Dataset Information

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study.

ABSTRACT:

Background

Point-of-care rapid tests to identify SARS-CoV-2 can have clinical benefits.

Methods

A 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.

Results

A 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.

Conclusions

The 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.

SUBMITTER: Thirion-Romero I

PROVIDER: S-EPMC8526115 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study.

Thirion-Romero Ireri I Guerrero-Zúñiga Dr Selene DS Arias-Mendoza Dr Alexandra DA Cornejo-Juárez Dr Dora Patricia DDP Meza-Meneses Dr Patricia DP Torres-Erazo Dr Darwin Stalin DDS Hernández-Gilsoul Dr Thierry DT Galindo-Fraga Dr Arturo DA Villegas-Mota Dr Isabel DI Sepúlveda-Delgado Dr Jesús DJ Ávila-Ríos Dr Santiago DS Becerril-Vargas Dr Eduardo DE Fernández-Plata Rosario R Pérez-Kawabe Tit Midori TM Coeto-Cano Dr Ana DA Vázquez-Pérez Dr Joel Armando DJA Kawa-Karasik Dr Simón DS Reyes-Terán Dr Gustavo DG Pérez-Padilla Dr José Rogelio DJR

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20211020

<h4>Background</h4>Point-of-care rapid tests to identify SARS-CoV-2 can have clinical benefits.<h4>Methods</h4>A 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.<h4>Re ...[more]

PMID: 34678504

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Project description:BackgroundAccurate 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%.MethodsThis 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.ResultsWe 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.ConclusionThe 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.

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:BackgroundPerformance of the SD Biosensor saliva antigen rapid test was evaluated at a large designated testing site in non-hospitalized patients, with or without symptoms.MethodAll eligible people over 18 years of age presenting for a booked appointment at the designated SARS-CoV-2 testing site were approached for inclusion and enrolled following verbal informed consent. One nasopharyngeal swab was taken to carry out the default antigen rapid test from which the results were reported back to the patient and one saliva sample was self-taken according to verbal instruction on site. This was used for the saliva antigen rapid test, the RT-PCR and for virus culture. Sensitivity of the saliva antigen rapid test was analyzed in two ways: i, compared to saliva RT-PCR; and ii, compared to virus culture of the saliva samples. Study participants were also asked to fill in a short questionnaire stating age, sex, date of symptom onset. Recommended time of ≥30mins since last meal, drink or cigarette if applicable was also recorded. The study was carried out in February-March 2021 for 4 weeks.ResultsWe could include 789 people with complete records and results. Compared to saliva RT-PCR, overall sensitivity and specificity of the saliva antigen rapid test was 66.1% and 99.6% which increased to 88.6% with Ct ≤30 cutoff. Analysis by days post onset did not result in higher sensitivities because the large majority of people were in the very early phase of disease ie <3 days post onset. When breaking down the data for symptomatic and asymptomatic individuals, sensitivity ranged from 69.2% to 50% respectively, however the total number of RT-PCR positive asymptomatic participants was very low (n = 5). Importantly, almost all culture positive samples were detected by the rapid test.ConclusionOverall, the potential benefits of saliva antigen rapid test, could outweigh the lower sensitivity compared to nasopharyngeal antigen rapid test in a comprehensive testing strategy, especially for home/self-testing and in vulnerable populations like elderly, disabled or children where in intrusive testing is either not possible or causes unnecessary stress.

Dataset Information

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study.

Background

Methods

Results

Conclusions

Publications

Evaluation of Panbio rapid antigen test for SARS-CoV-2 in symptomatic patients and their contacts: a multicenter study.

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