scholarly journals Performance Validation of COVID-19 Self-Conduct Buccal and Nasal Swabs RTK-Antigen Diagnostic Kit

Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2245
Author(s):  
Mohammad Nur Amin Kalil ◽  
Wardah Yusof ◽  
Naveed Ahmed ◽  
Mohd Hashairi Fauzi ◽  
Mimi Azliha Abu Bakar ◽  
...  
Keyword(s):  
Rapid Test ◽  
Medical Personnel ◽  
Viral Proteins ◽  
Nasopharyngeal Swab ◽  
Rapid Diagnostics ◽  
Test Device ◽  
First Line ◽  
Diagnostic Assays ◽  
Nasal Swabs ◽  
Performance Validation

The antigen rapid diagnostic test (Ag-RDT) is an immunodiagnostic test that detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from a patient’s respiratory tract. This study focused on evaluating the performance of self-conduct buccal and nasal swabs RTK-antigen test compared to nasopharyngeal swab RTK-based COVID-19 diagnostic assays, Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) (Abbott Rapid Diagnostics Jena GmbH, Jena, Germany) used in hospitals for first-line screening. The sensitivity and specificity of the paired RTK-Ag test in detecting the an-tigen were calculated at 96.4% and 100%, respectively. Fisher exact tests showed the association between nasopharyngeal swabs RTK-Ag assay and buccal-nasal swabs RTK-Ag from ProdetectTM is significant (p-values < 0.001). The result showed that a self-conducted buccal and nasal RTK-antigen rapid test by the patients is comparable to the results obtained from a rapid test device conducted by trained medical personnel using a nasopharyngeal swab.

scholarly journals SARS-CoV-2 in peritoneal swabs from asymptomatic patients undergoing emergency abdominal surgery

2021 ◽  
Vol 2021 (4) ◽  
Author(s):  
Jasim AlAradi ◽  
Rawan A Rahman AlHarmi ◽  
Mariam AlKooheji ◽  
Sayed Ali Almahari ◽  
Mohamed Abdulla Isa ◽  
...  
Keyword(s):  
Peritoneal Fluid ◽  
Case Series ◽  
Rapid Test ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
Protective Measures ◽  
The Public ◽  
Asymptomatic Patients ◽  
Number Of Patients ◽  
Viral Transfer

Abstract This is a case series of five patients with acute abdomen requiring surgery who tested positive for coronavirus disease 2019 (COVID-19) and were asymptomatic, with the purpose of detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in peritoneal fluid. Nasopharyngeal swab was done as a prerequisite for admission or prior to admission as part of random testing. Two methods of viral testing were employed: Xpert® Xpress SARS-CoV-2 (rapid test) and real-time reverse transcription polymerase chain reaction (RT-PCR). Either or both tests were done, with the former performed for patients requiring surgery immediately. Surgery was performed within 24–36 h from admission. Peritoneal fluid swabs were obtained for the detection of SARS-CoV-2 using RT-PCR test. Swabs were immediately placed in viral transfer media and delivered to the public health laboratory in an ice bag. SARS-CoV-2 was not detected in peritoneal swabs. Due to the limited number of patients, further studies are required; yet, protective measures should still be taken by surgeons when dealing with COVID-19 cases.

scholarly journals Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for the diagnosis of COVID-19 in primary healthcare centers

2020 ◽  
Author(s):  
Eliseo Albert ◽  
Ignacio Torres ◽  
Felipe Bueno ◽  
Dixie Huntley ◽  
Estefanía Molla ◽  
...  
Keyword(s):  
Primary Healthcare ◽  
Rapid Test ◽  
Field Evaluation ◽  
Antigen Test ◽  
Rt Pcr ◽  
Test Device ◽  
Specificity And Sensitivity ◽  
Primary Healthcare Centers

AbstractWe evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.

scholarly journals Comparison of Quidel Sofia SARS FIA Test to Hologic Aptima SARS-CoV-2 TMA Test for Diagnosis of COVID-19 in Symptomatic Outpatients

2020 ◽  
Author(s):  
Eric T. Beck ◽  
Wendy Paar ◽  
Lara Fojut ◽  
Jordan Serwe ◽  
Renee R. Jahnke
Keyword(s):  
Symptom Onset ◽  
Care Center ◽  
Urgent Care ◽  
Molecular Diagnostic ◽  
Nasopharyngeal Swab ◽  
Urgent Care Center ◽  
Ct Value ◽  
High Prevalence ◽  
Nasal Swabs ◽  
Molecular Diagnostic Test

The Quidel Sofia SARS FIA test (SOFIA) is a rapid antigen immunoassay for detection of SARS-CoV-2 viral proteins from nasal or nasopharyngeal swab specimens. The purpose of this study was to compare the results of the SOFIA test to the Hologic Aptima SARS-CoV-2 TMA test (APTIMA TMA), a high-throughput molecular diagnostic test that uses transcription mediated amplification for detection of SARS-CoV-2 nucleic acid from upper respiratory specimens. Three hundred and 40-seven symptomatic patients, from an urgent care center in an area with a high prevalence of SARS-CoV-2 infections, were tested in parallel using nasal swabs on the SOFIA test and nasopharyngeal swabs on the APTIMA TMA test. The SOFIA test demonstrated an 82.0% positive percent agreement (PPA) compared to the APTIMA TMA test for symptomatic patients tested ≤ 5 days from symptom onset and a 54.5% PPA for symptomatic patients > 5 days from symptom onset. The Cepheid Xpert Xpress SARS-CoV-2 RT-PCR test was used to determine the cycle threshold (Ct) value from any specimens that were discrepant between the SOFIA and APTIMA TMA tests. Using a Ct value of ≤ 35 as a surrogate for SARS-CoV-2 culture positivity, we estimate that the SOFIA test detected 87.2% of symptomatic patients tested ≤ 5 days from symptom onset that were likely to be culture positive.

scholarly journals Investigation, Analysis and Management Application of Mental Resilience and Psychosomatic State of The Medical Team Against COVID-19

2020 ◽  
Author(s):  
Xiao-li xu ◽  
Li Guangyao ◽  
Huang Shunhong ◽  
Liu Bin ◽  
Zhang Sibing
Keyword(s):  
Great Influence ◽  
Medical Personnel ◽  
Chinese Version ◽  
Cluster Sampling ◽  
Medical Team ◽  
First Line ◽  
Team Members ◽  
Resilience Scale ◽  
Management Application ◽  
Mental Resilience

Abstract Objective: to understand the mental resilience and psychosomatic status quo of first-line anti-epidemic medical team members, so as to provide a reference basis for mastering the mental health status of medical team members and promoting the improvement of mental resilience. Methods: a cluster sampling method was used to conduct mobile phone questionnaire survey on the selected subjects using the staff status questionnaire and Chinese version of mental resilience scale (Chinese version of cd-risc). Results: the total score of mental resilience of the medical team was 65.40 ± 13.90 points higher than that of the Chinese community. However, the tenacity of men was higher than that of women (P < 0.05). In terms of psychosomatic state influence score, the psychosomatic influence of first-line task on women was greater than that on men (P < 0.01). Conclusion: the anti-epidemic task has a great influence on the psychosomatic state of the first-line medical personnel, and the first-line medical personnel should be provided with better social and psychological support. Frontline medical personnel should be good at actively seeking social support and learn to adopt a positive way of coping.

scholarly journals Application of the amplification-free SERS-based CRISPR/Cas12a platform in the identification of SARS-CoV-2 from clinical samples

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Jiajie Liang ◽  
Peijun Teng ◽  
Wei Xiao ◽  
Guanbo He ◽  
Qifang Song ◽  
...  
Keyword(s):  
Nucleic Acids ◽  
Point Of Care ◽  
Clinical Samples ◽  
Nasopharyngeal Swab ◽  
Enhancement Effect ◽  
Diagnostic Assays ◽  
Point Of Care Test ◽  
Raman Enhancement ◽  
Potential Strategy ◽  
Refractory Diseases

AbstractThe control of contagious or refractory diseases requires early, rapid diagnostic assays that are simple, fast, and easy-to-use. Here, easy-to-implement CRISPR/Cas12a-based diagnostic platform through Raman transducer generated by Raman enhancement effect, term as SERS-CRISPR (S-CRISPR), are described. The S-CRISPR uses high-activity noble metallic nanoscopic materials to increase the sensitivity in the detection of nucleic acids, without amplification. This amplification-free platform, which can be performed within 30–40 min of incubation time, is then used for detection of SARS-CoV-2 derived nucleic acids in RNA extracts obtained from nasopharyngeal swab specimens (n  =  112). Compared with the quantitative reverse transcription polymerase chain reaction (RT-qPCR), the sensitivity and specificity of S-CRISPR reaches 87.50% and 100%, respectively. In general, the S-CRISPR can rapidly identify the RNA of SARS-CoV-2 RNA without amplification and is a potential strategy for nucleic acid point of care test (POCT).

scholarly journals High Rate of Circulating MERS-CoV in Dromedary Camels at Slaughterhouses in Riyadh, 2019

2020 ◽  
Author(s):  
Taibh Aljasim ◽  
Abdulrahman Almasoud ◽  
Haya A. Aljami ◽  
Mohamed W. Alenazi ◽  
Suliman A. Alsagaby ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Vaccine Development ◽  
Sequence Similarity ◽  
Rapid Test ◽  
Respiratory Illness ◽  
Human Infection ◽  
High Rate ◽  
Serum Samples ◽  
Spike Gene ◽  
Nasal Swabs

Background: MERS-CoV is a zoonotic virus that have emerged in humans in 2012 and caused severe respiratory illness with mortality rate of 34.4%. Since its appearance, MERS-CoV have been reported in 27 countries and most of these cases were in Saudi Arabia. So far, dromedaries are considered to be the intermediate host and the only known source of human infection. Method: This study was designed to determine the seroprevalence and the infection rate of MERS-CoV in slaughtered food-camels in Riyadh, Saudi Arabia. A total of 171 nasal swabs along with 161 serum samples were collected during the winter; from January to April 2019. Nasal swabs were examined by Rapid test and RT-qPCR to detect MERS-CoV RNA, while serum samples were tested primarily using S1-based ELISA Kit to detect MERS-CoV (IgG) antibodies and subsequently by MERS pseudotyped viral particles (MERSpp) neutralization assay for confirmation. Genetic diversity of the positive isolates was determined based on the amplification and sequencing of the spike gene. Results: Our results showed high prevalence (38%) of MERS-CoV infection in slaughtered camels and high seropositivity (70.81%) during the time of the study. These data indicate previous and ongoing MERS-CoV infection in camels. Phylogenic analysis revealed relatively low genetic variability among our isolated samples. When these isolates were aligned against published spike sequences of MERS-CoV, deposited in global databases, there was sequence similarity of 94%. Conclusion: High seroprevalence and high genetic stability of MERS-CoV in camels indicating that camels pose a public health threat. The widespread of MERS-CoV infections in camels increases the risk of future zoonotic transmission into people with direct contact with these infected camels. This study confirms re-infections in camels, highlighting a challenge for vaccine development when it comes to protective immunity.

scholarly journals Performance of Seven SARS-CoV-2 Self-Tests Based on Saliva, Anterior Nasal and Nasopharyngeal Swabs Corrected for Infectiousness in Real-Life Conditions: A Cross-Sectional Test Accuracy Study

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1567
Author(s):  
Miroslav Homza ◽  
Hana Zelena ◽  
Jaroslav Janosek ◽  
Hana Tomaskova ◽  
Eduard Jezo ◽  
...  
Keyword(s):  
Real Life ◽  
High Capacity ◽  
Nasopharyngeal Swab ◽  
Test Accuracy ◽  
Cross Sectional ◽  
Predictive Values ◽  
Nasal Swabs ◽  
Accuracy Study ◽  
Testing Center ◽  
Antigen Tests

Many studies reported good performance of nasopharyngeal swab-based antigen tests for detecting SARS-CoV-2-positive individuals; however, studies independently evaluating the quality of antigen tests utilizing anterior nasal swabs or saliva swabs are still rare, although such tests are widely used for mass testing. In our study, sensitivities, specificities and predictive values of seven antigen tests for detection of SARS-CoV-2 (one using nasopharyngeal swabs, two using anterior nasal swabs and four using saliva) were evaluated. In a setting of a high-capacity testing center, nasopharyngeal swabs for quantitative PCR (qPCR) were taken and, at the same time, antigen testing was performed in accordance with manufacturers’ instructions for the respective tests. In samples where qPCR and antigen tests yielded different results, virus culture was performed to evaluate the presence of the viable virus. Sensitivities and specificities of individual tests were calculated using both qPCR and qPCR corrected for viability as the reference. In addition, calculations were also performed for data categorized according to the cycle threshold and symptomatic status. The test using nasopharyngeal swabs yielded the best results (sensitivity of 80.6% relative to PCR and 91.2% when corrected for viability) while none of the remaining tests (anterior nasal swab or saliva-based tests) came even close to the WHO criteria for overall sensitivity. Hence, we advise caution when using antigen tests with alternative sampling methods without independent validation.

scholarly journals Diagnostic accuracy of two commercial SARS-CoV-2 Antigen-detecting rapid tests at the point of care in community-based testing centers

2020 ◽  
Author(s):  
Alice Berger ◽  
Marie Therese Ngo Nsoga ◽  
Francisco Javier Perez-Rodriguez ◽  
Yasmine Abi Aad ◽  
Pascale Sattonnet-Roche ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Rapid Test ◽  
Diagnostic Value ◽  
Rapid Diagnostic Tests ◽  
Ease Of Use ◽  
Rt Pcr ◽  
Test Device ◽  
Community Based ◽  
Rapid Tests

AbstractBackgroundAntigen-detecting rapid diagnostic tests for SARS-CoV-2 offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic.MethodsWe performed a prospective, single-center, point of care validation of two antigen-detecting rapid diagnostic tests (Ag-RDT) in comparison to RT-PCR on nasopharyngeal swabs.FindingsBetween October 9th and 23rd, 2020, 1064 participants were enrolled. The Panbio™Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1-5 days post symptom onset, combined Ag-RDT sensitivity was above 95%.InterpretationWe provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.FundingFoundation of Innovative Diagnostics (FIND), Fondation privée des HUG, Pictet Charitable Foundation.

scholarly journals Real-life evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients

2020 ◽  
Author(s):  
Ignacio Torres ◽  
Sandrine Poujois ◽  
Eliseo Albert ◽  
Javier Colomina ◽  
David Navarro
Keyword(s):  
Point Of Care ◽  
Real Life ◽  
Rapid Test ◽  
Optimal Timing ◽  
Upper Respiratory Tract ◽  
Limited Information ◽  
Rt Pcr ◽  
Test Device ◽  
Household Contacts ◽  
Close Contacts

ABSTRACTObjectivesThere is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for the purpose.MethodsA total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Household (n=338) contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case and non-household contacts (n=296) at a median of 6 days (range, 1-7) after exposure. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Massachusetts, USA).ResultsIn total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI: 37.4-58.9) and 100% (95% CI: 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI: 38.9-62.5) than in non-household (35.7%; 95% CI:16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (P<0.001) to become symptomatic than their negative counterparts.ConclusionThe Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.

scholarly journals Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type

2020 ◽  
Author(s):  
Paul R. Lephart ◽  
Michael Bachman ◽  
William LeBar ◽  
Scott McClellan ◽  
Karen Barron ◽  
...  
Keyword(s):  
Nasal Swab ◽  
The United States ◽  
Nucleic Acid Amplification Test ◽  
Nucleic Acid Amplification ◽  
Molecular Diagnostic ◽  
Nasopharyngeal Swab ◽  
Diagnostic Assays ◽  
Comparable Performance ◽  
Indications For Use ◽  
Significant Factors

AbstractThe advent of the COVID-19 pandemic in the United States created a unique situation where multiple molecular diagnostic assays with various indications for use in the detection of SARS-CoV-2 rapidly received Emergency Use Authorization by the FDA, were validated by laboratories and utilized clinically, all within a period of a few weeks. We compared the performance of four of these assays that were being evaluated for use at our institution: Abbott RealTime m2000 SARS-CoV-2 Assay, DiaSorin Simplexa COVID-19 Direct, Cepheid Xpert Xpress SARS-CoV-2 and Abbott ID NOW COVID-19. Nasopharyngeal and nasal specimens were collected from 88 ED and hospital-admitted patients and tested by the four methods in parallel to compare performance. ID NOW performance stood out as significantly worse than the other three assays despite demonstrating comparable analytic sensitivity. Further study determined that the use of a foam nasal swab compared to a nylon flocked nasopharyngeal swab, as well as use in a population chronically vs. acutely positive for SARS-CoV-2, were significant factors in the poor comparable performance.

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