Seroprevalence of anti-SARS-CoV-2 antibodies in high-risk occupational and low-risk groups in southwestern Iran

Background: Monitoring the spread of SARS-CoV-2 has been considered by the World Health Organization (WHO). We examined the prevalence of anti-SARS-CoV-2 immunoglobulin antibodies in southwestern Iran in spring 2020. The circulation of SARS-CoV-2 is high in the general population, especially among health care workers (HCWs) who are in close contact with patients. Objectives: The aim of this study was to determine the prevalence of anti-SARS-CoV-2 antigen in high-risk occupational and low-risk groups to investigate risk factors for serum positivity in Shiraz, southwestern Iran. Methods: A cross-sectional survey was performed on 366 participants (204 from high-risk and 162 from low-risk subjects). IgG and IgM antibodies were detected using Pishtaz Teb COVID-19 ELISA Kits to evaluate SARS-CoV-2-antigen in serum samples. After enzyme-linked immunosorbent assay (ELISA), serum prevalence, as well as IgG/IgM positive factors, was determined using logistic regression. Results: From July to September 2020 (a few months after reporting the first case of COVID-19 cases in Iran), out of 366 survived people, 72 (40.9%) were IgG positive, and 50 (27.5%) were IgM positive. The frequency of positive serology for IgG and IgM antibodies in individuals aged < 30 years was higher in the low-risk group than in the high-risk group. Multivariate logistic regression showed that headache (OR 0.312 [95% CI: 0.136 - 0.717]) and cough (OR 0.427 [95% CI: 0.182 - 1.004]) factors were associated with IgG or IgM positive serology. Conclusions: Between July and September 2020, the prevalence of anti-SARS-CoV-2 antigen was high in Shiraz. The prevalence of SARS-CoV-2 IgG/IgM antibodies in the high-risk group and their family as low risk was shown to increase viral infection due to close contact with COVID 19 patients than in the general population. Several factors were found to be related to the prevalence of anti-SARS-CoV-2 antigen that needs to be considered by policymakers to determine what to do about the SARS-CoV-2 pandemic.

Advancements in COVID- 19 Testing: An in-depth overview.

COVID-19 rapidly evolved as a pandemic, killing and hospitalising millions of people, creating unprecedented hurdles for communities and health care systems worldwide. The rapidly evolving pandemic prompted the head of the World Health Organisation to deliver a critical message: "test, test, test." The response from the diagnostic industry and researchers worldwide was overwhelming, resulting in more than a thousand commercial tests available in the market worldwide. Several sampling approaches and diagnostic techniques have been employed from the early stages of the pandemic, such as SARS-CoV-2 detection by targeting the viral RNA or protein, indirectly via antibody testing, biochemical estimation, and various imaging techniques, and many are still in the various stages of development and yet to be marketed. Accurate testing techniques and appropriate sampling are the need of the hour to manage, diagnose and treat the pandemic, especially in the current crisis, where SARS-CoV-2 undergoes constant mutation, evolving into various strains, which are pretty challenging. The article discusses various testing techniques as well as screening methods for detection, treatment, and management of COVID-19 transmission, such as NAAT, PCR, isothermal detection including RT-LAMP, RPA, NASBA, RCA, SDA, NEAR, and TMA, CRISPR strategy, nanotechnology approach, metagenomic profiling, point of care tests, virus neutralization test, ELISA, biomarker estimation, utilization of imaging techniques such as CT, ultrasonography, brain MRI in COVID-19 complications, and other novel strategies including microarray methods, microfluidic methods and artificial intelligence with an emphasis on advancements in the testing strategies for the diagnosis, management, and prevention of COVID-19.

Community pharmacy experience in SARS-CoV-2 antigen detection testing programs

BACKGROUND: SARS-CoV-2 infection was an unprecedented pandemic with unprecedented global health and socio-economic impact. More than 13 million cases had been confirmed in Spain by August 2022, and diagnostic testing to detect cases of infection in the country has helped to partially mitigate the spread of the virus. In 2021, the first self-testing antigen tests were marketed for dispensing in community pharmacies, and over-the-counter dispensing was allowed from July of that year. The network of community pharmacies played a key role, not only in the informed dispensing of these tests, but also in actively participating in the performance, supervision and reporting of results to the health authorities, and even in the issuing of digital certificates. A compilation has been made of all the available data on the subject, with a deadline of 13 February 2022, which is considered to be the end of the sixth wave of the epidemic in Spain. The results of the action taken by community pharmacies in twelve Autonomous Communities, which somehow participated in these initiatives by carrying out or supervising a total of 1,043,800 tests, from which 109,570 positive cases (10.5% of the total) were detected and reported to the National Health System, are presented in this article. Although the results are provisional, because many of the programmes are still ongoing, they are a clear demonstration of the potential that community pharmacies can play in Public Health work.

Rapid cassette test results in anti-SARS-CoV-2 antibody screening verification by electrochemiluminescence immunoassay method

Objective: Since the resumption of face-to-face education in October 2020, which was suspended due to the COVID-19 pandemic, coincides with the period when SARS-CoV-2 infection rates in young adults are on the rise. This study focuses on the 2019 corona virus outbreak in young adults, the largest link in the chain of transmission, which can be defined as silent contagious agents. It is aimed to provide epidemiological data by detecting virus disease (COVID-19) seropositivity with two different serological methods, and to evaluate the symptom-test performance relationship of asymptomatic/mild symptom/symptomatic cases. Methods: A cross-sectional study was conducted with students studying at Cappadocia University health programs between December 2020 and February 2021 and who will attend practice courses face-to-face. Participants were surveyed about their COVID-19 symptoms and disease histories based on SARS-CoV-2 exposure. For SARS-CoV-2 antibody detection, blood samples were taken from the participants and investigated with a single lateral flow immunoAssay (LFIA, Novatech, Turkey) cassette test. The samples with positive test result were then SARS-CoV-2 Anti-N IgM+IgG;SARS-CoV-2 Anti-S IgM+IgG;SARS-CoV-2 Anti-RBD IgG;It was re-evaluated using the electrochemiluminescence immunoassay (ECLIA) method with the anti-SARS-CoV-2 kit (Roche, Germany). Results: Of the 239 samples participating in the study, 50 (20.9%) samples that were positive for SARS-CoV2 IgM/ IgG according to the LFIA method were then studied again with the ECLIA method. According to the ECLIA result, 72% (36/50) of individuals against both nucleocapsid (N) and spike (S) antigens, and 70% (35) against RBD antigen were seropositive. Based on the ECLIA test results, 239 samples were studied and 50 samples were found to be IgM/IgG positive, with a sensitivity of 64% and a specificity of 93%. Contingence history was reported in 46% (n=23) of patients who were seropositive by both methods, while 30% (n=15) showed a COVID-19 clinic. Fifty four percent (n=27) of the participants reported that they did not have a PCR (polymerase chain reaction) test, but antibody response was observed in all of them. Only 28% (n=14) of seropositive patients reported positive PCR results, and 4% of them stated that they had a chronic disease. It will be important to continue to observe the serological status of young people, particularly in the context of new COVID-19 variants and in the low interest in mass vaccination campaigns targeting young people. Conclusion: It is thought that the performance of ECLIA with rapid casette test does not have a good degree of agreement and confirmation with different immunoassay tests would be more useful for epidemiological surveillance. Especially the new COVID-19 in the context of the variants and targeting youth due to the lack of interest in vaccination champaigns continue to monitor the serological status of young people it will be important.

Utility of COVID-19 antigen testing in the emergency department.

BACKGROUND: The BinaxNOW coronavirus disease 2019 (COVID-19) Ag Card test (Abbott Diagnostics Scarborough, Inc.) is a lateral flow immunochromatographic point-of-care test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein antigen. It provides results from nasal swabs in 15 minutes. Our purpose was to determine its sensitivity and specificity for a COVID-19 diagnosis. METHODS: Eligible patients had symptoms of COVID-19 or suspected exposure. After consent, 2 nasal swabs were collected; 1 was tested using the Abbott RealTime SARS-CoV-2 (ie, the gold standard polymerase chain reaction test) and the second run on the BinaxNOW point of care platform by emergency department staff. RESULTS: From July 20 to October 28, 2020, 767 patients were enrolled, of which 735 had evaluable samples. Their mean (SD) age was 46.8 (16.6) years, and 422 (57.4%) were women. A total of 623 (84.8%) patients had COVID-19 symptoms, most commonly shortness of breath (n = 404; 55.0%), cough (n = 314; 42.7%), and fever (n = 253; 34.4%). Although 460 (62.6%) had symptoms ≤7 days, the mean (SD) time since symptom onset was 8.1 (14.0) days. Positive tests occurred in 173 (23.5%) and 141 (19.2%) with the gold standard versus BinaxNOW test, respectively. Those with symptoms >2 weeks had a positive test rate roughly half of those with earlier presentations. In patients with symptoms ≤7 days, the sensitivity, specificity, and negative and positive predictive values for the BinaxNOW test were 84.6%, 98.5%, 94.9%, and 95.2%, respectively. CONCLUSIONS: The BinaxNOW point-of-care test has good sensitivity and excellent specificity for the detection of COVID-19. We recommend using the BinasNOW for patients with symptoms up to 2 weeks.

Performance of the PanbioTM COVID-19 Ag rapid test in a health care setting in Ouagadougou, Burkina Faso

This study aimed to evaluate the performance of the PanbioTM Covid-19 Ag Rapid Test (Abbott) in a medical center in Ouagadougou. The PanbioTM COVID-19 Ag test was evaluated from January 26 to March 31, 2021 in symptomatic and asymptomatic patients in the medical Centre of Kossodo. A total of 268 individuals were tested by both SARS-CoV-2 RT-PCR, and antigen RDT. Of these 268 individuals, 52 were positive and 216 were negative for COVID-19 RT-PCR. The performance parameters of the test and its Kappa agreement with the RT-PCR were calculated according to the presence or absence of symptoms in the patients on one hand, and according to the time onset of symptoms on the other hand. The sensitivity of the PanbioTM COVID-19 Ag Rapid Test ranged from 29.63% (95% CI: 13.75 to 50.18) among COVID-19 asymptomatic patients, to 87.5% (95% CI: 52.91 to97.76) among symptomatic patients with symptom onset time of 1-5 days. Similarly, the PanbioTM COVID-19 Ag Rapid Test specificity was 97.3% (95% CI: 90.58 to 99.67) and 96.4% (95% CI: 91.81 to 98.82) in symptomatic and asymptomatic RT PCR negative patients. The PanbioTM COVID-19 Ag Rapid Test shows good performance in detecting COVID-19 cases in patients with a symptom onset time of less than seven (7) days. This performance is even better when the symptom onset is reduced to five (5) days. The results show that the antigen RDT is not suitable for COVID-19 detection among asymptomatic patients.

New insights on malaria

Malaria is long known as a deadly vector borne infection, caused by five parasite species of the coccidian genus Plasmodia that are present in as many as 85 countries. Despite significant progresses have been achieved to control the infection by early diagnosis and artemisinin combination treatment, insecticide-treated nets and indoor residual spraying, malaria still represents a major public health issue in many endemic low-income countries. New diagnostic tools of higher sensitivity and specificity are now available for use in endemic countries to better guide diagnosis and treatment. In particular, highly sensitive rapid antigenic tests are now available and the loop-mediated isothermal amplification is a very promising and highly sensitive diagnostic tool. After 2015, decreasing morbidity and mortality trends have been stagnating because of limited funding, emergence of parasite and vector resistance to drugs and insecticides respectively and, recently, by the disrupting effect of COVID-19 pandemic. The incomplete knowledge of the complex immunity of malaria infection has slowed the development of an effective vaccine. However, in 2021, the RTS-S vaccine, however of suboptimal protective efficacy, has been made available for routine use in children above 5 months of age. Population movements has increased the chance of observing imported malaria in non-endemic areas, where malaria competent vectors may still exist.

Clinical profile of scrub typhus patients during COVID pandemic: a sub-Himalayan single center experience

Introduction: Scrub typhus is tropical zoonotic disease, commonly presented with multi organ dysfunction and high mortality rate in untreated patients. This study was done to identify clinical features commonly associated with scrub typhus during COVID pandemics, parameters associated with severe scrub typhus and mortality. Methods: This retrospective study was done in a tertiary care hospital with a total of 52 admitted scrub typhus positive patients in October 2020 to February 2022. Diagnosis was established by scrub IgM ELISA or Rapid antigen test. The clinical and laboratory data, duration of hospital stay and outcomes were collected. Common clinical and laboratory findings were of descriptive analysis. Factors associated with mortality were analysed using Chi-square test. Results: Fever was the most common presenting symptoms on admission (94.2%) followed by respiratory abnormalities (38.46%). Acute kidney injury was the most common organ failure on admission (67.3%), followed by acute liver injury (46.2%) and thrombocytopenia (32.7%). MODS was seen in 46.15%. Of the total, 30.8% were admitted in ICU. Mortality was seen in 7.7% of all patients. On Chi-square analysis, altered mental status and coagulopathy were associated with significant mortality with p value <0.05. Conclusion: Scrub typhus can manifest with potentially life-threatening complications such as acute kidney injury, acute liver injury, thrombocytopenia and MODS. The overall case-fatality rate was 7.7%, and presence of altered mental status and coagulopathy were associated with higher mortality. As per literature, COVID has changed few clinical profiles of scrub typhus compared to same center experience before.

COVID-19 diagnostics and early phase clinical trials: challenges and risk mitigation in the Omicron variants era

The evolution of the coronavirus disease 2019 (COVID-19) pandemic and widespread community of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants continues to present new challenges for early phase clinical trials and COVID-19 diagnostic strategies. Many regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to provide updated guidance on the operations of clinical trials during the pandemic. However, guidance is limited with respect to medical and scientific specific issues, such as COVID-19 diagnostics. Here we discuss, the challenges for early phase studies associated with COVID-19 diagnostics in the Omicron era and potential risk mitigation strategies in the face of continued widespread community transmission. We note how careful consideration and planning can help mitigating the risk of COVID-19 impacting the medical and scientific validity and patient safety in clinical trials. Clinical study design should consider mitigation strategies at the patient, investigator, and clinical research organization (CRO)/Sponsor level following evaluation of the overall for their specific study/investigational product and patient overall wellbeing. Specific language regarding COVID-19-related policies and procedures should be included in the study protocol. Special considerations should be taken for novel immunotherapeutics which may require interruption in the event of a subject developing COVID-19 or for investigative products that may have hazardous interactions with commonly prescribed anti-COVID-19 therapies. Moving forward, its essential for trials to remain adaptable to evolving nature of the pandemic. © Journal of Laboratory and Precision Medicine. All rights reserved.

Lessons Learned from In-Person Conferences in the Times of COVID-19.

Scientific societies and conference secretariats have recently resumed in-person meetings after a long pause owing to the COVID-19 pandemic. Some safety measures continue to be implemented at these in-person events to limit the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With increased numbers of waves of infection, caused by the emergence of SARS-CoV-2 variants, additional information is needed to ensure maximal safety at in-person events. The MEX-DART case study was conducted at the in-person Hep-DART 2021 conference, which was held in Los Cabos, Mexico, in December 2021. Many COVID-19 safety measures were implemented, and incidence of SARS-CoV-2 infection during the conference was tested onsite. In this study, we highlight the specific conditions and safety measures set in place at the conference. In addition to vaccination requirements, social distancing, and mask wearing, daily rapid testing was implemented for the duration of the conference. At the end of the 4-day meeting, none of the 166 delegates (and family members attending the conference) had tested antigen positive for SARS-CoV-2. Two delegates tested positive in the week after the conference; the timing of their positive test result suggests that they contracted the virus during their travels home or during postconference vacationing. We believe that this model can serve as a helpful template for organizing future in-person meetings in the era of COVID-19 and any other respiratory virus pandemics of the future. While the outcomes of this case study are encouraging, seasonal surges in respiratory virus infections such as SARS-CoV-2, RSV, and influenza virus incidence suggest that continued caution is warranted.

Prospective study of three saliva qualitative antigen testing kits for the detection of SARS-CoV-2 among mainly symptomatic patients in Japan.

INTRODUCTION: Rapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated. METHODS: A prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva between June 2022 and July 2022 in Japan using real-time reverse transcription polymerase chain reaction (RT-qPCR) as a reference. A nasopharyngeal sample and a saliva sample were simultaneously obtained, and RT-qPCR was performed. RESULTS: In total, saliva samples and nasopharyngeal samples were collected from 471 individuals (RT-qPCR-positive, n = 145) for the analysis. Of these, 96.6% were symptomatic. The median copy numbers were 1.7 × 106 copies/mL for saliva samples and 1.2 × 108 copies/mL for nasopharyngeal samples (p < 0.001). Compared with the reference, the sensitivity and specificity were 44.8% and 99.7% for ImunoAce SARS-CoV-2 Saliva, 57.2% and 99.1% for Espline SARS-CoV-2 N, and 60.0% and 99.1% for QuickChaser Auto SARS-CoV-2, respectively. The sensitivities of all antigen testing kit were 100% for saliva samples with a high viral load (>107 copies/mL), whereas the sensitivities were <70% for high-viral-load nasopharyngeal samples (>107 copies/mL). CONCLUSION: COVID-19 rapid antigen detection kits with saliva showed high specificity, but the sensitivity varied among kits, and were also insufficient for the detection of symptomatic COVID-19 patients.

Lessons From the Field: Rapid Antigen Testing Is Efficient and Practical for Mitigation of Coronavirus Disease 2019 Outbreaks in Long-Term Care Facilities.

Background: Mitigation of coronavirus disease 2019 (COVID-19) outbreaks in long-term care facilities (LTCFs) is facilitated by rapid identification and isolation of infectious individuals to interrupt viral transmission. Immunochromatographic (IC) tests, or rapid antigen tests, have high sensitivity and specificity during the contagious period for COVID-19. Mathematical modeling predicts frequent IC surveillance will be more efficient than polymerase chain reaction (PCR)-based strategies, especially during community surges when reporting of PCR results can be delayed. However, there are few published field studies evaluating IC testing strategies in this long-term care setting. Methods: In fall and winter of 2020, the Marin Health and Human Services Department implemented thrice-weekly IC mass testing by nonlaboratory workers in outbreaks that occurred in 2 LTCFs, in addition to then-standard semiweekly PCR testing. The IC test performance was characterized using same-day PCR specimens as reference standard. Cumulative incidence and duration of transmission for the 2 IC intervention facility outbreaks were compared with 6 reference LTCFs that used weekly to semiweekly PCR alone during an outbreak response. Results: Of 123 same-day test pairs, IC test sensitivity and specificity were 75% (95% confidence interval [CI], 48%-93%) and 100% (95% CI, 97%-100%), respectively. The median duration of outbreak transmission was 19.5 days in the 2 intervention sites and 28 days in the reference facilities (P = .40). Cumulative incidence for the outbreaks among LTCF residents was 41% in the intervention facilities versus 52% in the reference facilities (P = .04, Fisher 2-sided exact). Conclusions: Thrice-weekly mass IC testing as used by nonlaboratory personnel can be highly practical and effective for COVID-19 outbreak mitigation in the LTCF setting.

Hesitancy to Undergo SARS-CoV-2 Rapid Antigen Testing in China: Nationwide Cross-sectional Study.

BACKGROUND: SARS-CoV-2 rapid antigen testing (RAT) could be a useful supplementary test to diagnose larger numbers of acute asymptomatic infections and alleviate the limitations of polymerase chain reaction testing. However, hesitancy to undergo SARS-CoV-2 RAT may compromise its implementation. OBJECTIVE: We aimed to understand the prevalence and correlates of hesitancy to undergo RAT among adults not infected with SARS-CoV-2 in mainland China. METHODS: A nationwide cross-sectional survey on hesitancy to undergo SARS-CoV-2 RAT was conducted among adults not infected with SARS-CoV-2 in mainland China between April 29, 2022, and May 10, 2022. Participants completed an online questionnaire that covered the following COVID-19-related factors: sociodemographic characteristics, experiences of COVID-19 restrictions and knowledge of COVID-19, and attitude toward COVID-19 and its screening. This study was a secondary analysis of data from the survey. We compared the characteristics of participants by hesitancy to undergo SARS-CoV-2 RAT. Thereafter, logistic regression with a sparse group minimax concave penalty was used to identify correlates of hesitancy to undergo RAT. RESULTS: We recruited 8856 individuals with diverse demographic, socioeconomic, and geographic characteristics in China. Eventually, 5388 participants (valid response rate of 60.84%; 52.32% [2819/5388] women; median age 32 years) were included in the analysis. Among the 5388 participants, 687 (12.75%) expressed hesitancy to undergo RAT and 4701 (87.25%) were willing to undergo RAT. Notably, those who were from the central region (adjusted odds ratio [aOR] 1.815, 95% CI 1.441-2.278) and those who received COVID-19 information from traditional media (aOR 1.544, 95% CI 1.279-1.863) were significantly more likely to report hesitancy to undergo RAT (both P<.001). However, those who were women (aOR 0.720, 95% CI 0.599-0.864), were older (aOR 0.982, 95% CI 0.969-0.995), had postgraduate education (aOR 0.612, 95% CI 0.435-0.858), had children (<6 years old) and elders (>60 years old) in the family (aOR 0.685, 95% CI 0.510-0.911), had better knowledge about COVID-19 (aOR 0.942, 95% CI 0.916-0.970), and had mental health disorders (aOR 0.795, 95% CI 0.646-0.975) were less likely to report hesitancy to undergo RAT. CONCLUSIONS: Hesitancy to undergo SARS-CoV-2 RAT was low among individuals who were not yet infected with SARS-CoV-2. Efforts should be made to improve the awareness and acceptance of RAT among men, younger adults, individuals with a lower education or salary, families without children and elders, and individuals who access COVID-19 information via traditional media. In a reopening world, our study could inform the development of contextualized mass screening strategies in general and the scale-up of RAT in particular, which remains an indispensable option in emergency preparedness.

Comparison between the Sofia SARS Antigen FIA Test and the PCR Test in Detection of SARS-CoV-2 Infection.

OBJECTIVE: The purpose of this study was to compare Quidel's rapid antigen test Sofia SARS antigen Fluorescent Immunoassay (FIA) (Sofia) with the real-time reverse transcription-polymerase chain reaction (rRT-PCR) test. METHODS: Two samples were taken from each test subject-1 for testing with the Sofia test and 1 for testing with the rRT-PCR test. In total, swabs were taken from 146 subjects who presented symptoms of infection (group 1) and 672 subjects who were tested regardless of symptoms (group 2). RESULTS: In group 1, the sensitivity of the antigen test was 90.0% and its specificity 97.5%. In group 2, however, the sensitivity of the antigen test was 81.4% and the specificity 98.9%. In addition to asymptomatic patients, false-negative results of rapid antigen tests also occurred in subjects with high threshold values (cycle threshold > 30). CONCLUSION: Our results show that the Sofia test meets the standards for diagnostic tests according to the criteria of the World Health Organization, as they show high sensitivity and specificity, and perhaps most importantly, a high negative predictive value (> 95%).

Cost-Benefit of Real-Time Multiplex PCR Testing of SARS-CoV-2 in German Hospitals.

BACKGROUND: The current Omicron COVID-19 pandemic has significant morbidity worldwide. OBJECTIVE: Assess the cost-benefit relation of implementing PCR point-of-care (POCT) COVID-19 testing in the emergency rooms (ERs) of German hospitals and in the case of inpatient admission due to other acute illnesses. METHODS: A deterministic decision-analytic model simulated the incremental costs of using the Savanna® Multiplex RT-PCR test compared to using clinical judgement alone to confirm or exclude COVID-19 in adult patients in German ERs prior to hospitalization or just prior to discharge. Direct and indirect costs were evaluated from the hospital perspective. Nasal or nasopharyngeal swabs of patients suspected to have COVID-19 by clinical judgement, but without POCT, were sent to external labs for RT-PCR testing. RESULTS: In probabilistic sensitivity analysis, assuming a COVID-19 prevalence ranging between 15.6-41.2% and a hospitalization rate between 4.3-64.3%, implementing the Savanna® test saved, on average, €107 as compared to applying the clinical-judgement-only strategy. A revenue loss of €735 can be avoided when SARS-CoV-2 infection in patients coming unplanned to the hospital due to other acute illnesses are excluded immediately by POCT. CONCLUSIONS: Using highly sensitive and specific PCR-POCT in patients suspected of COVID-19 infection at German ERs may significantly reduce hospital expenditures.

Feasibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen self-testing in school and summer camp attendees.

Background: SARS-CoV-2 screening is one of the pillars of non-pharmaceutical preventive strategies to early identify and isolate infected individuals and therefore decrease community incidence. Methods: We assessed the feasibility of severe acute respiratory syndrome coronavirus 2 self-testing with antigen-detecting rapid diagnostic tests in attendees of educational settings. Results: A total of 305 students (88.15%) and 41 staff (11.85%) from 9 to 56 years old participated in the self-testing procedure and answered the survey at the end of the study. 91.3% (n = 313) did not need help, 96.1% of participants reported the same outcome as the healthcare workers. 94.5% strongly or slightly agree with the statement "I would repeat the experience". Conclusion: The study demonstrates that self-testing is acceptable and usable in children, adolescents and adults when the epidemiological situation may require a systematic screening of these populations, although supervision by health care or previously trained personnel is recommended for younger age groups.

Quantitative Analysis of the Effectiveness of Antigen- and Polymerase Chain Reaction-Based Combination Strategies for Containing COVID-19 Transmission in a Simulated Community.

The number of coronavirus disease 2019 (COVID-19) cases continues to surge, overwhelming healthcare systems and causing excess mortality in many countries. Testing of infectious populations remains a key strategy to contain the COVID-19 outbreak, delay the exponential spread of the disease, and flatten the epidemic curve. Using the Omicron variant outbreak as a background, this study aimed to evaluate the effectiveness of testing strategies with different test combinations and frequencies, analyze the factors associated with testing effectiveness, and optimize testing strategies based on these influencing factors. We developed a stochastic, agent-based, discrete-time susceptible-latent-infectious-recovered model simulating a community to estimate the association between three levels of testing strategies and COVID-19 transmission. Antigen testing and its combination strategies were more efficient than polymerase chain reaction (PCR)-related strategies. Antigen testing also showed better performance in reducing the demand for hospital beds and intensive care unit beds. The delay in the turnaround time of test results had a more significant impact on the efficiency of the testing strategy compared to the detection limit of viral load and detection-related contacts. The main advantage of antigen testing strategies is the short turnaround time, which is also a critical factor to be optimized to improve PCR strategies. After modifying the turnaround time, the strategies with less frequent testing were comparable to daily testing. The choice of testing strategy requires consideration of containment goals, test efficacy, community prevalence, and economic factors. This study provides evidence for the selection and optimization of testing strategies in the post-pandemic era and provides guidance for optimizing healthcare resources.

Say Yes! COVID Test: A Health Communication Campaign to Encourage Use of Rapid, At-Home Antigen Testing in Underserved and Historically Marginalized Communities.

This paper describes a robust health communication campaign that supported Say Yes! COVID Test, the first National Institutes of Health (NIH)-sponsored initiative promoting community-wide, at-home, rapid antigen testing for severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), the cause of the COVID-19 pandemic. The primary goals of the health communication campaign were to promote awareness of the program among local residents, facilitate test kit distribution, and encourage frequent test kit use. To plan and implement the campaign, the team applied principles of social marketing. The populations of focus were adult residents of selected communities in North Carolina (Greenville, Pitt County) and Tennessee (Chattanooga, Hamilton County), with an emphasis on underserved and historically marginalized populations. Following an accelerated planning phase, the campaign included digital, out-of-home, television, and radio advertising, in addition to public relations and organic social media. Collectively, this campaign coupled with our grassroots community engagement efforts facilitated the distribution of 66 035 test kits across both communities, or more than 1.6 million at-home tests. Facebook ads were the most successful in driving online test kit orders (7.9% conversion rate in Pitt County; 8.1% conversion rate in Chattanooga), although employing a variety of marketing channels enabled reach across multiple subpopulations. Market research data indicated high program awareness but low uptake in testing. Lessons learned from campaign planning and implementation can inform future public health initiatives, including selecting the appropriate marketing mix to facilitate awareness, and collaborating with community partners and local health departments to ensure successful program execution.

Accuracy of an antigen-detecting SARS-CoV-2 assay with self- and provider-collected specimens interpreted visually and with BD Veritor™ Plus analyzer.

Background: SARS-CoV-2 rapid antigen tests (RATs) are in high demand for reducing the spread of SARS-CoV-2. Reduced involvement from health care professionals (HCPs) for collection and interpretation could significantly foster the wide-spread implementation of RATs, but data evaluating RATs, when used by lay people, is limited. Objective: To valuate agreement between BD Veritor test results for self- and HCP-collected specimens, and visually- and analyzer-interpreted results. Methods: Individuals with onset of COVID-19 symptoms within five days of enrollment had three nasal swabs collected; one self-collected and the other two HCP-collected. One HCP-collected swab was stored for future testing while the order of the other two (self and HCP) was randomized before testing. with the BD Veritor System for Rapid Detection of SARS-CoV-2. Results were first assessed visually, followed by interpretation with the analyzer. Results: When self-collection was compared to HCP collection for SARS-CoV-2 detection, interpretation by analyzer resulted in positive percent agreement (PPA) of 94.7% (95% CI 82.7, 98.5) and negative percent agreement (NPA) of 99.0% (95% CI 97.5, 99.6). When visual interpretation was compared to analyzer-read results, collection by HCPs had a PPA of 97.4% (95% CI 86.5, 99.5) and NPA of 99.8% (95% CI 98.6, 100.0) while self-collection resulted in PPA of 94.9% (95% CI 83.1, 98.6) and NPA of 99.8% (95% CI 98.6, 100). Conclusions: Similar PPA and NPA were observed for self- and HCP-collected specimens as well as visually- and analyzer-interpreted tests. The equivalence in performance supports the use of expanded collection and testing methods.

Real-world assessment of the clinical performance of COVID-VIRO ALL IN rapid SARS-CoV-2 antigen test.

OBJECTIVES: Since the external validation of severe acute respiratory syndrome coronavirus 2 antigen rapid diagnostic tests (SARS-CoV-2 RDT-Ags) is a necessary requisite before they can be introduced into routine clinical practice, this study reports the results of a real-world assessment of the clinical performance of the new COVID-VIRO ALL IN device. METHODS: The study population consisted in 165 outpatients (median age: 43 years, range: 14-68 years; 66.1% females) who had paired nasal and nasopharyngeal samples collected upon hospital presentation. The samples were concomitantly tested with the AAZ-LMB COVID-VIRO ALL IN SARS-CoV-2 RDT-Ag and with Cepheid Xpert Xpress SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR). RESULTS: The number of subjects with positive RT-PCR results (i.e., mean Ct value <45) was 116 (70.3%), 109 (66.1%) and 86 (52.1%) with mean Ct values <37 and <30, respectively. In all RT-PCR positive samples, COVID-VIRO ALL IN displayed 78.8% agreement, 0.698 sensitivity, 1.000 specificity, 0.583 negative predictive value (NPV) and 1.000 positive predictive value (PPV) compared to RT-PCR. The median Ct value of samples testing positive with COVID-VIRO ALL IN was significantly lower than those testing negative (22.8 vs. 32.2; p<0.001). In samples with high viral load (i.e., Ct value <30), COVID-VIRO ALL IN displayed 92.1% agreement, 0.895 sensitivity, 0.949 specificity, 0.983 NPV and 0.951 PPV compared to RT-PCR. CONCLUSIONS: Although the diagnostic performance of COVID-VIRO ALL IN do not exactly match those of the manufacturer, its high NPV in high viral load samples would enable fast-track and rapid identification of highly contagious subjects.