Evaluation of a rapid antigen detection test (Panbio™ COVID-19 Ag Rapid Test Device) as a point-of-care diagnostic tool for COVID-19 in a pediatric emergency department.
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SUBMITTER: Carbonell-Sahuquillo S
PROVIDER: S-EPMC8426967 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesThere is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for this purpose.MethodsA total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Two nasopharyngeal swabs were collected from household (n = 338) and non-household contacts (n = 296) of COVID-19 cases. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, MA, USA).ResultsHousehold contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case, whereas non-household contacts (n = 296) were tested at a median of 6 days (range, 1-7) after exposure. In total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI 37.4-58.9) and 100% (95% CI 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI 38.9-62.5) than in non-household (35.7%; 95% CI 16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (p < 0.001) to become symptomatic than their negative counterparts.DiscussionThe Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.
| S-EPMC7833843 | biostudies-literature
Project description: Not available
| S-EPMC8111145 | biostudies-literature
Project description:The standard RT-PCR assay for coronavirus disease 2019 (COVID-19) is laborious and time-consuming, limiting testing availability. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the Panbio™ COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swab specimens. This prospective multicentre study was carried out in ten Spanish university hospitals and included individuals with clinical symptoms or epidemiological criteria of COVID-19. Only individuals with ≤7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the PanbioRT as a point-of-care test and a diagnostic RT-PCR test. Among the 958 patients studied, 325 (90.5%) had true-positive results. The overall sensitivity and specificity for the PanbioRT were 90.5% (95%CI 87.5-93.6) and 98.8% (95%CI 98-99.7), respectively. Sensitivity in participants who had a threshold cycle (CT) < 25 for the RT-PCR test was 99.5% (95%CI 98.4-100), and in participants with ≤5 days of the clinical course it was 91.8% (95%CI 88.8-94.8). Agreement between techniques was 95.7% (κ score 0.90; 95%CI 0.88-0.93). The PanbioRT performs well clinically, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. The results must be interpreted based on the local epidemiological context.
| S-EPMC7884234 | biostudies-literature
Project description:ObjectiveReverse transcription-polymerase chain reaction is a gold standard diagnostic tool for coronavirus disease-2019. Limited coverage and long turnaround times are linked to the poor response to the pandemic in developing countries like Ethiopia. To overcome the challenges, rapid antigen diagnostic kits are recommended if their diagnostic performance is at an acceptable level. We explored the performance of the Panbio™ coronavirus disease-2019 antigen rapid diagnostic test in diagnosing the coronavirus disease-2019 infection.MethodsA cross-sectional study was conducted on coronavirus disease-2019 suspected patients in Wollega University Referral Hospital, from 1 April to 30 May 2021. After obtaining consent/ assent, sociodemographic and pair of nasopharyngeal samples were collected from each and examined by Panbio antigen rapid diagnostic test and reverse transcription-polymerase chain reaction. Data were entered and analysed using SPSS version 24. Sensitivity, specificity, positive and negative predictive values, and kappa values were calculated.ResultsA total of 148 coronavirus disease-2019 suspected individuals (54.1% male) participated in the study. Of all, 73 (49.3%) were positive for severe acute respiratory syndrome corona virus by reverse transcription-polymerase chain reaction test. The sensitivity and specificity of Panbio were found 81% (95% confidence interval: 71%-91%) and 98.7% (95% confidence interval: 96%-100%), respectively. From 75 negative and 73 positive samples by reverse transcription-polymerase chain reaction, 1 (1.33%) and 14 (19.18%) were found false positive and negative by antigen rapid diagnostic test, respectively. Positive predictive value and negative predictive value of Panbio were 98.3% and 84.1%, respectively, and test agreement was substantial (kappa value = 0.80).ConclusionPanbio has fine performance in suspected patients. Further studies are needed to examine the accuracy of self-collecting and patient self-testing with healthcare workers, using antigen rapid diagnostic test against the reference standard.
| S-EPMC9289906 | biostudies-literature
Project description:ObjectivesWe aimed to evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.MethodsThe study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.FindingsA total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.InterpretationAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our data do not support the sole use of Panbio™ Ag-RDT in asymptomatic individuals.FundingNone.
| S-EPMC7881288 | biostudies-literature
Project description:PurposeHealthcare workers have experienced high levels of anxiety during the COVID-19 pandemic, particularly when caring for patients with unknown infection status. We trialled rapid preoperative point-of-care COVID-19 testing using the Abbott ID NOW™ COVID-19 for clinical validation in an urgent surgical population at a single centre in British Columbia, Canada. Here, we sought to determine the opinions and beliefs of operating room (OR) staff on the usefulness and effectiveness of point-of-care tests on workflow and wellbeing in the OR.MethodsThis descriptive study used a mixed-methods cross-sectional survey of all OR staff (nurses, anesthesiologists, surgeons, and ancillary staff) at a single centre after using the ID NOW for three months. Outcomes of interest included healthcare worker satisfaction with the ID NOW, effects on OR workflow, and worries about COVID-19 transmission.ResultsThe overall response rate was 56% (n = 133), and was highest among anesthesiologists (100%, n = 38). Respondents were satisfied with the performance of the ID NOW for rapid COVID-19 testing in preoperative patients, giving it a mean (standard deviation [SD]) rate of 4.4 [1.4] on a five-point scale. Most (115/128, 90%) recommended continued use of the ID NOW on asymptomatic patients while there are active cases of COVID-19 in the community. Respondents felt that preoperative COVID-19 testing with the ID NOW made the OR safer for staff (mean [SD] rate, 4.2 [0.8]) and patients (mean [SD] rate, 4.0 [0.9]).ConclusionDuring the COVID-19 pandemic, it is important to maintain the physical and mental wellbeing of hospital staff. Rapid point-of-care testing increased the sense of workplace safety, improved morale, and reduced worry associated with COVID-19 without excessive disruption of OR workflow.
| S-EPMC8296831 | biostudies-literature
Project description:The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag-RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We evaluated Panbio and SD-Biosensor Ag-RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (C t ) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD-Biosensor. Sensitivity for samples with C t ≤ 20 was 100% for both assays and for samples with C t = 20-25 was 93.0% (Panbio) and 95.3% (SD-Biosensor) (p = 1.000). Sensitivity decreased for samples wit C t = 25-30 (Panbio: 41.3%, SD-Biosensor: 52.2%, p = 0.125) and samples with C t ≥ 30 (Panbio: 5.0%, SD-Biosensor: 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD-Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (C t ≤ 25): Panbio, 98.9%, kappa = 0.974; SD-Biosensor, 97.4%, kappa = 0.940. Agreement between Ag-RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD-Biosensor Ag-RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (C t ≤ 25) or samples within seven d.p.o.
| S-EPMC8242635 | biostudies-literature
Project description: Not available
| S-EPMC7879056 | biostudies-literature
Project description:AimsTo validate the diagnostic accuracy of the Augurix SARS-CoV-2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID-19.MethodsIn this unmatched 1:1 case-control study, blood samples from 46 real-time RT-PCR-confirmed SARS-CoV-2 hospitalized cases and 45 healthy donors (negative controls) were studied. Diagnostic accuracy of the IgG RDT was assessed against both an in-house recombinant spike-expressing immunofluorescence assay (rIFA), as an established reference method (primary endpoint), and the Euroimmun SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) (secondary endpoint).ResultsCOVID-19 patients were more likely to be male (61% vs 20%; P = .0001) and older (median 66 vs 47 years old; P < .001) than controls. Whole blood IgG-RDT results showed 86% and 93% overall Kendall concordance with rIFA and IgG ELISA, respectively. IgG RDT performances were similar between plasma and whole blood. Overall, RDT sensitivity was 88% (95% confidence interval [95%CI]: 70-96), specificity 98% (95%CI: 90-100), PPV 97% (95%CI: 80-100) and NPV 94% (95%CI: 84-98). The IgG-RDT carried out from 0 to 6 days, 7 to 14 days and > 14 days after the SARS-CoV-2 RT-PCR test displayed 30%, 73% and 100% positivity rates in the COVID-19 group, respectively. When considering samples taken >14 days after RT-PCR diagnosis, NPV was 100% (95%CI:90-100), and PPV was 100% (95%CI:72-100).ConclusionsThe Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings, where its use could be considered in the absence of routine diagnostic serology facilities.
| S-EPMC7404380 | biostudies-literature
Project description:AIMS:Providing a ready-to-use reverse transcriptase qPCR (RT-qPCR) method fully validated to detect the SARS-CoV-2 with a higher exclusivity than this shown by early published RT-qPCR designs. METHODS AND RESULTS:The specificity of the GPS™ CoVID-19 dtec-RT-qPCR test by analysis of sequence alignments was approached and compared with other RT-qPCR designs. The GPS™ CoVID-19 dtec-RT-qPCR test was validated following criteria of UNE/EN ISO 17025:2005 and ISO/IEC 15189:2012. Diagnostic validation was achieved by two independent reference laboratories, the Instituto de Salud Carlos III, (Madrid, Spain), the Public Health England (Colindale, London, UK), and received the label CE-IVD. The GPS design showed the highest exclusivity and passed all parameters of validation with strict acceptance criteria. Results from reference laboratories 100% correlated with these obtained by using reference methods and showed 100% of diagnostic sensitivity and specificity. CONCLUSIONS:The CE-IVD GPS™ CoVID-19 dtec-RT-qPCR test, available worldwide with full analytical and diagnostic validation, is the more exclusive for SARS-CoV-2 by far. SIGNIFICANCE AND IMPACT OF THE STUDY:Considering the CoVID-19 pandemic status, the exclusivity of RT-qPCR tests is crucial to avoid false positives due to related coronaviruses. This work provides of a highly specific and validated RT-qPCR method for detection of SARS-CoV-2, which represents a case of efficient transfer of technology successfully used since the pandemic was declared.
| S-EPMC7405274 | biostudies-literature