Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19.
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ABSTRACT:
SUBMITTER: Fenollar F
PROVIDER: S-EPMC8111145 | 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:We evaluated the Panbio™ COVID-19 Ag Rapid Test Device as a point-of-care diagnostic tool for COVID-19 in 357 patients at a pediatric emergency department. Thirty-four patients tested positive by reverse transcription polymerase chain reaction, of which 24 were positive by the antigen assay. The sensitivity and specificity of the assay were 70.5% and 100%, respectively.
| S-EPMC8426967 | 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: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:BackgroundAntigen-based point-of-care tests for identification of SARS-CoV-2 may markedly enhance effectiveness of population-based controlling strategies. Previous studies have demonstrated >70% sensitivity and high specificity compared with reverse transcriptase real-time PCR (RT-PCR) in symptomatic individuals, but test performance for asymptomatic individuals is unknown.MethodsTest performance of the Panbio COVID-19 Ag Rapid Test (Abbott) was compared with RT-PCR in a longitudinal cohort study of asymptomatic football players and staff members of professional football clubs. Based on timing of symptoms and prior and subsequent test results, positive RT-PCR tests were categorised as presymptomatic, early or late infection, or persistent RNA shedding.Findings2425 tests were performed in 824 individuals, of which 52 (6.3%) were SARS-CoV-2 positive based on RT-PCR. There were 2406 paired sets from asymptomatic subjects for analysis. Sixteen Panbio tests were inconclusive, for which sensitivity analyses were performed (considering results as either positive or negative or being excluded). Sensitivity of Panbio for screening of asymptomatic individuals ranged from 80.0% (61.4-92.3) to 86.67% (69.2-96.2) and specificity from 99.53% (95% CI 99.2 to 99.8) to 100% (95% CI 99.8 to 100). Sensitivity of Panbio to detect subjects with presymptomatic/early infection (n=42) ranged from 81.82% (95% CI 67.3 to 91.8) to 90.91% (95% CI 78.3 to 97.5) with specificity always above 99%.InterpretationThe Panbio COVID-19 Ag rapid test identifies 81%-90% of presymptomatic and early asymptomatic SARS-CoV-2 infections with high specificity. This test may therefore be adopted in testing strategies such as targeted screening of specific populations where prevalence is low.
| S-EPMC8520587 | biostudies-literature
Project description:BackgroundPoint-of-care rapid tests to identify SARS-CoV-2 can have clinical benefits.MethodsA cross-sectional study in adults visiting emergency services or screening sites of referral hospitals for COVID-19 to validate the diagnostic performance of a rapid antigen test for SARS-CoV-2 (Abbott's Panbio) compared with reverse transcription-polymerase chain reaction (RT-PCR) testing. Tests were performed by health personnel in a routine situation during a COVID-19 outbreak.ResultsA total of 1060 participants (mean age 47, 46% with a self-reported comorbidity) were recruited from 8 hospitals in Mexico. Participants provided 1060 valid Panbio rapid test-RT-PCR test pairs with 45% testing positive in the RT-PCR. Overall sensitivity of the Panbio test was 54.2% (95% CI 51%-57%), and 69.1% (95% CI 66%-73%) for patients during the first week of symptoms. Sensitivity depended on viral load (cycle threshold (Ct) of RT-PCR) and days of symptoms. With a Ct ≤25, sensitivity was 82% (95% CI, 76%-87%). Specificity of the Panbio test was >97.8% in all groups.ConclusionsThe Panbio rapid antigen test for SARS-CoV-2 had good specificity but low sensitivity. A negative test requires confirmation with RT-PCR, especially for testing after the first week of symptoms.
| S-EPMC8526115 | biostudies-literature
Project description: Not available
| S-EPMC8397931 | biostudies-literature
Project description: Not available
| S-EPMC7879056 | biostudies-literature
Project description:BackgroundAntigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients.MethodsWe conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland.Results402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2-86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9-99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7-99.0%) was obtained with the Ag-RDT using OPS.InterpretationBased on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.
| S-EPMC8224876 | biostudies-literature