Broad CRSP offers Observed and Unobserved Self-Swab Nasal Collections to accommodate a variety of individual diagnostic testing needs.
Observed Self-Swab Nasal Collection requires a Medical Professional at the testing site to supervise the process. Medical Professionals include MDs, PAs, NPs, RNs, LPNs and EMTs. Observations of self-swabbing can be done by trained staff under the direction of the medical professional. Observers do not have to be healthcare professionals, but must be trained in the self swabbing process, proper use of PPE, and handling of specimens. Video observation is considered telehealth which is not approved for this process.
Guidelines for site set up, supplies, and overall collection process are outlined in the Supervised Collection Logistics document
Additional resources:
How To Properly Apply a Barcode To a Sample Tube (video)
Observed Self-Swab Collection Instructions
How to collect an Observed nasal swab sample (video)
Unobserved Self-Swab Nasal Collection requires the set up of 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. Unobserved devices can be taken home by the participant or used on-site at the time of collection. Medical professionals are no longer needed on site to supervise or observe collection.
Guidelines for site set up, supplies, and overall collection process are outlined in the Unobserved Self-Swab Site Instructions
Additional Resources: Step-by-Step Unobserved Nasal Swab Instructions
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.
