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:ObjectivesTo our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.MethodsRAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR.ResultsOut of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11).ConclusionThe Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.
| S-EPMC7662075 | biostudies-literature
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:Background Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97%. Methods This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention’s (CDC) rRT-PCR test. Results We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8–26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4–50.9%), specificity 98.5% (95% CI: 97.8–99.0%), PPV 90.8% (95% CI: 86.8–93.9%) and NPV 85.0% (95% CI: 83.4–86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3–66.7%) and specificity was 98.1% (95% CI: 96.7–99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3–40.4%) and specificity was 98.7% (95% CI: 97.8–99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2–74.3%), and 53.3% (95% CI: 40.0–66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9–91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30. Conclusion The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR.
| S-EPMC9876661 | 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:Rapid on-site diagnosis of emerging pathogens is key for early identification of infected individuals and for prevention of further spreading in a population. Currently available molecular diagnostic tests are instrument-based whereas rapid antibody and antigen tests are often not sufficiently sensitive for detection in pre-symptomatic subjects. There is a need for rapid point of care molecular screening tests that can be easily adapted to emerging pathogens and are selective, sensitive, reliable in different settings around the world. We have developed a simple, rapid (<30 min), and inexpensive test for SARS-CoV-2 that is based on combination of isothermal reverse transcription recombinase polymerase amplification (RT-RPA) using modified primers and visual detection with paper-based microfluidics. Our test (CoRapID) is specific for SARS-CoV-2 (alpha to omicron variants) and does not detect other coronaviruses and pathogens by in silico and in vitro analysis. A two-step test protocol was developed with stable lyophilized reagents that reduces handling by using portable and disposable components (droppers, microapplicators/swabs, paper-strips). After optimization of assay components and conditions, we have achieved a limit of detection (LoD) of 1 copy/reaction by adding a blocking primer to the lateral flow assay. Using a set of 138 clinical samples, a sensitivity of 88.1% (P < 0.05, CI: 78.2-93.8%) and specificity of 93.9% (P < 0.05, CI: 85.4-97.6%) was determined. The lack of need for instrumentation for our CoRapID makes it an ideal on-site primary screening tool for local hospitals, doctors' offices, senior homes, workplaces, and in remote settings around the world that often do not have access to clinical laboratories.
| S-EPMC9890548 | 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