Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant.
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ABSTRACT:
SUBMITTER: de Michelena P
PROVIDER: S-EPMC8863328 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
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Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant.
de Michelena Paula P Torres Ignacio I Ramos-García Ángela Á Gozalbes Victoria V Ruiz Nidia N Sanmartín Ana A Botija Pilar P Poujois Sandrine S Huntley Dixie D Albert Eliseo E Navarro David D
The Journal of infection 20220222 5
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Project description:ObjectivesAntigen rapid diagnostic tests (Ag-RDTs) play an important role in the diagnosis of SARS-CoV-2. They are easier, quicker, and less expensive than the "gold standard" RT-PCR and therefore widely in use. Reliable clinical data with respect to Ag-RDT performance in SARS-CoV-2 Omicron VOCs is limited. Consequently, the objective of this study was to determine the impact different VOCs - especially Omicron - have on the clinical performance of an Ag-RDT.MethodsWe compared the clinical performance of the Sofia SARS-CoV-2 Ag-RDT to RT-PCR in a real-world, single-centre study in a clinical point-of-care setting in patients admitted to a large hospital via the emergency department from 2 November 2020 to 4 September 2022.ResultsAmong 38,434 Ag-RDT/RT-PCR tandems taken, 1528 yielded a SARS-CoV-2 positive RT-PCR test result, with a prevalence of 4.0% (95% CI, 3.8 - 4.2). Overall sensitivity of the Ag-RDT was 63.7% (95% CI, 61.3 - 66.1) and overall specificity was 99.6% (95% CI, 99.5 - 99.6). Ag-RDT sensitivity was dependent on viral load (VL), as the sensitivity increased to 93.2% (95% CI, 91.5 - 94.6) in samples with a VL >106 SARS-CoV-2 copies/ml. Furthermore, the Ag-RDT was more sensitive in men, and older patients. Variant-dependent sensitivity assessment showed that the sensitivity was significantly lower in Omicron-VOC (64.1%; 95% CI, 60.5 - 67.6) compared to SARS-CoV-2 Wild-type samples (70.0%; 95% CI, 59,8 - 78,6) (binomial test; p-value <0.001). Analyzing the limits of detection (LoD) showed a 27 times higher 95% LoD for the Omicron-VOC BA.5 compared to the SARS-CoV-2 Wild-type.ConclusionAg-RDT sensitivity for detection of patients with lower viral loads and with Omicron-VOC is reduced, limiting the effectiveness of Ag-RDTs. However, Ag-RDTs are still an unreplaceable tool for widely available, quick, and inexpensive point-of-care SARS-CoV-2 diagnostics.
| S-EPMC10181871 | biostudies-literature
Project description:ObjectivesTo our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.MethodsRAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR.ResultsOut of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11).ConclusionThe Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.
| S-EPMC7662075 | biostudies-literature
Project description:The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) Omicron was classified as a variant of concern in November 2021. The sublineage BA.2 spreads rapidly worldwide. Currently, there is a lack of data for the parallel comparison of Rapid Antigen Test (RAT) Kits to detect SARS-CoV-2 Omicron BA.2. We evaluated the analytical sensitivity of 12 RAT kits to detect Omicron BA.2 in the present study. Analytical sensitivity was determined by means of the limit of detection (LOD). We prepared a dilution set using a respiratory specimen collected from a COVID-19 patient infected by Omicron BA.2. The reverse transcription-polymerase chain reaction was used as a reference method. The LOD results showed that all 12 RAT kits had comparable analytical sensitivity to detect Omicron BA.2. The RAT kits selected in the current study may be used for the first-line screening of the rapid spreading Omicron BA.2.
| S-EPMC9347738 | biostudies-literature
Project description:On the 11th of March 2020, the world faced a new global pandemic, COVID-19 which is a disease caused by the novel coronavirus, it had multiple devastating outcomes on multiple sectors along with significant rates of mortality. These challenges encouraged the development of multiple testing methods, as well as anti-viral medications such as Molnupiravir, as well as evaluating the efficacy of available medications against it, like; Azithromycin, Ritonavir and Hydroxychloroquine. Vaccination against COVID-19 forged into a significant challenge, few months ensuing the first case of SARS-CoV-2, which was diagnosed in December 2019, in Wuhan-China, thus, multiple vaccines were approved for use around the world to combat this pandemic. Our study includes a sample of 556 oncology patients at Augusta Victoria Hospital in Jerusalem, all patients were tested using Panbio rapid antigen test and Allplex PCR Assay. The main objective was to study the sensitivity and specificity of Rapid antigen test, which contributes to a faster isolation call and management of infected patients, thus decreasing the risk on spread to other patients and health care. Patients were categorized based on two factors: Ct range and age group and studying their possible effect on false-negative results. Patients with Ct value less than 20, had the highest detection rate which is consistent with other studies in the literature. The sensitivity and specificity of Panbio Rapid Antigen testing were of 69.9% and 100%, respectively. A correlation between age group and false negative results could not be made, but a correlation between Ct value and false negative result was noticed, Ct value was directly related to false negative results. P-value of 0.007 indicated that results were statistically significant where PCR test is considered more sensitive compared to rapid antigen test.
| S-EPMC11296623 | biostudies-literature
Project description: Not available
| S-EPMC8397931 | biostudies-literature
Project description:Thailand is among many countries severely affected by COVID-19 since the beginning of the global pandemic. Thus, a deliberate planning of health care resource allocation against health care demand in light of the new SARS-CoV-2 variant, Omicron, is crucial. This study aims to forecast the trends in COVID-19 cases and deaths from the Omicron variant in Thailand. We used a compartmental susceptible-exposed-infectious-recovered model combined with a system dynamics model. We developed four scenarios with differing values of the reproduction number (R) and vaccination rates. In the most pessimistic scenario (R = 7.5 and base vaccination rate), the number of incident cases reached a peak of 49,523 (95% CI: 20,599 to 99,362) by day 73, and the peak daily deaths grew to 270 by day 50. The predicted cumulative cases and deaths at the end of the wave were approximately 3.7 million and 22,000, respectively. In the most optimistic assumption (R = 4.5 and speedy vaccination rate), the peak incident cases was about one third the cases in the pessimistic assumption (15,650, 95% CI: 12,688 to 17,603). In the coming months, Thailand may face a new wave of the COVID-19 epidemic due to the Omicron variant. The case toll due to the Omicron wave is likely to outnumber the earlier Delta wave, but the death toll is proportionately lower. Vaccination campaigns for the booster dose should be expedited to prevent severe illnesses and deaths in the population.
| S-EPMC9320113 | biostudies-literature
Project description:Large-scale screening for SARS-CoV-2 infection is an important tool for epidemic prevention and control. The appearance of new variants associated with specific mutations can call into question the effectiveness of rapid diagnostic tests (RDTs) deployed massively at national and international levels. We compared the clinical and virological characteristics of individuals infected by Delta or Omicron variants to assess which factors were associated with a reduced performance of RDT. A commercially available RDT as well as the evaluation of the viral load (VL) and the detection of replicate intermediates (RIs) were carried out retrospectively on positive SARS-CoV-2 nasopharyngeal specimens from health care workers of the Pitié-Salpêtrière Hospital infected by the Delta or Omicron variant between July 2021 and January 2022. Of the 205 samples analyzed (104 from individuals infected with Delta and 101 with Omicron), 176 were analyzed by RDT and 200 by RT-PCR for VL and RIs. The sensitivity of the TDR for Omicron was significantly lower than that observed for Delta (53.8% versus 74.7%, respectively, P < 0.01). Moreover, the Delta VL was significantly higher than that measured for Omicron (median Ct 21.2 versus 24.1, respectively, P < 0.01) and associated with the positivity of the RDT in multivariate analysis. We demonstrate a lower RDT sensitivity associated with a lower VL at the time of diagnosis on Omicron-infected individuals in comparison to those infected with the Delta variant. This RDT lower sensitivity should be taken into account in the large-scale screening strategy and in particular in case of strong suspicion of infection where testing should be repeated. IMPORTANCE Previous reports have shown a variability in the diagnostic performance of RDTs. In the era of SARS-CoV-2 variants and the use of RDT, mutation associated with these variants could affect the test performance. We evaluate the sensitivity of the RDT Panbio COVID-19 Ag (Abbott) with two variants of concern (VOC), the Delta and Omicron variants. In order to investigate whether clinical characteristics or virological characteristics can affect this sensitivity, we collected clinical information and performed a specific RT-PCR that detected the RIs as a marker of the viral replication and viral cycle stage. Our results showed that Omicron was less detected than the Delta variant. A lower viral load of Omicron variant in comparison to Delta variant explained this decreased sensitivity, even if they are at the same stage of the disease and the viral cycle and should be taken into account with the use of RDT as diagnostic tool.
| S-EPMC9603576 | biostudies-literature
Project description:ObjectivesThere is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for this purpose.MethodsA total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Two nasopharyngeal swabs were collected from household (n = 338) and non-household contacts (n = 296) of COVID-19 cases. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, MA, USA).ResultsHousehold contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case, whereas non-household contacts (n = 296) were tested at a median of 6 days (range, 1-7) after exposure. In total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI 37.4-58.9) and 100% (95% CI 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI 38.9-62.5) than in non-household (35.7%; 95% CI 16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (p < 0.001) to become symptomatic than their negative counterparts.DiscussionThe Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.
| S-EPMC7833843 | biostudies-literature
Project description:As we move into the third year with COVID-19, many countries have attempted to manage the disease as an endemic. However, this is limited by the disease's morbidity and mortality, the emergence of new strains, and the effectiveness of the vaccine. This brief report describes, evaluates, and discusses the implementation of regular antigen rapid tests (ARTs) for COVID-19 in hemodialysis units. We introduced ARTs during the surge in our hemodialysis units. As compliance with the test was mandatory by regulatory requirements, we surveyed patients and caregivers to measure their acceptability, appropriateness, and feasibility of the ART's implementation. Acceptability measured confidence and level of comfort when performing ART tests, while appropriateness measured the perception of the necessity of ARTs, safety in the dialysis unit with the implementation of ARTs, and understanding using a Likert scale. Feasibility measured the perception of the timely start of dialysis treatment and the convenience of the test. Our survey found that ARTs were acceptable to 98% of patients and caregivers, with the majority reporting no discomfort. The majority of the patients agreed that ARTs were appropriate and feasible. We reported successful ART implementation in a healthcare setting with no false-positive or transmission within the unit during this period. Nevertheless, the long-term implementation outcome will require further evaluation.
| S-EPMC9690273 | biostudies-literature
Project description: Not available
| S-EPMC8111145 | biostudies-literature