| Literature DB >> 35626400 |
Kate Cox1, Laura Haggerty1, Kate Abeln1, Luis Hernandez2, Jessica Wicker2, Leah Padgett2, Mary Beth Privitera1.
Abstract
This study demonstrates that students in kindergarten through eighth grade can use the XpressCollect nasal swab to self-collect a specimen under the guidance of a teacher. This phased study was conducted with parents, teachers, and students. Phases 1 and 2 were conducted as interviews with teachers and parents to assess the suitability of the XpressCollect for children in kindergarten through eighth grade. Additionally, teacher and parent feedback was obtained to develop and optimize the instructional materials for subsequent phases. In Phases 3 and 4, teachers guided small groups and full classes of students through the sample collection process with XpressCollect. The samples collected by the students were sent to a laboratory to analyze the effectiveness of specimen self-collection based on the presence of ribonuclease P (RNase P) on each nasal swab. The presence of RNase P enables disease determination; thus, student samples were analyzed for adequate or inadequate sampling. All students in kindergarten through eighth grade are capable of self-collecting an anterior nares specimen with XpressCollect, as the laboratory results identified acceptable RNase P Ct values for the samples collected in a classroom setting.Entities:
Keywords: COVID-19; SARS-CoV-2 testing; nasal swab; school testing; self-collection
Year: 2022 PMID: 35626400 PMCID: PMC9140182 DOI: 10.3390/diagnostics12051245
Source DB: PubMed Journal: Diagnostics (Basel) ISSN: 2075-4418
Phased Study Objectives.
| Study Phase | User Group | Objectives |
|---|---|---|
| Phase 1—Initial Review | Teacher |
Determine what is needed to create clear instructions for students in grades K–8 (e.g., graphics, amount of text to include). Determine the process of distributing and collecting samples in the classroom. Determine whether modifications to the XpressCollect system are necessary in order to support classroom use. Determine the optimal way to communicate the results. |
| Phase 2—Secondary Review | Teacher |
Determine what is needed to create clear instructions for students in grades K–8 (e.g., graphics, amount of text to include). Determine the process of distributing and collecting samples in the classroom. Determine whether improvements to instructions are necessary to be effective for the intended users (school children). Determine if modifications to the XpressCollect system are necessary in order to support classroom use. Assess the instructional materials for implementation within a classroom setting. Determine the optimal way to communicate the results. |
| Parent |
Determine what is needed to create clear instructions for children. | |
| Phase 3—Initial Classroom Review | Teacher |
Assess the instructional materials for implementation within a classroom setting. |
| Student |
Determine whether teachers are able to guide students in grades K–8 in self-collection using the XpressCollect system. Determine the process of distributing and collecting samples in the classroom. Determine whether students can successfully use the XpressCollect system. | |
| Phase 4—Final Classroom Review | Teacher |
Determine if the XpressCollect system is able to be used in a classroom setting. Determine whether the instruction materials are effective. |
| Student |
Determine whether students can successfully use the XpressCollect system. |
Sample size and distribution by phase.
| Study Phase | User Group | Role | Sample Size | Distribution |
|---|---|---|---|---|
| Phase 1 | Teacher | Participate in individual interviews | 10 | K–2: |
| Phase 2 | Teacher | Participate in individual interviews | 8 | K–2: |
| Parent | Participate in individual interviews | 4 | K–2: | |
| Phase 3 | Teacher | Attend teacher introduction; execute student testing in group sessions of 3–5 students | 8 | K–2: |
| Student | Participate in group sessions of 3–5 students self-swabbing | 36 | K–2: | |
| Phase 4 | Teacher | Attend teacher introduction; execute student testing in group sessions of 20 students | 18 | 2 participants per grade (K–8th) |
| Student | Participate in group sessions of 20 students self-swabbing | 176 | K: |
Materials evaluated during the associated study phases.
| Phase | Materials Evaluated |
|---|---|
| Phase 1 | XpressCollect |
| Animal cartoon instructions | |
| Instructions depicting hands | |
| Instructions without words | |
| Phase 2 | XpressCollect |
| Conceptual prototypes 1 | |
| Five-step instructions | |
| Eight-step instructions | |
| Animation of swabbing process | |
| Instructional video with children | |
| Teacher guide | |
| Phase 3 | XpressCollect |
| Modified swab (Concept B) | |
| Five-step instructions | |
| Eight-step instructions | |
| Instructional video with children | |
| Teacher guide | |
| Phase 4 | XpressCollect |
| Modified swab (Concept B) | |
| Five-step instructions | |
| Eight-step instructions | |
| Instructional video with children | |
| Teacher guide |
1 See Figure 2 for images of conceptual swab prototypes.
Figure 1XpressCollect swab (left) and tube (right).
Figure 2Prototype concepts: (a) key twist concept; (b) elongated concept; (c) colored cap concept; (d) marker concept.
Figure 3Concept B modified swab.
Figure 4Concept B modified swab open.
Figure 5Number of use problems per task by grade range in Phase 3 using XpressCollect.
Figure 6RNase P Ct values for 176 self-collected samples using the XpressCollect compared to the modified swab concept B, as detected by either the (a) UltraDx SARS-CoV-2 or (b) TaqManTM RNase P assay. The mean Ct value for each condition is marked by a horizontal line.
Figure 7Number of use problems per task by grade in Phase 4 using XpressCollect.
Students that experienced use problems removing the XpressCollect swab from the tube.
| Grade | Percentage of Students Who Had No Use Problems | Percentage of Students with Use Problems Removing Swab from Tube | Percentage of Students Who Could Not Remove Swab from Tube Independently |
|---|---|---|---|
| Kindergarten | 10% | 90% | 75% |
| 1st | 12% | 88% | 71% |
| 2nd | 25% | 75% | 60% |
| 3rd | 42% | 58% | 5% |
| 4th | 15% | 85% | 10% |
| 5th | 60% | 40% | 0% |
| 6th | 80% | 20% | 0% |
| 7th | 85% | 15% | 15% |
| 8th | 55% | 45% | 10% |
Figure 8Comparison of observed use problems between XpressCollect and modified swab concept B in Phase 3.
Figure 9Comparison of observed use problems between XpressCollect and modified swab concept B in Phase 4.
Figure 10Percentage of students experiencing use problems per task across Phases 3 and 4 using XpressCollect.
Figure 11Proposed workflow for classroom self-collection with XpressCollect.