scholarly journals Unexpected False-Positive Rates in Pediatric SARS-CoV-2 Serology Using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG Assay

2021 ◽  
Author(s):  
Daniel Geisler ◽  
Megan Culler Freeman ◽  
Glenn J Rapsinski ◽  
Sarah E Wheeler
Keyword(s):  
Performance Studies ◽  
False Positive ◽  
Pediatric Population ◽  
Serum Samples ◽  
Population Prevalence ◽  
False Positivity ◽  
Assay Performance ◽  
Improve Accuracy ◽  
Pediatric Populations ◽  
Serologic Assay

Abstract Objectives Serologic assay performance studies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-​2) in pediatric populations are lacking, and few seroprevalence studies have routinely incorporated orthogonal testing to improve accuracy. Methods Remnant serum samples for routine bloodwork from 2,338 pediatric patients at UPMC Children’s Hospital of Pittsburgh were assessed using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG (EuroIGG) assay. Reactive cases with sufficient volume were also tested using 3 additional commercial assays. Results Eighty-five specimens were reactive according to the EuroIGG, yielding 3.64% (95% confidence interval [CI], 2.91%-4.48%) seropositivity, of which 73 specimens had sufficient remaining volume for confirmation by orthogonal testing. Overall, 19.18% (95% CI, 10.18%-28.18%) of samples were positive on a second and/or third orthogonal assay. This 80.82% false positivity rate is disproportionate to the expected false positivity rate of 50% given our pediatric population prevalence and assay performance. Conclusions In pediatric populations, false-positive SARS-CoV-2 serology may be more common than assay and prevalence parameters would predict, and further studies are needed to establish the performance of SARS-CoV-2 serology in children.

scholarly journals Differential Performance of CoronaCHEK SARS-CoV-2 Lateral Flow Antibody Assay by Geographic Origin of Samples

2021 ◽  
Author(s):  
Owen R Baker ◽  
M. Kate Grabowski ◽  
Ronald M Galiwango ◽  
Aminah Nalumansi ◽  
Jennifer Serwanga ◽  
...  
Keyword(s):  
False Positive ◽  
Geographic Origin ◽  
Febrile Illness ◽  
Lateral Flow ◽  
Serum Samples ◽  
False Positive Test ◽  
Assay Performance ◽  
History Of ◽  
The Impact ◽  
Prevalence Ratios

Background: We assessed the performance of CoronaCHEK lateral flow assay on samples from Uganda and Baltimore to determine the impact of geographic origin on assay performance. Methods: Serum samples from SARS-CoV-2 PCR+ individuals (Uganda: 78 samples from 78 individuals and Baltimore: 266 samples from 38 individuals) and from pre-pandemic individuals (Uganda 1077 and Baltimore 532) were evaluated. Prevalence ratios (PR) were calculated to identify factors associated with a false-positive test. Results: After first positive PCR in Ugandan samples the sensitivity was: 45% (95% CI 24,68) at 0-7 days; 79% (95%CI 64,91) 8-14 days; and 76% (95%CI 50,93) >15 days. In samples from Baltimore, sensitivity was: 39% (95% CI 30, 49) 0-7 days; 86% (95% CI 79,92) 8-14 days; and 100% (95% CI 89,100) 15 days post positive PCR. The specificity of 96.5% (95% CI 97.5,95.2) in Ugandan samples was significantly lower than samples from Baltimore 99.3% (95% CI 98.1,99.8), p<0.01. In Ugandan samples, individuals with a false positive result were more likely to be male (PR 2.04, 95% CI 1.03,3.69) or individuals who had a fever more than a month prior to sample acquisition (PR 2.87, 95% CI 1.12,7.35). Conclusions: Sensitivity of the CoronaCHEK was similar in samples from Uganda and Baltimore. The specificity was significantly lower in Ugandan samples than in Baltimore samples. False positive results in Ugandan samples appear to correlate with a recent history of a febrile illness, potentially indicative of a cross-reactive immune response in individuals from East Africa.

The Safety and Efficacy Evaluation of Dexmedetomidine for Procedural Sedation and Postoperative Behaviors in Pediatric Populations: A Systematic Review and Meta-analysis

2021 ◽  
pp. 106002802110098
Author(s):  
Linguang Gan ◽  
Xiaohong Zhao ◽  
Xiangjian Chen
Keyword(s):  
Pediatric Population ◽  
Meta Analysis ◽  
Procedural Sedation ◽  
Cochrane Library ◽  
Control Group ◽  
High Dose ◽  
Efficacy Evaluation ◽  
Safety And Efficacy ◽  
Ovid Medline ◽  
Pediatric Populations

Background: This study systematically evaluated the safety and efficacy of dexmedetomidine for procedural sedation and postoperative behaviors in a pediatric population as well as whether the results met the information required to draw conclusions. Objective: To evaluate the safety and efficacy evaluation of dexmedetomidine for procedural sedation and postoperative behaviors in a pediatric population. Methods: PubMed, Cochrane library, Web of Science and Ovid MEDLINE were searched to obtain randomized controlled trials (RCTs) comparing dexmedetomidine with control medicine and comparing different doses of dexmedetomidine. Results: There were a total of 16 RCTs for a total of 3240 patients. Dexmedetomidine slowed down the heart rate (HR; mean difference: −13.27; 95% CI: −16.41 to 10.14; P < 0.001) and reduced postoperative delirium (risk ratio [RR]: 0.31; 95% CI: 0.20-0.50; P < 0.001), the number of pain patients (RR: 0.48; 95% CI: 0.30-0.75; P = 0.002), and desaturation (RR: 0.34; 95% CI: 0.13-0.89; P = 0.03) compared with the control group. The limitation was that it was difficult to determine the range of low- and high-dose dexmedetomidine. Conclusion and Relevance: Dexmedetomidine slowed down intraoperative HR within the normal range, which might reduce myocardial oxygen consumption. It reduced postoperative pain and postoperative complications: delirium and desaturation. Dexmedetomidine showed no dose-dependent increase in the procedural sedation time of pediatric patients. Clinically, dexmedetomidine can improve pediatric procedural sedation and postoperative behavior, and it can be considered as a related medicine for safety in pediatric surgery.

scholarly journals Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan

2020 ◽  
Author(s):  
RIn Yokoyama ◽  
Makoto Kurano ◽  
Yoshifumi Morita ◽  
Takuya Shimura ◽  
Yuki Nakano ◽  
...  
Keyword(s):  
Measurement System ◽  
False Positive ◽  
Laboratory Testing ◽  
Antibody Test ◽  
Measurement Range ◽  
Antibody Assay ◽  
Serum Samples ◽  
Igg Antibody ◽  
Antibody Titers ◽  
Pcr Test

PCR methods are presently the standard for the diagnosis of Coronavirus disease 2019 (COVID-19), but additional methodologies are needed to complement PCR methods, which have some limitations. Here, we validated and investigated the usefulness of measuring serum antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the iFlash3000 CLIA analyzer. We measured IgM and IgG titers against SARS-CoV-2 in sera collected from 26 PCR-positive COVID-19 patients, 53 COVID-19-suspected but PCR-negative patients, and 20 and 100 randomly selected non-COVID-19 patients who visited our hospital in 2020 and 2017, respectively. The within-day and between-day precisions were regarded as good, since the coefficient variations were below 5%. Linearity was also considered good between 0.6 AU/mL and 112.7 AU/mL for SARS-CoV-2 IgM and between 3.2 AU/mL and 55.3 AU/mL for SARS-CoV-2 IgG, while the linearity curves plateaued above the upper measurement range. We also confirmed that the seroconversion and no-antibody titers were over the cutoff values in all 100 serum samples collected in 2017. These results indicate that this measurement system successfully detects SARS-CoV-2 IgM/IgG. We observed four false-positive cases in the IgM assay and no false-positive cases in the IgG assay when 111 serum samples known to contain autoantibodies were evaluated. The concordance rates of the antibody test with the PCR test were 98.1% for SARS-CoV-2 IgM and 100% for IgG among PCR-negative cases and 30.8% for SARS-CoV-2 IgM and 73.1% for SARS-CoV-2 IgG among PCR-positive cases. In conclusion, the performance of this measurement system is sufficient for use in laboratory testing.

scholarly journals Physical activity versus metformin for increasing insulin sensitivity in children and adolescents at-risk for type 2 diabetes

2016 ◽  
Vol 85 (2) ◽  
pp. 26-28
Author(s):  
Andrew D Hanna ◽  
Natalie V Scime
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
At Risk ◽  
Insulin Sensitivity ◽  
Children And Adolescents ◽  
Pediatric Population ◽  
Current Evidence ◽  
Beneficial Effects ◽  
Pediatric Populations

Global rates of type 2 diabetes (T2D) among children and adolescents are steadily rising. As such, an increasing amount of attention and research has begun to focus on strategies to prevent this chronic and burdensome disease in pediatric populations. The purpose of this article is to briefly review current evidence pertaining to the effectiveness of physical activity versus metformin in improving insulin sensitivity of children at-risk (ie, obese and/or insulin resistant) for developing T2D. Potential barriers to each preventative intervention will also be discussed. Physical activity, both aerobic and resistance, has demonstrated effectiveness in a moderate number of demographically diverse pediatric studies. However, the pediatric population is already alarmingly sedentary with barriers such as lack of motivation, social stigma and discomfort presenting a challenge. A small number of studies have demonstrated the beneficial effects of metformin in children and adolescents for improved insulin sensitivity. However, longer and larger studies are required to confirm these findings and elucidate upon the long-term safety and efficacy of this pharmaceutical in pediatric populations. While no head-to-head studies examining physical activity and metformin exist in pediatric populations and more research is needed, current evidence seems to favour the use of physical activity given the larger quantity of studies and generalizability of its beneficial effects. Thus, physical activity should be emphasized in clinical and public health practice when targeting at-risk children and adolescents to prevent a T2D diagnosis.

Traumatic brain injury in pediatric patients: evidence for the effectiveness of decompressive surgery

2011 ◽  
Vol 31 (5) ◽  
pp. E5 ◽  
Author(s):  
Geoffrey Appelboom ◽  
Stephen D. Zoller ◽  
Matthew A. Piazza ◽  
Caroline Szpalski ◽  
Samuel S. Bruce ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Adult Population ◽  
Pediatric Trauma ◽  
Anatomical Variations ◽  
Decompressive Surgery ◽  
Pediatric Populations ◽  
The Impact

Traumatic brain injury (TBI) is the current leading cause of death in children over 1 year of age. Adequate management and care of pediatric patients is critical to ensure the best functional outcome in this population. In their controversial trial, Cooper et al. concluded that decompressive craniectomy following TBI did not improve clinical outcome of the analyzed adult population. While the study did not target pediatric populations, the results do raise important and timely clinical questions regarding the effectiveness of decompressive surgery in pediatric patients. There is still a paucity of evidence regarding the effectiveness of this therapy in a pediatric population, and there is an especially noticeable knowledge gap surrounding age-stratified interventions in pediatric trauma. The purposes of this review are to first explore the anatomical variations between pediatric and adult populations in the setting of TBI. Second, the authors assess how these differences between adult and pediatric populations could translate into differences in the impact of decompressive surgery following TBI.

Evaluation of the Diagnostic Criteria for Anti-NMDA Receptor Encephalitis in Japanese Children

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000011789
Author(s):  
Hiroya NISHIDA ◽  
Kuniko KOHYAMA ◽  
Satoko KUMADA ◽  
Jun-ichi TAKANASHI ◽  
Akihisa OKUMURA ◽  
...  
Keyword(s):  
Nmda Receptor ◽  
Diagnostic Criteria ◽  
Predictive Value ◽  
False Positive ◽  
Pediatric Population ◽  
True Positive ◽  
Positive Group ◽  
Nmdar Encephalitis ◽  
Clinical Diagnostic ◽  
Clinical Diagnostic Criteria

OBJECTIVE:To evaluate the validity of the 2016 clinical diagnostic criteria proposed for probable anti-NMDA receptor (NMDAR) encephalitis in children, we tested the criteria in a Japanese pediatric cohort.METHODS:We retrospectively reviewed clinical information of patients with neurological symptoms whose CSF were analyzed for NMDAR antibodies (Abs) in our laboratory from January 1, 2015, to March 31, 2019.RESULTS:Overall, 137 cases were included. Of the 41 cases diagnosed as probable anti-NMDAR encephalitis (“criteria-positive”) according to the 2016 criteria, 13 were positive and 28 were negative for anti-NMDAR Abs. Of the 96 criteria-negative cases, three were positive and 93 were negative for anti-NMDAR Abs. The sensitivity of the criteria was 81.2%, specificity was 76.9%, positive predictive value (PPV) was 31.7%, and negative predictive value was 96.9%. Compared with the true-positive group, the false-positive group contained more male than female patients (male:female, 4:9 in the true-positive vs. 19:9 in the false-positive group, p = 0.0425). The majority of the cases with false-positive diagnoses were associated with neurological autoimmunity.CONCLUSION:The clinical diagnostic criteria are reliable for deciding to start immunomodulatory therapy in the criteria-positive cases. Low PPV may be caused by a lower prevalence of NMDAR encephalitis and/or lower level of suspicion for encephalitis in the pediatric population. Physicians should therefore continue differential diagnosis, focusing especially on other forms of encephalitis.Classification of Evidence:This study provides Class IV evidence that the proposed diagnostic criteria for anti-NMDAR encephalitis in children has a sensitivity of 81.2% and a specificity of 76.9%.

scholarly journals Age- and sex-specific reference intervals for the serum cystatin C/creatinine ratio in healthy children (0–18 years old)

2019 ◽  
Vol 47 (7) ◽  
pp. 3151-3159 ◽  
Author(s):  
Changjin Liu ◽  
Jing Wen ◽  
Jialin Xiang ◽  
Xuhong Ouyang ◽  
Yan Yang ◽  
...  
Keyword(s):  
Cystatin C ◽  
Pediatric Population ◽  
Age Groups ◽  
Serum Markers ◽  
Reference Intervals ◽  
Specific Reference ◽  
Healthy Children ◽  
Serum Samples ◽  
Serum Cystatin C ◽  
Age And Sex

Objective This study aimed to investigate serum levels of the cystatin C (CysC)/creatinine (Cr) ratio and renal serum markers (CysC, Cr, urea, and uric acid [UA]) for different ages and by sex. We also aimed to establish pediatric reference intervals for the serum CysC/Cr ratio. Methods Serum samples were collected from 4765 healthy children (0–18 years old). Serum markers of renal function were measured, and the CysC/Cr ratio of each participant was calculated and statistically analyzed. Results The renal marker CysC did not substantially change after 1 year old. Cr, urea, and UA levels generally increased with age. However, the serum CysC/Cr ratio steadily decreased with age. The CysC/Cr ratio showed significant differences in age among all age groups and varied with sex, except for in the 1 to 6-year-old groups. The overall serum CysC/Cr ratio in girls was higher than that in boys. Conclusion Reference intervals of the serum CysC/Cr ratio in the pediatric population were established. These intervals need to be partitioned by age and sex.

scholarly journals New Automated Immunoassay Measuring Immunoglobulin A Antigliadin Antibodies for Prediction of Celiac Disease in Childhood

2001 ◽  
Vol 8 (3) ◽  
pp. 564-570 ◽  
Author(s):  
E. Grodzinsky ◽  
A. Ivarsson ◽  
P. Juto ◽  
P. Olcén ◽  
K. Fälth-Magnusson ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Characteristic Curve ◽  
Immunoglobulin A ◽  
Total Serum ◽  
Small Intestinal Mucosa ◽  
Serum Samples ◽  
Serological Tests ◽  
Population Prevalence ◽  
Serum Iga ◽  
Antigliadin Antibodies

ABSTRACT The prevalence of celiac disease (CD) in Sweden is about 4 cases per 1,000 people. Screening for CD with serological tests indicates similar high prevalences in many other countries. Between 1 November 1992 and 30 April 1995, 133 children (9 months to 16.7 years of age) with suspected CD were studied. The predictive value (PV) of immunoglobulin A antigliadin antibodies (IgA-AGA) in the serum as assayed with two new commercial automated immunoassays—the Pharmacia CAP System Gliadin IgA FEIA (CAP) and the UNICAP-100 (UNICAP)—and with three “in-house” methods was evaluated using assessment of the small intestinal mucosa morphology as the “gold standard.” All serum samples were analyzed for total serum IgA. At presentation the diagnostic sensitivities and specificities of the different tests varied from 0.72 to 0.88 and 0.67 to 0.87, respectively. All methods showed a higher sensitivity for CD in younger children. The area under each assay's receiver operating characteristic curve was calculated and varied between 0.82 and 0.89. The positive and negative PVs for the CAP and UNICAP, which were assays with a high sensitivity and a high specificity, respectively, were estimated. In the clinically selected population (prevalence of CD, 1 in 3) the positive PV was about 55%, and in the general population (prevalence, 1 in 250) it was about 1%. The negative PVs for both CAP and UNICAP were close to 100%; thus, when the AGA test was negative, the risk for CD was small. Interestingly, five children had serum IgA levels below the detection limit (<0.07 g/liter) when on a gluten-free diet, whereas they had normal levels at the time of the first biopsy. In conclusion, the automated immunoassays—based on ImmunoCAP technology—for analysis of IgA-AGA had a reliability comparable to that of the in-house methods.

scholarly journals Incidence and Characteristics of Vancomycin Nonsusceptible Strains of Methicillin-Resistant Staphylococcus aureus at Hershey Medical Center

2008 ◽  
Vol 52 (12) ◽  
pp. 4510-4513 ◽  
Author(s):  
Klaudia Kosowska-Shick ◽  
Lois M. Ednie ◽  
Pamela McGhee ◽  
Kathy Smith ◽  
Cynthia D. Todd ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
False Positive ◽  
Methicillin Resistant Staphylococcus Aureus ◽  
Medical Center ◽  
Screening Method ◽  
Brain Heart Infusion ◽  
Methicillin Resistant ◽  
Repeat Testing ◽  
False Positivity ◽  
Positive Results

ABSTRACT All 982 methicillin-resistant Staphylococcus aureus strains collected from August 2006 to December 2007 were tested for vancomycin susceptibility by using 3-μg/ml vancomycin brain heart infusion screening plates, a vancomycin Etest, and a vancomycin/teicoplanin macro Etest. Three vancomycin-intermediate Staphylococcus aureus (VISA) (0.3%) and two heterogeneous VISA (0.2%) isolates were identified. The screening method yielded 895 cases of ≤1 colony and 87 positive results (with growth of >1 colony after 48 h); further Etests showed 82/87 isolates with growth on screening plates to be false positive. Repeat testing showed a false-positivity rate of only 15 of the original 87 isolates by plate screening.

False-Positive Titers of Thyroid Autoantibodies in Patients Undergoing Hemodialysis?

1991 ◽  
Vol 37 (12) ◽  
pp. 2153-2154 ◽  
Author(s):  
Ljerka Lukinac ◽  
Zvonko Kusic ◽  
Petar Kes
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
False Positive ◽  
Serum Samples ◽  
Standard Procedures ◽  
Before And After ◽  
Thyroid Function Testing ◽  
Total Triiodothyronine ◽  
The Difference ◽  
Function Testing

Abstract Concentrations of thyroid-related hormones in serum of patients with chronic renal failure are known to be abnormal (1, 2). In our study on thyroid-function testing of patients undergoing hemodialysis, we determined, in addition to concentrations of free and total triiodothyronine, free and total thyroxin, “reverse” triiodothyronine, and thyroxin-binding globulin, the titers of thyroglobulin and microsomal autoantibodies (TGA and TMA, respectively). The study was provoked by the appearance of an uncommon agglutination pattern in the control wells of some samples from patients with chronic renal failure during the standard procedures of detecting TGA and TMA with hemagglutination methods (Thymune-T and Thymune-M assays from Welcome, London, U.K.). For these samples we were not certain whether positive titers for TGA and (or) TMA represented false-positive or true-positive values. Therefore, we assayed the absorbed serum samples and samples after addition of excess nonspecific immunoglobulin. Furthermore, we wanted to determine the difference in TGA and TMA titers of serum samples before and after hemodialysis.

Sign in / Sign up

Export Citation Format

Share Document