Challenges around current implementation of two novel diagnostic tools for SARS-CoV-2 virus, to determine the timing of de-isolation of COVID-19 patients in the ICU

• CoLab score and v-PCR test can be both smoothly implemented in an ICU • Timely de-isolation improves quality of care and brings cost savings • Regular validation of these diagnostic tests is needed due to virus mutations • Changing conditions in a pandemic challenge validation of viral diagnostic tools With the CoLab score and/or the viability polymerase chain reaction (v-PCR) test, one can determine sooner than currently possible when a COVID-19 patient can be de-isolated. The CoLab score detects host response (blood), v-PCR test intact SARS-CoV-2 particles (nasopharyngeal swab). We investigated a potential implementation of these tests in the ICU. Based on interviews in two Dutch hospitals, a FRAM model was built to visualize the process of clinical use of both tests. MIDI questionnaire (implementation), and mini-HTA tool (effects/costs) served as research framework. Work processes fit well within the current care (ICU, laboratories, IT). Correct determination of blood parameters and representativeness of the swab are crucial. Optimal interdisciplinary collaboration, knowledge of benefits of timely de-isolation, and validity are relevant for implementation. De-isolation improves ICU workflow and quality of care. Expected gains are fewer days in isolation and cost savings from reduced use of disposable protective material. Healthcare staff welcomes the potential of these tests. However, constantly changing conditions due to virus mutations, emergence of other viruses, (not present at the beginning of the pandemic when the tests were validated), relatively quick changes in patient types and numbers of ICU hospitalized patients during a pandemic, impact test validity and the need for implementation. Both tools can be implemented in the ICU with minor requirements. Timely de-isolation improves quality of care and brings cost savings. The need for implementation now is questionable. Regular validation remains a challenge due to ever-changing circumstances.