Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients

Hirotsu, Yosuke; Maejima, Makoto; Shibusawa, Masahiro; Nagakubo, Yuki; Hosaka, Kazuhiro; Amemiya, Kenji; Sueki, Hitomi; Hayakawa, Miyoko; Mochizuki, Hitoshi; Tsutsui, Toshiharu; Kakizaki, Yumiko; Miyashita, Yoshihiro; Yagi, Shusuke; Kojima, Satoshi; Omata, Masao

doi:10.1016/j.ijid.2020.08.029

Cited by 231 publications

(275 citation statements)

References 22 publications

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“…Interestingly, we observed an excellent correlation between the antigen signal and Ct values obtained by RT-PCR ( Figure 2 ). Hirotsu et al evaluated another automated AG test, namely the LUMIPULSE SARS-CoV-2 Ag kit (Fujirebio, Tokyo, Japan), performed on a LUMIPULSE G600II chemiluminescent assay [ 29 ]. Out of 58 RT-PCR positive patients, 26 (44.8%) were negative on the LUMIPULSE.…”

Section: Discussionmentioning

confidence: 99%

“…Out of 58 RT-PCR positive patients, 26 (44.8%) were negative on the LUMIPULSE. The specificity of the test ranged from 97.3% to 99.6% [ 29 , 30 ]. They also observed a weaker correlation with viral load (i.e., R 2 = 0.77) compared to our evaluation with the VITROS automated assay (i.e., R 2 = 0.94), which in our hands, showed excellent clinical performance.…”

Section: Discussionmentioning

confidence: 99%

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Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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“…The sensitivity of the first antigenic tests was significantly lower than that detected by the nucleic acids (56.2% (IC95%: 29.5-79.8%)) with a comparable specificity (99.5% (IC95% (98.1%-99.9%)) [25]). However, the new generation of antigenic tests present, during the first week of infection, comparable values of sensitivity and specificity [26][27][28]. It has been shown that for viral loads below 2 log copies/mL the correlation between antigen and molecular techniques is 100%, while it drops to 60% with viral loads of 1-2 log copies/mL, and to 33% with viral loads <1 log copies/mL.…”

Section: Procedures For Collecting Transporting and Storing The Nasopmentioning

confidence: 99%

“…It has been shown that for viral loads below 2 log copies/mL the correlation between antigen and molecular techniques is 100%, while it drops to 60% with viral loads of 1-2 log copies/mL, and to 33% with viral loads <1 log copies/mL. As a consequence, other factors related to viral load can be used as surrogate markers of the validity of antigen tests: i) duration of infection: during the first week of symptoms the sensitivity of the ADT is on average 93.9% (95% CI: 86.5-97.4%) [28]; ii) Ct index: the sensitivity of ADT is 98% (95% CI: 90-100%) for Ct ≤25, and 57% (95% CI: 48-65%) for Ct ≥30 [26,27] . According to these data it can be affirmed that ADT have special clinical utility in suspected cases during the first 5-7 days of symptoms.…”

Section: Procedures For Collecting Transporting and Storing The Nasopmentioning

confidence: 99%

Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings

Candel

Barreiro²,

Román³

et al. 2020

Rev Esp Quimioter

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The high transmissibility of SARS-CoV-2 before and shortly after the onset of symptoms suggests that only diagnosing and isolating symptomatic patients may not be sufficient to interrupt the spread of infection; therefore, public health measures such as personal distancing are also necessary. Additionally, it will be important to detect the newly infected individuals who remain asymptomatic, which may account for 50% or more of the cases. Molecular techniques are the “gold standard” for the diagnosis of SARS-CoV-2 infection. However, the massive use of these techniques has generated some problems. On the one hand, the scarcity of resources (analyzers, fungibles and reagents), and on the other the delay in the notification of results. These two facts translate into a lag in the application of isolation measures among cases and contacts, which favors the spread of the infection. Antigen detection tests are also direct diagnostic methods, with the advantage of obtaining the result in a few minutes and at the very “pointof-care”. Furthermore, the simplicity and low cost of these tests allow them to be repeated on successive days in certain clinical settings. The sensitivity of antigen tests is generally lower than that of nucleic acid tests, although their specificity is comparable. Antigenic tests have been shown to be more valid in the days around the onset of symptoms, when the viral load in the nasopharynx is higher. Having a rapid and real-time viral detection assay such as the antigen test has been shown to be more useful to control the spread of the infection than more sensitive tests, but with greater cost and response time, such as in case of molecular tests. The main health institutions such as the WHO, the CDC and the Ministry of Health of the Government of Spain propose the use of antigenic tests in a wide variety of strategies to respond to the pandemic. This document aims to support physicians involved in the care of patients with suspected SC2 infection, in the context of a growing incidence in Spain since September 2020, which already represents the second pandemic wave of COVID-19.

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“…Low-cost, rapid antigenbased tests [106,[114][115][116][117][118]121] POC platforms utilizing isothermal and RT-PCR tests [14,207] CRISPR-based lateral flow assay strips [43] Interpandemic Pandemic phase Interpandemic…”

Section: Compliance With Ethical Standardsmentioning

confidence: 99%

SARS-CoV-2 pandemic: a review of molecular diagnostic tools including sample collection and commercial response with associated advantages and limitations

et al. 2020

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The unprecedented global pandemic known as SARS-CoV-2 has exercised to its limits nearly all aspects of modern viral diagnostics. In doing so, it has illuminated both the advantages and limitations of current technologies. Tremendous effort has been put forth to expand our capacity to diagnose this deadly virus. In this work, we put forth key observations in the functionality of current methods for SARS-CoV-2 diagnostic testing. These methods include nucleic acid amplification-, CRISPR-, sequencing-, antigen-, and antibody-based detection methods. Additionally, we include analysis of equally critical aspects of COVID-19 diagnostics, including sample collection and preparation, testing models, and commercial response. We emphasize the integrated nature of assays, wherein issues in sample collection and preparation could impact the overall performance in a clinical setting.

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Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients

Cited by 231 publications

References 22 publications

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings

SARS-CoV-2 pandemic: a review of molecular diagnostic tools including sample collection and commercial response with associated advantages and limitations

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