healthy control (HC) samples. Groups of bacteria are differently abundant in each clinical situation, and bacterial metabolic pathways also diverge along the carcinogenesis cascade. This information may support future microbiome interventions aiming to face the carcinogenesis process and/or reduce GC risk.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3715-3715
Author(s):  
Ana Villegas ◽  
Ana Gaya ◽  
Emilio Ojeda ◽  
Ataulfo Gonzalez ◽  
Alvaro Urbano ◽  
...  

Abstract Background Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, life threatening hematopoietic stem cell disorder with chronic hemolytic anemia, peripheral blood cytopenias and thrombosis Aims To observe the PNH clone and LDH evolution of the Spanish patients enrolled in the International PNH Registry, the thrombotic events and the role of eculizumab Methods We analyzed the 117 patients enrolled in the Registry until Dec. 31st 2012, classified in 3 groups: Classic/ hemolytic (group I, n 59), PNH with another bone marrow disorder (group II, n 42) and Subclinical (group III, n 14). The variables analyzed were PNH clone size, LDH levels, and incidence of thrombosis. Medians and percentages should be taken with caution due to the relatively small sample size. In addition to data collected in the Registry, additional patient information was obtained from local physicians. Results The median (range) age at presentation was 36.6 yrs. (16-83); 48 patients (41.0%) were women. Median (range) time from disease start to enrollment was 11.3 years in group I (0.1-41.2), 3.5 in II (0.1-33.8) and 3.4 (0.3-20.8) in III. A total of 49 patients (39 in group I) were started on eculizumab, 38 prior to enrollment (31 in group I) and 11 on or after enrollment; 3 were treated prior to enrollment but discontinued for different reasons (pregnancy, ending trial, access problems). Clone evolution (Table 1). In group I the median clone size remained stable during the follow-up period in the Registry; however, 4 patients in group II evolved to group I, with granulocyte clones > 50% and LDH levels >2000 U/L, while 3 initially in group I evolved to group II at 6, 12 and 18 months respectively. At enrollment 64 patients had a clone ≥30% and 31<30%; 7 patients in group II had a clone ≥30% despite hypoplasia, and they were treated with eculizumab. In groups I and II median clone size increased from Diagnosis to Enrollment in line with the physiopathology of the disease. LDH evolution (Table 2). Median LDH levels at diagnosis were higher in group I. In this group the decrease in LDH level between Diagnosis and Enrollment could be attributed to the start of treatment in 31 patients before the enrollment visit, but that hypothesis will need confirmation in future analysis. Thrombotic episodes (Table 3). Twenty six patients (22.6%) presented 52 TEs along the study period, 41 in group I and 11 in group II. Of the 26, fourteen presented 1 TE, six 2, one 3, four 2 and one 5. Twenty five patients presented 51 TEs since the moment of diagnosis while they were not being treated with eculizumab. Only one patient in the treated group presented a TE (CVA), of which he recovered well; after 30 months of the episode continues with the treatment and scores 90 in the Karnofsky index. Fifty eight percent of the patients presenting TEs were male, showing they may be more prone to TE than women. Conclusions These data show the dynamic features of the disease in some patients, which justifies the necessity of regularly monitoring the clone size LDH levels are higher in patients with classical PNH at diagnostic; the effect of the treatment in the whole cohort will require future analysis Thrombosis is highly prevalent in PNH; 22.6% of the patients in this sample had at least 1 episode along their time in the study. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5336-5336
Author(s):  
Jean Paul Atallah ◽  
Basem Azab ◽  
Abhirami Vivekanandarajah ◽  
Ali Naboush ◽  
Houssein Abdul Sater ◽  
...  

Abstract Background Cancer associated inflammation is one of the key determinants of outcome in patients with cancer. An elevated neutrophil: lymphocyte ratio (NLR) has been identified as a predictor of worse survival in patients with various solid tumors compared to hematologic malignancies but no reports yet examined its impact on multiple myeloma. The aim of this study was to examine the prognostic value of an elevated NLR in multiple myeloma. Methods We had approval by our institutional review board to collect the data on patients diagnosed with multiple myeloma at Staten Island University Hospital between year 2000 and 2012 identified from our local cancer database. Data on demographics, conventional prognostic markers, laboratory analyzes including blood count results, and histopathology were collected and analyzed. A cox proportional survival analysis was carried out to assess the relationship between NLR and mortality. NLR was assessed as a continuous variable as well as categorical variable (quartile 0.5-1.5, 1.6-2.2, 2.3-3.8, and 3.9-22.3). Results A total of 96 patients were identified with a median age at diagnosis of 70 (IQR of 61 to 79) years. The median neutrophil count was 3.5 (2.5—5.1) x 10-9/liters, median lymphocyte count 1.5 (1.05-2.4) × 10-9/liters, while the NLR was 2.28 (1.53-3.88). The median overall survival was 147.5 weeks, IQR (88.5-320). NLR did not prove to be a significant predictor of death as a continuous variable (0.95 (0.85-1.06), p =0.35). Furthermore, there was no significant difference in survival with any of the quartiles of NLR. Compare to lowest quartile of NLR, Hazards ratio for the consecutive quartiles were 1.25 (0.56-2.79, p 0.55), 1.36 (0.61-3.04, p=0.45) and 0.89 (0.36-2.22, p=0.80). Conclusion NLR does not appear to offer useful predictive ability for outcome and survival in multiple myeloma patients. Our study is limited with small sample size, further studies are needed to validate our results. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4265-4265 ◽  
Author(s):  
Prajwal Dhakal ◽  
Vijaya R. Bhatt

Abstract Introduction Patients with a history of HIT, who require cardiopulmonary bypass (CPB), have limited anticoagulation options. Unfractionated heparin (UFH) is preferred by surgeons during CPB because of their extensive experience, short half-life of the drug, and the availability of protamine sulfate to reverse its effect. However, heparin re-challenge may be associated with a risk of recurrence of HIT. A number of instances of successful heparin re-exposure during CPB have been reported in HIT patients. However, small sample size of these reports and a lack of systemic review have prevented better understanding of the potential complications. The objective of this study was to determine the safety of heparin re-exposure in HIT patients and various strategies utilized to reduce the recurrence of HIT. Methods Using several search terms, all cases of heparin re-exposure in HIT patients published and indexed in English language in Pubmed by June 2014 were reviewed. The bibliography of each relevant article was searched for additional related reports. The diagnosis of HIT was based on the clinical probability or 4T scoring system and laboratory tests. The exposure to either UFH or low molecular weight heparin (LMWH) in patients with a history of HIT was considered a re-exposure. In two cases, heparin was used multiple times for repeated cardiovascular surgeries after an initial diagnosis of HIT. Each re-exposure was determined as a different instance of re-exposure during analysis. Results A total of 136 patients with a history of HIT had 141 instances of heparin re-exposure. Median age was 56 years (6 weeks -87 yrs) and 67% were males. Regarding the original HIT diagnosis, UFH (98%) and nadroparin (2%) were the causative agents. Thrombotic complications occurred in 23%. The pretest probability score was high in 79% and moderate in 21%. Platelet aggregation studies (66%), enzyme linked immunosorbent assay (ELISA)/enzyme immunoassay (EIA) (20%), serotonin release assay (SRA) (2%), and both SRA and EIA (12%) were performed for diagnosis. Cardiac (76%) and vascular surgeries (11%) were the most common indications for heparin re-exposure. Although 67% were re-exposed to heparin after 3 months of HIT diagnosis, 11%, 8% and 15% were re-exposed within 1 week, between 1 week to 1 month, and 1 month to 3 months of HIT diagnosis respectively. Anti-platelet factor 4/heparin antibodies were positive in 63% before re-exposure. UFH (93%) or LMWH (7%) were the utilized agents during re-exposure. Sixteen patients (11%) underwent plasmapheresis to lower the level of anti-platelet factor 4/heparin antibodies before the re-exposure. Non-heparin anticoagulants such as bivalirudin, fondaparinux, danaparoid, r-hirudin, argatroban, lepirudin, and warfarin were used singly or in combination after the exposure in 63% of patients. With heparin re-exposure, 4.2% had complications, which included recurrence of HIT (2.1%), and bleeding (2.1%). Among the patients with HIT recurrence (n=3), one patient was re-exposed to UFH within a week of HIT diagnosis and shortly after platelet recovery with LMWH (Intensive Care Med. 1991;17(3):185-6.). The other two patients were initially diagnosed with HIT more than 5 years back and tested negative for anti-platelet factor 4/heparin antibody prior to heparin re-exposure. Conclusion A review of the published reports indicates that intra-operative heparin re-exposure in patients with HIT has a small risk of developing thrombocytopenia or recurrence of HIT. The use of pre-exposure plasmapheresis in patients with positive anti-platelet factor 4/heparin antibody and post-exposure non-heparin anticoagulants may have reduced the risk of recurrence of HIT. Given several limitations of such retrospective review, prospective studies are needed to validate these results. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3472-3472
Author(s):  
Sarah Agamah

Background Sickle Cell Disease (SCD) is the most common lethal genetic blood disease in the world, impacting approximately 100,000 people in the US, and about 25 million people worldwide (WHO, CDC 2019). Some literature refers to the SCD patients' barriers to appropriate care as "biopsychospiritual," indicating the complexity of the disease, and hence, call for a multi-dimensional approach to care (Adegbola et al., 2012). Considering the role of energy, protein and Vitamin D deficiency in SCD patients, a multi-dimensional approach to care that includes nutritional supplementation is worth investigating (Hyacinth, Gee and Hibbert 2010). There is limited research that illuminates the relationship between nutrition, food insecurity and health outcomes of those with SCD. Patients with SCD experiencing challenges of undernutrition are more prone to growth retardation in childhood, disease exacerbation, impaired immune function, and poor ulcer healing among other complications (Mandese et al., 2015). In Chicago, Illinois on the South and West Side where many SCD patients live, it is estimated that 35.1%-57.8% of people are food insecure (Gunderson, Dewey, Crumbaugh,Kato & Engelhard, 2016). This study aims to better understand food insecurity for SCD patients at the University of Illinois Hospital and Health Science Systems (UIHHSS) in Chicago, the largest adult sickle cell center in the Midwest. Physicians are uniquely positioned to address health inequities among their patients when they practice patient centered-care (Law, Leung, Veinot, Miller & Mylopoulos, 2016). Research shows that healthcare providers who are aware of external factors such as food insecurity, can be better advocates for their patients, and help them find ways to gain access to healthy foods (Nesbitt and Palomarez, 2016). Methods An exploratory study involving data collection of patient demographics, food consumption, and ability to access food was conducted. All patients at the Sickle Cell Clinic at UIHHSS who were interested in participating received a full explanation of the purpose of the study.Twenty-seven adult patients (19 female, 8 male) were recruited in the Sickle Cell Center waiting room. Food intake by patients with SCD was documented using the validated Food Insecurity Experience Scale (FIES) from the Food and Agriculture Organization (FAO). Participants self-administered the FIES questionnaire, followed by a one-on-one discussion with the interviewer. Qualitative data gathered from the follow-up interviews was used to investigate themes and provide clarity. Demographic information was collected to supplement the screening tool, as it is not a sufficient stand alone measure. Patient zip codes were referenced with the Distressed Community Index (DCI), a comparative measure of community well-being using census bureau data from 2012-2016. Outcomes Results of the analysis indicated the nutritional status of sickle cell patients and identified barriers to food access especially economic factors. Of the twenty-seven patients interviewed, 40% screened moderate and 22% screened as severe for food insecurity. The remaining 48% screening negative for food insecurity, but 80% of all patients did not consume the daily recommended dietary allowance of vegetables and fruits, and 44% worried about having enough money for food, citing that the cost of healthy food was a barrier to eating healthy. Based on zip code, 80% of patients live in a high DCI zone. Discussion and Limitations This study utilizes convenience sampling with a small sample size, which limits external validity. Conclusions from the data should not be made, but rather used to design larger confirmatory studies. The information could aid in aligning undernourished patients with social support and provide potential insight for clinicians into the management of patients with SCD. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4811-4811
Author(s):  
Hafsa Farooq ◽  
Alfred I Lee ◽  
Lawrence Young ◽  
Katharine Henderson

OBJECTIVE:Patients with hereditary hemorrhagic telangiectasia (HHT) and liver arteriovascular malformations (AVMs) may develop high output cardiac failure. Iron deficiency anemia is common in HHT patients and is believed to adversely impact cardiac index (CI) but has not been systemically studied in this population. We performed a retrospective study to assess the relationships among hemoglobin, iron, and CI. METHOD:Chart records were reviewed of HHT patients with liver AVMs who were seen at Yale HHT Center from 2003-2019 and who had undergone cardiac catheterization with calculation of CI. For each patient, clinical history, laboratory studies, and CI were recorded. All variables were categorized according to median of interquartile range and analyzed using Spearman's correlation coefficients. RESULT:Seventeen patients with HHT and liver AVMs were identified who had undergone cardiac catheterization. Median age was 68 years (range, 36-85); 15 were female and 2 males. Median values of hemoglobin, ferritin, and CI were 10.6 g/ld., 35 ng/mL, and 4.77L/m/m2, respectively. A statistically significant, inverse correlation between hemoglobin and CI was observed (R = -0.45, P = 0.03). Serum iron and CI were also negatively correlated although the association was not significant (R = -0.3, P = 0.17). No significant correlation of serum ferritin with CI was seen (R = 0.05, P = 0.8). CONCLUSION:Anemia is negatively correlated with CI in HHT patients with liver AVMs. The impact of iron indices on CI is uncertain and partly limited by our small sample size. Larger studies incorporating multivariable analyses are warranted. Figure Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4938-4938 ◽  
Author(s):  
Zhongbo Hu ◽  
Simone Megan Chang ◽  
Ramzi Younis ◽  
Ofelia A. Alvarez

Abstract Background:The prevalence of obstructive sleep apnea syndrome (OSA) in children with sickle cell disease (SCD) is higher than in the general pediatric population. Adenotonsillectomy involves significantly increased risks in patients with SCD because of the need for general anesthesia,which could induce a vaso-occlusive event. Various preoperative regimens have been suggested to reduce peri-operative risks for SCD patients. Objective: We retrospectively reviewed the perioperative management for pediatric SCD patients undergoing adenotonsillectomy. We sought to identify the optimal preoperative hemoglobin (Hb) level for patients to have lowest risk of post-operative complications. Methods: Children between 1 and 18 years old with SCD including HbSS, HbSC, HbS beta thalassemia (Sβ0 and Sβ+) who underwent adenotonsillectomy from 2007 to 2017 were identified at Holtz Children's Hospital. Patients without these diseases who underwent the procedures were collected as a control. The study was approved by the University of Miami Institutional Review Board (IRB). De-identified data were exported to GraphPad Prism version 5.02 to perform the statistical analyses. Means were analyzed by student t test, rates by Chi-squared test. p < 0.05 is considered statistically significant. Results: Thirty-four patients with SCD (mean 7.1 yrs) and 145 controls (mean 7.0 yrs) were identified with adenotonsillectomy (see Table 1). SCD patients had significant longer hospital stay (2.6 versus 0.9 days, p< 0.001), and higher postoperative complication rates than the control group (20.6% vs 4.0%, p= 0.02). Most of the sickle cell patients' complications were hypoxemia (5 out of 7), except one supraventricular tachycardia and one headache. Four out of 7 patients with pretransfusion (pretrx) Hb level above 10 g/dL received manual exchange transfusion to keep Hb over 10 g/dL. None had complication or PICU stay. When patients' pretrx Hb levels was 9-10 g/dL, 5/8 received transfusion without significant complications, with the goal of not increasing post transfusion Hb over 11.5 g/dL. Most patients with pretrx Hb level 7-9 g/dL received simple blood transfusion. For patients with preoperative Hb level 9-11.5 g/dL, the PICU transfer rate was significantly lower than ones with Hb <9 or >= 11.5 g/dL (11.5% vs 60%, p=0.04; see Figure 1). Complication rates were also lower in the Hb 9-11.5 g/dL group, but without statistical difference (19.2% vs 40%, p=0.3). Data is limited by small sample size in the SCD group. Conclusion(s): We concluded that for pediatric SCD patients planning for adenotonsillectomy, it is better to keep the posttransfusion Hb level at least above 9 mg/dL but less than 11.5 g/dL before procedure to avoid significant post operational complications. If pretransfusion Hb level is above 9 mg/dL, exchange transfusion by partial phlebotomy or simple transfusion (not to exceed 11.5 g/dL) may be considered. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 9 (2) ◽  
pp. 357 ◽  
Author(s):  
Daniel Torassa ◽  
Pablo Naldini ◽  
José Luis Calvo-Guirado ◽  
Enrique Fernández-Bodereau

In many clinical situations, rehabilitation with implants in the posterior maxillary region is complicated by limited bone availability. In this context, the use of 4 mm long implants (known as extra-short implants) may be used thanks to the concept of osseointegration enhancement. It has been demonstrated that short implants offer an alternative to the regeneration procedures involved in placing longer implants in areas where bone height is compromised. This prospective pilot study tested a treatment protocol in which 11 extra-short (4 mm) implants were splinted to 11 mesially placed longer (8 mm) implants in the posterior maxillary regions of partially edentulous patients, without using supplementary bone regeneration procedures. Eleven patients were included in this single cohort study. The clinical performance of the extra-short implants was assessed during a two-year follow-up period, obtaining a 100% survival rate and mean bone loss of 0.3 mm. Implant stability measured by resonance frequency analysis (RFA) at the time of placement was 54.9 ± 4.9, increasing to 77.0 ± 2.6 at 24 months. The study demonstrated the gradual consolidation of osseointegration in bone of less-than-ideal quality in the posterior maxillary region. The results obtained show that a partially edentulous maxilla with reduced bone height may be rehabilitated by using an extra-short implant splinted to a mesial implant of 8mm length or longer. Despite the small sample size, this pilot study observed that extra-short implants achieved adequate bone stability and clinical performance after a 24-month follow-up.


Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 869
Author(s):  
Angela Prendin ◽  
Benedicta Tabacco ◽  
Paola Claudia Fazio ◽  
Veronica Strini ◽  
Luca Brugnaro ◽  
...  

(1) Background: a review of the literature found a lack of standardized pediatric guidelines regarding wound management after cardiac surgery. (2) Objective: the aim of the study is to investigate the cardiac surgical wound management in Italian pediatric cardiac intensive care units. (3) Methods: we sent an online questionnaire to the 13 Italian pediatric cardiac intensive care units. (4) Results: ten pediatric cardiac intensive care units (77%) have a protocol for the management of the cardiac surgical wound. The staff members that mainly have the responsibility for the wound management after cardiac surgery are registered nurses and physicians together both in the pediatric cardiac intensive care units (69%), and when a patient is transferred to another ward (62%). Thirty-eight percent of the pediatric cardiac intensive care units have a protocol used to monitor wound infection, and the staff mostly uses a written shift report (54%) to monitor the infection. (5) Discussion: this is the first survey to investigate the management of the wound after cardiac surgery in Italian pediatric cardiac intensive care units. The small sample size and the fact that the centers involved are only Italian cardiac intensive care units are the limits of this study. (6) Conclusions: in the Italian pediatric cardiac intensive care units it emerged that there is a diversity in the treatments adopted and a lack of specific protocols in the management of the pediatric cardiac surgical wound.


2021 ◽  
Vol 70 (7) ◽  
Author(s):  
William Stokes ◽  
Byron M. Berenger ◽  
Takshveer Singh ◽  
Ifueko Adeghe ◽  
Angela Schneider ◽  
...  

Introduction. The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection. Gap statement. Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size. Aim. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing. Methodology. Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene. Results. In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0–94.1%) and 91.6 % (85.1–95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h (n=62), ID NOW PPA increased to 98.2 %. Conclusion. Results from the ID NOW were reliable, especially when adhering to the manufacturer’s recommendations for testing.


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