Clinical evaluation of the Cue's COVID‑19 diagnostic test to detect SARS‐CoV‐2 in the upper respiratory tract

Abstract

Point-of-care testing (POCT) known as near-patient testing has a relatively lower cost and short turnaround time. It is obvious that a short turnaround time can potentially improve patient care and outcomes by providing quick access to test results, expediting medical diagnosis, and facilitating earlier and more rapid decisions on treatment. 1,2 Another benefit of POCT is that it can be performed by clinical staff without laboratory training. POCT can be done at a healthcare provider's office, outpatient clinic, emergency room, and healthcare nursing home. 3,4 More than 2 years into the COVID-19 | 3517 Donato and colleagues performed the prospective study in the outpatient setting, and the Ct value or viral load of the positive specimens was random. 11 Our positive specimens were carefully selected to verify the lower sensitivity, and a majority of them (61.1%, 11 of 18) had high Ct values (>30.0). In our evaluation, the clinical performance of the Cue's COVID-19 test started to decline as the Ct values increased reflecting decreasing viral loads. This phenomenon was also observed in other rapid NAAT POCTs such as the ID NOW COVID-19 test which has the lower performance for specimens displaying the Ct value higher than 30.0. 12 Given the persistence of the SARS-CoV-2 testing backlog, low availability of testing supply, and shortage of licensed personnel in clinical laboratories, we need to migrate more testing capacity to the outpatient setting and the Cue's COVID-19 test is a good option. AUTHOR CONTRIBUTIONS Tung Phan and Alan Wells designed the study and wrote the manuscript. Zachary Cravener, Melissa McCullough, Ashley Mays, and Jamie Gribschaw managed the testing.

Miniaturized Real-Time PCR systems for SARS-CoV-2 detection at the Point-of-Care

“…Nevertheless, the sensitivity is lower in comparison with Cepheid xpert® xpress SARS-CoV-2 point-of-care test [40] and the positive agreement with central laboratory tests is 91,7%.…”

UbiNAAT: a multiplexed point-of-care nucleic acid diagnostic platform for rapid at-home pathogen detection

“…Cue Health's isothermal nucleic acid amplification tests (NAATs) have been demonstrated to yield similar sample sensitivity compared to Cepheid's GeneXpert, yet have been limited in widespread adoption, in large part because of the high cost of their disposable. 30 Lucira Health initially developed an RT-LAMP POC platform for COVID testing, before expanding their test platform into a multiplexed platform that simultaneously detects SARS-CoV-2, influenza A, and influenza B. 24,31 Visby Medical's 3-assay POC respiratory panel for COVID, influenza A, and influenza B enabled qualitative detection of multiple respiratory illnesses from a single patient sample, which could be operated in a CLIA-waived setting.…”