Chaturvedi, Saurabh. Sensitivities of three rapid antigen tests with nasal self-sampling decreased during the emergence of omicron but was only statistically significant for Clinitest. Conclusions Sensitivities of three rapid antigen tests with nasal self-sampling decreased during the emergence of omicron but was only statistically significant for Clinitest. This ensures excellent accuracy and quick and simple outcomes. Preliminary research by the FDA, in collaboration with the National Institutes of Health's Rapid Acceleration of Diagnostics program, used samples from patients confirmed to be infected with the. *Flowflex is the most accurate antigen test in the market in both clinical . Status validatie SARS-CoV-2 antigeen sneltesten, 10 Mar 2021 [Dutch]. At the time, this change in testing policy was covered by multiple national news outlets. Image Credit: Roman Zaeits / Shutterstock.com. Since regional variations in the Netherlands are small (data not shown), we are confident that omicron accounted for more than 90% of infections in all test sites from 12 January 2022 onwards. The US Food and Drug Administration has granted an Emergency Use Authorization to an over-the-counter (OTC) COVID-19 test that agency officials say will double at-home testing capacity. The TGA is reviewing all COVID-19-specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (ARTG). Information on the potential impact of these mutations on the performance of Ag-RDTs is not yet available. The polymerase chain reaction test, or PCR test typically available at a hospital or a lab is usually more on the mark. A recent paper demonstrated that LFTs, when used correctly, are likely to have a sensitivity above 80% and in many cases above 90%. 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. It found four cases in which individuals transmitted the virus to others while still testing negative on rapid tests. Early diagnosis of COVID-19 is essential to prevent further infections and the degradation to severe disease. This site needs JavaScript to work properly. Finally, self-reported user experiences with each rapid antigen test and self-reported numbers of infections that may have been missed by baseline RT-PCR testing were assessed. Bookshelf 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. It is intended for self-testing use. Anyone with COVID symptoms should get a PCR test, even if they have had a negative result on a lateral flow test. The SARS-CoV-2 Ag-RDT is advantageous for its ability to provide rapid results, low cost, and remain independent of the laboratory at the point of care. A Flowflex SARS-CoV-2 antigen rapid test kit is seen on the Watsons Singapore website on Mar 4, 2022. These tests have been freely distributed by the Dutch Ministry of Health, Welfare, and Sport across various target audiences. Individuals were eligible if aged 16 years or older and willing and able to sign a digital informed consent form in Dutch. 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). Higher sensitivities were observed after applying the viral load cut-off, but all stratification trends remained similar, except differences in sensitivity for previous SARS-CoV-2 infection status no longer appeared statistically significant for Flowflex (see supplementary figure S2). We assessed whether performance of the three rapid antigen tests with nasal self-sampling changed over time during the emergence of omicron, using 2 tests to assess the sensitivities and specificities of the tests in different inclusion weeks and comparing the sensitivities in the first inclusion week with the sensitivities in the last inclusion week. Its important to test at the right time and that is when you start experiencing symptoms. Most analyses, apart from the time trend analyses, included data from the latter omicron period. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Antigen tests, such as the Flowflex COVID-19 Antigen Home Test detect proteins from the virus. Please use one of the following formats to cite this article in your essay, paper or report: Chaturvedi, Saurabh. Specificities varied between 93.2% and 99.6% over time. 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). Rapid antigen tests show lower sensitivity for Omicron than for earlier SARS-CoV-2 variants. 2021. The former vice president has become the Democratic front-runner with primary victories across the country. Design: As a result, additional studies on the diagnostic accuracy of Ag-RDTs for the new Omicron VOC are urgently required to inform public health responses. WvdB, SDP, VFZ, LS, and MK were responsible for laboratory analyses and data processing. This original guidance reflects the low rate of reinfection during this window, meaning false positives could force people to unnecessarily self-isolate. ES and RPV contributed equally as first authors. official website and that any information you provide is encrypted 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. First, its likely that vaccinated people or those with immunity from prior infection have symptoms even before they become infectious, as these are immune responses. But one company is carving out room in the COVID-19 testing world . Performance of rapid antigen tests for omicron could be different because of alterations in viral proteins and infection dynamics. 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 mutations in the nucleocapsid protein potentially affected the different epitopes used in each test, which might explain the differences in analytical sensitivity between Ag-RDTs. As recently as Tuesday, FDA acting Commissioner Janet Woodcock repeated concerns about rapid tests and the omicron variant during a Senate hearing. Supplementary table S1 presents the characteristics of the participants for the delta-omicron transition phase and table 1 for phases 1 and 2. Variants of the corona virus 2021 [updated 2 December 2021]. Non-statistically significant differences of >10% were found for MPBio with nasal self-sampling and for Clinitest with nasal self-sampling and combined oropharyngeal and nasal self-sampling. Sensitivity. McGill University in Canada states that rapid tests are more likely to miss the omicron variant, compared with any other variant. 6497 people with covid-19 symptoms aged 16 years presenting for testing. If you have come into contact with an infected person, it could take a few days for a positive result to show up. 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. accurate result. 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. A collection point for lateral flow test kits in Amersham, Buckinghamshire. 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). Covid-19 antigen rapid test kits are pictured in Washington, D.C., on Dec. 30. . Saurabh Chaturvedi is a freelance writer from Jaipur, India. 2021. 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? Our data show that this was associated with a reduction in risk but did not minimise transmission risks because of the likelihood of false negative rapid antigen test results. Image Credit: Roman Zaeits / Shutterstock.com, https://www.medrxiv.org/content/10.1101/2021.12.18.21268018v1, Clec9A-RBD immunization could trigger robust and sustained systemic and mucosal immune responses against rapidly evolving SARS-CoV-2 variants, 25% of COVID-19 patients have lasting reduction in lung function, In-depth assessment of muscle biopsies in patients with long COVID, Study shows antibody-dependent SARS-CoV-2 transmission and pathogenesis, Rebounding of COVID-19 symptoms and viral load are common among untreated COVID-19 patients. Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the omicron period: a cross-sectional study. Please note: your email address is provided to the journal, which may use this information for marketing purposes. 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. 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. 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. A positive self-test result justifies prompt self-isolation without the need for confirmatory testing. QUICK - Get Results in 15 minutes. 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 . Data requestors will need to sign a data sharing agreement. Please enable it to take advantage of the complete set of features! 2021 Jun 22;22(1):412. doi: 10.1186/s13063-021-05241-5. doi: 10.1002/14651858.CD013705.pub2. The test is available in 1-Pack, 2-Pack and 5-Pack. Epub 2022 Nov 13. 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. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. The Omicron BA.5 variantthe strain of COVID-19 that's currently dominating in the United Statesis good at evading immunity from both vaccines and previous COVID infection. 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. Some of the subgroups that we evaluated may have had lower viral loads on average. Secondary outcomes were diagnostic accuracies stratified by reason for testing (confirmatory testing after a positive self-test result at ones own initiative, type of symptoms, close contact with an index case, or other reason), covid-19 vaccination status (no vaccination or vaccinated once, twice, or three times), previous SARS-CoV-2 infection, sex, and age (16-40 years, >40 years). (A different rule applies if you are an unvaccinated person who has been in close contact with someone who has tested positive: you must self-isolate for 10 days. An official website of the United States government. LFTs identify specific viral proteins that are present inside your nose when coronavirus is infecting you. 2023 Mar;29(3):391.e1-391.e7. SD Biosensor Standard Q COVID-19 AG Home Test ART kits are seen on the Watsons Singapore . News-Medical. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. Design Prospective cross sectional diagnostic test accuracy study. Test site staff asked people visiting one of the participating sites whether they would be willing to participate in the study. 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. 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. doi: 10.1016/j.cmi.2022.11.004. But the dawn of omicron has changed the efficacy of these tests. 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. RT-PCR=reverse transcription polymerase chain reaction, Flow of participants who used the MPBio (MP Biomedicals) rapid antigen test with nasal or combined oropharyngeal and nasal self-sampling, Tilburg, the Netherlands during omicron period. 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. 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. Then on Wednesday, The White House announced a $1 billion investment to manufacture at-home . The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis. Instead, What they are saying now is that if you are LFT-negative on two days then you are very likely no longer contagious and can go to work. Author(s) (or their employer(s)) 2019. Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing WHO; 2022 9 Mar 2022. 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 language and environment for statistical computing. New research suggests that some rapid antigen tests are not sensitive enough to detect asymptomatic COVID-19 infections. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error, Flow of participants who used the Flowflex (Acon Laboratories) rapid antigen test with nasal self-sampling during the omicron period, Rotterdam, the Netherlands. 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). Differences across subgroups were less pronounced in the confirmatory testers, with much higher sensitivities among confirmatory testers in all strata. 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. . 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%. Idaho lawmaker wants to criminalize the most-used COVID-19 vaccines, What is Orthrus? The analytical sensitivity to detect the SARS-CoV-2 Omicron variant was lower than that for the other VOCs in most of the tests evaluated. Sensitivities of all three rapid antigen tests were highest during the first week (fig 7) when omicron accounted for 28.6% of infections: 87.0% (79.7% to 92.4%) for Flowflex, 80.0% (51.9% to 95.7%) for MPBio, and 83.1% (72.9% to 90.7%) for Clinitest. Vertical line indicates sensitivity of the rapid antigen test in the overall study population, 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. Not all U.S. presidents are missed once they leave the White House. 73.3. We postulate several reasons for the somewhat lower sensitivities with omicron. Baseline characteristics of participants in the period when omicron dominated, stratified by rapid antigen test. Petersen agrees that people are unlikely to remain infectious, though it is not impossible. The polymerase chain reaction test, or PCR test typically available at a hospital or a lab is usually more on the mark. These findings should be interpreted with caution because of the larger uncertainty around these subgroup specific accuracy estimates. Clipboard, Search History, and several other advanced features are temporarily unavailable. But that isnt to say rapid tests dont work. As expected, RT-PCR positivity percentages were close to 100% in the confirmatory testers and substantially lower (30% to 43%) in the group that tested for other reasons. 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). Re-use permitted under CC BY-NC. Because omicron was emerging at the start of the study in mid-December 2021, we extended the study to ensure accrual of at least 335 positive RT-PCR test results for each rapid antigen test and sampling strategy when omicron accounted for >90% of infections.16. 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. The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. ECRI analysts found that some tests require particularly fine motor skills or have . A big reason behind this trend is the popularity of at-home tests. 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. 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. In this analytical method using a cultured virus, considerable heterogeneity in sensitivity patterns across variants and between individual assays was also observed. As a result, during those weeks the exposure-testing intervals of participants may have been increased, resulting in somewhat lower viral loads at the time of inclusion in the study. A special thanks to Esther Stiefelhagen, Renske Beekes, Sophie Neeleman, Eveline Westergaard, Roel Ensing, Wendy Mouthaan, and Timo Boelsums for their logistic support during the study conductwritten permission was obtained from each to list their names. While analytical tests with a cultured virus may be a substitute for clinical sensitivity, they are not a substitute for clinical evaluations and have various limitations. 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. Dissemination to participants and related patient and public communities: The Dutch Outbreak Management Team that provides guidance to the Ministry of Health, Welfare, and Sport on covid-19 policy has advised, based on the results of this study, that rapid antigen tests can be used in the home setting for detection of a SARS-CoV-2 infection in individuals with symptoms, and that confirmation by a reverse transcription polymerase chain reaction test at a test site is no longer necessary. sharing sensitive information, make sure youre on a federal The. AsI previously reported, omicron subvariants have a shorter incubation period, which is why thesymptomsmay appear earlier. Original reporting and incisive analysis, direct from the Guardian every morning. 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. If interested, they received information about the study, a test site specific rapid antigen test, and an email with a link to study documentation. Risks of. FOIA Yes. 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 pre-VOC SARS-CoV-2 strains. *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. Cochrane Database Syst Rev. 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. See rights and permissions. We studied the diagnostic accuracy of three widely available commercial rapid antigen tests (see box 1) with unsupervised self-sampling during and after the emergence of omicron, using reverse transcription polymerase chain reaction (RT-PCR) as the reference standard; evaluated whether accuracies of tests with nasal self-sampling changed over time; and quantified whether diagnostic performance was improved with the addition of oropharyngeal to nasal self-sampling. Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study. These data suggest that inexperienced individuals are as capable as experienced individuals at performing these tests unsupervised at home. and transmitted securely. Rijksoverheid. 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). Study shows COVID-19 rates were likely forty-times higher than CDC estimates during BA.4/BA.5 dominant period in the U.S. "This action highlights our . Please continue to test on a daily basis, urges Irene Petersen, professor of epidemiology and health informatics at University College London. HHS Vulnerability Disclosure, Help By continuing to browse this site you agree to our use of cookies. 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. InteliSwab (OraSure) Good. We do not capture any email address. The idea of a throat swab is not in and of itself a radical step. We believe all of them detect omicron, she said of the at-home rapid tests. Combined indicator: 14-day notification rate, testing rate and test positivity, updated 16 September 2021, weeks 35-36 2021 [updated 16 September 2021]. 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. (accessed March 04, 2023). Will a U.S. COVID-19 vaccine maker be able to stay in business? Direct Comparison of SARS-CoV-2 Nasal RT-PCR and Rapid Antigen Test (BinaxNOW) at a Community Testing Site During an Omicron Surge. Ag-RDT buffer with no virus was used as a negative control. JHHMvdW and KGMM contributed equally as senior authors. 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). Euro Surveill 2021;26:26. The visible test band in the presence of a visible control band was considered positive. 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. 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. 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. BMJ 2021;374:n1676. Self-testing for SARS-CoV-2 may potentially lower the threshold for testing and would allow individuals to obtain a result quickly and at their own convenience, which in turn could support the early detection of infectious people and reduce community transmission, Real world evidence on the performance of unsupervised nasal and combined oropharyngeal and nasal self-sampling in the omicron variant period is needed to accurately inform end users and policy makers, The sensitivities of three commercially available rapid antigen tests performed with nasal self-sampling decreased during the emergence of omicron, from 87% to 81% for Flowflex, 83% to 76% for MPBio, and 80% to 67% for Clinitest, with only Clinitest reaching statistical significance, Addition oropharyngeal to nasal self-sampling was associated with an improvement in the sensitivity of MPBio from 70% to 83% and Clinitest from 70% to 77% (not done for Flowflex), most notably in individuals who visited the test site for reasons other than to confirm a positive self-test result, Based on these findings, the manufacturers of MPBio and Clinitest may consider extending their instructions for use to include combined oropharyngeal and nasal self-sampling; other manufacturers should consider evaluating this as well.