Clinical evaluation of DIAGNOVIR SARS-CoV-2 ultra-rapid antigen test performance compared to PCR-based testing

Seymen, Ali Aytac; Gülten, Ezgi; Özgür, Erol; Ortaç, Bülend; Akdemir, Irem; Çınar, Güle; Sarıcaoğlu, Elif Mükime; Güney-Esken, Gülen; Akkuş, Erman; Can, Füsun; Karahan, Zeynep Ceren; Azap, Alpay; Tuncay, Erkan

doi:10.1038/s41598-023-31177-8

Cited by 5 publications

(3 citation statements)

References 45 publications

(61 reference statements)

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“…These symptomatic individuals were likely to be confirmed as SARS-CoV-2 infection in real-life applications [ 27 ]. On the other hand, asymptomatic individuals at the screening point would likely be pre-symptomatic or infected without developing symptoms [ 28 ]. Therefore, it is thus necessary to confirm SARS-CoV-2 status by performing tests periodically with asymptomatic people in correctional facilities [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022

Lee,

Park,

et al. 2023

Infect Chemother

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Background The number of confirmed cases of individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection increased rapidly due to the Omicron variant. Correctional facilities are vulnerable to infectious diseases, and they introduced rapid antigen tests (RATs) to allow for early detection and rapid response. We aimed to evaluate the diagnostic performance and usefulness of SARS-CoV-2 RATs in newly incarcerated people. Materials and Methods We conducted a cross-sectional study at correctional facilities in Korea from 9 March to 22 May 2022. The study population was newly incarcerated people who were divided into two groups. In one group, 799 paired SARS-CoV-2 RATs and real-time polymerase chain reaction (RT-PCR) were conducted simultaneously in 522 individuals in March 2022. In the other group, 4,034 paired RATs and RT-PCR consecutively in 4,034 participants; only individuals with negative RATs results underwent RT-PCR from April to May 2022. We analyzed data using descriptive statistics and a logistic regression model. Results Among the 799 specimens in March, RT-PCR was positive in 72 (9.0%), and among the 4,034 specimens in April - May 2022, RT-PCR was positive in 40 (1.0%). Overall, the RATs had a sensitivity of 58.3%, specificity of 100.0%, positive predictive value (PPV) of 100.0%, and negative predictive value (NPV) of 96.0%. Asymptomatic individuals constituted 98.2% of the study group, and symptomatic individuals 1.8%. In asymptomatic cases, the sensitivity of RATs was 52.5%, specificity was 100.0%, PPV was 100.0%, and NPV was 96.3%. In symptomatic cases, the sensitivity of RATs was 84.6%, specificity was 100.0%, PPV was 100.0%, and NPV was 33.3%. Sensitivity ( P = 0.034) and NPV ( P = 0.004) differed significantly according to the presence and absence of symptoms, and the F1 score was the highest at 0.9 in symptomatic individuals in March. There was a positive linear trend in the proportion of false-negative RATs in newly incarcerated people following the weekly incidence of SARS-CoV-2 ( P = 0.033). The best-associated predictors of RATs for SARS-CoV-2 infection involved symptoms, timing of sample collection, and repeat testing. Conclusion Sensitivity and NPV significantly depend on whether symptoms are present, and the percentage of false negatives is correlated with the incidence. Thus, using RATs should be adjusted according to the presence or absence of symptoms and the incidence of SARS-CoV-2 infection in the community. RATs could be a useful screening tool as an effective first-line countermeasure because they can rapidly identify infectious patients and minimize SARS-CoV-2 transmission in correctional facilities.

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Section: Discussionmentioning

confidence: 99%

Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022

Lee,

Park,

et al. 2023

Infect Chemother

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“…A study on several currently available RAT kits demonstrated a similar level of sensitivity to Omicron and non-Omicron variants (On/Go, 76.4% and 71.0%; iHealth, 73.0%, and 71.0%; QuickVue, 84.3%, and 74.3%; BinaxNOW, 69.7%, and 71.0%; and InBios, 66.3% and 64.5%, respectively) [ 45 ]. However, most of these studies only evaluated the sensitivity and specificity for detecting Omicron B.1.1529 but not for detecting currently circulating subvariants [ 45 , 46 , 49 ]. A study reported that most of the Omicron subvariants accumulated amino acid substitutions in the N protein [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

“…Apart from the studies that reported the decline of the RAT for Omicron detection, other studies claimed that some of the currently available RATs are not affected by the emergence of Omicron [45][46][47][48], particularly when being used to assess the samples with high viral load. The DIAGNOVIR SARS-CoV-2 ultra-rapid antigen test, for example, was reported to demonstrate high performance in detecting most SARS-CoV-2 variants including Wuhan, Alpha (B1.17), Beta (B.1.351), Delta (B.1.617.2), and Omicron (B.1.1529) [49]. A study on several currently available RAT kits demonstrated a similar level of sensitivity to Omicron and non-Omicron variants (On/Go, 76.4% and 71.0%; iHealth, 73.0%, and 71.0%; QuickVue, 84.3%, and 74.3%; BinaxNOW, 69.7%, and 71.0%; and InBios, 66.3% and 64.5%, respectively) [45].…”

Section: Plos Onementioning

confidence: 99%

Efficacy of novel SARS-CoV-2 rapid antigen tests in the era of omicron outbreak

Widyasari

Kim

2023

PLoS ONE

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Following the outbreak of Omicron and its subvariants, many of the currently available rapid Ag tests (RATs) showed a decrease in clinical performance. In this study, we evaluated the clinical sensitivity of the SARS-CoV-2 Rapid Antigen Test 2.0 for nasopharyngeal swabs and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal for nasal swabs in 56 symptomatic individuals by comparing the results between RATs, RT-PCR, Omicron RT-PCR, and whole-genome sequencing (WGS). Furthermore, sequences of the Omicron subvariants’ spike proteins were subjected to phylogenetic analysis. Both novel RATs demonstrated a high sensitivity of up to 92.86%, (95% CI 82.71%– 98.02%), 94.23%, (95% CI 83.07%– 98.49%), and 97.95% (95% CI 87.76%– 99.89%) compared to the RT-PCR, Omicron RT-PCR, and WGS, respectively. The clinical sensitivity of RATs was at its highest when the Ct value was restricted to 15≤Ct<25, with a sensitivity of 97.05% for RdRp genes. The Omicron RT-PCR analysis revealed subvariants BA.4 or BA.5 (76.8%) and BA.2.75 (16.1%). Subsequently, the WGS analysis identified BA.5 (65.5%) as the dominant subvariant. Phylogenetic analysis of the spike protein of Omicron’s subvariants showed a close relationship between BA.4, BA.5, and BA.2.75. These results demonstrated that SARS-CoV-2 Rapid Antigen Test 2.0 and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal are considered useful and efficient RATs for the detection of SARS-CoV-2, particularly during the current Omicron subvariants wave.

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High‐Precision Viral Detection Using Electrochemical Kinetic Profiling of Aptamer‐Antigen Recognition in Clinical Samples and Machine Learning

Sen,

Zhang,

Sakib

et al. 2024

Angewandte Chemie

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High‐precision viral detection at point of need with clinical samples plays a pivotal role in the diagnosis of infectious diseases and the control of a global pandemic. However, the complexity of clinical samples that often contain very low viral concentrations makes it a huge challenge to develop simple diagnostic devices that do not require any sample processing and yet are capable of meeting performance metrics such as very high sensitivity and specificity. Herein we describe a new single‐pot and single‐step electrochemical method that uses real‐time kinetic profiling of the interaction between a high‐affinity aptamer and an antigen on a viral surface. This method generates many data points per sample, which when combined with machine learning, can deliver highly accurate test results in a short testing time. We demonstrate this concept using both SARS‐CoV‐2 and Influenza A viruses as model viruses with specifically engineered high‐affinity aptamers. Utilizing this technique to diagnose COVID‐19 with 37 real human saliva samples results in a sensitivity and specificity of both 100% (27 true negatives and 10 true positives, with 0 false negative and 0 false positive), which showcases the superb diagnostic precision of this method.

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Clinical evaluation of DIAGNOVIR SARS-CoV-2 ultra-rapid antigen test performance compared to PCR-based testing

Cited by 5 publications

References 45 publications

Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022

Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022

Efficacy of novel SARS-CoV-2 rapid antigen tests in the era of omicron outbreak

High‐Precision Viral Detection Using Electrochemical Kinetic Profiling of Aptamer‐Antigen Recognition in Clinical Samples and Machine Learning

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