Unobserved collection requires schools to set up Device Pick-Up and Drop-Off site(s) with the required components (waste, computer access, barcode printer, etc.), and trained staff to obtain consent, provide basic quality control of samples, and prepare for transport.
A Medical Professional is not required at the testing site to supervise the process. A step-by-step guide on staffing logistics, pick-up and drop off instructions can be found here.
General Kit Pick-Up Instructions
- School complete steps required in Getting Started including defining eligibility for testing, ordering physician, and CareEvolve set up.
- Eligible participants visit pick-up station as directed by institution, where they receive an Unobserved Self-Swab Nasal Collection Device containing:
A re-sealable bag with
- 1 Collection Tube
- 1 individually wrapped Anterior Nasal Swab
- Detailed instructions on How To Self Swab
Participants will be instructed to swab and drop off sample on same day (Step-by-Step Unobserved Nasal Swab Instructions)
General Device Drop-Off Instructions
- Participant will visit a designated “Covid Testing Drop off” location, provide ID, and hand bag with collected tube to staff.
- Staff will inspect sample for useability, and prepare for testing by printing barcode and attaching to tube.
- Participant will confirm the name, DOB, zip code and information on the barcode and provide collection time for specimen.
- Staff will register test in CareEvolve and prepare tube for packaging and transport to the laboratory. All tubes collected on any given day are transported to the Broad CRSP laboratory at the end of that day. (see Packing & Shipping)
Limitations and Disclosures for CRSP SELF SWAB DEVICES
For Emergency Use Authorization (EUA) only.
For prescription use only.
For in vitro diagnostic use only.
For professional use only.
For use by people 18 years of age or older.
The CRSP Self-Swab Kit collection device is only authorized for use in conjunction with an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is indicated for use with dry nasal swab specimens collected with the CRSP Self-Swab Kit.
Results are for the detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay is only for use under the Food and Drug Administration's Emergency Use Authorization.