scholarly journals Anterior nasal versus nasal mid-turbinate sampling for a SARS-CoV-2 antigen-detecting rapid test: does localisation or professional collection matter?

2021 ◽  
Author(s):  
Olga Nikolai ◽  
Chiara Rohardt ◽  
Frank Tobian ◽  
Andrea Junge ◽  
Victor M. Corman ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Rapid Test ◽  
Nasopharyngeal Swab ◽  
Diagnostic Accuracy Study ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Accuracy Study ◽  
Polymerase Chain ◽  
Sensitivity Specificity ◽  
Antigen Testing

AbstractObjectivesThe aim of this diagnostic accuracy study was direct comparison of two different nasal sampling methods for an antigen-based rapid diagnostic test (Ag-RDT) that detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Furthermore, the accuracy and feasibility of self-sampling was evaluated.MethodsThis manufacturer-independent, prospective diagnostic accuracy study, compared professional anterior nasal (AN) and nasal mid-turbinate (NMT) sampling for a WHO-listed SARS-CoV-2 Ag-RDT. A second group of participants collected a NMT sample themselves and underwent a professional nasopharyngeal swab for comparison. The reference standard was real-time polymerase chain reaction (RT-PCR) using combined oro-/nasopharyngeal sampling. Individuals with high suspicion of SARS-CoV-2 infection were tested. Sensitivity, specificity, and percent agreement were calculated. Self-sampling was observed without intervention. Feasibility was evaluated by observer and participant questionnaires.ResultsAmong 132 symptomatic adults, both professional AN- and NMT-sampling yielded a sensitivity of 86.1% (31/36 RT-PCR positives detected; 95%CI: 71.3-93.9) and a specificity of 100.0% (95%CI: 95.7-100). The positive percent agreement (PPA) was 100% (95%CI: 89.0-100). Among 96 additional adults, self NMT- and professional NP-sampling yielded an identical sensitivity of 91.2% (31/34; 95%CI 77.0-97.0). Specificity was 98.4% (95%CI: 91.4-99.9) with NMT- and 100.0% (95%CI: 94.2-100) with NP-sampling. The PPA was 96.8% (95%CI: 83.8-99.8). Most participants (85.3%) considered self-sampling as easy to perform.ConclusionProfessional AN- and NMT-sampling are of equivalent accuracy for an Ag-RDT in ambulatory symptomatic adults. Participants were able to reliably perform the NMT-sampling themselves, following written and illustrated instructions. Nasal self-sampling will likely facilitate scaling of SARS-CoV-2 antigen testing.

scholarly journals Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected anterior nasal versus nasopharyngeal swab

2020 ◽  
Author(s):  
Andreas K. Lindner ◽  
Olga Nikolai ◽  
Chiara Rohardt ◽  
Susen Burock ◽  
Claudia Hülso ◽  
...  
Keyword(s):  
Healthcare Professionals ◽  
Rapid Test ◽  
High Viral Load ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
Test Procedures ◽  
Testing Strategies ◽  
Percent Agreement ◽  
Accuracy Study ◽  
Antigen Testing

AbstractBackgroundNasopharyngeal (NP) swab samples for antigen-detecting rapid diagnostic tests (Ag-RDTs) require qualified healthcare professionals and are frequently perceived as uncomfortable by patients.MethodsWe performed a manufacturer-independent, prospective diagnostic accuracy study, comparing professional-collected anterior nasal (AN) to nasopharyngeal swab, using the test kits of a WHO-listed SARS-CoV-2 Ag-RDT (STANDARD Q COVID-19 Ag Test, SD Biosensor), which is also being distributed by Roche. Individuals with high suspicion for COVID-19 infection were tested. The reference standard was RT-PCR using a combined oro-/nasopharyngeal swab sample. Percent positive and negative agreement, as well as sensitivity and specificity were calculated.ResultsAmong the 179 participants, 41 (22.9%) tested positive for SARS-CoV-2 by RT-PCR. The positive percent agreement of the two different sampling techniques for the Ag-RDT was 93.5% (CI 79.3-98.2). The negative percent agreement was 95.9% (CI 91.4-98.1). The Ag-RDT with AN-sampling showed a sensitivity of 80.5% (33/41 PCR positives detected; CI 66.0-89.8) and specificity of 98.6% (CI 94.9-99.6) compared to RT-PCR. The sensitivity with NP-sampling was 73.2% (30/41 PCR positives detected; CI 58.1-84.3) and specificity was 99.3% (CI 96.0-100). In patients with high viral load (>7.0 log10 RNA SARS-CoV2/swab), the sensitivity of the Ag-RDT with AN-sampling was 100% and 94.7% with NP-sampling.ConclusionThis study demonstrates that sensitivity of a WHO-listed SARS-CoV-2 Ag-RDT using a professional AN-sampling kit is at least equal to that of the NP-sampling kit, although confidence intervals overlap. Of note, differences in the IFUs of the test procedures could have contributed to different sensitivities. AN-sampling can be performed with less training, reduces patient discomfort, and it enables scaling of antigen testing strategies. Additional studies of patient self-sampling should be considered to further facilitate the scaling-up of Ag-RDT testing.

scholarly journals Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab

2020 ◽  
Author(s):  
Andreas K. Lindner ◽  
Olga Nikolai ◽  
Franka Kausch ◽  
Mia Wintel ◽  
Franziska Hommes ◽  
...  
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
High Viral Load ◽  
Ease Of Use ◽  
Healthcare Personnel ◽  
Nasopharyngeal Swab ◽  
Swab Sample ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Accuracy Study

AbstractBackgroundTwo antigen-detecting rapid diagnostic tests (Ag-RDTs) are now approved through the WHO Emergency Use Listing procedure and can be performed at the point-of-care. However, both tests use nasopharyngeal (NP) swab samples. NP swab samples must be collected by trained healthcare personnel with protective equipment and are frequently perceived as uncomfortable by patients.MethodsThis was a manufacturer-independent, prospective diagnostic accuracy study with comparison of a supervised, self-collected anterior nose (AN) swab sample with a professional-collected NP swab sample, using a WHO-listed SARS-CoV-2 Ag-RDT, STANDARD Q COVID-19 Ag Test (SD Biosensor), which is also being distributed by Roche. The reference standard was RT-PCR from an oro-/nasopharyngeal swab sample. Percent positive and negative agreement as well as sensitivity and specificity were calculated.ResultsAmong the 289 participants, 39 (13.5%) tested positive for SARS-CoV-2 by RT-PCR. The positive percent agreement of the two different sampling techniques for the Ag-RDT was 90.6% (CI 75.8-96.8). The negative percent agreement was 99.2% (CI 97.2-99.8). The Ag-RDT with AN sampling showed a sensitivity of 74.4% (29/39 PCR positives detected; CI 58.9-85.4) and specificity of 99.2% (CI 97.1-99.8) compared to RT-PCR. The sensitivity with NP sampling was 79.5% (31/39 PCR positives detected; CI 64.5-89.2) and specificity was 99.6% (CI 97.8-100). In patients with high viral load (>7.0 log 10 RNA SARS-CoV2/swab), the sensitivity of the Ag-RDT with AN sampling was 96% and 100% with NP sampling.ConclusionSupervised self-sampling from the anterior nose is a reliable alternative to professional nasopharyngeal sampling using a WHO-listed SARS-CoV-2 Ag-RDT. Considering the ease-of-use of Ag-RDTs, self-sampling and potentially patient self-testing at home may be a future use case.

scholarly journals Validation of the Panbio™ COVID-19 Antigen Rapid Test (Abbott) to screen for SARS-CoV-2 infection in Sint Maarten: a diagnostic accuracy study

2021 ◽  
Author(s):  
Colin King ◽  
Eva Lista-de Weever ◽  
Maria Henry ◽  
Radjin Steingrover ◽  
Chérina Fleming ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Close Contact ◽  
Rapid Test ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
The Public ◽  
Negative Results ◽  
Accuracy Study ◽  
Antigen Tests ◽  
Dutch Caribbean

AbstractObjectivesControl of the pandemic has required countries to look for other forms of tests besides the gold standard real-time polymerase chain reaction (RT-PCR). Rapid antigen tests (RAT), though less sensitive than RT-PCR, offer the possibility of rapid, inexpensive and early detection of the most infectious COVID-19 cases. Only very few studies have assessed the performance of the Abbott Panbio COVID-19 RAT among asymptomatic people or in Latin America. This study set out to validate this test among people attending the public test street in Sint Maarten, Dutch Caribbean.MethodsPeople of all ages were recruited from the public COVID-19 test street regardless of COVID-19 symptoms. They received a nasopharyngeal swab for the Abbott Panbio COVID-19 RAT and the RT-PCR Qtower. Diagnostic accuracy of the RAT was compared to the RT-PCR among the overall study population and for subgroups with/without symptoms, with/without close contact and different Ct values.ResultsUsing a RT-PCR Ct cut-off value of <33, 119 out of 1,411 people (8.4%) tested positive for SARS-CoV-2. Most were asymptomatic (59%). The overall sensitivity and specificity of the RAT was 84% (95% CI 76.2-90.1) and 99.9% (95% CI 99.6-100) respectively. The sensitivity reduced to 67.6% (95% CI: 49.5%, 82.6%) among people without symptoms, regardless of whether they were in close contact with a known COVID-19 case. Sensitivity reduced considerably with a Ct cut-off value of <35.ConclusionsThe Abbott Panbio RAT is a valid and cheaper alternative to RT-PCR when used on symptomatic individuals among the general population. However, among asymptomatic people it should not be used as a stand-alone test and negative results should be confirmed with RT-PCR.

scholarly journals High Resolution CHEST CT(HRCT) Evaluation in Patients Hospitalized with COVID-19 Infection

2020 ◽  
Author(s):  
Maulin Patel ◽  
Junad Chowdhury ◽  
Matthew Zheng ◽  
Osheen Abramian ◽  
Steven Verga ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
High Resolution ◽  
Diagnostic Accuracy ◽  
Reverse Transcriptase ◽  
Retrospective Analysis ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
Chain Reaction ◽  
Bottom Line ◽  
Polymerase Chain

AbstractIntroductionCurrently the main diagnostic modality for COVID-19 (Coronavirus disease-2019) is reverse transcriptase polymerase chain reaction (RT-PCR) via nasopharyngeal swab which has high false negative rates. We evaluated the performance of high-resolution computed tomography (HRCT) imaging in the diagnosis of suspected COVID-19 infection compared to RT-PCR nasopharyngeal swab alone in patients hospitalized for suspected COVID-19 infection.MethodsThis was a retrospective analysis of 324 consecutive patients admitted to Temple University Hospital. All hospitalized patients who had RT-PCR testing and HRCT were included in the study. HRCTs were classified as Category 1, 2 or 3. Patients were then divided into four groups based on HRCT category and RT-PCR swab results for analysis.ResultsThe average age of patients was 59.4 (±15.2) years and 123 (38.9%) were female. Predominant ethnicity was African American 148 (46.11%). 161 patients tested positive by RT-PCR, while 41 tested positive by HRCT. 167 (52.02%) had category 1 scan, 63 (19.63%) had category 2 scan and 91 (28.35%) had category 3 HRCT scans. There was substantial agreement between our radiologists for HRCT classification (κ = 0.64). Sensitivity and specificity of HRCT classification system was 77.6 and 73.7 respectively. Ferritin, LDH, AST and ALT were higher in Group 1 and D-dimers levels was higher in Group 3; differences however were not statistically significant.ConclusionDue to its high infectivity and asymptomatic transmission, until a highly sensitive and specific COVID-19 test is developed, HRCT should be incorporated into the assessment of patients who are hospitalized with suspected COVID-19.Key PointsKey QuestionCan High Resolution CT chest (HRCT) improve diagnostic accuracy of current Nasopharyngeal swab in suspected COVID-19 patients?Bottom LineIn this retrospective analysis, our novel HRCT classification identified 20% of all COVID-19 patients who had negative nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) tests but had HRCT findings consistent with COVID-19 pneumonia. These patients were ruled out for other infections and laboratory markers were similar to other RT-PCR positive patientsWhy Read onOur new HRCT classification when combined with RT-PCR can improve diagnostic accuracy while promptly improving triaging in COVID-19 patients.

scholarly journals Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study

Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1766
Author(s):  
Sofia Balaska ◽  
Dimitrios Pilalas ◽  
Anna Takardaki ◽  
Paraskevoula Koutra ◽  
Eleftheria Parasidou ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Healthcare Workers ◽  
Reference Method ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Convenience Sample ◽  
Accuracy Study ◽  
Diagnostic Samples ◽  
Saliva Test

Nasopharyngeal swab specimen (NPS) molecular testing is considered the gold standard for SARS-CoV-2 detection. However, saliva is an attractive, noninvasive specimen alternative. The aim of the study was to evaluate the diagnostic accuracy of Advanta Dx SARS-CoV-2 RT-PCR saliva-based assay against paired NPS tested with either NeumoDxTM SARS-CoV-2 assay or Abbott Real Time SARS-CoV-2 assay as the reference method. We prospectively evaluated the method in two settings: a diagnostic outpatient and a healthcare worker screening convenience sample, collected in November–December 2020. SARS-CoV-2 was detected in 27.7% (61/220) of diagnostic samples and in 5% (10/200) of screening samples. Overall, saliva test in diagnostic samples had a sensitivity of 88.5% (77.8–95.3%) and specificity of 98.1% (94.6–99.6%); in screening samples, the sensitivity was 90% (55.5–99.7%) and specificity 100% (98.1–100%). Our data suggests that the Fluidigm Advanta Dx RT-PCR saliva-based assay may be a reliable diagnostic tool for COVID-19 diagnosis in symptomatic individuals and screening asymptomatic healthcare workers.

scholarly journals Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

2021 ◽  
Author(s):  
Julian A. F. Klein ◽  
◽  
Lisa J. Krüger ◽  
Frank Tobian ◽  
Mary Gaeddert ◽  
...  
Keyword(s):  
High Viral Load ◽  
Performance Comparison ◽  
World Health ◽  
Nasopharyngeal Swab ◽  
Rapid Diagnostics ◽  
Sample Collection ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Polymerase Chain ◽  
Health Organization

AbstractIn 2020, the World Health Organization (WHO) recommended two SARS-CoV-2 lateral flow antigen-detecting rapid diagnostics tests (Ag-RDTs), both initially with nasopharyngeal (NP) sample collection. Independent head-to-head studies are necessary for SARS-CoV-2 Ag-RDT nasal sampling to demonstrate comparability of performance with nasopharyngeal (NP) sampling. We conducted a head-to-head comparison study of a supervised, self-collected nasal mid-turbinate (NMT) swab and a professional-collected NP swab, using the Panbio™ Ag-RDT (distributed by Abbott). We calculated positive and negative percent agreement between the sampling methods as well as sensitivity and specificity for both sampling techniques compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR). A SARS-CoV-2 infection could be diagnosed by RT-PCR in 45 of 290 participants (15.5%). Comparing the NMT and NP sampling the positive percent agreement of the Ag-RDT was 88.1% (37/42 PCR positives detected; CI 75.0–94.8%). The negative percent agreement was 98.8% (245/248; CI 96.5–99.6%). The overall sensitivity of Panbio with NMT sampling was 84.4% (38/45; CI 71.2–92.3%) and 88.9% (40/45; CI 76.5–95.5%) with NP sampling. Specificity was 99.2% (243/245; CI 97.1–99.8%) for both, NP and NMT sampling. The sensitivity of the Panbio test in participants with high viral load (> 7 log10 SARS-CoV-2 RNA copies/mL) was 96.3% (CI 81.7–99.8%) for both, NMT and NP sampling. For the Panbio supervised NMT self-sampling yields comparable results to NP sampling. This suggests that nasal self-sampling could be used for to enable scaled-up population testing.Clinical Trial DRKS00021220.

scholarly journals Evaluation of the Panbio™ COVID-19 Ag Rapid Test at an Emergency Room in a Hospital in São Paulo, Brazil

2021 ◽  
Author(s):  
Klinger Soares Faíco-Filho ◽  
Francisco Estivallet Finamor Júnior ◽  
Luiz Vinícius Leão Moreira ◽  
Paulo Ricardo Gessolo Lins ◽  
Alberto Fernando Oliveira Justo ◽  
...  
Keyword(s):  
Emergency Room ◽  
Diagnostic Test ◽  
Gold Standard ◽  
Rapid Test ◽  
Sao Paulo ◽  
Rapid Screening ◽  
São Paulo ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Sensitivity Specificity

Introduction: The performance characteristics of the Panbio™ COVID-19 Ag test were evaluated against RT-PCR – considered the gold-standard for the detection of SARS-CoV-2 – at an emergency room in São Paulo, Brazil. The study aimed to determine the sensitivity, specificity, positive percent agreement (PPA), and negative percent agreement (NPA) as compared to RT-PCR. Methods: Specimens from 127 suspected patients were tested by both the Panbio™ COVID-19 Ag test and by RT-PCR. Results: Evaluation of the agreement between the Panbio™ COVID-19 Ag test and RT-PCR indicated an overall sensitivity of 84% (95%CI, 75-93.8%) and an overall specificity of 98% (95%CI, 96-98.8%). The Panbio™ COVID-19 Ag test showed 97% sensitivity and 99% NPA for subjects with Ct values ≤ 25 (N=37). Conclusion: The Panbio™ COVID-19 Ag test is suitable for use as a diagnostic test for the rapid screening of patients presenting COVID-19 symptoms, or those suspected with being infected, prior to being admitted to hospital.

scholarly journals DIAGNOSTIC ACCURACY OF PANBIO COVID-19 RAPID ANTIGEN METHOD FOR SCREENING IN EMERGENCY CASES

2021 ◽  
Vol 71 (5) ◽  
pp. 1607-10
Author(s):  
Raja Kamran Afzal ◽  
Saad Ali ◽  
Farooq Ahmad ◽  
Shafia Nasir ◽  
Muhammad Younas ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Diagnostic Accuracy ◽  
Predictive Value ◽  
Military Hospital ◽  
Ethical Review ◽  
Nasopharyngeal Swab ◽  
Chain Reaction ◽  
Cross Sectional ◽  
Polymerase Chain ◽  
Sensitivity Specificity

Objective: To determine the diagnostic accuracy of PANBIO COVID-19 rapid antigen method in nasopharyngeal swab, for screening of COVID-19 infection in emergency cases. Study Design: Cross-sectional validation study. Place and Duration of Study: Department of Microbiology, Combined Military Hospital, Multan, from Jan to Mar 2021. Methodology: After taking approval from institutional ethical review committee, total 1539 patients were included in this study according to sample size. With informed consent, nasopharyngeal swab specimens were taken for PANBIO COVID-19 rapid antigen method from each patient presenting as emergency medical/surgical case to Combined Military Hospital Multan as well as for Polymerase Chain Reaction for SARS CoV-2 RNA. PANBIO COVID-19 rapid antigen method and polymerase chain reaction for SARS CoV-2 RNA were performed simultaneously on swabs. Polymerase chain reaction for SARS CoV-2 RNA was considered to be the gold standard for comparison with the PANBIO COVID-19 rapid antigen method. Results: A total of 21 patients had SARS CoV-2 RNA detected by polymerase chain reaction indicating COVID-19 infection. Out of polymerase chain reaction positive patients, PANBIO™ COVID-19 Ag test was able to detect 19 cases. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy was calculated and found to be 90.47%, 100%, 100%, 99.8% and 99.8% respectively. Conclusion: PANBIO™ COVID-19 rapid antigen method was found to have excellent diagnostic accuracy in detection of COVID-19 infection. It can provide as a good alternate test for screening of masses with a short turn around time of only 15 minutes.

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