Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study

Ferté, Thomas; Ramel, Viviane; Cazanave, Charles; Lafon, Marie‐Edith; Bebear, Cécile; Malvy, Denis; Georges-Walryck, Agnès; Dehail, Patrick

doi:10.1016/j.jcv.2021.104878

Cited by 39 publications

(29 citation statements)

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“…A similarly low sensitivity was observed regarding symptomatic and asymptomatic subgroups in our study. The low sensitivity in the asymptomatic subgroup was also observed in other studies 3 , 11 , 12 , 13 , 14 and this lack of sensitivity of rapid antigen diagnostic tests has been known for many years for the influenza virus. 15 The high NPV and low PPV observed in the asymptomatic subgroup can be explained by the low prevalence as previously highlighted.…”

Section: Discussionsupporting

confidence: 69%

What is the true place of the SARS‐CoV‐2 rapid point‐of‐care antigen test in the hospital setting? Lessons learned from real life

Roger

Lefeuvre

Pivert

et al. 2021

Journal of Medical Virology

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To assist in the clinical management of patients and to support infection control, we tested the use of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) point‐of‐care antigen test (AgPOC) for unplanned hospitalization, coupled with a nucleic acid amplification test (NAAT) using specimens collected at the same time upon arrival. The aim of this study was to assess the performance of the AgPOC in this specific use compared to NAAT for SARS‐CoV‐2 diagnosis, in the context of the low prevalence of infection. For 5 months (between two peaks in France of the SARS‐CoV‐2 pandemic), all patients admitted who undertook the AgPOC/NAAT paired tests were included in the study. AgPOC performances were determined considering the clinical status and the delay of symptoms onset. NAAT and AgPOC results were available for 4425 subjects. AgPOC results showed a homogeneous specificity (>97%) but a low sensitivity at 45.8%. Considering the national guidelines, sensitivity dropped to 32.5% in cases of symptomatic patients with symptoms older than 5 days or more. This study shows the poor performance of AgPOC for entry screening of patients in hospitals. AgPOC may represent a useful tool in the hospital setting only if the use is restricted to patients with consistent symptoms less than 4 days old.

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Section: Discussionsupporting

confidence: 69%

What is the true place of the SARS‐CoV‐2 rapid point‐of‐care antigen test in the hospital setting? Lessons learned from real life

Roger

Lefeuvre

Pivert

et al. 2021

Journal of Medical Virology

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“…To support the results obtained with RdRp gene, we also performed another qPCR targeting both the N gene and RdRp gene on the remaining samples (ex vivo infection media: n = 9 samples for H0 and n = 9 samples for H24), using a commercial kit (ARGENE SARS-CoV-2 R-GENE kit, #423735, Biomérieux) [ 32 ].…”

Section: Methodsmentioning

confidence: 99%

Exploration of the ocular surface infection by SARS-CoV-2 and implications for corneal donation: An ex vivo study

et al. 2022

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Background The risk of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission through corneal graft is an ongoing debate and leads to strict restrictions in corneas procurement, leading to a major decrease in eye banking activity. The aims of this study are to specifically assess the capacity of human cornea to be infected by SARS-CoV-2 and promote its replication ex vivo, and to evaluate the real-life risk of corneal contamination by detecting SARS-CoV-2 RNA in corneas retrieved in donors diagnosed with Coronavirus Disease 2019 (COVID-19) and nonaffected donors. Methods and findings To assess the capacity of human cornea to be infected by SARS-CoV-2, the expression pattern of SARS-CoV-2 receptor angiotensin-converting enzyme 2 (ACE-2) and activators TMPRSS2 and Cathepsins B and L in ocular surface tissues from nonaffected donors was explored by immunohistochemistry (n = 10 corneas, 78 ± 11 years, 40% female) and qPCR (n = 5 corneas, 80 ± 12 years, 40% female). Additionally, 5 freshly excised corneas (80 ± 12 years, 40% female) were infected ex vivo with highly concentrated SARS-CoV-2 solution (106 median tissue culture infectious dose (TCID50)/mL). Viral RNA was extracted from tissues and culture media and quantified by reverse transcription quantitative PCR (RT-qPCR) (viral RNA copies) 30 minutes (H0) and 24 hours (H24) after infection. To assess the risk of corneal contamination by SARS-CoV-2, viral RNA was tested by RT-qPCR (Ct value) in both corneas and organ culture media from 14 donors diagnosed with COVID-19 (74 ± 10 years, 29% female) and 26 healthy donors (79 ± 13 years, 57% female), and in organ culture media only from 133 consecutive nonaffected donors from 2 eye banks (73 ± 13 years, 29% female). The expression of receptor and activators was variable among samples at both protein and mRNA level. Based on immunohistochemistry findings, ACE-2 was localized mainly in the most superficial epithelial cells of peripheral cornea, limbus, and conjunctiva, whereas TMPRSS2 was mostly expressed in all layers of bulbar conjunctiva. A significant increase in total and positive strands of IP4 RNA sequence (RdRp viral gene) was observed from 30 minutes to 24 hours postinfection in central cornea (1.1 × 108 [95% CI: 6.4 × 107 to 2.4 × 108] to 3.0 × 109 [1.4 × 109 to 5.3 × 109], p = 0.0039 and 2.2 × 107 [1.4 × 107 to 3.6 × 107] to 5.1 × 107 [2.9 × 107 to 7.5 × 107], p = 0.0117, respectively) and in corneoscleral rim (4.5 × 109 [2.7 × 109 to 9.6 × 109] to 3.9 × 1010 [2.6 × 1010 to 4.4 × 1010], p = 0.0039 and 3.1 × 108 [1.2 × 108 to 5.3 × 108] to 7.8 × 108 [3.9 × 108 to 9.9 × 108], p = 0.0391, respectively). Viral RNA copies in ex vivo corneas were highly variable from one donor to another. Finally, viral RNA was detected in 3 out of 28 corneas (11%) from donors diagnosed with COVID-19. All samples from the 159 nonaffected donors were negative for SARS-CoV-2 RNA. The main limitation of this study relates to the limited sample size, due to limited access to donors diagnosed with COVID-19 and concomitant decrease in the procurement corneas from nonaffected donors. Conclusions In this study, we observed the expression of SARS-CoV-2 receptors and activators at the human ocular surface and a variable increase in viral RNA copies 24 hours after experimental infection of freshly excised human corneas. We also found viral RNA only in a very limited percentage of donors with positive nasopharyngeal PCR. The low rate of positivity in donors diagnosed with COVID-19 calls into question the utility of donor selection algorithms. Trial registration Agence de la Biomédecine, PFS-20-011 https://www.agence-biomedecine.fr/.

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“…From October 28 to November 20, 2020, a SARS‐CoV‐2 test in the Bordeaux University Health Campus showed that the overall sensitivity and specificity of the Abbott Pan Bio SARS‐CoV‐2 antigenic rapid test were 63.5% and 100%, respectively, while in the asymptomatic subgroup, the above date changed to 35.0% and 100%, respectively. 25 In a community screening in Taiwan Province, 70 out of 2096 antigen rapid test specimens were confirmed to be positive for nucleic acids, with a positive rate of 3.33%. 26 The sensitivity and specificity of rapid antigen detection were 76.39% and 99.26%, respectively.…”

Section: Introductionmentioning

confidence: 99%

“…Another study published by Okoye et al 24 used Abbott BinaxNOW COVID‐19 antigen detection reagent to screen 2645 asymptomatic college students, and a similar low detection rate was obtained. From October 28 to November 20, 2020, a SARS‐CoV‐2 test in the Bordeaux University Health Campus showed that the overall sensitivity and specificity of the Abbott Pan Bio SARS‐CoV‐2 antigenic rapid test were 63.5% and 100%, respectively, while in the asymptomatic subgroup, the above date changed to 35.0% and 100%, respectively 25 . In a community screening in Taiwan Province, 70 out of 2096 antigen rapid test specimens were confirmed to be positive for nucleic acids, with a positive rate of 3.33% 26 .…”

Section: Introductionmentioning

confidence: 99%

Performance and application evaluation of SARS‐CoV‐2 antigen assay

Shao

Meng

2022

Journal of Medical Virology

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Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleic acid detection is the gold standard for the laboratory diagnosis of coronavirus disease 2019 (COVID‐19). However, this method has high requirements for practitioners' skills and testing sites, so it is not easy to popularize and promote the application in places other than large hospitals. In addition, the detection flux of SARS‐CoV‐2 nucleic acid is small, and the whole detection process takes much time, which cannot meet the actual needs of rapid screening in large quantities. The WHO conditionally approved a batch of SARS‐CoV‐2 antigen reagents for clinical application to alleviate this contradiction. SARS‐CoV‐2 antigen detection offers a trade‐off among clinical performance, speed and accessibility. With the gradual increase in clinical application, the accumulated clinical data show that the sensitivity and specificity of the SARS‐CoV‐2 antigen assay are over 80% and 97%, respectively, which can basically meet the requirements of the WHO. However, the sensitivity of the SARS‐CoV‐2 Antigen Assay among asymptomatic people in low prevalence areas of COVID‐19 cannot meet the standard, leading to a large number of missed diagnoses. In addition, the detection ability of SARS‐CoV‐2 antigen reagent for different SARS‐CoV‐2 mutant strains differs greatly, especially for those escaping the COVID‐19 vaccines. In terms of results interpretation, it is highly reliable to exclude SARS‐CoV‐2 infection based on the high negative predictive value of the SARS‐CoV‐2 antigen assay. However, in the low prevalence environment, the probability of false positives of the SARS‐CoV‐2 antigen assay is high, so the positive results need to be confirmed by the SARS‐CoV‐2 nucleic acid reagent. The SARS‐CoV‐2 antigen assay is only a supplement to SARS‐CoV‐2 nucleic acid detection and can never completely replace it. To date, SARS‐CoV‐2 nucleic acid detection continues to be the standard laboratory method for COVID‐19 diagnosis.

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Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study

Cited by 39 publications

References 3 publications

What is the true place of the SARS‐CoV‐2 rapid point‐of‐care antigen test in the hospital setting? Lessons learned from real life

What is the true place of the SARS‐CoV‐2 rapid point‐of‐care antigen test in the hospital setting? Lessons learned from real life

Exploration of the ocular surface infection by SARS-CoV-2 and implications for corneal donation: An ex vivo study

Performance and application evaluation of SARS‐CoV‐2 antigen assay

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