Diagnostic Utility of Antigen Detection Rapid Diagnostic Tests for Covid- 19: A Systematic Review and Meta-Analysis

Ebrahimi, Mina; Harmooshi, Narges Nazari; Rahim, Fakher

doi:10.1101/2021.04.02.21254714

Cited by 5 publications

(3 citation statements)

References 45 publications

(68 reference statements)

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“…However, we are also aware of the presence of several studies reporting the poor performance of rapid antigen tests, including the RAHT 27,28 . The difference in the performance and sensitivity of rapid antigen tests, including the RAHT, may be due to such factors as the type of samples, the type of assays, the time of sample collection, the accuracy of sampling, and the transport and storage 21,29 …”

Section: Discussionmentioning

confidence: 99%

“…27,28 The difference in the performance and sensitivity of rapid antigen tests, including the RAHT, may be due to such factors as the type of samples, the type of assays, the time of sample collection, the accuracy of sampling, and the transport and storage. 21,29 Finally, the RAHT is increasingly used for screening COVID-19…”

Section: Analyzes Of the Correlation Between Ct Values And Dso Bymentioning

confidence: 99%

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Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset

Shin

Lee

Widyasari

et al. 2022

Clinical Laboratory Analysis

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Background Surveillance and control of SARS‐CoV‐2 outbreak through gold standard detection, that is, real‐time polymerase chain reaction (RT‐PCR), become a great obstacle, especially in overwhelming outbreaks. In this study, we aimed to analyze the performance of rapid antigen home test (RAHT) as an alternative detection method compared with RT‐PCR. Methods In total, 79 COVID‐19‐positive and 217 COVID‐19‐negative patients confirmed by RT‐PCR were enrolled in this study. A duration from symptom onset to COVID‐19 confirmation of <5 days was considered a recruiting criterion for COVID‐19‐positive cases. A nasal cavity specimen was collected for the RAHT, and a nasopharyngeal swab specimen was collected for RT‐PCR. Results Sensitivity of the STANDARD Q COVID‐19 Ag Home Test (SD Biosensor, Korea), compared with RT‐PCR, was 94.94% (75/79) (95% [confidence interval] CI, 87.54%–98.60%), and specificity was 100%. Sensitivity was significantly higher in symptomatic patients (98.00%) than in asymptomatic (89.66%) patients ( p ‐value = 0.03). There was no difference in sensitivity according to the duration of symptom onset to confirmation (100% for 0–2 days and 96.97% for 3–5 days, respectively) ( p ‐value = 1.00). The RAHT detected all 51 COVID‐19 patients whose Ct values were ≤25 (100%), whereas sensitivity was 73.33% (11/15) among patients with Ct values >25 ( p ‐value = 0.01). Conclusion The RAHT showed an excellent sensitivity for COVID‐19‐confirmed cases, especially for those with symptoms. There was a decrease in sensitivity when the Ct value is over 25, indicating that RAHT screening may be useful during the early phase of symptom onset, when the viral numbers are higher and it is more transmissible.

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Section: Discussionmentioning

confidence: 99%

Section: Analyzes Of the Correlation Between Ct Values And Dso Bymentioning

confidence: 99%

Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset

Shin

Lee

Widyasari

et al. 2022

Clinical Laboratory Analysis

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“…Some studies have suggested low sensitivity in screening asymptomatic patients 29,31,32 . Various authors have cited lower sensitivity in patients with low viral load (high Ct values on RT-PCR); hence RT-PCR testing should continue to be offered where clinical suspicion is high 24,30,33 . The users should follow manufacturers laid down testing procedures to avoid potentially misleading false-negative or false-positive results.…”

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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Performance of a rapid antigen test for SARS-CoV-2 in Kenya

Onsongo

Otieno

Duijn

et al. 2022

Diagnostic Microbiology and Infectious Disease

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Diagnostic Utility of Antigen Detection Rapid Diagnostic Tests for Covid- 19: A Systematic Review and Meta-Analysis

Cited by 5 publications

References 45 publications

Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset

Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset

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

Performance of a rapid antigen test for SARS-CoV-2 in Kenya

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