Update March 14

The Department of Pathology and Laboratory Medicine is currently offering two avenues for coronavirus testing.  Our in house test, developed by Genmark and validated in our CLIA lab at HUP, is being reserved for sick patients in the ED (regular and obstetric), PUI as defined by consultation with infection control team for inpatients,  and Occupational Medicine, because reagent supplies are very limited for our in house test. This is happening across the three downtown hospitals.   We expect to be able to increase the scale of testing using this assay over the next few weeks but this test cannot scale to cover all our needs. This test must be ordered through consultation with Infection Control.

For outpatients (and people with suspected exposures, ambulatory testing), we can send the test out to ARUP or Quest with a several day turnaround time.  This test is orderable in Epic as Miscellaneous send out.

Roche's COVID test obtained FDA clearance last night on the Cobas 6800 platform. This is the Roche test mentioned in the President's television address yesterday. We have this instrumentation in the lab and our team will be working with Roche over the next couple of weeks to bring this assay in house at HUP.  This is a high throughput test which should give us significant capacity (500 tests/day to start).

Finally, we are also working on developing an in house lab developed test that is similar to the CDC test kit to help bridge gaps in testing between the two commercial platforms.  Having testing on multiple platforms should also help us mitigate supply chain issues, which are already cropping up nationwide.

I would like to thank our outstanding teams in Molecular Pathology, Microbiology and Lab Operations team for their tireless work to bring the Genmark test in house over the course of a few days. I would also like to thank Mike Feldman for his very effective leadership of these efforts.

Best,

David Roth