scholarly journals Side-by-Side Comparison of Three Fully Automated SARS-CoV-2 Antibody Assays with a Focus on Specificity

2020 ◽  
Vol 66 (11) ◽  
pp. 1405-1413 ◽  
Author(s):  
Thomas Perkmann ◽  
Nicole Perkmann-Nagele ◽  
Marie-Kathrin Breyer ◽  
Robab Breyer-Kohansal ◽  
Otto C Burghuber ◽  
...  

Abstract Background In the context of the COVID-19 pandemic, numerous new serological test systems for the detection of anti-SARS-CoV-2 antibodies rapidly have become available. However, the clinical performance of many of these is still insufficiently described. Therefore, we compared 3 commercial CE-marked, SARS-CoV-2 antibody assays side by side. Methods We included a total of 1154 specimens from pre-COVID-19 times and 65 samples from COVID-19 patients (≥14 days after symptom onset) to evaluate the test performance of SARS-CoV-2 serological assays by Abbott, Roche, and DiaSorin. Results All 3 assays presented with high specificities: 99.2% (98.6–99.7) for Abbott, 99.7% (99.2–100.0) for Roche, and 98.3% (97.3–98.9) for DiaSorin. In contrast to the manufacturers’ specifications, sensitivities only ranged from 83.1% to 89.2%. Although the 3 methods were in good agreement (Cohen’s Kappa 0.71–0.87), McNemar tests revealed significant differences between results obtained from Roche and DiaSorin. However, at low seroprevalences, the minor differences in specificity resulted in profound discrepancies of positive predictive values at 1% seroprevalence: 52.3% (36.2–67.9), 77.6% (52.8–91.5), and 32.6% (23.6–43.1) for Abbott, Roche, and DiaSorin, respectively. Conclusion We found diagnostically relevant differences in specificities for the anti-SARS-CoV-2 antibody assays by Abbott, Roche, and DiaSorin that have a significant impact on the positive predictive values of these tests.

Author(s):  
Thomas Perkmann ◽  
Nicole Perkmann-Nagele ◽  
Marie-Kathrin Breyer ◽  
Robab Breyer-Kohansal ◽  
Otto C Burghuber ◽  
...  

ABSTRACTBackgroundIn the context of the COVID-19 pandemic, numerous new serological test systems for the detection of anti-SARS-CoV-2 antibodies have become available quickly. However, the clinical performance of many of them is still insufficiently described. Therefore we compared three commercial, CE-marked, SARS-CoV-2 antibody assays side by side.MethodsWe included a total of 1,154 specimens from pre-COVID-19 times and 65 samples from COVID-19 patients (≥14 days after symptom onset) to evaluate the test performance of SARS-CoV-2 serological assays by Abbott, Roche, and DiaSorin.ResultsAll three assays presented with high specificities: 99.2% (98.6-99.7) for Abbott, 99.7% (99.2-100.0) for Roche, and 98.3% (97.3-98.9) for DiaSorin. In contrast to the manufacturers’ specifications, sensitivities only ranged from 83.1% to 89.2%. Although the three methods were in good agreement (Cohen’s Kappa 0.71-0.87), McNemar’s test revealed significant differences between results obtained from Roche and DiaSorin. However, at low seroprevalences, the minor differences in specificity resulted in profound discrepancies of positive predictability at 1% seroprevalence: 52.3% (36.2-67.9), 77.6% (52.8-91.5), and 32.6% (23.6-43.1) for Abbott, Roche, and DiaSorin, respectively.ConclusionWe find diagnostically relevant differences in specificities for the anti-SARS-CoV-2 antibody assays by Abbott, Roche, and DiaSorin that have a significant impact on the positive predictability of these tests.


Author(s):  
Aparajita Dasgupta ◽  
Foulisa Pyrbot ◽  
Bobby Paul ◽  
Soumit Roy ◽  
Pritam Ghosh ◽  
...  

Introduction: Hypertension is a major risk factor for cardiovascular and cerebrovascular diseases. Thus, regular and accurate measurement of Blood Pressure (BP) is essential for its early diagnosis and follow-up. There is a surge in popularity of digital sphygmomanometer due to its convenience of use and functionality. In contrast, the traditional universally accepted sphygmomanometer is aneroid type, hence there arise a need for comparison of digital and universally accepted Aneroid Sphygmomanometer in terms of agreement and correlation. Aim: To evaluate the agreement and correlation between blood pressure measurement by digital and aneroid sphygmomanometer. Materials and Methods: The clinic based cross-sectional study was conducted in the Out Patient Department (OPD) of Urban Heath Centre, All India Institute of Hygiene and Public Health, Kolkata, West Bengal, India. Adults visiting the OPD on two chosen days of the week, between June 2019 to July 2019 were selected using systematic random sampling. A total of 400 participants were included. Agreement and correlation between BP measurements by digital and aneroid sphygmomanometer was analysed by Cohen’s Kappa, Bland Altman Plot along with sensitivity, specificity and predictive values using Microsoft Excel and Statistical Package for the Social Sciences (SPSS) version 16.0. the p-value <0.05 was considered significant for the statistical test in the analysis. Results: Cohen’s Kappa value (0.59) revealed these two tools had moderate agreement in diagnosing hypertension. Sensitivity and specificity of digital sphygmomanometer taking aneroid sphygmomanometer as gold standard is 86% and 83.1% respectively. The BP readings of these two-tools showed moderate correlation as Intraclass Correlation Coefficient (ICC) for Systolic BP (SBP) and Diastolic BP (DBP) were 0.804 and 0.624, respectively. Bland Altman plot showed gross disagreement of SBP findings and disagreement between DBP findings was also noted. Conclusion: Digital device was found to be less accurate in detecting hypertension. Therefore, more similar research work is solicited to verify the accuracy of the very easy to use, the Digital BP monitor.


Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1436 ◽  
Author(s):  
Adelle M. Gadowski ◽  
Tracy A. McCaffrey ◽  
Stephane Heritier ◽  
Andrea J. Curtis ◽  
Natalie Nanayakkara ◽  
...  

The aim of this study was to assess the relative validity and reproducibility of a six-item Australian Short Dietary Screener (Aus-SDS). The Aus-SDS assessed the daily intake of core food groups (vegetables, fruits, legumes and beans, cereals, protein sources and dairy sources) in 100 Australians (52 males and 48 females) aged ≥70 years. Relative validity was assessed by comparing intakes from the Aus-SDS1 with an average of three 24-h recalls (24-HRs), and reproducibility using two administrations of the Aus-SDS (Aus-SDS1 and Aus-SDS2). Cohen’s kappa statistic between the Aus-SDS1 and 24-HRs showed moderate to good agreement, ranging from 0.44 for fruits and dairy to 0.64 for protein. There was poor agreement for legume intake (0.12). Bland–Altman plots demonstrated acceptable limits of agreement between the Aus-SDS1 and 24-HRs for all food groups. Median intakes obtained from Aus-SDS1 and Aus-SDS2 did not differ. For all food groups, Cohen’s kappa statistic ranged from 0.68 to 0.89, indicating acceptable agreement between the Aus-SDS1 and Aus-SDS2. Spearman’s correlation coefficient between Aus-SDS1 and 24-HRs across all food groups ranged from 0.64 for fruit to 0.83 for protein. We found the Aus-SDS to be a useful tool in assessing daily intake of core food groups in this population.


2021 ◽  
pp. 1-35
Author(s):  
Jun S Lai ◽  
Jason Loh ◽  
Jia Ying Toh ◽  
Ray Sugianto ◽  
Marjorelee T Colega ◽  
...  

Abstract Advances in technology enabled the development of a web-based, pictorial food frequency questionnaire (FFQ) to collect parent-report dietary intakes of 7-year-old children in the GUSTO study. This study aimed to compare intakes estimated from a paper-FFQ and a web-FFQ, and examine the relative validity of both FFQs against 3-day diet records (3DDR). Ninety-two mothers reported food intakes of their 7-year-old child on a paper-FFQ, a web-FFQ and a 3DDR. A usability questionnaire collected participants’ feedback on the web-FFQ. Correlations and agreement in energy, nutrients and food groups intakes between the dietary assessments were evaluated using Pearson’s correlation, Lin’s concordance, Bland-Altman plots, Cohen’s kappa and tertile classification. The paper- and web-FFQ had good correlations (≥0.50) and acceptable-good agreement (Lin’s concordance ≥0.30; Cohen’s kappa ≥0.41; ≥50% correct and ≤10% mis-classification into same or extreme tertiles). Compared to 3DDR, both FFQs showed poor agreement (<0.30) in assessing absolute intakes except micronutrients (web-FFQ had acceptable-good agreement); but showed acceptable-good ability to classify children into tertiles (κ≥0.21; ≥40% and ≤15% correct or misclassification). Bland-Altman plots suggest good agreement between web-FFQ and 3DDR in assessing micronutrients and several food groups. The web-FFQ was well-received (e.g. >89% found it user-friendly), and majority (81%) preferred the web-FFQ over the paper-FFQ. The newly developed web-FFQ produced intake estimates comparable to the paper-FFQ, has acceptable-good agreement with 3DDR in assessing absolute micronutrients intakes, and acceptable-good ability to classify children according to categories of intakes. The positive acceptance of the web-FFQ makes it a feasible tool for future dietary data collection.


2020 ◽  
Author(s):  
Ousenu Karimo ◽  
Innocent Mbulli Ali ◽  
Leonard Fonkeng Sama ◽  
Francois Marcel Nsangou Ndam ◽  
Thibau Florant Tchouangueu ◽  
...  

Abstract Background: The diagnosis of Typhoid fever, based on the Widal slide agglutination test, remains a major hurdle in developing countries like Cameroon due to varied perceptions of the value of the Widal test in determining clinical decision making. We undertook a study to evaluate the diagnostic performance of the Widal test and the typhidot immunoassay in patients suspected of having typhoid fever in the Menoua division, West Region of Cameroon. Methods: Blood and stool samples were collected from 558 consenting febrile patients on the basis of suspicion of typhoid fever. These patients attended three district health services of the Menoua division between April 2018 and September 2019. These patients had clinical symptoms suggestive of typhoid fever as determined by their consultant. Serum from whole blood was used for the Widal slide agglutination test and for the Typhidot rapid immunoassay test based on manufacturer’s guidelines. A composite reference of fever plus positive coproculture for Salmonella enteric serovars typhi and paratyphi was used as reference. The sensitivity, specificity, predictive values of the positive and negative tests were calculated as well as the Cohen’s Kappa for agreement between the two tests. Results: Of 558 patients, 12.90% tested positive for the reference method, 57.17% tested positive for the Widal slide agglutination test while 15.59% were positive for typhidot-IgM. The overall sensitivity, specificity, predictive values of the positive and negative tests were 80.56%, 94.03%, 66.6% and 97.03% respectively for typhidot-IgM; 94.44%, 48.35%, 21.32% and 98.33% for Widal slide agglutination test. The Cohen’s kappa estimates were 0.1660 (0.121-0.211), 0.386 (0.312-0.460) for Widal test and typhidot immunoassay respectively, with agreements of 53.76% and 76.16% respectively. Conclusion: The Widal test was found to have a lower predictive value for the diagnosis of typhoid fever in our setting. However, the Typhidot test, although better, was not ideal. Diagnosis of typhoid fever should therefore rely on adequate clinical suspicion and a positive Typhidot test to improve the clinical management of Typhoid fever in our setting.


2021 ◽  
Vol 9 ◽  
Author(s):  
Pellegrino Cerino ◽  
Alfonso Gallo ◽  
Biancamaria Pierri ◽  
Carlo Buonerba ◽  
Denise Di Concilio ◽  
...  

The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG–IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Abbott IgG, Siemens, and Roche total Ig tests, respectively. When we explored the agreement among the rapid tests and the serologic assays, we reported good agreement for Abbott, Siemens, and Roche (Cohen's Kappa coefficient 0.69, 0.67, and 0.67, respectively), whereas we found moderate agreement for Liaison (Cohen's kappa coefficient 0.58). Our study showed that Abbott and Liaison SARS-CoV-2 CLIA IgG, Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays, and LFIA Technogenetics IgG-IgM COVID-19 have good agreement in seroprevalence assessment. In addition, our findings indicate that the prevalence of IgG and total Ig antibodies against SARS-CoV-2 at the time of the study was as low as around 3%, likely explaining the amplitude of the current second wave.


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Renata Baronaite ◽  
Merete Engelhart ◽  
Troels Mørk Hansen ◽  
Gorm Thamsborg ◽  
Hanne Slott Jensen ◽  
...  

Anti-nuclear antibodies (ANA) have traditionally been evaluated using indirect fluorescence assays (IFA) with HEp-2 cells. Quantitative immunoassays (EIA) have replaced the use of HEp-2 cells in some laboratories. Here, we evaluated ANA in 400 consecutive and unselected routinely referred patients using IFA and automated EIA techniques. The IFA results generated by two independent laboratories were compared with the EIA results from antibodies against double-stranded DNA (dsDNA), from ANA screening, and from tests of the seven included subantigens. The final IFA and EIA results for 386 unique patients were compared. The majority of the results were the same between the two methods (n=325, 84%); however, 8% (n=30) yielded equivocal results (equivocal-negative and equivocal-positive) and 8% (n=31) yielded divergent results (positive-negative). The results showed fairly good agreement, with Cohen’s kappa value of 0.30 (95% confidence interval (CI) = 0.14–0.46), which decreased to 0.23 (95% CI = 0.06–0.40) when the results for dsDNA were omitted. The EIA method was less reliable for assessing nuclear and speckled reactivity patterns, whereas the IFA method presented difficulties detecting dsDNA and Ro activity. The automated EIA method was performed in a similar way to the conventional IFA method using HEp-2 cells; thus, automated EIA may be used as a screening test.


Author(s):  
Marija Sarić Matutinović ◽  
Tania Diana ◽  
Biljana Nedeljković Beleslin ◽  
Jasmina Ćirić ◽  
Miloš Žarković ◽  
...  

Background: Thyrotropin receptor autoantibodies (TSH-R-Ab) are indispensable biomarkers in the laboratory assessment of thyroid-associated orbitopathy (TAO). Clinical sensitivity of three different assays for TSH-R-Ab determination was evaluated in patients with TAO. Methods: 87 consecutive TAO patients were enrolled and their serum samples analyzed in parallel with three assays. An ECLIA competitive binding and a chemiluminescent bridge immunoassay were used to measure total and binding TSH-R-Ab concentration, while their functional activity was determined using a stimulatory TSH-R-Ab (TSAb) cell-based bioassay. Results: Compared to the two binding assays (ECLIA p<0.001, bridge p=0.003), the TSAb bioassay was more sensitive pertaining to the positive detection of TSH-R-Ab in TAO patients. No difference (p=0.057) was noted between the ECLIA and bridge assays regarding sensitivity rate. All patients with active and/or moderate-to-severe TAO tested positive in the TSAb bioassay (100% and 100%, respectively), while the positivity rates for bridge and ECLIA binding assays were 89.7% and 82.1% for active TAO, and 90.2% and 86.3% for severe TAO, respectively. Negative predictive values of the bioassay, bridge, and ECLIA assays were 100%, 75%, and 71%, respectively for active TAO, and 100%, 86%, and 71%, respectively for moderate-to-severe TAO. The superiority of the bioassay was most prominent in euthyroid (ET) TAO. Positivity rates of the TSAb bioassay, bridge and ECLIA binding assays were 89.6%, 75%, and 64.6%, respectively for inactive TAO; 86.1%, 69.4%, and 52.8%, respectively for mild TAO; 87.5%, 62.5%, and 12.5%, respectively for euthyroid TAO. The bridge assay correlated better with the ECLIA binding assay (ρ=0.893, p<0.001), compared to the bioassay (ρ=0.669, p<0.001). Conclusions: In patients with TAO of various activity and severity, the TSAb bioassay demonstrates a superior clinical performance compared to both ECLIA and bridge binding assays.


2018 ◽  
Vol 8 (4) ◽  
pp. 54-57
Author(s):  
Sabina Poudel ◽  
Minu Dhungana ◽  
Rajani Karki ◽  
Prabhat Shrestha

Introduction: Lateral throat form (LTF) is the critical area which has to be recorded properly for obtaining proper retention and stability in complete denture especially in geriatric patients with resorbed ridges. Popular method used for determining LTF is Neil’s method which depends on the forces applied by the floor of mouth when the tongues protrude out. Since the perception of the forces differs among different operators, there are high chances of error in the classification. So, customized instrument was fabricated to prevent this inter-observer variation. The aim of the study was to compare the inter-observer accuracy between Neil’s method of classifi­cation and classification done by customized gauze. Methods and methodology: Total 30 edentulous patients were taken. Two observers measured the LTF depth by customized tool and also by Neil’s method. Cohen’s kappa test was used to evaluate the agreement between two operators in two different classifications. Result: The agreement between the two observers was evaluated by means of Cohen’s kappa value. There was good agreement between observers in proposed classification done by customized tool with kappa value 0.658 and fair inter-observer agreement with kappa value 0.0492. Conclusion: The method of measuring the depth of LTF with fabricated instrument was more accurate and reliable than Neil’s method.


Author(s):  
Karimo Ousenu ◽  
Innocent Mbulli Ali ◽  
Leonard Fonkeng Sama ◽  
Marcel Nsangou Ndam ◽  
Thibau Florant Tchouangueu ◽  
...  

Background. The diagnosis of typhoid fever based on the Widal slide agglutination test remains a major hurdle in developing countries due to varied perceptions of the value of the Widal test in determining clinical decision-making. We undertook a study to evaluate the diagnostic performance of the Widal test and the Typhidot immunoassay in patients suspected of having typhoid fever in the Menoua division, West Region of Cameroon. Methods. Blood and stool samples were collected from 558 consenting febrile patients on the basis of suspicion of typhoid fever. These patients attended three district health services of the Menoua division between April 2018 and September 2019. These patients had clinical symptoms suggestive of typhoid fever as determined by their consultant. Serum was used for the Widal slide agglutination test and for the Typhidot rapid immunoassay test based on manufacturer’s guidelines. A composite reference of fever plus positive coproculture for Salmonella typhi and Salmonella paratyphi was used as the reference. The sensitivity, specificity, and predictive values of the positive and negative tests were calculated as well as Cohen’s kappa for agreement between the two tests. Results. Of 558 patients, 12.90% tested positive for the reference method, 57.17% tested positive for the Widal slide agglutination test, while 15.59% were positive for Typhidot-IgM. The overall sensitivity, specificity, and predictive values of the positive and negative tests were 80.56%, 94.03%, 66.6%, and 97.03% for Typhidot-IgM and 94.44%, 48.35%, 21.32%, and 98.33% for the Widal slide agglutination test, respectively. Cohen’s kappa estimates were 0.1660 (0.121–0.211) and 0.386 (0.312–0.460) for the Widal test and Typhidot immunoassay for 53.6% and 76.16% agreements of all observations, respectively. Conclusion. The Widal test was found to have a lower predictive value for the diagnosis of typhoid fever in our setting. However, the Typhidot test, although better, was not ideal. Diagnosis of typhoid fever should therefore rely on adequate clinical suspicion and a positive Typhidot test to improve the clinical management of typhoid fever in our setting.


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