How much will the tests cost? How do these prices compare to private lab test costs?
Per test costs vary based on the volume of tests being processed. Higher upfront funding support would enable higher test volumes and lower per test costs. We have developed a range of testing scenarios based on different funding levels. In Phase I, the per test cost is $73.93 for 5,000 tests. If fully funded in Year 1, we could perform 100,000 tests for $37.55 each. These costs are inclusive of consumables, PPE, and personnel. We do not yet have a cost estimate for serological typing as these tests were very recently approved by the FDA and we scoping costs. Data regarding the costs of testing at private labs in Hawaiʻi has not been made publicly available at this time. However, by one estimate tests processed through private labs cost about $120 each (Lt. Gov. Josh Green, 4/8/2020).
Who will have access to these services? Who is handling billing?
Our goal is to increase in-state testing capacity as a service to the people of Hawaiʻi. We are forming partnerships to specifically process tests from houseless and underserved communities across the state as these individuals likely have less access to testing and may have higher comorbidity factors that predispose them to more severe COVID-19 outcomes. Importantly, we are working with University Health Partners (UHP) to also establish a HIPAA-secure database and result reporting system for patients, physicians, and DOH. UHP will also handle billing procedures and we intend to charge tests at cost. Once billing is in place, we will be able to expand our services as appropriate to contract with the public or private sector to provide testing for labor unions and private businesses.
What are the TMC Lab needs around PPE?
We have assembled a team of qualified individuals who do not require additional certification. The technical staff will require basic familiarization with protocols but are already familiar with molecular techniques. The clinical lab is a Biosafety Level (BSL) 2 lab and does not require special PPE training. As we do not intend to collect samples directly from patients, we will not require special PPE (e.g. N95 masks) that are currently in short supply.
How will you address supply chain shortages for testing supplies?
As local labs are moving towards the worldwide trend of adopting automated Roche testing kits, Hawaiʻi remains at the tail end of a long and fragile global supply chain that is straining to meet worldwide demand for COVID testing.The TMC Laboratory will conduct diagnostic testing for COVID-19 using Food and Drug Administration (FDA)-approved protocols for real-time reverse transcription polymerase chain reaction (rRT-PCR) with standards on four FDA-approved ABI 7500 Real Time machines. We have selected this platform specifically to avoid competing with the Diagnostic Laboratory Services (DLS) and Clinical Labs of Hawaii (CLH) for testing supplies. DLS and CLH use different testing methods. Faculty and staff from Tropical Medicine Clinical Laboratory have long-standing relationships with Applied Biosystems, Inc. and many other vendors with assurances of providing all equipment, materials and supplies necessary for conducting COVID-19 testing. Arrangements are being made for monthly shipments of reagents and supplies. Necessary kits and machines to begin testing are currently in-stock.
Can you use saliva from patients instead of nasopharyngeal swabs?
“Saliva Testing” is a technique that we could develop, but currently only Rutgers University’s lab is approved by the FDA under their EUA for analyzing such specimens. If we have to develop, we will need to transfer the technology to Hawaii and obtain an FDA EUA approval for our specific lab. Although this is something we can do, it will require additional funds to develop the assay at JABSOM, validate the process and get FDA/EUA approval.
Stanford University is pooling patient samples together to process more samples quickly, can the Tropical Medicine Clinical Lab do this too?
At this time, pooling patient samples approach is not allowed in the U.S. by FDA/CDC. Any facility doing non-research testing will need to follow FDA/CDC guidelines, if the information is to be reported to the patient for patient care/management. Stanford is assessing “pool testing” under a research protocol approved by their institution. Please note that the RT-PCR methods used in the Stanford study are also not FDA/EUA approved.