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ES performed the statistical analysis and verified the underlying data in close collaboration with RPV and KGMM. Petersen agrees that people are unlikely to remain infectious, though it is not impossible. 2023 Jan 19;13(2):281. doi: 10.3390/life13020281. . Sensitivity. Idaho lawmaker wants to criminalize the most-used COVID-19 vaccines, What is Orthrus? 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 . A big reason behind this trend is the popularity of at-home tests. NO SYMPTOMS Needed - The Flowflex COVID-19 Home Test has been authorized to test patients with or without COVID-19 symptoms. Molenkamp R, Igloi Z. Individuals with a negative self-test result should adhere to general preventive measures because a false negative result cannot be ruled out. LFTs identify specific viral proteins that are present inside your nose when coronavirus is infecting you. Variables like how the test is administered can also contribute to the accuracy of the . Overall sensitivities with combined oropharyngeal and nasal self-sampling were 83.0% (78.8% to 86.7%) for MPBio and 77.3% (72.9% to 81.2%) for Clinitest. Rapid tests seem to be less sensitive for newer COVID variants in general, a letter published in April by researchers from the Harvard T.H. It can also be that earlier in the infection by BA.4 and BA.5, you dont produce enough of the SARS-CoV-2 protein, she added. Please enable it to take advantage of the complete set of features! Compared with the lateral flow test, the PCR test is far more sensitive. In participants who tested for other reasons, sensitivities were 52.4% (44.0% to 60.8%) for Flowflex, 51.5% (43.7% to 59.2%) for MPBio, and 49.5% (42.0% to 56.9%) for Clinitest with nasal self-sampling only, and 69.3% (58.6% to 78.7%) for MPBio and 59.9% (51.3% to 68.0%) for Clinitest with combined oropharyngeal and nasal self-sampling. RT-PCR=reverse transcription polymerase chain reaction, Flow of participants who used the Clinitest (Siemens-Healthineers) rapid antigen test with nasal or combined oropharyngeal and nasal self-sampling, Roosendaal, the Netherlands during omicron period. European Centre for Disease Prevention and Control (ECDC). 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. Results During phase 1, 45.0% (n=279) of participants in the Flowflex group, 29.1% (n=239) in the MPBio group, and 35.4% ((n=257) in the Clinitest group were confirmatory testers (previously tested positive by a self-test at own initiative). Early diagnosis of COVID-19 is essential to prevent further infections and the degradation to severe disease. ES, RPV, CRSN-I, and KGMM coordinated the study. counter self-test No This is an over-the-counter self-test No This is an over-the-counter self-test No This is an over-the-counter self-test Time to result ~15 minutes ~10 minutes ~15 minutes ~15 minutes Who can be tested? 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. MPBio and Clinitest were not CE marked for oropharyngeal and nasal sampling, but after safety checks by the quality team of the West-Brabant Public Health Service, and consultation with in-house in-vitro diagnostic regulation experts and the Medical Research Ethics Committee Utrecht, both tests were considered safe for use with oropharyngeal and nasal sampling. Fourthly, during the study period the participating test sites and laboratories experienced increasing requests for tests, exceeding the maximum capacity of the Dutch testing infrastructure. In late 2021 in the Netherlands, the public debate about covid-19 included discussions about the sensitivity of self-testing using commercially available tests. Please continue to test on a daily basis, urges Irene Petersen, professor of epidemiology and health informatics at University College London. Table 1 shows the inclusion dates for each test location and phase. Individuals with a negative self-test result should adhere to general preventive measures because a false negative result cannot be ruled out. 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. Accessibility 10.1136/bmj.n1676 When the pandemic began, at-home tests were considered to be about 70% to 80% accurate. Chaturvedi, Saurabh. In a post hoc analysis, we assessed the impact of self-testing frequency. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis. Our study provided direct evidence for the former, as sensitivity appeared to greatly improve when using a viral load cut-off. Sensitivities were substantially higher in confirmatory testers (those tested to confirm a positive self-test result) than in those who visited test sites for other reasons. Rapid antigen tests show lower sensitivity for Omicron than for earlier SARS-CoV-2 variants. This question became even more urgent with the rapid surge of the omicron variant, and with experts advertising combined oropharyngeal and nasal sampling in national news outlets. As the manufacturer, SD Biosensor, transitions to this new brand,. In the current study, the analytical sensitivity of the cultured virus to the Omicron variant and compared it to data previously obtained on other SARS-CoV-2 variants of concern (VOCs) including the Alpha, Beta, Gamma, and Delta variants, as well as a pre-VOC isolate of SARS-CoV-2 using seven Ag-RDTs. Matthews suggests getting a PCR test, and if that is also positive you could seek additional medical advice, as, although unlikely, in a very small number of cases it may mean you have an underlying medical condition. Symptomatic & Asymptomatic (need to retake test in 2-3 days, 36 hours apart) Symptomatic & Asymptomatic (need to retake . As we observed a decline in diagnostic accuracy with increasing dominance of the omicron variant in the nasal self-sampling period, the higher proportion of infections attributed to the omicron variant in the combined oropharyngeal and nasal self-sampling period may have led to an underestimation of the true difference in diagnostic accuracy between both sampling methods. The evaluated tests were Flowflex (Acon Laboratories; phase 1 only), MPBio (MP Biomedicals), and Clinitest (Siemens-Healthineers). All analyses were performed in R version 4.1.2 (2021-11-01) Bird Hippie.18, Flow of participants who used the Flowflex (Acon Laboratories) rapid antigen test with nasal self-sampling during the omicron period, Rotterdam, the Netherlands. This ensures excellent accuracy and quick and simple outcomes. Intelligence agencies have mixed opinions. This site needs JavaScript to work properly. Vertical line indicates sensitivity of the rapid antigen test in the overall study population, Sensitivities with 95% confidence intervals for the Clinitest (Siemens-Healthineers) 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. Another explanation might be that individuals with a previous infection have circulating anti-nucleocapsid protein antibodies,22 which might bind to the nucleocapsid protein produced during the new infection and thereby hamper the binding of monoclonal antibodies against the nucleocapsid protein in the test device. Participants: The FlowFlex antigen test is a COVID-19 antigen test kit authorized in the United Kingdom. These data suggest that inexperienced individuals are as capable as experienced individuals at performing these tests unsupervised at home. JHHMvdW and KGMM contributed equally as senior authors. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. Supplementary table S1 presents the characteristics of the participants for the delta-omicron transition phase and table 1 for phases 1 and 2. All tests are CE marked for nasal sampling. In this analytical method using a cultured virus, considerable heterogeneity in sensitivity patterns across variants and between individual assays was also observed. Nina Cosdon. Petersen emphasises that no test offers 100% accuracy, so please consider the risk of getting severe illness among your friends and family. government site. Participants received their RT-PCR result according to the public health services routine practice to direct any further management, such as isolation, if applicable. 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. 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). ES, RPV, LH, IKV, WvdB, SDP, EL, MH, RM, CW, IV, CRSN-I, SvdH, JAJWK, JHHMvdW, and KGMM designed the study. But the dawn of omicron has changed the efficacy of these tests. Test results can sometimes remain positive for a period after your isolation ends, but this does not necessarily mean you are still infectious.. Please contact your insurance provider to confirm eligibility and get information about your . As such, the results of our study have directly been disseminated and are currently incorporated in the nationwide testing policy. European Centre for Disease Prevention and Control (ECDC). During phase 2, 53.0% (n=288) of participants in the MPBio group and 44.4% (n=290) in the Clinitest group were confirmatory testers. Three public health service covid-19 test sites in the Netherlands, 21 December 2021 to 10 February 2022. Antigen tests are very specific for the COVID-19 virus but are not as sensitive as molecular tests. ), Majid says there is no need to keep on testing repeatedly if you have had a positive LFT result confirmed by a PCR test. Rapid antigen tests show lower sensitivity for Omicron than for earlier SARS-CoV-2 variants. We thank the participants and study staff at the participating public health service test sites, participating laboratories, University Medical Center Utrecht, and RIVM for their contributions to the study. Tags: Coronavirus, pandemic, public health. It is possible for . This . Venekamp RP, Schuit E, Hooft L, Veldhuijzen IK, van den Bijllaardt W, Pas SD, Zwart VF, Lodder EB, Hellwich M, Koppelman M, Molenkamp R, Wijers CJH, Vroom IH, Smeets LC, Nagel-Imming CRS, Han WGH, van den Hof S, Kluytmans JAJW, van de Wijgert JHHM, Moons KGM. Posted in: Device / Technology News | Medical Science News | Medical Research News | Disease/Infection News, Tags: Antigen, Assay, Coronavirus, Coronavirus Disease COVID-19, Diagnostic, Diagnostics, Genomic, in vivo, Laboratory, Mutation, Omicron, Polymerase, Polymerase Chain Reaction, Protein, Public Health, Respiratory, Ribonucleic Acid, RNA, SARS, SARS-CoV-2, Severe Acute Respiratory, Severe Acute Respiratory Syndrome, Syndrome, Virus. Straightforward and easy to read. 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. All authors approved the submission of the current version of the manuscript. Participants were asked to complete the study procedures at home as soon as possible, and within three hours of their test site visit. 2023 Mar;29(3):391.e1-391.e7. A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial. Objective To assess the performance of rapid antigen tests with unsupervised nasal and combined oropharyngeal and nasal self-sampling during the omicron period. Most participants (84.5%, n=5490) performed the rapid antigen test within three hours of visiting the test site. However, the observed decline was only statistically significant for Clinitest. A recent paper demonstrated that LFTs, when used correctly, are likely to have a sensitivity above 80% and in many cases above 90%. Brakenhoff TB, Franks B, Goodale BM, van de Wijgert J, Montes S, Veen D, Fredslund EK, Rispens T, Risch L, Dowling AV, Folarin AA, Bruijning P, Dobson R, Heikamp T, Klaver P, Cronin M, Grobbee DE; COVID-RED Consortium. Funding: This study was funded by the Dutch Ministry of Health, Welfare, and Sport. Petersen says there are two probable reasons for this. All Rights Reserved. He is a gold medalist in Masters in Pharmaceutical Chemistry and has extensive experience in medical writing. It is a nasal-only swab test that employs cutting-edge technology. Risks of. Individual participant data collected during the study will be available, after deidentification of all participants. while also discussing the various products Sartorius produces in order to aid in this. For testing the diagnostic accuracy of the SCoV-2 Ag Detect Rapid Test, they collected two anterior nasopharyngeal swab samples from 802 SARS-CoV-2-infected participants reporting onset of . 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. ES and RPV contributed equally as first authors. Self-isolation for those who test positive but are asymptomatic begins from the day they take the test, not the day they receive a positive result as stated in an earlier version. The researchers followed the manufacturers instructions to perform all Ag-RDT assays, with the exception of the addition of a five microliter (L) virus dilution into the proprietary buffer, and then applied to the Ag-RDT in duplicates under Biological Safety Laboratory 3 (BSL3) conditions. Supplementary table S7 presents diagnostic accuracies stratified by all reasons for testing. InteliSwab (OraSure) Good. Then on Wednesday, The White House announced a $1 billion investment to manufacture at-home . Published by BMJ. on this website is designed to support, not to replace the relationship Copyright 2023 BMJ Publishing Group Ltd, Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study, Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis, Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021, Detection of SARS-CoV-2 infection in the general population by three prevailing rapid antigen tests: cross-sectional diagnostic accuracy study. 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. On Monday, the FDA authorized the Flowflex test - made at ACON laboratories in Southern California. 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. We performed complete cases analysis because the number of individuals without RT-PCR or rapid antigen test results was low (see fig 1, fig 2, and fig 3). and transmitted securely. Retrieved on March 04, 2023 from https://www.news-medical.net/news/20211229/Rapid-antigen-tests-show-lower-sensitivity-for-Omicron-than-for-earlier-SARS-CoV-2-variants.aspx. However, the gold standard remains the polymerase chain reaction (PCR) test, which detects viral load and infectiousness at lower levels, including before and after the time range in which they are picked up by LFTs. Confirmatory testers did have more self-testing experience than non-confirmatory testers (>10 self-tests reported by 37.2% v 30.0% of participants in the Flowflex group, 42.0% v 25.7% in the MPBio group, and 22.5% v 19.6% in the Clinitest group, respectively). However, David Matthews, a professor of virology at the University of Bristol, says that a thicker line could mean in theory at least there is more N protein. Coronavirus antigen detection test system. Baseline characteristics of participants in the period when omicron dominated, stratified by rapid antigen test. Sensitivities were observed to increase when the tests (assessed for MPBio and Clinitest only) used combined oropharyngeal and nasal self-sampling instead of nasal self-sampling only. Sign up to receive the latest updates from U.S News & World Report and our trusted partners and sponsors. However, sensitivities declined to 80%, 70%, and 70%, respectively, in the omicron period. 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. 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. A recent small study found that at-home antigen coronavirus tests could miss omicron cases for several days while a person is infected. 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. Bar charts indicate the percentage of SARS-CoV-2 infections attributable to omicron according to the national pathogen surveillance, while the numbers indicate the number of participants included in each week. *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. Sensitivities were substantially higher in confirmatory testers (93.6%, 83.6%, and 85.7%, respectively) than in those who tested for other reasons (52.4%, 51.5%, and 49.5%, respectively). There are currently 16 Covid-19 self-test kits approved for use here. 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). 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). 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). PMC This site complies with the HONcode standard for trustworthy health information: verify here. We also showed that the performance of rapid antigen tests can be improved by adding oropharyngeal to nasal self-sampling. In case of a positive self-test result, self-isolation is required, but confirmatory testing seems unnecessary in most situations if the infection rate is high. Conclusions: 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. When a self-test result was negative, individuals were allowed to go to work or school. New. In the Netherlands, all available SARS-CoV-2 self-tests are lateral flow antigen tests. A total of 3076 individuals participated in the delta-omicron transition phase before phase 1 (see supplementary figure S1) and a further 2199 in phase 1 and 1222 individuals in phase 2 (fig 1, fig 2, and fig 3). The Biden administration is planning to send the first shipment of a total of 500 million COVID-19 tests directly to Americans later this month. Epub 2022 Nov 13. Sixthly, nasal and combined oropharyngeal and nasal self-sampling were conducted in different time periods, but the omicron variant was present in >90% of samples in the national surveillance in both periods. Considerations on the use of self-tests for COVID-19 in the EU/EEA. Original reporting and incisive analysis, direct from the Guardian every morning. A table showing the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) test which is not authorized by the FDA and the Flowflex COVID-19 Antigen Home Test which is authorized. Illustration by Zo Peterson, Deseret News. A positive self-test result justifies prompt self-isolation without the need for confirmatory testing. accurate result. "Omicron is so . You can cut this isolation period down to seven days if you receive negative LFTs on days six and seven, 24 hours apart. BMJ 2021;374:n1676. From April 2021 the ministry distributed almost 120 million rapid antigen tests for self-use, of which 10.6 million were Flowflex, 28.7 million MPBio, and 12.4 million Clinitest. Overall sensitivities 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 (table 2, fig 4, fig 5, and fig 6). Testing for adults and children ages 2+ years, with or . Matthews says the new guidance does not negate the earlier advice. The Flowflex COVID-19 Antigen Home Test, which the FDA authorized for emergency use on Oct. 4, gave a correct positive result 93% of the time and a correct negative result 100% of the time in a . Current analyses only include those who reported any SARS-CoV-2 infection related symptom at the time of sampling, regardless of the reason for visiting the test site. The viral loads should therefore be considered as best estimates. The omicron variant accounted for 73 percent of new coronavirus cases between Dec. 12 and Saturday, according to modeled projections from the Centers for Disease Control and Prevention. Provenance and peer review: Not commissioned; externally peer reviewed. 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). The manuscripts guarantor (KGMM) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained. 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. 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. Volk's advice is to wait at least five days after exposure to do a rapid test. Test site staff asked people visiting one of the participating sites whether they would be willing to participate in the study. But some tests may. Trained test site staff then took a swab sample for routine RT-PCR testing. 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. The Omicron variant, initially isolated on the Vero-TMPRSS cells, was then crossed by a stock passage (p2) prepared on VeroE6. Acon Flowflex OTC Rapid Antigen Kits - Spectrum Medical is a preferred U.S. distributor for the one-test kit, which leverages lateral flow technology to detect the presence of SARS-Cov-2 and other . The Flowflex COVID-19 Antigen Home Tes t is an easy-to-use, rapid nasal swab test that detects an active COVID-19 infection in 15 minutes. During phase 2, 53.0% (n=288) of participants in the MPBio group and 44.4% (n=290) in the Clinitest group were confirmatory testers. "Rapid antigen tests show lower sensitivity for Omicron than for earlier SARS-CoV-2 variants". The polymerase chain reaction test, or PCR test typically available at a hospital or a lab is usually more on the mark. 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.

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