Research Requiring Point-of-Care Testing at Johns Hopkins

July 1, 2019

What is Point of Care Testing (POCT)?

Point-of-Care Testing (POCT) refers to in vitro diagnostic devices or kits used to perform clinical testing outside of the central or core lab facility.   Also known as Near Patient Testing, this testing is often performed in the area near the patient or directly in front of the patient.  Common Point of Care Tests include glucose meters, handheld INR testing, urine dipsticks, or lateral flow pregnancy tests (hCG).

How do I know if the testing for our protocol is considered clinical?

Testing is considered clinical if a patient care decision may be made based on the result – this includes screening for study eligibility.  Any contemporaneous testing where the result will be available to the clinician when the clinician is present with the patient (meaning the results could influence care decisions), or where the result is returned to the patient is considered clinical testing, as it has the potential to be used clinically.  Retrospective testing of samples can still be considered clinical testing if there is a potential for follow-up with the patient based on this testing. 

Who do I contact if my study requires POCT?

Researchers that will utilize POCT should contact the Johns Hopkins POCT Office (POCT [email protected]) or the Director of POCT at Johns Hopkins, William Clarke, PhD at [email protected].

What does oversight of POCT entail?

Oversight of POCT includes ensuring that the device or testing kit has been properly validated, and that all regulations regarding training, competency, test performance, and documentation are met.  The degree of oversight will depend on the complexity of the testing and the length of the study.

Are there any costs associated with POCT Oversight?

In addition to the cost of devices and materials, there is a minimal cost associated with personnel support for oversight of testing.  The final cost will be proportional to the amount of effort required for oversight and the length of the study.

Am I required to obtain approval from the POCT Office or Director before submitting my protocol to the IRB?

You are not required to obtain approval from the POCT Office or Director before submitting your protocol to the IRB.  However, it may be beneficial to include them in protocol development and budget discussions so that you can avoid modifications to the protocol after initial approval, and to account for the costs associated with oversight of testing before finalizing the budget.