Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals

Peña, Mónica; Ampuero, Manuel; Garcés, Carlos; Gaggero, Aldo; García, Patricia; Velasquez, María Soledad; Luza, Ricardo; Alvarez, Pía; Paredes, Fabio; Acevedo, Johanna; Farfán, Mauricio J.; Solari, Sandra; Soto-Rifo, Ricardo; Valiente-Echeverría, y Fernando

doi:10.1101/2021.02.12.21251643

Cited by 17 publications

(21 citation statements)

References 12 publications

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“…At the end of the data extraction process, 37 studies were still in preprint form [4,171,173,174,177,180,190,192,201,204,205,207,211,214–216,218,220,222,223,225,227,231,233,234,238,240,244,247,253,257,265,267,284,287,290,293]. All studies were written in English, except for two in Spanish [175, 280].…”

Section: Resultsmentioning

confidence: 99%

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

Brümmer

Katzenschlager

Gaeddert

et al. 2021

Preprint

102

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Background: SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being inte-grated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensi-tivity and specificity) of commercially available Ag-RDTs. Methods: We registered the review on PROSPERO (Registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix and bioRvix, FINDdx) for publications up until December 11th, 2020. Descriptive analyses of all studies were performed and when more than four studies were avail-able, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcriptase polymerase chain reaction testing. We assessed heterogeneity by subgroup analyses ((1) performed conform with manufacturers instructions for use (IFU) or not, (2) symptomatic vs. asymptomatic, (3) duration of symptoms less than seven days vs. more than seven days, (4) Ct-value <25 vs. <30 vs. >30, (5) by sample type)) and with meta-regression. We assessed study quality and risk of bias using the QUADAS 2 assessment tool. Results: From a total of 11,715 articles, we extracted 98 analytical and clinical data sets. 74 clinical accuracy data sets were evaluated that included 31,202 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity was 73.8% (CI 68.6 to 78.5). If analysis was re-stricted to studies that followed the Ag-RDT manufacturers instructions using fresh upper res-piratory swab samples, the sensitivity increased to 79.1% (95%CI 75.0 to 82.8). The SD Biosensor Standard Q and Abbott Panbio showed the highest sensitivity with 81.7% and 72.7%, respectively. The best Ag-RDT performance was found with nasopharyngeal sampling (77.3%, CI 72.0 to 81.9) in comparison to other sample types (e.g., anterior nasal or mid turbinate 63.5%, CI 49.5 to 75.5). Testing in the first week from symptom onset resulted in higher sensitivity (87.5%, CI 86.0 to 89.1) compared to testing after one week (64.1%, CI 54.4 to 73.8). The tests performed markedly better on samples with lower Ct-values, i.e., <30 (87.9%, CI 86.7 to 88.8), in comparison to those with Ct >30 (47.8%, CI 41.1 to 54.5). Bias concerns were raised across all data sets, and financial support from the manufacturer was reported in 28.2% of data sets. Conclusion: As Ag-RDTs detect most cases within the first week of symptom onset and those with high viral load, they can have high utility for screening purposes in the early phase of disease, and thus can be a valuable tool to fight the spread of SARS-CoV-2. Standardization of con-duct and reporting of clinical accuracy studies would improve comparability and use of data.

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Section: Resultsmentioning

confidence: 99%

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

Brümmer

Katzenschlager

Gaeddert

et al. 2021

Preprint

102

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“…Though helpful, the limitations of these kits should be noted by the users. Some studies have suggested low sensitivity in screening asymptomatic patients 29,31,32…”

Section: Discussionmentioning

confidence: 99%

Field performance of NowCheck rapid antigen test for SARS-CoV-2 in Kisumu County, western Kenya

Onsongo

Otieno

Duijn

et al. 2021

Preprint

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Background Low- and middle-income countries (LMICs) are increasingly adopting low-cost Coronavirus disease 2019 (COVID-19) rapid antigen tests to meet the high demand for SARS-CoV-2 testing. Whilst testing using real-time polymerase chain reaction (RT-PCR) is the current gold standard, its widespread use in LMICs is limited by high costs, turnaround times and is not readily available in most places. COVID-19 antigen tests (Ag-RDT) provide a suitable alternative due to their low cost, rapid turnaround time and easy to set up and use. This study aimed to assess the field performance of the NowCheck COVID-19 antigen kit (Ag-RDT) as a point of care test (POCT) in select healthcare facilities in western Kenya. Methods We conducted a prospective multi-facility field evaluation study of the NowCheck COVID-19 rapid antigen test (Ag-RDT) compared to SARS-CoV-2 RT-PCR (RT-PCR). After obtaining informed consent, trained laboratory technicians collected two pairs of oropharyngeal and nasopharyngeal swabs, both antigen and RT-PCR testing, first for Ag-RDT and next for RT-PCR. We performed Ag-RDTs on-site and shared the results with both the study participants and their healthcare providers within 15-30 minutes. We carried out all RT-PCR tests in a central referral laboratory. The turnaround time for RT-PCR results was typically 24-48 hours. We captured the results of both methods using an electronic digital application. Findings Between December 2020 and March 2021, we enrolled 997 participants who met the Kenyan Ministry of Health COVID-19 case definition. The median age of study participants was 39 years (range one to 80 years), with 54% male. Ag-RDT had a sensitivity of 84.5% (76.0-90.8) and a specificity of 94.4% (95% CI: 92.7-95.8) with an accuracy of 94.2% (92.5- 95.6) when a cycle threshold value (Ct value) of ≤35 was used. The highest sensitivity of 87.7% (77.2-94.5) was observed in samples with Ct values ≤ 30 and the highest specificity of 97.5% (96.2-98.5) at Ct value of <40. Interpretation The NowCheck COVID-19 Ag-RDT showed good performance in field evaluation in multiple healthcare facilities in a developing country. The sensitivity of the kit exceeded the minimum recommended cut-off of 80% as recommended by WHO1. The high specificity of this kit at 94.4% at Ct values ≤33 and 97.5% at Ct values <40 matched that of real-time PCR, making it a good rule-out test for symptomatic patients with COVID-19- like symptoms. The faster turnaround time to results, lower cost, simple analytical steps requiring no equipment or infrastructure makes antigen testing an attractive field-screening method to meet the high demand for COVID-19 testing.

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“…A pesar del enorme esfuerzo por aumentar la capacidad diagnóstica, se hizo necesario incrementar el número de exámenes, sin un incremento del gasto. Esto, sumado a la falta de reactivos para las técnicas de RT-PCR a nivel mundial, varios laboratorios nacionales comenzaron a desarrollar e implementar nuevas técnicas o estrategias de diagnóstico, como por ejemplo, omitir el paso de www.revinf.cl Editorial extracción del ARN viral para realizar la reacción de RT-PCR 3 , utilizar métodos in home de extracción de ARN 4 , técnicas de MALDI-TOF 5 , muestras agrupadas o pool testing 6 y pruebas rápidas de antígenos 7,8 , entre otras. De estas estrategias, actualmente el pool testing y las pruebas rápidas de antígenos han sido las metodologías adoptadas por el MINSAL para diagnóstico de SARS-CoV-2.…”

Section: Nuevas Técnicas De Diagnóstico De Sars-cov-2unclassified

Rol de los laboratorios públicos en el diagnóstico SARS-CoV-2 en la pandemia de COVID-19: Experiencia, desafíos y oportunidades Marzo 2021

Acevedo-Muñoz¹,

Benadof-Fuentes²,

Farfán-Urzua³

2021

Rev. chil. infectol.

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Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals

Cited by 17 publications

References 12 publications

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

Field performance of NowCheck rapid antigen test for SARS-CoV-2 in Kisumu County, western Kenya

Rol de los laboratorios públicos en el diagnóstico SARS-CoV-2 en la pandemia de COVID-19: Experiencia, desafíos y oportunidades Marzo 2021

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