Epidemiological Predictors of Positive SARS-CoV-2 Polymerase Chain Reaction Test in Three Cohorts: Hospitalized Patients, Healthcare Workers, and Military Population, Serbia, 2020.

(1) Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its resulting coronavirus disease 2019 (COVID-19) has caused a fast-moving pandemic. Diagnostic testing, aimed to identify patients infected with SARS-CoV-2, plays a key role in controlling the COVID-19 pandemic in different populations. (2) Methods: This retrospective cohort study aimed to investigate predictors associated with positive polymerase chain reaction (PCR) SARS-CoV-2 test results in hospitalized patients, healthcare workers (HCWs), and military personnel (MP) during 2020, before the widespread availability of COVID-19 vaccines. Persons with a positive test result were compared with persons with a negative test result in three cohorts during the study period. (3) Results: A total of 6912 respondents were tested, and 1334 (19.3%) of them had positive PCR SARS-CoV-2 test results. Contact with a known COVID-19 case within 14 days (p < 0.001; OR: 1.48; 95% CI: 1.25-1.76), fever (p < 0.001; OR: 3.66; 95% CI: 3.04-4.41), cough (p < 0.001; OR: 1.91; 95% CI: 1.59-2.30), headache (p = 0.028; OR: 1.24; 95% CI: 1.02-1.50), and myalgia/arthralgia (p < 0.001; OR: 1.99; 95% CI: 1.65-2.42) were independently associated with positive PCR SARS-CoV-2 test results in the cohort of MP. Furthermore, fever (p < 0.001; OR: 2.75; 95% CI: 1.83-4.13), cough (p < 0.001; OR: 2.04; 95% CI: 1.32-3.13), headache (p = 0.008; OR: 1.76; 95% CI: 1.15-2.68), and myalgia/arthralgia (p = 0.039; OR: 1.58; 95% CI: 1.02-2.45) were independently associated with positive PCR SARS-CoV-2 test results in the cohort of HCWs. Moreover, independent predictors of positive PCR SARS-CoV-2 test results in hospitalized patients were contact with a known COVID-19 case within 14 days (p < 0.001; OR: 2.56; 95% CI: 1.71-3.83), fever (p < 0.001; OR: 1.89; 95% CI: 1.38-2.59), pneumonia (p = 0.041; OR: 1.45; 95% CI: 1.01-2.09), and neurological diseases (p = 0.009; OR: 0.375; 95% CI: 0.18-0.78). (4) Conclusions: According to data gathered from cohorts of hospitalized patients, HCWs, and MP, before the widespread availability of COVID-19 vaccines in Serbia, we can conclude that predictors of positive PCR SARS-CoV-2 test results in MP and HCWs were similar. Accurate estimates of COVID-19 in different population groups are important for health authorities.

Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) and influenza share similar symptoms, which hampers diagnosis. Given that they require different containment and treatment strategies, fast and accurate distinction between the two infections is needed. This study evaluates the sensitivity and specificity of the microfluidic antigen LumiraDx SARS-CoV-2 and Flu A/B Test for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B from a single nasal swab. METHODS: Nasal samples were collected from patients as part of the ASPIRE (NCT04557046) and INSPIRE (NCT04288921) studies at point-of-care testing sites in the USA. ASPIRE study participants were included after developing COVID-19 symptoms in the last 14 days or following a positive SARS-CoV-2 test in the last 48 h. INSPIRE study participants were included after developing influenza symptoms in the last 4 days. Samples were extracted into proprietary buffer and analysed using the LumiraDx SARS-CoV-2 and Flu A/B Test. A reference sample was taken from each subject, placed into universal transport medium and tested using reference SARS-CoV-2 and influenza reverse transcription polymerase chain reaction (RT-PCR) tests. The test and reference samples were compared using the positive percent agreement (PPA) and negative percent agreement (NPA), together with their 95% confidence intervals (CIs). RESULTS: Analysis of the data from the ASPIRE (N = 124) and INSPIRE (N = 159) studies revealed high levels of agreement between the LumiraDx SARS-CoV-2 and Flu A/B Test and the reference tests in detecting SARS-CoV-2 (PPA = 95.5% [95% CI 84.9%, 98.7%]; NPA = 96.0% [95% CI 90.9%, 98.3%]), influenza A (PPA = 83.3% [95% CI 66.4%, 92.7%]; NPA = 97.7% [95% CI 93.4%, 99.2%]) and influenza B (PPA = 80.0% [95% CI 62.7%, 90.5%]; NPA = 95.3% [95% CI 90.2%, 97.9%]). CONCLUSIONS: The LumiraDx SARS-CoV-2 and Flu A/B Test shows a high agreement with the reference RT-PCR tests while simultaneously detecting and differentiating between SARS-CoV-2 and influenza A/B. TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT04557046 and NCT04288921.

Comparison between the analytical sensitivity and clinical performance of two cobas SARS-CoV-2 tests based on high-throughput and point-of-care systems.

Objectives: This study examined analytical sensitivity, specificity, and the clinical performance in detecting SARS-CoV-2 of the Cobas SARS-CoV-2 Test based on the high-throughput Cobas 6800 system and the Cobas SARS-CoV-2 & Flu A/B Test based on the point-of-care cobas Liat system. Methods: The commercial reagents containing SARS-CoV-2 RNA subgenomes were diluted for assessing the sensitivity of the RT-qPCR assay. 385 nasopharyngeal swab specimens taken from contacts of COVID-19 cases were tested for the SARS-CoV-2 detection with both Cobas SARS-CoV-2 Tests. Results: In analytical sensitivity assays, the Cobas SARS-CoV-2 & Flu A/B Test on the Liat system had a lower limit of detection (12.5-25 copies/mL) than the cobas SARS-CoV-2 Test on the cobas 6800 system (25-50 copies/mL). In clinical performance assays, the cobas SARS-CoV-2 Test demonstrated 89.36% (42 out of 47) PPA (positive percent agreement) and 98.82% (334 out of 338) NPA (negative percent agreement) compared to the results of the Cobas SARS-CoV-2 & Flu A/B test. Among five discordant specimens, four had the positive result of the cobas SARS-CoV-2 test, but the negative result of the cobas SARS-CoV-2 & Flu A/B Test. Moreover, these discordant specimens had the Ct values of greater than 33 for the cobas SARS-CoV-2 Test, implying a very small number of virions in the samples. Remarkably, four specimens with a presumptive positive result of the cobas SARS-CoV-2 test had been confirmed by the Cobas SARS-CoV-2 & Flu A/B Test. Next, the scatter plots of the Ct values showed a highly positive correlation between cobas SARS-CoV-2 & Flu A/B Test and the cobas SARS-CoV-2 Test (R-squared value = 0.954-0.962). Conclusions: Both SARS-CoV2 tests of the cobas 6800 and Liat systems produce reliable high throughput and point-of-care assays respectively for the early virus detection and the personal care decision-making during COVID-19 pandemic.

Evaluation of the Biomeme Franklin Human Performance Factors: Final Report

U.S. Army Combat Capabilities Development Command Chemical Biological Center (CCDC CBC) scientists completed an evaluation of the human performance factors related to the execution of COVID-19 testing using the SARS-CoV-2 Test Kit including (1) ease of use, (2) workflow development and assessment, and (3) time to results and sample throughput. The assay was found to require a fairly complex laboratory in order to safely process the samples due to the need for a biosafety cabinet to contain any SARS-CoV-2 containing aerosols. The workflow required nearly 3.5 h to complete 7 extractions, set up the seven RT-PCR reactions plus the two control RT-PCR reactions, run the RT-PCR on the Biomeme Franklin thermocycler, and interpret results. Therefore, throughput was estimated at 42 samples per 24 period on a single Franklin thermocycler.

Acceptable performance of the Abbott ID NOW among symptomatic individuals with confirmed COVID-19.

Introduction. The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection.Gap statement. Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size.Aim. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing.Methodology. Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene.Results. In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0-94.1%) and 91.6 % (85.1-95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h (n=62), ID NOW PPA increased to 98.2 %.Conclusion. Results from the ID NOW were reliable, especially when adhering to the manufacturer's recommendations for testing.

Is naso-pharyngeal swab always safe for SARS-CoV-2 testing? An unusual, accidental foreign body swallowing.

Long and sharp objects can be foreign body intentionally or accidentally ingested. Timing of endoscopy relies on foreign body shape and size, localization in gastrointestinal tract, patient's clinical conditions, occurrence of symptoms, or onset of complications. We present a case of a 47-year-old male with no known comorbidity, who accidentally swallowed a portion of a naso-pharyngeal swab half-broken during the second diagnostic test for SARS-CoV-2. The intact swab had a total length of 15 cm and was made of wood. The patient was asymptomatic, laboratory tests were normal, and neck-chest-abdominal X-ray and CT scan were negative for major complications. Upper gastrointestinal endoscopy was promptly performed to prevent the long sharp swab from crossing the pylorus leading to serious complications and, therefore, risk surgical intervention. The patient was intubated and the procedure was carried out under general anesthesia. In the gastric body, broken naso-pharyngeal swab was detected among the food debris, and using a latex rubber hood, the 7.5 cm foreign body was removed with a retrieval alligator-tooth forceps. Our hospital is located in a high-risk area of COVID-19 outbreak where many naso-pharyngeal swabs are performed, and to our knowledge, this is the first report of swab ingestion during SARS-CoV-2 test.

Considerations for Continuing Semielective and Emergency Otolaryngological Procedures During the COVID-19 Pandemic.

INTRODUCTION: During the COVID-19 pandemic, worldwide over 600,000 human beings died due to the cause of the disease. In order to deescalate the transmission rate and to avoid crush loading the countries medical health systems social distancing, face masks, and lockdowns have been considered essential by the majority of governments. Whereas some countries have highly reduced or completely stopped otorhinolaryngological procedures, other countries have continued selected surgeries. The objective of this study was to analyze procedures and outcomes of continuing semielective and emergency surgeries during the COVID-19 pandemic. METHODS: Retrospective analysis of n = 750 patients who received semi-elective or emergency surgery between March 26 and June 16, 2020, in the Otolaryngology Department of the Friedrich-Alexander-University of Erlangen-Nürnberg. All patients were screened for COVID symptoms and swabbed for SARS-CoV-2 prior to surgery. RESULTS: Of the n = 750 patients, n = 699 patients received semielective surgery and n = 51 emergency surgery. For 27 patients, the swab result could not be awaited due to a life-threatening condition. In these cases, surgery was performed in full protective equipment. No patient was tested positive during or after the surgery (follow-up 45 to 127 days). No member of the medical personnel showed symptoms or was tested positive after contact with patients. Due to the continuation of surgeries, patients' lives were saved and improvement of long-term quality-of-life and outcomes is anticipated. CONCLUSIONS: Continuing selected otorhinolaryngological surgeries is crucial for patients' health, survival, and long-time quality of life, yet, the protection of the medical personnel has to be granted.