flowflex covid test accuracy omicron

73.3. Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study - September 16, 2022 Ewoud Schuit, assistant professor 1 2, Roderick P Venekamp, associate professor 1, Lotty Hooft, professor 1 2, Irene K Veldhuijzen, senior epidemiologist 3, Inconclusive represents a combination of tests that showed no control line, test tubes were dropped, and test result was difficult to interpret (eg, faint line). Researchers found that the sensitivity of three rapid antigen tests -- the ability to correctly identify a true positive sample -- declined as Omicron became the dominant variant. Additional strengths include the large numbers of participants recruited at multiple test sites, the low percentage of missing values, reference test sampling and rapid antigen test self-testing within a few hours, unsupervised self-testing mimicking the real world context of self-testing, blinding of participants to the reference test result, blinding of laboratory staff to the rapid antigen test result, and the use of a viral load cut-off. The study is reported according to the Standards for Reporting Diagnostic Accuracy Studies (STARD) 2015 guidelines.13, This prospective diagnostic test accuracy study was embedded within the Dutch public infrastructure for covid-19 testing. Objective: Not all U.S. presidents are missed once they leave the White House. Packaged in a white box and given the. The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical. Image Credit: Roman Zaeits / Shutterstock.com. When a self-test result was negative, individuals were allowed to go to work or school. A language and environment for statistical computing. We simply feel they are somewhat less sensitive than they were to some of the previous variants.. Since individuals in these two subgroups are not equally distributed across age and sex groups, the diagnostic performance in age and sex subgroups may be affected as well. Even though antigen test kits in the U.S. are designed for a nasal swab, home tests are designed for a throat swab in other . At the time, this change in testing policy was covered by multiple national news outlets. Combined indicator: 14-day notification rate, testing rate and test positivity, updated 16 September 2021, weeks 35-36 2021 [updated 16 September 2021]. Inconclusive represents a combination of tests that showed no control line, test tubes were dropped, and test result was difficult to interpret (eg, faint line). In this interview, we speak to Ceri Wiggins, a Director at AstraZeneca, about the many applications of CRISPR and its role in discovering new COPD therapies. The highest overall sensitivity for all SARS-CoV-2 used was shown by Flowflex, which detected Omicron with slightly higher sensitivity than Delta variant but lower than Alpha, Beta, Gamma, and. 2023 Mar;29(3):391.e1-391.e7. BMJ 2021;374:n1676. Design: Sign up to receive the latest updates from U.S News & World Report and our trusted partners and sponsors. On Twitter, Mina, the testing expert who has supported adding a throat swab, noted that while the strategy does "likely improve sensitivity," it "may potentially cause a slightly greater . Secondly, we did not determine the virus lineage in individual samples but relied on the national pathogen surveillance data to estimate the weekly prevalence of the omicron variant.16 This surveillance system includes about 2000 random samples from positive samples across the country on a weekly basis. Centrum Infectieziektebestrijding RIVM. But the dawn of omicron has changed the efficacy of these tests. Apart from the vast number of spike mutations, the Omicron variant also has mutations in the nucleocapsid protein, which is the target of almost all Ag-RDTs. FOIA accurate result. The main outcomes were sensitivity, specificity, and positive and negative predictive values of each self-test, with RT-PCR testing as the reference standard. In a post hoc analysis, we assessed the impact of self-testing frequency. Vertical line indicates sensitivity of the rapid antigen test in the overall study population, Sensitivities with 95% confidence intervals for the MPBio (MP Biomedicals) rapid antigen test using reverse transcription polymerase chain reaction (RT-PCR) as reference test, stratified according to covid-19 vaccination status, previous infection status, sex, and age, with nasal or combined oropharyngeal and nasal self-sampling. Its more likely that there are some LFTs which seem to be able to detect a very small amount of viral protein for a long time, she says. Epidemiologische situatie van SARS-CoV-2 in Nederland [Dutch] 2021 [updated 28 September 2021]. and transmitted securely. Second, it is possible though uncertain that transmission with Omicron occurs at lower viral loads. No commercial re-use. According to national SARS-CoV-2 pathogen surveillance, during the study period the percentage of infections attributable to omicron increased from 29% (week 51 in 2021) to 99% (week 5 in 2022; >95% BA.1 variant).151617 From 12 January 2022 onwards, omicron accounted for >90% of infections. A person's viral load, respiratory secretions, and the window of infectiousness for the virus may affect the ability of a rapid antigen test to detect Omicron. The recall of the test, which the government estimates has 200,000 in U.S. circulation, may confuse consumers between two Flow flex branded antigen tests. The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used. During the initial study weeks (in 2021 and the first week in 2022) and during phase 1 (weeks 2 to 3 (MPBio and Clinitest) and weeks 2 to 5 (Flowflex) in 2022), participants received instructions to perform the rapid antigen test at home using only nasal self-sampling according to the manufacturers instructions. Compilation of the top interviews, articles, and news in the last year. Matthews says that any reinfection will probably be a mild cold as you will have built up a bigger and better army of memory T and B cells, as long as you are otherwise healthy. Firstly, the sample size calculation was based on the primary analysis, and diagnostic accuracy variables are by definition less precise for stratified and weekly analyses. Disclaimer. PCR tests, which can detect even trace amounts of the virus, have long been considered the gold standard of coronavirus testing. Previous studies, including our own studies, have shown that antigen tests require a higher viral load to show positivity than molecular tests such as RT-PCR.257 This was confirmed in the current study: the mean viral load in confirmatory testers was higher than in the non-confirmatory testers. Primary outcomes were diagnostic accuracy (sensitivity, specificity, and positive and negative predictive values with corresponding 95% confidence intervals) of each rapid antigen test either with nasal self-sampling or with combined oropharyngeal and nasal self-sampling, and RT-PCR testing as reference. Testing for adults and children ages 2+ years, with or . Since the beginning of the COVID-19 pandemic, the Food and Drug Administration has authorized dozens of coronavirus tests for use in labs, doctors offices and even in homes. Clipboard, Search History, and several other advanced features are temporarily unavailable. Proposals should be directed to the corresponding author to gain access to the data. The test is available in 1-Pack, 2-Pack and 5-Pack. The largest differences in RT-PCR positivity and performances of the rapid antigen tests were between confirmatory testers and individuals who visited the test site for other reasons (table 2, fig 4, fig 5, and fig 6). We postulate several reasons for the somewhat lower sensitivities with omicron. The viral loads should therefore be considered as best estimates. Recent studies from the United States and Italy that evaluated rapid antigen tests when omicron was dominant, found comparable sensitivities of 74% (128/173 RT-PCR positive results) and 82% (126/154 RT-PCR positive results), although sampling was performed by professionals and sample sizes were smaller.1112. The researchers suggest that repeat testing be done for people who initially test negative on rapid tests, saying that persons who have low levels of virus detectable on PCR but not antigen test may be either at the upswing or downswing of their infection. "Rapid antigen tests show lower sensitivity for Omicron than for earlier SARS-CoV-2 variants". 1. Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J, Taylor M, Cunningham J, Davenport C, Dittrich S, Emperador D, Hooft L, Leeflang MM, McInnes MD, Spijker R, Verbakel JY, Takwoingi Y, Taylor-Phillips S, Van den Bruel A, Deeks JJ; Cochrane COVID-19 Diagnostic Test Accuracy Group. Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test, Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab, Serological markers of SARS-CoV-2 infection; anti-nucleocapsid antibody positivity may not be the ideal marker of natural infection in vaccinated individuals, Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands, Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19), Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study, Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study - September 16, 2022, http://creativecommons.org/licenses/by-nc/4.0/, https://www.ecdc.europa.eu/sites/default/files/documents/Considerations-use-of-self-tests-for-COVID-19-in-the-EU-EEA-17-March2021-erratum.pdf, https://www.ecdc.europa.eu/en/publications-data/combined-indicator-week-36-2021, https://coronadashboard.rijksoverheid.nl/landelijk/varianten, https://www.rivm.nl/coronavirus-covid-19/virus/varianten, https://www.rivm.nl/sites/default/files/2021-09/COVID-19_WebSite_rapport_wekelijks_20210928_1146_final.pdf, Birmingham and Solihull Mental Health NHS Foundation Trust: Consultant Psychiatrist General Adult - Orsborn House CMHT, NHS Tayside: Salaried GP with Special Interest in Drug Use, Harm and Reduction, Birmingham and Solihull Mental Health NHS Foundation Trust: Consultant Psychiatrist General Adult - Northcroft CMHT, Brent Area Medical Centre: Salaried GP - Brent Area Medical Centre, Womens, childrens & adolescents health. doi: 10.1016/j.cmi.2022.11.004. When Omicron first hit in late 2021, the FDA said that . However, we believe that this estimate is still more meaningful than using arbitrary cycle threshold value cut-offs of 25 or 30, as is often done.2324 Fifthly, we did not collect detailed information on the exact timing of RT-PCR sampling and rapid antigen testing. Overall sensitivities with nasal self-sampling were 79.0% (95% confidence interval 74.7% to 82.8%) for Flowflex, 69.9% (65.1% to 74.4%) for MPBio, and 70.2% (65.6% to 74.5%) for Clinitest. The viral load of each sample was estimated from the cycle threshold value of that sample using formulas based on the results of a previous study (see supplementary material 3). Risks of. If the latter is the case, it is important that people start to isolate as soon as they have any symptoms that suggest they may have Covid, even if the LFT is negative, she says. Cochrane Database Syst Rev. A Flowflex SARS-CoV-2 antigen rapid test kit is seen on the Watsons Singapore website on Mar 4, 2022. We do not capture any email address. Boxes of BinaxNow home COVID-19 tests made by Abbott are shown for sale at a store, Nov. 15, 2021, in Lakewood, Wash. All participants signed an informed consent form before any study procedure. Idaho lawmaker wants to criminalize the most-used COVID-19 vaccines, What is Orthrus? Self-testing, without supervision of a trained professional, lowers the threshold for testing and allows individuals to obtain a result quickly, at their own convenience. New research suggests that some rapid antigen tests are not sensitive enough to detect asymptomatic COVID-19 infections. 2021 Mar 24;3(3):CD013705. These are the costs and features of each at-home molecular test: Cue COVID-19 Test Accuracy: . It is possible for . A big reason behind this trend is the popularity of at-home tests. Our empirical data did show lower sensitivities in these groups. A handful of rapid antigen tests are available without a prescription, including the Abbott BinaxNOW, the Ellume Covid-19 Home Test and the Quidel QuickVue At-Home Covid-19 Test. News-Medical. (2022, September 22). Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the Dutch Ministry of Health, Welfare, and Sport for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. The overall sensitivity of rapid antigen tests was 63%. News-Medical, viewed 04 March 2023, https://www.news-medical.net/news/20211229/Rapid-antigen-tests-show-lower-sensitivity-for-Omicron-than-for-earlier-SARS-CoV-2-variants.aspx. 6497 people with covid-19 symptoms aged 16 years presenting for testing. Sensitivities and specificities with 95% confidence intervals of Flowflex (Acon Laboratories), MPBio (MP Biomedicals), and Clinitest (Siemens-Healthineeers) with nasal self-sampling using reverse transcription polymerase chain reaction as reference test by week of inclusion, before and after application of a viral load cut-off. The original patients sequence, as well as the virus isolate of the passage, had the following mutations and deletion in the nucleocapsid: R203K, G204R, P13L, and Del31-33. When combined oropharyngeal and nasal self-sampling was compared with nasal self-sampling, sensitivities were found to be slightly higher in confirmatory testers (87.4% and 86.1%, respectively) and substantially higher in those testing for other reasons (69.3% and 59.9%, respectively). Flowflex is FDA Emergency Use Authorized (EUA) for self-testing without the need for a prescription. News-Medical.Net provides this medical information service in accordance Manufacturers of MPBio and Clinitest may consider extending their instructions for use to include combined oropharyngeal and nasal self-sampling, and other manufacturers of rapid antigen tests should consider evaluating this as well. . test, 61 percent of those with Omicron infections also tested positive on a rapid antigen test within 48 hours, compared with 46. Supplementary table S1 presents the characteristics of the participants for the delta-omicron transition phase and table 1 for phases 1 and 2. This large diagnostic accuracy evaluation of three commercially available SARS-CoV-2 rapid antigen tests (Flowflex, MPBio, and Clinitest) with unsupervised nasal self-sampling by individuals with symptoms showed a decline in overall sensitivities with the emergence of omicron. Please use one of the following formats to cite this article in your essay, paper or report: Chaturvedi, Saurabh. All Rights Reserved. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the Dutch Ministry of Health, Welfare, and Sport for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. The fast-spreading Omicron variant has made us increasingly reliant on at-home rapid antigen tests to tell us whether we have Covid-19. Please see the ACON Laboratories announcement for details. How reliable are covid-19 lateral flow tests for detecting omicron? RIVM Centrum Infectieziektebestrijding. Stratification by reason for testing revealed that the changes in sensitivity over time were similar but more pronounced in non-confirmatory testers than in confirmatory testers, although confidence intervals were wide (see supplementary figure S5). Finally, slight differences in sampling methods (combined oropharyngeal and nasal versus more invasive oropharyngeal and nasopharyngeal) for the reference (RT-PCR) test, might have influenced the results of the study. A faint positive lateral flow test result is shown in the image above Credit: Sun Online. That should mean more virus and therefore more infectivity in principle, but no one has tested that idea, he says. As such, the results of our study have directly been disseminated and are currently incorporated in the nationwide testing policy. Vertical line indicates sensitivity of the rapid antigen test in the overall study population. The evaluated tests were Flowflex (Acon Laboratories; phase 1 only), MPBio (MP Biomedicals), and Clinitest (Siemens-Healthineers). Three public health service covid-19 test sites in the Netherlands, 21 December 2021 to 10 February 2022. The FDA is warning people to follow the instructions of at-home Covid-19 rapid tests and only swab their noses pushing back against viral reports that the tests are more accurate when users . BD Veritor (Becton Dickinson) Okay (marginally acceptable) 51.8. New. Additionally, the Del31-33 deletion is found in the Omicron nucleocapsid protein, along with another P13L mutation, which is present in some but not all Omicron sequences. Funding: This study was funded by the Dutch Ministry of Health, Welfare, and Sport. Trained test site staff then took a swab sample for routine RT-PCR testing. If interested, they received information about the study, a test site specific rapid antigen test, and an email with a link to study documentation. Thirdly, the viral load calculations were based on standard curves in a previous study.2 These standard curves were not repeated with each RT-PCR run in this study. The visible test band in the presence of a visible control band was considered positive. The accuracy varies with when the tests are taken, she added. SD Biosensor Standard Q COVID-19 AG Home Test ART kits are seen on the Watsons Singapore . Individuals with a negative self-test result should adhere to general preventive measures because a false negative result cannot be ruled out. 10.1371/journal.pmed.1003735 *Important notice: medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. During the study period, 21 December 2021 to 10 February 2022, these indications were having any symptom of potential SARS-CoV-2 infection; being identified as having close contact with an index case of SARS-CoV-2 infection; testing positive on any commercially available rapid antigen test after self-sampling at own initiative (confirmatory testers); or having returned from a country listed by the government as high risk.14. Contributors: KGMM initiated the study. Supplementary table S7 presents diagnostic accuracies stratified by all reasons for testing. Chan School of Public Health said. Palm Beach County Health Director Dr. Alina Alonso said Tuesday about 2% of the new cases in Palm Beach County are omicron. Molenkamp R, Igloi Z. Some home tests. government site. These effects might be test device specific given the variability in the performance across the three rapid antigen tests.5 We also found trends towards slightly higher sensitivities in participants who had not been vaccinated against covid-19 for MPBio and Clinitest with nasal self-sampling, but all confidence intervals overlapped with those who had been vaccinated against covid-10 once, twice, and three times, and no differential impact was observed when combined oropharyngeal and nasal self-sampling was applied. The US Food and Drug Administration has authorized ACON Laboratories' Flowflex test, saying it will double at-home testing capacity in the US. After applying the viral load cut-off, sensitivities were observed to increase to 89.8% (86.0% to 92.9%) and 83.7% (79.5% to 87.3%), respectively (see supplementary figure S2). Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Sensitivities of MPBio and Clinitest improved after the addition of oropharyngeal to nasal self-sampling. Still, the study found that the rapid tests missed about 35% of all coronavirus cases confirmed with PCR tests with any level of viral load. Therefore, we are confident that combined oropharyngeal and nasal self-sampling is superior to nasal self-sampling only in the omicron era. NHS rules state that if you test positive your isolation period begins on the day that your symptoms developed or the day that you took the test if you dont have symptoms, and ends 10 days later. Results: This was the viral load cut-off above which 95% of people with a positive RT-PCR test result had a positive virus culture result based on previous work.2 Furthermore, considering the large influence of confirmatory testers in our study populations, all analyses were repeated stratified by confirmatory testing (yes or no). 2023 Jan 19;13(2):281. doi: 10.3390/life13020281. Study: Analytical sensitivity of seven SARS-CoV-2 antigen-detecting rapid tests for Omicron variant. Participants: The study, which hasnt been peer reviewed, looked at over 700 people who used a walk-up testing site in San Francisco in early January. sharing sensitive information, make sure youre on a federal A recent paper demonstrated that LFTs, when used correctly, are likely to have a sensitivity above 80% and in many cases above 90%. Azeem Majid, a professor of primary care and public health at Imperial College London, notes that the test is not designed to estimate how infectious you may be. Data from the FDA suggested that these at-home tests do detect the omicron variant but may have reduced sensitivity.. Although rapid antigen tests were initially introduced for use by trained professionals, they are currently widely available over the counter. The con is that they may not be as accurate very early. Ag-RDT buffer with no virus was used as a negative control. Values are numbers (percentages) unless stated otherwise. Table 1 shows the inclusion dates for each test location and phase. BMC Med 2022;20:97. You could become infectious after you take the test, which is why scientists recommend taking it as close to your social plans as possible, ideally within an hour. RT-PCR=reverse transcription polymerase chain reaction, Sensitivities with 95% confidence intervals for the Flexflow (Acon Laboratories) rapid antigen test with nasal self- sampling using reverse transcription polymerase chain (RT-PCR) reaction as reference test, stratified according to covid-19 vaccination status, previous infection status, sex, and age. Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Domen J, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, McInnes MD, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Omicron is currently behind a majority of COVID-19 cases. The Food and Drug Administration previously noted that some rapid coronavirus tests might be less sensitive to the omicron variant, which is the dominant strain circulating in the U.S. RT-PCR=reverse transcription polymerase chain reaction, In our previous study of self-testing using the Roche/SD-Biosensor (Roche Diagnostics) SARS-CoV-2 nasal rapid antigen test, a sensitivity of 79% was observed in participants with symptoms.7 For the present study, we conservatively assumed sensitivities of 70% for all three rapid antigen tests irrespective of sampling method, with an error margin of 5%, type I error of 5%, and power of 80%. Study: Abbotts Rapid Test Works on Omicron, Boxes of BinaxNow home COVID-19 tests made by Abbott are shown for sale at a store, Nov. 15, 2021, in Lakewood, Wash.(Ted S. Warren/AP). A collection point for lateral flow test kits in Amersham, Buckinghamshire. Not required because the study was judged by the Medical Research Ethics Committee Utrecht to be outside the scope of the Dutch Medical Research Involving Human Subjects Act (protocol No 21-818 /C). The results take up to 30 minutes. Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the omicron period: a cross-sectional study. If you suspect you have COVID-19, even though your rapid test was negative, the FDA advises to follow up with a PCR test especially if you are experiencing symptoms. One study showed improved sensitivity of a rapid antigen test with combined throat and nasal sampling by trained professionals.12 Currently, real world data on comparative accuracy of rapid antigen tests with unsupervised nasal self-sampling or combined oropharyngeal and nasal self-sampling are lacking. Anyone with COVID symptoms should get a PCR test, even if they have had a negative result on a lateral flow test. See this image and copyright information in PMC. Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Experts say that rapid tests are an important tool as the U.S. sees record coronavirus cases, but a testing shortage in the U.S. is preventing many from accessing the at-home tests. The https:// ensures that you are connecting to the Abstracts of Presentations at the Association of Clinical Scientists 143. When the pandemic began, at-home tests were considered to be about 70% to 80% accurate. Conversely, the Flowflex SARS-CoV-2 Antigen Rapid Test (ACON Laboratories) showed a higher sensitivity for delta compared with other Ag-RDT kits ( appendix pp 1-2 ). 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However, in non-confirmatory testers, we found the opposite (51.3% v 73.1% for Flowflex, 47.9% v 54.0% for MPBio, and 41.4% v 55.9% for Clinitest, respectively). Only the MPBio test with combined oropharyngeal and nasal self-sampling met the World Health Organizations standards for rapid antigen tests (80% sensitivity and 97% specificity among individuals with symptoms).19, Our pre-omicron studies, and when less than 5% of participants were confirmatory testers, found sensitivities of 72% to 83% for three different rapid antigen tests when performed by trained professionals, and 78.5% for the Roche/SD Biosensor rapid antigen test with unsupervised nasal self-sampling.72021 The sensitivities we found in the first week of the current study, when delta was still highly dominant, were similar (Flowflex 87%, MPBio 80%, and Clinitest 83%), although the percentage of confirmatory testers was much higher (21% to 24%) than in the previous studies. 2021 Jun 22;22(1):412. doi: 10.1186/s13063-021-05241-5. Intelligence agencies have mixed opinions. It is a nasal-only swab test that employs cutting-edge technology. Sensitivities decreased from 87.0% to 80.9% (P=0.16 by 2 test), 80.0% to 73.0% (P=0.60), and 83.1% to 70.3% (P=0.03), respectively, when transitioning from omicron accounting for 29% of infections to >95% of infections. Participants had a swab sample taken for reverse transcription polymerase chain reaction (RT-PCR, reference test) and received one rapid antigen test to perform unsupervised using either nasal self-sampling (during the emergence of omicron, and when omicron accounted for >90% of infections, phase 1) or with combined oropharyngeal and nasal self-sampling in a subsequent (phase 2; when omicron accounted for >99% of infections).

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