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(searched for: doi:10.3389/fmed.2020.00225)
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, Tom Lutalo, , Henry Bukenya, James Peter Eliku, Isaac Ssewanyana, Susan Nabadda, Christopher Nsereko, Matthew Cotten, Robert Downing, et al.
Published: 10 May 2022
Abstract:
Objective: The objective of this study was to evaluate the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting to identify those that could be recommended for use in the diagnosis of SARS-CoV-2 infection in Uganda. Methods: This was a cross-sectional prospective study. Nasopharyngeal swabs were collected consecutively from COVID-19 PCR positive and COVID-19 PCR negative participants at isolation centers and points of entry, and tested with the SARS-CoV-2 Ag RDTs. Test sensitivity and specificity were generated by comparing results against qRT-PCR results (Berlin Protocol) at a cycle threshold (Ct) cut-off of ≤39. Sensitivity was also calculated at Ct cut-offs ≤29 and ≤33. Results: None of the Ag RDTs had a sensitivity of ≥80% at Ct cut-off values ≤33 and ≤39. Two kits, Panbio COVID-19 Ag and VivaDiag SARS-CoV-2 Ag had a sensitivity of ≥80% at a Ct cut-off value of ≤29. Four kits: BIOCREDIT COVID -19 Ag, COVID-19 Ag Respi-Strip, MEDsan® SARS-CoV-2 Antigen Rapid Test and Panbio COVID-19 Ag Rapid Test had a specificity of ≥97%. Conclusions: This evaluation identified one Ag RDT, Panbio COVID-19 Ag with a performance at high viral load (Ct value ≤29) reaching that recommended by WHO. This kit was recommended for screening of patients with COVID -19-like symptoms presenting at health facilities.
Shagun Sharma, Surabhi Shrivastava, , Beena Rai, Aniruddha B. Pandit
Published: 26 April 2022
The publisher has not yet granted permission to display this abstract.
Published: 25 April 2022
by MDPI
Nanomaterials, Volume 12; https://doi.org/10.3390/nano12091456

Abstract:
Coronaviruses, that are now well-known to the public, include a family of viruses that can cause severe acute respiratory syndrome (SARS) and other respiratory diseases, such as Middle East respiratory syndrome (MERS). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the seventh member of this coronavirus family, was detected in 2019 and can cause a number of respiratory symptoms, from dry cough and fever to fatal viral pneumonia. Various diagnostic assays ranging from real-time polymerase chain reaction (RT-PCR) to point-of-care medical diagnostic systems have been developed for detection of viral components or antibodies targeting the virus. Point-of-care assays allow rapid diagnostic assessment of infectious patients. Such assays are ideally simple, low-cost, portable tests with the possibility for on-site field detection that do not require skilled staff, sophisticated equipment, or sample pretreatment, as compared to RT-PCR. Since early 2021 when new SARS-CoV-2 variants of concern increased, rapid tests became more crucial in the disease management cycle. Among rapid tests, gold nanoparticle (GNP)-based lateral flow assays (LFAs) have high capacity for performing at the bedside, paving the way to easy access to diagnosis results. In this review, GNP-based LFAs used for either COVID-19 proteins or human response antibodies are summarized and recommendations for their improvement have been suggested.
Maniya Arshadi, Fatemeh Fardsanei, Behnaz Deihim, Zahra Farshadzadeh, Farhad Nikkhahi, Farima Khalili, Giovanni Sotgiu, Amir Hashem Shahidi Bonjar, Rosella Centis, , et al.
Published: 7 April 2022
Frontiers in Medicine, Volume 9; https://doi.org/10.3389/fmed.2022.870738

Abstract:
Introduction: Reverse transcription-polymerase chain reaction (RT-PCR) to detect SARS-CoV-2 is time-consuming and sometimes not feasible in developing nations. Rapid antigen test (RAT) could decrease the load of diagnosis. However, the efficacy of RAT is yet to be investigated comprehensively. Thus, the current systematic review and meta-analysis were conducted to evaluate the diagnostic accuracy of RAT against RT-PCR methods as the reference standard. Methods: We searched the MEDLINE/Pubmed and Embase databases for the relevant records. The QUADAS-2 tool was used to assess the quality of the studies. Diagnostic accuracy measures [i.e., sensitivity, specificity, diagnostic odds ratio (DOR), positive likelihood ratios (PLR), negative likelihood ratios (NLR), and the area under the curve (AUC)] were pooled with a random-effects model. All statistical analyses were performed with Meta-DiSc (Version 1.4, Cochrane Colloquium, Barcelona, Spain). Results: After reviewing retrieved records, we identified 60 studies that met the inclusion criteria. The pooled sensitivity and specificity of the rapid antigen tests against the reference test (the real-time PCR) were 69% (95% CI: 68–70) and 99% (95% CI: 99–99). The PLR, NLR, DOR and the AUC estimates were found to be 72 (95% CI: 44–119), 0.30 (95% CI: 0.26–0.36), 316 (95% CI: 167–590) and 97%, respectively. Conclusion: The present study indicated that using RAT kits is primarily recommended for the early detection of patients suspected of having COVID-19, particularly in countries with limited resources and laboratory equipment. However, the negative RAT samples may need to be confirmed using molecular tests, mainly when the symptoms of COVID-19 are present.
Harald H. Kessler, Florian Prüller, Melina Hardt, Evelyn Stelzl, Esther Föderl-Höbenreich, Sabine Pailer, Andreas Lueger, Philipp Kreuzer, Kurt Zatloukal,
Clinical Chemistry and Laboratory Medicine (CCLM); https://doi.org/10.1515/cclm-2021-1276

Abstract:
Objectives: Rapid antigen tests (RAT) can provide valuable information on the presence or absence SARS-CoV-2 within 15 min without the need of a laboratory. The analytical and diagnostic characteristics of available RATs has led to the question whether they can safely distinguish between infectious and non-infectious patients in an acute care setting. Methods: Three nasopharyngeal swabs for the analysis by RAT, reverse transcriptase real time polymerase chain reaction (RT-qPCR), and a cell culture based infection assay were collected from 67 patients that presented to the emergency department of the University Hospital of Graz (Austria). The first swab was used for on-site RAT testing in the emergency department using the Roche SARS-CoV-2 RAT. The second swab was sent to the central laboratory of the hospital for RT-qPCR with two independent methods (Cepheid Xpert® Xpress SARS-CoV-2 assay and Roche Cobas SARS-CoV-2 Test) and repeat RAT testing using the same commercial test. With the third swab a cell culture-based infection assay was performed. Results: The RATs performed from independent samples showed substantial agreement (Cohen’s-kappa: 0.73, p<0.001). All patients with a positive RAT had positive RT-qPCR with cycle threshold (ct) values 25 did not induce cytopathic effects that were related to SARS-CoV-2. The infection assays from four RAT-negative patients showed cytopathic effects that were induced by other pathogens. Conclusions: The SARS-CoV-2 RAT from Roche Diagnostics is a valuable tool for managing symptomatic patients. RAT-negative patients may be regarded as non-contagious.
Paraskevi C. Fragkou, Giulia De Angelis, Giulia Menchinelli, Fusun Can, Federico Garcia, Florence Morfin-Sherpa, Dimitra Dimopoulou, Elisabeth Mack, Adolfo de Salazar, Adriano Grossi, et al.
Published: 22 February 2022
Clinical Microbiology and Infection; https://doi.org/10.1016/j.cmi.2022.02.011

The publisher has not yet granted permission to display this abstract.
Hyun-Kyung Oh, Kihyeun Kim, Jinhee Park, , Simon Maher,
Published: 17 February 2022
Biosensors and Bioelectronics, Volume 205; https://doi.org/10.1016/j.bios.2022.114094

The publisher has not yet granted permission to display this abstract.
Giredhar Muthiah, Ankita Sarkar, Shounak Roy, Prem Singh, Praveen Kumar, Keshav Bhardwaj,
Published: 6 February 2022
The publisher has not yet granted permission to display this abstract.
Wei Li Ang, Rachel Rui Xia Lim, Adriano Ambrosi,
Published: 15 January 2022
The publisher has not yet granted permission to display this abstract.
Mbow Moustapha, Diallo Ibrahima, Diouf Mamadou, Cissé Marouba, Gningue Moctar, Mboup Aminata, Leye Nafissatou, Lo Gora, Dia Yacine Amet, Padane Abdou, et al.
International Journal of Clinical Virology, Volume 6, pp 001-006; https://doi.org/10.29328/journal.ijcv.1001041

Abstract:
Purpose: Real-time reverse-transcription polymerase chain reaction (RT-PCR)-based testing remains the gold standard for the diagnosis of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the high diagnosis demand of SARS-CoV-2 and the limited resources for RT-PCR testing, especially in Low-Income Countries (LICs), antigen-based methods are being considered as an option. The aim of this study was to assess the performance of LumiraDx SARS-CoV-2 antigen assay for large population screening compared to RT-PCR. Methods: This evaluation was conducted on 4146 participants including travelers and participants under household survey and vaccine evaluation studies before injection of the first dose. Oropharyngeal and nasopharyngeal swaps were collected from each participant into 2 mL of viral transport medium (VTM) and 400 μl of VTM were used to assess the performance of LumiraDx SARS-CoV-2 antigen assay, compared to RT-PCR. Results: The prevalence of SARS-CoV-2 of the cohort was 4.5% with RT-PCR and 4.1% with LumiraDx antigen test. Compared to the RT-PCR, the sensitivity and specificity of the LumiraDx antigen SARS-CoV-2 test were 82,7% [95% CI 74.1-89,7] and 99.9% [95% CI 99.6-99.9] respectively. Given the RT-PCR threshold cycle (Ct) range, the sensitivity was 92.1% [95% CI 84.6-96.3] when the Ct value was below or equal 33 cycles, and 38.1% [95% CI 18.9-61.3] when it was above 33 cycles. The inter-rater reliability showed a kappa coefficient of 0.88 when considering all the patients and 0.94 for Ct values below 33 cycles. Conclusion: Our data have shown that the LumiraDx platform can be considered for large-scale testing of SARS-CoV-2.
Shachindra Kumar Pathak, Subramaniam Swaminathan, Anand Neelakantan, Nilotpal Behuria
INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH pp 64-67; https://doi.org/10.36106/ijsr/4702316

Abstract:
In this COVID – 19 pandemic, there's an urgent need for a sensitive and specic test which provides results in a short span of time. Rapid Antigen Tests, have the potential to replace RT-PCR tests as a conrmatory test. A comparative study of Point-of-Care test vis-à-vis gold standard test was carried out by the Surgical Department of a secondary level care hospital. A total of 112 patients, with various surgical emergencies were tested, by RADT and by RT-PCR for conrmation. Patients were managed based on RADT results as per the institutional algorithm. 107 RADTs tested negative while ve tested positive. 105 RT-PCR tested negative while seven tested positive. Two patients reported negative by RADT were reported as RT-PCR positive. Although RADTs have the potential, their sensitivity is highly variable. To establish them as diagnostic tests of choice, RADTs need to be developed further so as to ensure that their sensitivity is high and results are reproducible across multiple centers.
, Esraa Ibrahim A. Shaaban
Published: 1 January 2022
Nanotechnology Reviews, Volume 11, pp 680-698; https://doi.org/10.1515/ntrev-2022-0036

Abstract:
COVID-19 outbreak has become one of the catastrophic health emergencies that could threaten public health worldwide through several hospitalizations and thousands of deaths, leading to boosting global concern intensive precautionary measurements. The clinical and research trials are ongoing for developing several diagnostic tools, antiviral therapeutics, and vaccines versus COVID-19 infectiousness. This review argues the recent nanomedical progress and efficient nanomedicine applications and highlights relevant challenges and considerations of nano-based materials for combating COVID-19 infectiousness and severity. Eventually, we also provide futuristic avenues and perspectives paving the way to explore outstanding solutions for SARS-CoV-2 control and eradication.
Published: 29 December 2021
by MDPI
Biosensors, Volume 12; https://doi.org/10.3390/bios12010013

Abstract:
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory coronavirus 2 (SARS-CoV-2) is still raging all over the world. Hence, the rapid and sensitive screening of the suspected population is in high demand. The nucleocapsid protein (NP) of SARS-CoV-2 has been selected as an ideal marker for viral antigen detection. This study describes a lateral flow immunoassay (LFIA) based on colloidal gold nanoparticles for rapid NP antigen detection, in which sensitivity was improved through copper deposition-induced signal amplification. The detection sensitivity of the developed LFIA for NP antigen detection (using certified reference materials) under the optimized parameters was 0.01 μg/mL and was promoted by three orders of magnitude to 10 pg/mL after copper deposition signal amplification. The LFIA coupled with the copper enhancement technique has many merits such as low cost, high efficiency, and high sensitivity. It provides an effective approach to the rapid screening, diagnosis, and monitoring of the suspected population in the COVID-19 outbreak.
Akanksha Roberts, , Deepshikha Shahdeo, Narlawar Sagar Shrikrishna, Veerbhan Kesarwani, Milena Horvat,
Published: 14 December 2021
Frontiers in Immunology, Volume 12; https://doi.org/10.3389/fimmu.2021.732756

Abstract:
Coronavirus disease 2019 (COVID-19), which started out as an outbreak of pneumonia, has now turned into a pandemic due to its rapid transmission. Besides developing a vaccine, rapid, accurate, and cost-effective diagnosis is essential for monitoring and combating the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its related variants on time with precision and accuracy. Currently, the gold standard for detection of SARS-CoV-2 is Reverse Transcription Polymerase Chain Reaction (RT-PCR), but it lacks accuracy, is time-consuming and cumbersome, and fails to detect multi-variant forms of the virus. Herein, we have summarized conventional diagnostic methods such as Chest-CT (Computed Tomography), RT-PCR, Loop Mediated Isothermal Amplification (LAMP), Reverse Transcription-LAMP (RT-LAMP), as well new modern diagnostics such as CRISPR–Cas-based assays, Surface Enhanced Raman Spectroscopy (SERS), Lateral Flow Assays (LFA), Graphene-Field Effect Transistor (GraFET), electrochemical sensors, immunosensors, antisense oligonucleotides (ASOs)-based assays, and microarrays for SARS-CoV-2 detection. This review will also provide an insight into an ongoing research and the possibility of developing more economical tools to tackle the COVID-19 pandemic.
Dongbum Kim, Jinsoo Kim, Sangkyu Park, Minyoung Kim, Kyeongbin Baek, Mijeong Kang, Jun-Kyu Choi, Sony Maharjan, Madhav Akauliya, YoungHee Lee, et al.
Published: 7 December 2021
Frontiers in Microbiology, Volume 12; https://doi.org/10.3389/fmicb.2021.726231

Abstract:
SARS-CoV-2 infections continue to spread quickly by human-to-human transmission around the world. Therefore, developing methods to rapidly detect SARS-CoV-2 with high sensitivity are still urgently needed. We produced a monoclonal antibody that specifically detects the N protein of SARS-CoV-2 and recognizes N protein in cell lysates of SARS-CoV-2–infected Vero cells but not in cell lysates of MERS-CoV- or HCoV-OC43-infected Vero cells. This antibody recognized N protein in SARS-CoV-2 clades S, GR, and GH and recognized N protein in all the SARS-CoV-2 clades to ∼300 pfu. Previously, we reported that the coronavirus N protein interacts with the C-terminal domain of the spike protein (Spike CD). In this study, we developed an ELISA-based “bait and prey” system to confirm the interaction between SARS-CoV-2 Spike CD and N protein using recombinant fusion proteins. Furthermore, this system can be modified to quantitatively detect SARS-CoV-2 in culture media of infected cells by monitoring the interaction between the recombinant Spike CD fusion protein and the viral N protein, which is captured by the N protein–specific antibody. Therefore, we conclude that our N protein–specific monoclonal antibody and our ELISA-based bait and prey system could be used to diagnose SARS-CoV-2 infections.
Xiucai Zhang, Hanyan Meng, Huihui Liu,
Published: 2 December 2021
Journal of Medical Virology, Volume 94, pp 1357-1365; https://doi.org/10.1002/jmv.27494

The publisher has not yet granted permission to display this abstract.
Kaori Saito, Tomohiko Ai, Akinori Kawai, Jun Matsui, Yoshiyuki Fukushima, Norihiro Kikukawa, Takuya Kyoutou, Masayoshi Chonan, Takeaki Kawakami, Yoshie Hosaka, et al.
Published: 1 December 2021
Scientific Reports, Volume 11, pp 1-10; https://doi.org/10.1038/s41598-021-02636-x

Abstract:
Here, we aimed to evaluate the clinical performance of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit designed to detect the nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This kit comprises automated chemiluminescence detection systems. Western blot analysis confirmed that anti-SARS-CoV antibodies detected SARS-CoV-2N proteins. The best cut-off index was determined, and clinical performance was tested using 115 nasopharyngeal swab samples obtained from 46 patients with coronavirus disease 2019 (COVID-19) and 69 individuals who tested negative for COVID-19 through reverse transcription quantitative polymerase chain reaction (RT-qPCR). The HISCL Antigen assay kit showed a sensitivity of 95.4% and 16.6% in samples with copy numbers > 100 and < 99, respectively. The kit did not cross-react with human coronaviruses causing seasonal common cold and influenza, and none of the 69 individuals without COVID-19 were diagnosed with positive results. Importantly, 81.8% of the samples with low virus load (< 50 copy numbers) were diagnosed as negative. Thus, using HISCL antigen assay kits may reduce overdiagnosis compared with RT-qPCR tests. The rapid and high-throughput HISCL SARS-CoV-2 Antigen assay kit developed here proved suitable for screening infectious COVID-19 and may help control the pandemic.
, Jean-Claude Nguyen Van, Najoua El Helali, Julie Lourtet-Hascoet, Ines Jabnoune, Marie Liesse Pacreau, Yasmina Talb, Jacques Fourgeaud, Marianne Leruez-Ville, Benoît Pilmis, et al.
Published: 18 November 2021
Journal of Virological Methods, Volume 300; https://doi.org/10.1016/j.jviromet.2021.114366

The publisher has not yet granted permission to display this abstract.
Published: 29 October 2021
by MDPI
Viruses, Volume 13; https://doi.org/10.3390/v13112183

Abstract:
Rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are useful for rapid diagnosis in a variety of settings. Although many kinds of RATs are available, their respective sensitivity has not been compared. Here, we examined the sensitivity of 27 RATs available in Japan for the detection of the SARS-CoV-2 delta variant. All of the RATs tested detected the delta variant albeit with different sensitivities. Nine RATs (ESPLINE SARS-CoV-2, ALSONIC COVID-19 Ag, COVID-19 and Influenza A+B Antigen Combo Rapid Test, ImmunoArrow SARS-CoV-2, Fuji Dri-chem immuno AG cartridge COVID-19 Ag, 2019-nCoV Ag rapid detection kit, Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit, and Rabliss SARS-CoV-2 antigen detection kit COVID19 AG) showed superior sensitivity to the isolated delta variant. Although actual clinical specimens were not examined, the detection level of most of the RATs was 7500 pfu, indicating that individuals whose test samples contained less virus than that would be considered negative. Therefore, it is important to bear in mind that RATs may miss individuals shedding low levels of infectious virus.
, , Hacène Khiri, Vincent Garcia, Hortense Drouet, Patrick Philibert, Christina Psomas, Marion Delord, Frédérique Retornaz, Caroline Charpin, et al.
Published: 23 September 2021
Abstract:
Background & aim We investigated the combination of rapid antigen detection (RAD) and RT-qPCR assays in a stepwise procedure to optimize the detection of COVID-19. Methods From August 2020 to November 2020, 43,399 patients were screened in our laboratory for COVID-19 diagnostic by RT-qPCR using nasopharyngeal swab. Overall, 4,691 of the 43,399 were found to be positive, and 200 were retrieved for RAD testing allowing comparison of diagnostic accuracy between RAD and RT-qPCR. Cycle threshold (Ct) and time from symptoms onset (TSO) were included as covariates. Results The overall sensitivity, specificity, PPV, NPV, LR-, and LR+ of RAD compared with RT-qPCR were 72% (95%CI 62%–81%), 99% (95% CI95%–100%), 99% (95%CI 93%–100%), and 78% (95%CI 70%–85%), 0.28 (95%CI 0.21–0.39), and 72 (95%CI 10–208) respectively. Sensitivity was higher for patients with Ct ≤ 25 regardless of TSO: TSO ≤ 4 days 92% (95%CI 75%–99%), TSO > 4 days 100% (95%CI 54%–100%), and asymptomatic 100% (95%CI 78–100%). Overall, combining RAD and RT-qPCR would allow reducing from only 4% the number of RT-qPCR needed. Conclusions This study highlights the risk of misdiagnosing COVID-19 in 28% of patients if RAD is used alone. A stepwise analysis that combines RAD and RT-qPCR would be an efficient screening procedure for COVID-19 detection and may facilitate the control of the outbreak.
Chaolan Liang, Bochao Liu, Jinfeng Li, Jinhui Lu, Enhui Zhang, Qitao Deng, Ling Zhang, Ruiai Chen, Yongshui Fu, , et al.
Published: 12 September 2021
Sensors and Actuators B: Chemical, Volume 349; https://doi.org/10.1016/j.snb.2021.130718

The publisher has not yet granted permission to display this abstract.
International Journal of Environmental Research and Public Health, Volume 18; https://doi.org/10.3390/ijerph18179151

Abstract:
Introduction: Rapid antigen tests (RATs) are convenient for SARS-CoV-2 detection because they are simpler and faster than nucleic acid amplification tests (NAATs). This study aimed to assess the accuracy of a locally manufactured test; Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece) in a clinical setting and during mass screening. Methods: Nasopharyngeal samples from 624 individuals were analyzed. The results of the rapid test were compared to real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR). At the end of the test’s procedure, positive test strips were scanned in an S-Flow reader in order to roughly estimate the antigen concentration. Results: The lower limit of detection of the test was 468.75 genome copies/mL. The PROGNOSIS rapid test displayed a sensitivity of 85.5% (141/165) (95%CI: 79.1–90.5) and a specificity of 99.8% (458/459) (95%CI: 98.8–100.0%). The general inter-rater agreement was 0.89 (95%CI: 85.1–93.3). The regression analysis between the S-flow reader measurements (viral antigen) and the viral load of the positive samples demonstrated a weak correlation (R2 = 0.288, p< 0.001). Conclusion: The Rapid Test Ag 2019-nCoV demonstrated sufficient sensitivity, excellent specificity and could be available to be used with low overall cost. Thus, it could be used as point of care test, but also for mass screening for rapid detection of infected persons (e.g., for travelers).
Bochao Liu, Ze Wu, Chaolan Liang, Jinhui Lu, Jinfeng Li, Ling Zhang, Tingting Li, Wei Zhao, Yongshui Fu, Shuiping Hou, et al.
Published: 23 August 2021
Frontiers in Microbiology, Volume 12; https://doi.org/10.3389/fmicb.2021.692831

Abstract:
Since December 2019, a novel coronavirus (SARS-CoV-2) has resulted in a global pandemic of coronavirus disease (COVID-19). Although viral nucleic acid test (NAT) has been applied predominantly to detect SARS-CoV-2 RNA for confirmation diagnosis of COVID-19, an urgent need for alternative, rapid, and sensitive immunoassays is required for primary screening of virus. In this study, we developed a smartphone-based nanozyme-linked immunosorbent assay (SP-NLISA) for detecting the specific nucleocapsid phosphoprotein (NP) of SARS-CoV-2 in 37 serum samples from 20 COVID-19 patients who were diagnosed by NAT previously. By using SP-NLISA, 28/37 (75.7%) serum samples were detected for NP antigens and no cross-reactivity with blood donors’ control samples collected from different areas of China. In a control assay using the conventional enzyme-linked immunosorbent assay (ELISA), only 7/37 (18.91%) serum samples were detected for NP antigens and no cross-reactivity with control samples. SP-NLISA could be used for rapid detection of SARS-CoV-2 NP antigen in primary screening of SARS-CoV-2 infected individuals.
, , , Christian Erdmann, Stephani Schmitz, , , , Markus A. Weigand, , et al.
Published: 12 August 2021
Abstract:
Background SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs. Methods and findings We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 up until 30 April 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcription polymerase chain reaction (RT-PCR) testing. We assessed heterogeneity by subgroup analyses, and rated study quality and risk of bias using the QUADAS-2 assessment tool. From a total of 14,254 articles, we included 133 analytical and clinical studies resulting in 214 clinical accuracy datasets with 112,323 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity and specificity were 71.2% (95% CI 68.2% to 74.0%) and 98.9% (95% CI 98.6% to 99.1%), respectively. Sensitivity increased to 76.3% (95% CI 73.1% to 79.2%) if analysis was restricted to studies that followed the Ag-RDT manufacturers’ instructions. LumiraDx showed the highest sensitivity, with 88.2% (95% CI 59.0% to 97.5%). Of instrument-free Ag-RDTs, Standard Q nasal performed best, with 80.2% sensitivity (95% CI 70.3% to 87.4%). Across all Ag-RDTs, sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values, i.e., <20 (96.5%, 95% CI 92.6% to 98.4%) and <25 (95.8%, 95% CI 92.3% to 97.8%), in comparison to those with Ct ≥ 25 (50.7%, 95% CI 35.6% to 65.8%) and ≥30 (20.9%, 95% CI 12.5% to 32.8%). Testing in the first week from symptom onset resulted in substantially higher sensitivity (83.8%, 95% CI 76.3% to 89.2%) compared to testing after 1 week (61.5%, 95% CI 52.2% to 70.0%). The best Ag-RDT sensitivity was found with anterior nasal sampling (75.5%, 95% CI 70.4% to 79.9%), in comparison to other sample types (e.g., nasopharyngeal, 71.6%, 95% CI 68.1% to 74.9%), although CIs were overlapping. Concerns of bias were raised across all datasets, and financial support from the manufacturer was reported in 24.1% of datasets. Our analysis was limited by the included studies’ heterogeneity in design and reporting. Conclusions In this study we found that Ag-RDTs detect the vast majority of SARS-CoV-2-infected persons within the first week of symptom onset and those with high viral load. Thus, they can have high utility for diagnostic purposes in the early phase of disease, making them a valuable tool to fight the spread of SARS-CoV-2. Standardization in conduct and reporting of clinical accuracy studies would improve comparability and use of data.
, Abdullah S. Al‐Bogami, Wael Alshitari, Deia A. El-Hady, Tamer S. Saleh, Mohamed A. El-Mokhtar,
Published: 9 August 2021
BioChip Journal, Volume 15, pp 287-295; https://doi.org/10.1007/s13206-021-00030-3

Abstract:
As continues increasing the COVID-19 infections, there is an urgent need for developing fast, simple, selective, and accurate COVID-19 biosensors. A highly uniform gold (Au) microcuboid pattern was used as a microelectrode that allowed monitoring a small analyte. The electrochemical biosensor was used to monitor the COVID-19 S protein within a concentration range from 100 to 5 pmol L−1; it showed a lower detection limit of 276 fmol L−1. Finally, the developed COVID-19 sensor was used to detect a positive sample from a human patient obtained through a nasal swab; the results were confirmed using the PCR technique. The results showed that the SWV technique showed high sensitivity towards detecting COVID-19 and good efficiency for detecting COVID-19 in a positive human sample.
Nol Salcedo, Alexander Harmon,
Frontiers in Tropical Diseases, Volume 2; https://doi.org/10.3389/fitd.2021.707865

Abstract:
While molecular assays, such as reverse-transcription polymerase chain reaction (RT-PCR), have been widely used throughout the coronavirus disease 2019 (COVID-19) pandemic, the technique is costly and resource intensive. As a means to reduce costs and increase diagnostic efficiency, pooled testing using RT-PCR has been implemented. However, pooling samples for antigen testing has not been evaluated. Here, we propose a proof-of-concept pooling strategy for antigen testing that would significantly expand SARS-CoV-2 surveillance, especially for low-to-middle income countries, schools, and workplaces. Our laboratory-based testing demonstrates that combining of up to 20 nasal swab specimens per pool can expand surveillance with antigen tests, even if a pool contains only one positive sample.
Waleed A. El-Said, Abdullah S. Al-Bogami, Wael Alshitari
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, Volume 264, pp 120237-120237; https://doi.org/10.1016/j.saa.2021.120237

The publisher has not yet granted permission to display this abstract.
Slim Fourati, Céline Langendorf, Etienne Audureau, Dominique Challine, Justine Michel, Alexandre Soulier, Nazim Ahnou, Isaac Désveaux, Oriane Picard, Valérie Ortonne, et al.
Published: 25 July 2021
Journal of Clinical Virology, Volume 142, pp 104930-104930; https://doi.org/10.1016/j.jcv.2021.104930

The publisher has not yet granted permission to display this abstract.
, Luigi Di Matteo, Franca Gotta, Elisa Cornaglia, Daria Vay, Iacopo Megna, Rosalia Emanuela Pensato, Riccardo Boverio, Andrea Rocchetti
International Journal of Infectious Diseases, Volume 110, pp 135-140; https://doi.org/10.1016/j.ijid.2021.07.043

The publisher has not yet granted permission to display this abstract.
Rimjhim Kanaujia, Arnab Ghosh, Ritin Mohindra, Vidhi Singla, Kapil Goyal, Rajendra Gudisa, , Lalit Mohan, Navpreet Kaur, Gursimran Kaur Mohi, et al.
Indian Journal of Medical Microbiology, Volume 39, pp 457-461; https://doi.org/10.1016/j.ijmmb.2021.07.003

Abstract:
To determine the utility, diagnostic accuracy, sensitivity, specificity, and negative predictive value of the laboratory based Covid-19 antigen detection test (Coris Bio- Concept, Gembloux, Belgium) for the diagnosis of SARS-CoV-2 in a tertiary care hospital among symptomatic and asymptomatic patients.
Wanru Guo, Harini Lakshminarayanan, Alex Rodriguez-Palacios, Robert A Salata, Kaijin Xu, Mohamed S Draz
International Journal of Nanomedicine, pp 4813-4830; https://doi.org/10.2147/ijn.s302516

Abstract:
Human coronaviruses present a substantial global disease burden, causing damage to populations’ health, economy, and social well-being. Glycans are one of the main structural components of all microbes and organismic structures, including viruses—playing multiple essential roles in virus infection and immunity. Studying and understanding virus glycans at the nanoscale provide new insights into the diagnosis and treatment of viruses. Glycan nanostructures are considered potential targets for molecular diagnosis, antiviral therapeutics, and the development of vaccines. This review article describes glycan nanostructures (eg, glycoproteins and glycolipids) that exist in cells, subcellular structures, and microbes. We detail the structure, characterization, synthesis, and functions of virus glycans. Furthermore, we describe the glycan nanostructures of different human coronaviruses, such as human coronavirus 229E (HCoV-229E), human coronavirus OC43 (HCoV-OC43), severe acute respiratory syndrome-associated coronavirus (SARS-CoV), human coronavirus NL63 (HCoV-NL63), human coronavirus HKU1 (HCoV-HKU1), the Middle East respiratory syndrome-associated coronavirus (MERS-CoV), and how glycan nanotechnology can be useful to prevent and combat human coronaviruses infections, along with possibilities that are not yet explored.
Ryo Kobayashi, Ryosei Murai, Mikako Moriai, Shinya Nirasawa, Hitoshi Yonezawa, Takashi Kondoh, Masachika Saeki, Yuki Yakuwa, Yuki Sato, Yuki Katayama, et al.
Journal of Infection and Chemotherapy, Volume 27, pp 1477-1481; https://doi.org/10.1016/j.jiac.2021.06.019

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Kingsley Badu, Kolapo Oyebola, Julien Z. B. Zahouli, Adeniyi Francis Fagbamigbe, Dziedzom K. de Souza, Natisha Dukhi, Ebenezer F. Amankwaa, Mai F. Tolba, Augustina A. Sylverken, Lydia Mosi, et al.
Published: 17 June 2021
Frontiers in Medicine, Volume 8; https://doi.org/10.3389/fmed.2021.648660

Abstract:
The evolving nature of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has necessitated periodic revisions of COVID-19 patient treatment and discharge guidelines. Since the identification of the first COVID-19 cases in November 2019, the World Health Organization (WHO) has played a crucial role in tackling the country-level pandemic preparedness and patient management protocols. Among others, the WHO provided a guideline on the clinical management of COVID-19 patients according to which patients can be released from isolation centers on the 10th day following clinical symptom manifestation, with a minimum of 72 additional hours following the resolution of symptoms. However, emerging direct evidence indicating the possibility of viral shedding 14 days after the onset of symptoms called for evaluation of the current WHO discharge recommendations. In this review article, we carried out comprehensive literature analysis of viral shedding with specific focus on the duration of viral shedding and infectivity in asymptomatic and symptomatic (mild, moderate, and severe forms) COVID-19 patients. Our literature search indicates that even though, there are specific instances where the current protocols may not be applicable ( such as in immune-compromised patients there is no strong evidence to contradict the current WHO discharge criteria.
, Zahra Rostami, Hossein Vahidi
Expert Review of Clinical Immunology, Volume 17, pp 573-599; https://doi.org/10.1080/1744666x.2021.1908886

Abstract:
The gold standard for diagnosis of coronavirus disease 2019 (COVID-19) is detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription polymerase chain reaction (RT-PCR), which is expensive, time-consuming and may result in false-negative results. Serological tests can be employed for RT-PCR negative patients, contact tracing, determining the probability of protection against re-infection, and seroepidemiological studies. The main methodologies of serology-based tests for detection of SARS-CoV-2 including enzyme-linked immunosorbent assays (ELISAs), chemiluminescent immunoassays (CLIAs) and lateral flow immunoassays (LFIAs) were reviewed and their diagnostic performances were compared. Herein, a literature review on the databases of PubMed, Scopus and Google Scholar between January 01, 2020 and June 30, 2020 based on the main serological methods for COVID-19 detection with the focus on comparative experiments was performed. The review was updated on 31th December 2020. Serology testing could be considered as a part of diagnostic panel two weeks post symptom onset. Higher sensitivity for serology-based tests could be achieved by determining combined IgG/IgM titers. Furthermore, higher sensitive serological test detecting neutralization antibody could be developed by targeting spike (S) antigen. It was also demonstrated that the sensitivity of ELISA/CLIA-based methods are higher than LFIA devices.
, Dominic Affron, Babak Afrough, Anita Agasu, Mark Ainsworth, Alison Allanson, Katherine Allen, Collette Allen, Lorraine Archer, Natasha Ashbridge, et al.
Published: 29 May 2021
eClinicalMedicine, Volume 36; https://doi.org/10.1016/j.eclinm.2021.100924

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, , Masataka Hirabayashi, Kazuo Endo, Masahito Emura, Toru Kojima, Hitokazu Tsukao, Keisuke Tomii, Atsushi Nakagawa, Kojiro Otsuka, et al.
Open Forum Infectious Diseases, Volume 8; https://doi.org/10.1093/ofid/ofab282

Abstract:
Background Detailed differences in clinical information between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia (CP), which is the main phenotype of SARS-CoV-2 disease, and influenza pneumonia (IP) are still unclear. Methods A prospective, multicenter cohort study was conducted by including patients with CP who were hospitalized between January and June 2020 and a retrospective cohort of patients with IP hospitalized from 2009 to 2020. We compared the clinical presentations and studied the prognostic factors of CP and IP. Results Compared with the IP group (n = 66), in the multivariate analysis, the CP group (n = 362) had a lower percentage of patients with underlying asthma or chronic obstructive pulmonary disease (P < .01), lower neutrophil-to-lymphocyte ratio (P < .01), lower systolic blood pressure (P < .01), higher diastolic blood pressure (P < .01), lower aspartate aminotransferase level (P < .05), higher serum sodium level (P < .05), and more frequent multilobar infiltrates (P < .05). The diagnostic scoring system based on these findings showed excellent differentiation between CP and IP (area under the receiver operating characteristic curve, 0.889). Moreover, the prognostic predictors were different between CP and IP. Conclusions Comprehensive differences between CP and IP were revealed, highlighting the need for early differentiation between these 2 pneumonias in clinical settings.
, Juan Romanyk, Helena Moya Gutiérrez, Andrea Labrador Ballestero, Inés Pérez Ranz, Javier González Arroyo, Victoria González Ventosa, , Concepción Domingo Cruz, Juan Cuadros‐González
Journal of Medical Virology, Volume 93, pp 5650-5654; https://doi.org/10.1002/jmv.27089

Abstract:
The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag-RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We evaluated Panbio and SD-Biosensor Ag-RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (Ct) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD-Biosensor. Sensitivity for samples with Ct ≤ 20 was 100% for both assays and for samples with Ct = 20–25 was 93.0% (Panbio) and 95.3% (SD-Biosensor) (p = 1.000). Sensitivity decreased for samples wit Ct = 25–30 (Panbio: 41.3%, SD-Biosensor: 52.2%, p = 0.125) and samples with Ct ≥ 30 (Panbio: 5.0%, SD-Biosensor: 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD-Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (Ct ≤ 25): Panbio, 98.9%, kappa = 0.974; SD-Biosensor, 97.4%, kappa = 0.940. Agreement between Ag-RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD-Biosensor Ag-RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (Ct ≤ 25) or samples within seven d.p.o.
, , , , Mostafa Chashmpoosh, Seyyed Mojtaba Mousavi, Seyyed Alireza Hashemi,
Archives of Clinical Infectious Diseases, Volume 16; https://doi.org/10.5812/archcid.110667

Abstract:
: The virus causing COVID-19 disease is known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease spread rapidly and was transmitted like a contagious disease throughout China, and then it gradually spread in other parts of the world. Accordingly, the rapid and accurate detection of the SARS-CoV-2 virus plays an essential role in selecting timely treatments, saving lives, and preventing the spread of the disease. This study summarizes the methods used to identify coronavirus nucleic acid. The effectiveness of coronavirus nucleic acid detection kits by different samples and the performance of other diagnostic techniques are also addressed in this study. We searched Embase, Google Scholar, MEDLINE, Web of Science, Scopus, and PubMed databases as well as the references of all relevant articles in English published during 2019 - 2020 using keywords related to COVID-19, detection kits, and respiratory failure and proceedings from relevant conferences and congresses. The authors collected the relevant reports, and each of the authors independently reviewed the data published in different studies. The results of previous studies indicated that the diagnosis methods of the COVID-19 disease are the RT-PCR method, ELISA kits, quick tests, white blood cell count, C-reactive protein (CRP) levels, other laboratory factors and antigenic detection methods. Given the sensitivity and specificity of these methods at different periods using different samples, the disease interpretation can be performed accurately. The findings showed that proper laboratory equipment and appropriate laboratory kits are necessary for the rapid and precise identification of COVID-19.
Miroslav Homza, , , , Eduard Jezo, Alena Kloudova, Jakub Mrazek, ,
Published: 14 May 2021
Infectious Diseases, Volume 53, pp 661-668; https://doi.org/10.1080/23744235.2021.1914857

Abstract:
Antigen testing for SARS-CoV-2 is considered to be less sensitive than the standard reference method – real-time PCR (RT-PCR). It has been suggested that many patients with positive RT-PCR ‘missed’ by antigen testing might be non-infectious. In a real-world high-throughput setting for asymptomatic or mildly symptomatic patients, 494 patients were tested using RT-PCR as well as a single lateral flow antigen test (Ecotest, AssureTech, China). Where the results differed, virus viability was evaluated by cell culture. The test parameters were calculated with RT-PCR and RT-PCR adjusted on viability as reference standards. The overall sensitivity of the used antigen test related to the RT-PCR only was 76.2%, specificity was 97.3%. However, 36 out of 39 patients ‘missed’ by the antigen test contained no viable virus. After adjusting on that, the sensitivity grew to 97.7% and, more importantly for disease control purposes, the negative predictive value reached 99.2%. We propose that viability testing should be always performed when evaluating a new antigen test. A well-chosen and validated antigen test provides excellent results in identifying patients who are shedding viable virus (although some caveats still remain) in the real-world high-throughput setting of asymptomatic or mildly symptomatic individuals.
, Matteo Boattini, Anna Maria Barbui, , Franco Riccardini, Maurizio Coggiola, Enrico Lupia, Rossana Cavallo, Cristina Costa
Published: 21 April 2021
Journal of Clinical Virology, Volume 139, pp 104838-104838; https://doi.org/10.1016/j.jcv.2021.104838

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Julia Martín, , Agustin G. Asuero
Published: 19 April 2021
Microchemical Journal, Volume 167, pp 106305-106305; https://doi.org/10.1016/j.microc.2021.106305

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Victor M Corman, Verena Claudia Haage, Tobias Bleicker, Marie Luisa Schmidt, Barbara Mühlemann, Marta Zuchowski, Wendy K Jo, Patricia Tscheak, Elisabeth Möncke-Buchner, Marcel A Müller, et al.
Published: 7 April 2021
The publisher has not yet granted permission to display this abstract.
The American Journal of Tropical Medicine and Hygiene, Volume 104, pp 1526-1530; https://doi.org/10.4269/ajtmh.20-1526

Abstract:
Among 359 healthcare workers (HCW) employed in Panzi General Referral Hospital located in Bukavu in the Democratic Republic of Congo, 148 (41.2%) tested positive for SARS-CoV-2 antibodies. Thirty-three (22.3%) of the 148 personnel with positive serology reported symptoms evoking a prior COVID-19 illness. None of the infected HCWs reported COVID-related hospitalization, and all of them recovered. Our findings indicate high and underestimated circulation of SARS-CoV-2 within the Bukavu area.
, Cyril Debuysschere, Marc Decroly, Fatima-Zohra Bouazza, Vincent Collot, Charlotte Martin, Fanny Ponthieux, Hafid Dahma, Marius Gilbert, Magali Wautier, et al.
Published: 6 April 2021
Frontiers in Medicine, Volume 8; https://doi.org/10.3389/fmed.2021.650581

Abstract:
Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions.Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients.Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs.Conclusion: Using tests not considered the “gold standard” for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.
, Tatsuya Nagasawa, , , Sadatsugu Okuma, Katsuhito Kashiwagi, Tadashi Maeda, Taito Miyazaki, Sadako Yoshizawa, Kazuhiro Tateda
Journal of Infection and Chemotherapy, Volume 27, pp 613-616; https://doi.org/10.1016/j.jiac.2020.11.021

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Eliete A. Alvin, Anna V.B. e Borges, Rhéltheer de P. Martins, Marcela R. Lemes, Rafaela M. Barbosa, Carlo J.F. de Oliveira, Diógenes Meneses, Bruno G. Lucca, Noelio O. Dantas, Virmondes R. Junior, et al.
Biotechnology to Combat COVID-19 [Working Title]; https://doi.org/10.5772/intechopen.97056

Abstract:
Mass testing for COVID-19 is essential to defining patient management strategies, choosing the best clinical management, and dimensioning strategies for controlling viral dissemination and immunization strategies. Thus, it is of utmost importance to search for devices that allow a quick and reliable diagnosis of low cost that can be transposed from the bench to the bedside, such as biosensors. These devices can help choose the correct clinical management to minimize factors that lead to infected patients developing more severe diseases. The use of nanomaterials to modify biosensors’ surfaces to increase these devices’ sensitivity and their biofunctionality enables high-quality nanotechnological platforms. In addition to the diagnostic benefits, nanotechnological platforms that facilitate the monitoring of anti-SARS-CoV-2 antibodies may be the key to determining loss of protective immune response after an episode of COVID-19, which leads to a possible chance of reinfection, as well as how they can be used to assess and monitor the success of immunization strategies, which are beginning to be administered on a large scale and that the extent and duration of their protection will need to be determined. Therefore, in this chapter, we will cover nanomaterials’ use and their functionalities in the surface design of sensors, thus generating nanotechnological platforms in the various facets of the diagnosis of COVID-19.
New version
Jacqueline Dinnes, , Sarah Berhane, Melissa Taylor, Ada Adriano, Clare Davenport, Sabine Dittrich, Devy Emperador, Yemisi Takwoingi, Jane Cunningham, et al.
Cochrane Database of Systematic Reviews, Volume 2021; https://doi.org/10.1002/14651858.cd013705.pub2

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Naveen K. Singh, Partha Ray, Aaron F. Carlin, Celestine Magallanes, , , ,
Published: 26 February 2021
Biosensors and Bioelectronics, Volume 180, pp 113111-113111; https://doi.org/10.1016/j.bios.2021.113111

Abstract:
Significant barriers to the diagnosis of latent and acute SARS-CoV-2 infection continue to hamper population-based screening efforts required to contain the COVID-19 pandemic in the absence of widely available antiviral therapeutics or vaccines. We report an aptamer-based SARS-CoV-2 salivary antigen assay employing only low-cost reagents ($3.20/test) and an off-the-shelf glucometer. The test was engineered around a glucometer as it is quantitative, easy to use, and the most prevalent piece of diagnostic equipment globally, making the test highly scalable with an infrastructure that is already in place. Furthermore, many glucometers connect to smartphones, providing an opportunity to integrate with contact tracing apps, medical providers, and electronic health records. In clinical testing, the developed assay detected SARS-CoV-2 infection in patient saliva across a range of viral loads - as benchmarked by RT-qPCR - within 1 h, with 100% sensitivity (positive percent agreement) and distinguished infected specimens from off-target antigens in uninfected controls with 100% specificity (negative percent agreement). We propose that this approach provides an inexpensive, rapid, and accurate diagnostic for distributed screening of SARS-CoV-2 infection at scale.
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