Dataset Information

Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection.

ABSTRACT:

Objectives

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.

Methods

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.

Results

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 (C_T) < 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).

Conclusions

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.

SUBMITTER: Merino P

PROVIDER: S-EPMC7884234 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

Project description:BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients.MethodsFor this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed.ResultsDifferences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%).ConclusionsThe highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.