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

Author(s):  
Julian A.F. Klein ◽  
Lisa J. Kr&uumlger ◽  
Frank Tobian ◽  
Mary Gaeddert ◽  
Federica Lainati ◽  
...  

Background: In 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 demonstrated for SARS-CoV-2 Ag-RDTs nasal sampling to be a comparable and reliable alternative for nasopharyngeal (NP) sampling. Methods: 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 (the second WHO-listed SARS-CoV-2 Ag-RDT, distributed by Abbott). We calculated positive and negative percent agreement and, compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR), sensitivity and specificity for both sampling techniques. Results: 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. Conclusion: For the Panbio Ag-RDT supervised NMT self-sampling yields to results comparable to NP sampling. This suggests that nasal self-sampling could be used for scale-up population testing.


Author(s):  
Julian A. F. Klein ◽  
◽  
Lisa J. Krüger ◽  
Frank Tobian ◽  
Mary Gaeddert ◽  
...  

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.



2021 ◽  
Vol 10 (1) ◽  
pp. 65-74
Author(s):  
Germán Enrique Arenas ◽  
Jesús De León Martínez ◽  
Marcela Negrete Vasquez ◽  
Mario Lora ◽  
Martín Carvajal ◽  
...  

Introduction: the Coronavirus disease 2019 (COVID-19) was declared as a global pandemic by the World Health Organization on March 11, 2020. The clinical presentation and severity of the disease has been described from its most typical symptoms, the common cold, pneumonia and respiratory distress syndrome, to the involvement of other organs and systems such such as the gastrointestinal, renal and cardiovascular. Case report: we describe the first case of COVID-19 diagnosed in Cartagena, Colombia, on March 11, 2020, and its uncommon clinic presentation, which was almost unknown at the time. An 85-year-old woman with week-long initial symptoms of nausea and occasional vomiting, with progression to diarrhea and a 38.5 oC fever during the last three days. The patient came from Oxford, UK, and she had been on a Caribbean cruise excursion since the end of February, 2020. Chest computed tomography showed ground glass opacities in both peripheral and central lung fields, multilobar and predominantly subpleural; without evidence of consolidation or pleural effusion. COVID-19 was confirmed three days after admission, when a RT-PCR molecular test performed on a nasopharyngeal swab sample tested positive for SARS-Cov-2 Conclusion: this first case of COVID-19 diagnosed in Cartagena occurred at a time when our health system was not prepared to face the pandemic. However, despite having manifested with a clinical that had not been described at the time, and thanks to the epidemiological, clinical and imaging data, the case could be adequately approached, diagnosed and treated according to the necessary and recommended measures at the time.



2021 ◽  
pp. 24-30
Author(s):  
Aditi Munmun Sengupta ◽  
Diptendu Chatterjee ◽  
Bibhuti Saha

The real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered as the sensitive proof for detecting the viral infection of the SARS-CoV-2 virus obtained from respiratory samples. The quantitative values for the analysis are benecial for estimating the transmissibility of people who test positive for SARS-CoV-2. This can be further achieved by analyzing the samples by semiquantitative means through the interpretation of the cycle threshold (Ct) values of RT-PCR that represent the rst cycle of PCR at which a detectable signal appears during the assays. The Ct value shows a correlation between high viral load and disease infectiousness, which is observed with other respiratory viruses, including the inuenza B infection and rhinovirus infection. Hence, the present study aims to analyze the surveillance of COVID-19 to monitor longer-term epidemiologic trends and trends in deaths due to COVID-19. In order to achieve this aim, the present review was reported to the preferred reporting items for systematic reviews and meta-analysis statements (PRISMA) for analyzing the Ct value-based epidemic predictions and to monitor long-term epidemiologic trends of SARS-CoV-2 virus. Total 33 studies have been nalized for nding out the results of the study. The epidemiologic parameter and a representative of the surveillance data for reporting to the World Health Organization were fullled by analyzing the systematic review and metaanalysis of the selected study. Moreover, the evaluation of the impact of the pandemic on the health care system and society was achieved by analyzing the studies mentioned here.



Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1913
Author(s):  
Cristoforo Pomara ◽  
Francesco Sessa ◽  
Domenico Galante ◽  
Lorenzo Pace ◽  
Antonio Fasanella ◽  
...  

To date, little is known regarding the transmission risks of SARS-CoV-2 infection for subjects involved in handling, transporting, and examining deceased persons with known or suspected COVID-19 positivity at the time of death. This experimental study aims to define if and/or how long SARS-CoV-2 persists with replication capacity in the tissues of individuals who died with/from COVID-19, thereby generating infectious hazards. Sixteen patients who died with/from COVID-19 who underwent autopsy between April 2020 and April 2021 were included in this study. Based on PMI, all samples were subdivided into two groups: ‘short PMI’ group (eight subjects who were autopsied between 12 to 72 h after death); ‘long PMI’ (eight subjects who were autopsied between 24 to 78 days after death). All patients tested positive for RT-PCR at nasopharyngeal swab both before death and on samples collected during post-mortem investigation. Moreover, a lung specimen was collected and frozen at −80 °C in order to perform viral culture. The result was defined based on the cytopathic effect (subjective reading) combined with the positivity of the RT-PCR test (objective reading) in the supernatant. Only in one sample (PMI 12 h), virus vitality was demonstrated. This study, supported by a literature review, suggests that the risk of cadaveric infection in cases of a person who died from/with COVID-19 is extremely low in the first hours after death, becoming null after 12 h after death, confirming the World Health Organization (WHO) assumed in March 2020 and suggesting that the corpse of a subject who died from/with COVID-19 should be generally considered not infectious.



Author(s):  
Andreas K. Lindner ◽  
Olga Nikolai ◽  
Franka Kausch ◽  
Mia Wintel ◽  
Franziska Hommes ◽  
...  

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.



2020 ◽  
Author(s):  
Andreas K. Lindner ◽  
Olga Nikolai ◽  
Chiara Rohardt ◽  
Susen Burock ◽  
Claudia Hülso ◽  
...  

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.



2020 ◽  
Vol 15 (15) ◽  
pp. 1483-1487
Author(s):  
Nikhil S Sahajpal ◽  
Ashis K Mondal ◽  
Allan Njau ◽  
Sudha Ananth ◽  
Kimya Jones ◽  
...  

RT-PCR-based assays for the detection of SARS-CoV-2 have played an essential role in the current COVID-19 pandemic. However, the sample collection and test reagents are in short supply, primarily due to supply chain issues. Thus, to eliminate testing constraints, we have optimized three key process variables: RNA extraction and RT-PCR reactions, different sample types and media to facilitate SARS-CoV-2 testing. By performing various validation and bridging studies, we have shown that various sample types such as nasopharyngeal swab, bronchioalveolar lavage and saliva, collected using conventional nasopharyngeal swabs, ESwab or 3D-printed swabs and, preserved in viral transport media, universal transport media, 0.9% sodium chloride or Amies media are compatible with RT-PCR assay for COVID-19. Besides, the reduction of PCR reagents by up to fourfold also produces reliable results.



Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 363
Author(s):  
Vânia M. Moreira ◽  
Paulo Mascarenhas ◽  
Vanessa Machado ◽  
João Botelho ◽  
José João Mendes ◽  
...  

The rapid and accurate testing of SARS-CoV-2 infection is still crucial to mitigate, and eventually halt, the spread of this disease. Currently, nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) are the recommended standard sampling techniques, yet, these have some limitations such as the complexity of collection. Hence, several other types of specimens that are easier to obtain are being tested as alternatives to nasal/throat swabs in nucleic acid assays for SARS-CoV-2 detection. This study aims to critically appraise and compare the clinical performance of RT-PCR tests using oral saliva, deep-throat saliva/posterior oropharyngeal saliva (DTS/POS), sputum, urine, feces, and tears/conjunctival swab (CS) against standard specimens (NPS, OPS, or a combination of both). In this systematic review and meta-analysis, five databases (PubMed, Scopus, Web of Science, ClinicalTrial.gov and NIPH Clinical Trial) were searched up to the 30th of December, 2020. Case-control and cohort studies on the detection of SARS-CoV-2 were included. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2). We identified 1560 entries, 33 of which (1.1%) met all required criteria and were included for the quantitative data analysis. Saliva presented the higher accuracy, 92.1% (95% CI: 70.0–98.3), with an estimated sensitivity of 83.9% (95% CI: 77.4–88.8) and specificity of 96.4% (95% CI: 89.5–98.8). DTS/POS samples had an overall accuracy of 79.7% (95% CI: 43.3–95.3), with an estimated sensitivity of 90.1% (95% CI: 83.3–96.9) and specificity of 63.1% (95% CI: 36.8–89.3). The remaining index specimens could not be adequately assessed given the lack of studies available. Our meta-analysis shows that saliva samples from the oral region provide a high sensitivity and specificity; therefore, these appear to be the best candidates for alternative specimens to NPS/OPS in SARS-CoV-2 detection, with suitable protocols for swab-free sample collection to be determined and validated in the future. The distinction between oral and extra-oral salivary samples will be crucial, since DTS/POS samples may induce a higher rate of false positives. Urine, feces, tears/CS and sputum seem unreliable for diagnosis. Saliva testing may increase testing capacity, ultimately promoting the implementation of truly deployable COVID-19 tests, which could either work at the point-of-care (e.g. hospitals, clinics) or at outbreak control spots (e.g., schools, airports, and nursing homes).



2020 ◽  
Author(s):  
Andrea Bartolini ◽  
Margherita Scapaticci ◽  
Marina Bioli ◽  
Tiziana Lazzarotto ◽  
Maria Carla Re ◽  
...  

In March 2020, the World Health Organization (WHO) declared a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the absence of effective treatment or biomedical prevention, understanding potential post infection immunity has important implications for epidemiologic assessments. For this reason, increasing number of in vitro diagnostic companies are developing serological assays to detect antibodies against SARS-CoV-2, but most of them lack the validation by third parties in relation to their quality, limiting their usefulness. We submitted to serological screening by two different immunochromatographic (IC) rapid testing for detection of IgG and IgM against SARS-CoV-2, 151 asymptomatic or minimally symptomatic healthcare workers previously tested positive for SARS-CoV-2 RT-PCR in order to evaluate the performance of rapid assays. Results showed discrepancies between molecular and IC results, and an inconsistency of immunoglobulins positivity patterns when compared to ELISA/CLIA results, highlighting the absolute necessity of assays performance validation before their marketing and use, in order to avoid errors in the results evaluation at both clinical and epidemiological level.



2021 ◽  
pp. 2979-2983
Author(s):  
Hamong Suharsono ◽  
Ali Ghufron Mukti ◽  
Ketut Suryana ◽  
I. Wayan Masa Tenaya ◽  
Dilasdita Kartika Pradana ◽  
...  

Background and Aim: Coronavirus disease 2019 (COVID-19) is an acute infectious respiratory disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and has spread rapidly globally, resulting in a pandemic. In humans, the main routes of transmission are respiratory droplets and close contact with infected individuals or through contact with an object infected with the virus, followed by touching mouth, nose, or eyes. It is assumed that SARS-CoV-2 was originated in wild animals and was then transmitted to humans. Although some wildlife and domestic animals can be naturally or experimentally infected with the virus, the intermediate hosts that transmitted it to humans are still unknown. Understanding the dynamics of SARS-CoV-2 associated with possible zoonotic transmission of intermediate hosts is considered critical. Reportedly, cats or dogs living with COVID-19-positive humans tested positive for the disease, suggesting that the virus was transmitted to the animals from humans. Information regarding the epidemiological investigation and comprehensive studies is limited. Therefore, it is still unclear how high is the correlation of infection in humans and pet animals, especially those living together. The aim of this study was to investigate the possibility of SARS-CoV-2 infection in the pets of patients with COVID-19 who were hospitalized at the Wangaya hospital, Denpasar, Bali, Indonesia. Materials and Methods: A total of seven clinically asymptomatic pets (six dogs of different races and sexes and a cat [age, 360-2920 days]) were included in this study. These animals belonged to patients with confirmed SARS-CoV-2 infection from August to November 2020. Nasal swab and nasopharyngeal samples were collected from the pets individually under anesthetic condition and were collected 6-12 days after confirmed SARS-CoV-2 infection in owners and hospitalization at the Wangaya Hospital. The swab samples were then processed for RNA isolation and tested using reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2, in accordance with the World Health Organization manual 2020. Results: RT-PCR results for all seven RNA samples, prepared from the swab samples, were negative. For the samples, all PCR products were below the threshold limit, suggesting no genetic material belonging to the samples tested. Conclusion: This was the first preliminary study of COVID-19 on pets in pandemic using RT-PCR. The study tested a very limited quantity of samples, and all of them were negative. However, the way in which the samples were prepared was considered appropriate. Therefore, in further studies, testing of more samples of pets of more individuals with confirmed SARS-CoV-2 infection is required.



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