scholarly journals Implementation of SARS-CoV2 Screening in K-12 Schools using In-School Pooled Molecular Testing and Deconvolution by Rapid Antigen Test

Author(s):  
Nira R. Pollock ◽  
David Berlin ◽  
Sandra C. Smole ◽  
Lawrence C. Madoff ◽  
Catherine Brown ◽  
...  

SARS-CoV2 testing is one component of a multi-layered mitigation strategy to enable safe in-person school attendance for the K-12 school population. However, costs, logistics, and uncertainty about effectiveness are potential barriers to implementation. We assessed early data from the Massachusetts K-12 public school pooled SARS-CoV2 testing program, which incorporates two novel design elements: in-school “pod pooling” for assembling pools of dry anterior nasal swabs from 5-10 individuals, and positive pool deconvolution using the BinaxNOW antigen rapid diagnostic test (Ag RDT), to assess the operational and analytical feasibility of this approach. Over three months, 187,597 individual swabs were tested across 39,297 pools from 738 schools. The pool positivity rate was 0.8%; 98.2% of pools tested negative and 0.2% inconclusive, and 0.8% of pools submitted could not be tested. Of 310 positive pools, 70.6% had an N1 or N2 Ct value ≤ 30. In reflex testing (performed on specimens newly collected from members of the positive pool), 92.5% of fully deconvoluted pools with N1 or N2 target Ct ≤30 yielded a positive individual using the BinaxNOW test performed 1-3 days later. However, of 124 positive pools with full reflex testing data available for analysis, 32 (25.8%) of BinaxNOW pool deconvolution testing attempts did not detect a positive individual, requiring additional reflex testing. With sufficient staffing support and low pool positivity rates, pooled sample collection and reflex testing were feasible for schools. These early program findings confirm that screening testing for K-12 students and staff is achievable at scale with a scheme that incorporates in-school pooling, RT-PCR primary testing, and Ag RDT reflex/deconvolution testing.

2021 ◽  
Vol 2 (3) ◽  
pp. 241-254
Author(s):  
Pasquale Pisapia ◽  
Francesco Pepe ◽  
Antonino Iaccarino ◽  
Roberta Sgariglia ◽  
Mariantonia Nacchio ◽  
...  

Lung cancer is the leading cause of cancer death worldwide. Despite the emergence of highly effective targeted therapies, up to 30% of advanced stage non-small cell lung cancer (NSCLC) patients do not undergo tissue molecular testing because of scarce tissue availability. Liquid biopsy, on the other hand, offers these patients a valuable opportunity to receive the best treatment options in a timely manner. Indeed, besides being much faster and less invasive than conventional tissue-based analysis, it can also yield specific information about the genetic make-up and evolution of patients’ tumors. However, several issues, including lack of standardized protocols for sample collection, processing, and interpretation, still need to be addressed before liquid biopsy can be fully incorporated into routine oncology practice. Here, we reviewed the most important challenges hindering the implementation of liquid biopsy in oncology practice, as well as the great advantages of this approach for the treatment of NSCLC patients.


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Katherine O’Flaherty ◽  
Win Han Oo ◽  
Sophie G. Zaloumis ◽  
Julia C. Cutts ◽  
Kyaw Zayar Aung ◽  
...  

Abstract Background In the Greater Mekong Subregion (GMS), current malaria surveillance strategies rely on a network of village health volunteers (VHVs) reporting the results of rapid diagnostic tests (RDTs), known to miss many asymptomatic infections. Integration of more sensitive diagnostic molecular and serological measures into the VHV network may improve surveillance of residual malaria transmission in hard-to-reach areas in the region and inform targeted interventions and elimination responses. However, data on residual malaria transmission that would be captured by these measures in the VHV-led testing and treatment surveillance network in the GMS is unknown. Methods A total of 114 VHVs were trained to collect dried blood spots from villagers undergoing routine RDTs as part of VHV-led active and passive case detection from April 2015 to June 2016. Samples were subjected to molecular testing (quantitative polymerase chain reaction [qPCR]) to determine Plasmodium falciparum and P. vivax infection and serological testing (against P. falciparum and P. vivax antigens) to determine exposure to P. falciparum and P. vivax. Results Over 15 months, 114 VHVs performed 32,194 RDTs and collected samples for molecular (n = 13,157) and serological (n = 14,128) testing. The prevalence of molecular-detectable P. falciparum and P. vivax infection was 3.2% compared to the 0.16% prevalence of Plasmodium spp. by RDT, highlighting the large burden of infections undetected by standard surveillance. Peaks in anti-P. falciparum, but not P. vivax, merozoite IgG seroprevalence coincided with seasonal P. falciparum transmission peaks, even in those with no molecularly detectable parasites. At the individual level, antibody seropositivity was associated with reduced odds of contemporaneous P. falciparum (OR for PfCSP 0.51 [95%CI 0.35, 0.76], p = 0.001, PfAMA1 0.70 [95%CI 0.52, 0.93], p = 0.01, and PfMSP2 0.81 [95%CI 0.61, 1.08], p = 0.15), but not P. vivax infection (OR PvAMA1 1.02 [95%CI 0.73, 1.43], p = 0.89) indicating a potential role of immunity in protection against molecular-detectable P. falciparum parasitaemia. Conclusions We demonstrated that integration and implementation of sample collection for molecular and serological surveillance into networks of VHV servicing hard-to-reach populations in the GMS is feasible, can capture significant levels of ongoing undetected seasonal malaria transmission and has the potential to supplement current routine RDT testing. Improving malaria surveillance by advancing the integration of molecular and serological techniques, through centralised testing approaches or novel point-of-contact tests, will advance progress, and tracking, towards malaria elimination goals in the GMS.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Dandan Shan ◽  
Joseph M. Johnson ◽  
Syrena C. Fernandes ◽  
Hannah Suib ◽  
Soyoon Hwang ◽  
...  

AbstractThe COVID-19 pandemic continues to have an unprecedented impact on societies and economies worldwide. There remains an ongoing need for high-performance SARS-CoV-2 tests which may be broadly deployed for infection monitoring. Here we report a highly sensitive single molecule array (Simoa) immunoassay in development for detection of SARS-CoV-2 nucleocapsid protein (N-protein) in venous and capillary blood and saliva. In all matrices in the studies conducted to date we observe >98% negative percent agreement and >90% positive percent agreement with molecular testing for days 1–7 in symptomatic, asymptomatic, and pre-symptomatic PCR+ individuals. N-protein load decreases as anti-SARS-CoV-2 spike-IgG increases, and N-protein levels correlate with RT-PCR Ct-values in saliva, and between matched saliva and capillary blood samples. This Simoa SARS-CoV-2 N-protein assay effectively detects SARS-CoV-2 infection via measurement of antigen levels in blood or saliva, using non-invasive, swab-independent collection methods, offering potential for at home and point of care sample collection.


2021 ◽  
Author(s):  
José Cherem ◽  
Victor Satler Pylro ◽  
Katia Poles ◽  
Richardson Costa Carvalho ◽  
Ewerton Carvalho ◽  
...  

AbstractThe COVID-19 pandemic brought a series of challenges to the academic community. Social distancing measures imposed the interruption of face-to-face activities besides the implementation of remote work and online classes. For safe and gradual return, the monitoring of individuals, quick detection of infection, contact tracing, and isolation of those infected became essential. In this sense, we developed strategies to face the pandemic at the Federal University of Lavras (UFLA) - Brazil. A Telemedicine Program (TeleCovid) and the assemblage of a laboratory for SARS-CoV-2 molecular diagnosis (LabCovid) were essential measures for monitoring, preventing, and controlling outbreaks at the university. TeleCovid works with a team of students who guide and answer questions regarding COVID-19 and, when necessary, make the referral for online consultation with medical professionals. In the suspicion of SARS-CoV-2 infection, the doctor refers the patient for testing at LabCovid. LabCovid performs the sample collection using nasal swabs, followed by processing samples by the RT-qPCR method. We have placed all positive patients in isolation and tested their contacts. This approach meant that positive cases were identified early, thus avoiding outbreaks in different environments in face-to-face activities.


Author(s):  
Padmapriya Banada ◽  
David Elson ◽  
Naranjargal Daivaa ◽  
Claire Park ◽  
Samuel Desind ◽  
...  

ABSTRACTSensitive, accessible, and biosafe sampling methods for COVID-19 reverse-transcriptase polymerase chain reaction (RT-PCR) assays are needed for frequent and widespread testing. We systematically evaluated diagnostic yield across different sample collection and transport workflows, including the incorporation of a viral inactivation buffer. We prospectively collected nasal swabs, oral swabs, and saliva, from 52 COVID-19 RT-PCR-confirmed patients, and nasopharyngeal (NP) swabs from 37 patients. Nasal and oral swabs were placed in both viral transport media (VTM) and eNAT™, a sterilizing transport buffer, prior to testing with the Xpert Xpress SARS-CoV-2 (Xpert) test. The sensitivity of each sampling strategy was compared using a composite positive standard. Overall, swab specimens collected in eNAT showed superior sensitivity compared to swabs in VTM (70% vs 57%, P=0.0022). Direct saliva 90.5%, (95% CI: 82%, 95%), followed by NP swabs in VTM and saliva in eNAT, was significantly more sensitive than nasal swabs in VTM (50%, P<0.001) or eNAT (67.8%, P=0.0012) and oral swabs in VTM (50%, P<0.0001) or eNAT (56%, P<0.0001). Saliva and use of eNAT buffer each increased detection of SARS-CoV-2 with the Xpert test; however, no single sample matrix identified all positive cases.


Author(s):  
Brian Hart ◽  
Yuan-Po Tu ◽  
Rachel Jennings ◽  
Prateek Verma ◽  
Leah R Padgett ◽  
...  

ABSTRACTBackgroundThe exponential growth of COVID-19 cases and testing has created supply shortages at various points in the testing workflow. As of April 15, 2020 FDA recommendations only allowed for the use of nasopharyngeal, flocked mid turbinate, or foam nasal swabs, all of which are in very low supply. Polyester swabs are more readily available and mass producible. We compare the performance of polyester and foam swabs stored in different transport media.MethodsBoth polyester and foam nasal swabs were collected from convalescent COVID-19 patients at a single visit. Using the foam nasal swabs as the comparator, sensitivity of the polyester swabs in each media were calculated, three by three tables were constructed to measure concordance, and cycle threshold (Ct) values were compared.Findings126 visits had polyester and foam swabs stored in viral transport media (VTM), 51 had polyester and foam swabs stored in saline, and 63 had a foam swab in VTM and a polyester swab stored in a dry tube. Using nasal foam swabs as a comparator, polyester nasal swabs had a sensitivity of 86·5% when both samples were stored in VTM, 86·7% when both samples were stored in saline, and 72·4% when the polyester swab was stored dry and the foam swab was stored in VTM. Polyester and foam Ct values from the same visit were correlated, but polyester swabs showed decreased performance for cases with a viral load near the detection threshold and higher Ct values on average.InterpretationPolyester nasal swabs showed a reduction in performance from foam nasal swabs, but may still provide a viable sample collection method given the current supply shortages and public health emergency.FundingLaboratory testing was conducted with financial support from Thermo Fisher Scientific.


Author(s):  
Jeffrey A. SoRelle ◽  
Lenin Mahimainathan ◽  
Clare McCormick-Baw ◽  
Dominick Cavuoti ◽  
Francesca Lee ◽  
...  

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has presented significant challenges for laboratories including supply chain limitations with restricted access to reagents and sample collection materials (i.e. swabs, viral transport media (VTM)) for patients testing. Therefore, saliva has been evaluated as an alternative specimen for COVID-19 diagnosis. comparable performance between dry nasal swabs (NS) and nasopharyngeal swabs (NPS) collected in VTM has been observed with the ID NOW for SARS-CoV-2; the majority of false-negative results occur with higher cycle number (CN) or cycle threshold (Ct) values suggesting low viral load in these specimens. We performed clinical validation of saliva specimens on the ID NOW molecular platform to detect SARS-CoV-2. Saliva was compared to nasopharyngeal swabs tested on the ID NOW and the Cepheid molecular assay. We also performed stability studies of saliva samples over 5 days. A total of 96 saliva samples and 64 paired NPS were analyzed. We observed 78% (18/23) positive percent agreement (PPA) and 100% (44/44) negative percent agreement (NPA) between matched saliva and nasopharyngeal specimens performed on ID NOW. We found 83% (19/23) PPA and 100% NPA (25/25) between saliva run on the ID NOW and Cepheid assay. Six saliva specimens positive for SARS-CoV-2 were continuously positive for five days when stored at room temperature. Therefore, we propose further investigation of saliva as an alternative sample type for testing symptomatic patients with ID NOW as a promising method to address COVID-19 testing.


2020 ◽  
Author(s):  
Daniel G. Federman ◽  
Shaili Gupta ◽  
Gary Stack ◽  
Sheldon M. Campbell ◽  
David R. Peaper ◽  
...  

AbstractBackgroundThe global pandemic of Severe Acute Respiratory Syndrome-Related Coronavirus 2 (SARS-CoV2) has resulted in unprecedented challenges for healthcare systems. One barrier to widespread testing has been a paucity of traditional respiratory viral swab collection kits relative to the demand. Whether other sample collection kits, such as widely available MRSA nasal swabs can be used to detect SARS-CoV-2 is unknown.MethodsWe compared simultaneous nasal MRSA swabs (COPAN ESwabs ® 480C flocked nasal swab in 1mL of liquid Amies medium) and virals wabs (BD H192(07) flexible mini-tip flocked nasopharyngeal swabs in 3mL Universal Transport Medium) for SARS-CoV-2 PCR testing using Simplexa COVID-19 Direct assay on patients over a 4-day period. When the results were discordant, the viral swab sample was run again on the Cepheid Xpert Xpress ® SARS-CoV-2 assay.ResultsOf the 81 included samples, there were 19 positives and 62 negatives in viral media and 18 positives and 63 negative in the MRSA swabs. Amongst all included samples, there was concordance between the COPAN ESwabs ® 480C and the viral swabs in 78 (96.3%).ConclusionWe found a high rate of concordance in test results between COPAN ESwabs ® 480C in Amies solution and BD H192(07) nasopharyngeal swabs in in 3 mL of Universal Viral Transport medium viral media. Clinicians and laboratories should feel better informed and assured using COPAN ESwabs ® 480C to help in the diagnosis of COVID-19.


Author(s):  
Kevin D. Biesinger ◽  
Kent J. Crippen

In order for educators to effectively build, select and integrate technology into the delivery of curriculum and pedagogy, an accepted set of critical program design and delivery elements is needed. The authors propose that research based components such as user validation functions, trace methods, and worked examples be among these accepted design elements of technology supported learning environments. As for the pedagogical methods employed to effectively integrate technology into K-12 curricula, an epistemological shift is needed by which more instructors view learning from a student-centered perspective. Systematic changes needed to foster this view include a migration away from the traditional computer lab scenario, on-going professional development as a continuous support system, and the expectation that technology integration is required as an indication of quality instruction as evidenced in teacher evaluations.


Author(s):  
Karen Kellison ◽  
George Font

Video games are serious work for today’s students. 93% of the K-12 population plays video games on a regular basis. Educators are now pressed to determine the appropriate integration of this technology into the pedagogy of K-12 classrooms. Research indicates that there are positive effects from playing serious video games, those that aim to teach something. Students are motivated and engaged during such game play. Some speculate that players are using and developing cognitive brain capabilities that have been dormant. The question is whether or not these games, if adequately designed, will teach more than just the skill of playing the game. This chapter takes a look at the evolution of play and games in K-12 education and then seeks to define serious computer games in terms of positive design elements and integration techniques for K-12 classrooms. In conclusion, a research agenda that moves educational gaming forward is explored.


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