Id |
Subject |
Object |
Predicate |
Lexical cue |
T159 |
0-44 |
Sentence |
denotes |
Unmet Needs and the Diagnostic Test Pipeline |
T160 |
46-85 |
Sentence |
denotes |
Scaling Up Access to Diagnostic Testing |
T161 |
86-250 |
Sentence |
denotes |
In the face of a public health emergency, important first steps to expand testing capacity include relaxing and streamlining regulatory requirements and procedures. |
T162 |
251-478 |
Sentence |
denotes |
Local public health laboratories and academic diagnostic laboratories in the United States are being rapidly enabled to perform EUA-granted commercial assays and laboratory-developed tests using research use–only reagents (61). |
T163 |
479-648 |
Sentence |
denotes |
University research laboratories could also add capacity, although concerns exist regarding quality control and the absence of protocols for managing clinical specimens. |
T164 |
649-783 |
Sentence |
denotes |
Flexibility regarding nucleic acid extraction methods and amplification instruments when using CDC protocols is being introduced (34). |
T165 |
784-942 |
Sentence |
denotes |
National agencies are expeditiously making materials for test development and validation available to clinical laboratories and diagnostic test manufacturers. |
T166 |
943-1111 |
Sentence |
denotes |
Safely evaluating clinically stable persons for COVID-19 at traditional health care access points is resource intensive and slow, and risks exposing staff to infection. |
T167 |
1112-1342 |
Sentence |
denotes |
Many jurisdictions are enabling innovative testing venues, such as external tents or drive-through or “phone booth” testing, as well as home assessment teams to expedite specimen collection while limiting potential exposures (62). |
T168 |
1343-1430 |
Sentence |
denotes |
Telemedicine combined with at-home nasal swab self-testing also has been proposed (63). |
T169 |
1431-1622 |
Sentence |
denotes |
Of importance, in jurisdictions without universal health care coverage, policy solutions must be introduced to eliminate financial barriers to testing for uninsured and underinsured patients. |
T170 |
1623-1800 |
Sentence |
denotes |
Efforts to increase accessibility of testing for multiple use cases need to be coupled to appropriate public health interventions to isolate infected persons and their contacts. |
T171 |
1802-1879 |
Sentence |
denotes |
Alternatives to Usual Specimen Types, Collection Devices, and Transport Media |
T172 |
1880-1953 |
Sentence |
denotes |
Nasopharyngeal swabs are the recommended specimen for molecular analysis. |
T173 |
1954-2131 |
Sentence |
denotes |
The sudden demand for flocked nasopharyngeal swabs and viral transport medium generated by the pandemic has put enormous pressures on supply chain capacities for these products. |
T174 |
2132-2284 |
Sentence |
denotes |
As of 19 March 2020 the CDC made oropharyngeal, mid-turbinate, and nasal swabs acceptable specimen types if nasopharyngeal swabs are not available (31). |
T175 |
2285-2464 |
Sentence |
denotes |
Early-morning posterior oropharyngeal saliva samples (coughed up by clearing the throat) also have been assessed as useful specimen types and would not require use of a swab (48). |
T176 |
2465-2732 |
Sentence |
denotes |
The CDC has released a standard operating procedure for laboratories to create their own viral transport medium (64); other solutions also may be used if viral transport medium is unavailable, including phosphate-buffered saline, liquid Amies, and normal saline (65). |
T177 |
2733-2872 |
Sentence |
denotes |
The FDA has provided guidance on its Web site for alternative materials to collect and transport samples for RT-PCR SARS–CoV-2 assays (34). |
T178 |
2873-2964 |
Sentence |
denotes |
The diagnostic value of molecular testing of nonrespiratory specimens currently is unclear. |
T179 |
2966-3015 |
Sentence |
denotes |
Diagnostics Pipeline in the Short and Medium Term |
T180 |
3016-3352 |
Sentence |
denotes |
Although excellent tools exist for the diagnosis of symptomatic patients in well-equipped laboratories, important gaps remain in screening asymptomatic persons in the incubation phase, as well as for the accurate determination of live viral shedding among patients in the convalescence phase to inform de-isolation decisions (Figure 2). |
T181 |
3353-3473 |
Sentence |
denotes |
Further, it is critical to advance solutions that require less well-equipped laboratories to curb the pandemic globally. |
T182 |
3474-3707 |
Sentence |
denotes |
The Foundation for Innovative New Diagnostics (FIND) and others have created online resources to collate the rapidly evolving set of assays at various stages of development, from proof of concept to full regulatory approval (20, 53). |
T183 |
3708-3917 |
Sentence |
denotes |
Simple antigen-based tests, if sensitive enough, might be useful in lower-resource and home settings to inform quarantine and spatial distancing measures for patients without severe illness and their contacts. |
T184 |
3918-4247 |
Sentence |
denotes |
Novel technologies, such as Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-based diagnostics are being used to develop rapid, simple, low-cost, portable, temperature-stable assays for deployment in the field in nontraditional and resource-limited settings, such as airports and border crossings (20, 51, 54). |
T185 |
4248-4340 |
Sentence |
denotes |
Other technologies might be deployed to lower-resource settings if they can be standardized. |
T186 |
4341-4540 |
Sentence |
denotes |
For example, it might be possible to leverage existing loop-mediated isothermal amplification testing networks established for other diseases, such as human African trypanosomiasis surveillance (66). |