key: cord-0893725-iuxdgayq
authors: Phan, Tung; Cravener, Zachary; McCullough, Melissa; Mays, Ashley; Gribschaw, Jamie; Wells, Alan
title: Clinical evaluation of the Cue's COVID‑19 diagnostic test to detect SARS‐CoV‐2 in the upper respiratory tract
date: 2022-04-28
journal: J Med Virol
DOI: 10.1002/jmv.27805
sha: 88f9fdbde727b80dfb4322e3ec3fdacb18a6c330
doc_id: 893725
cord_uid: iuxdgayq

Point-of-care testing (POCT) known as near-patient testing has a relatively lower cost and short turnaround time. In this study, we performed the evaluation of the Cues COVID-19 test to detect SARS-CoV-2 in the upper respiratory tract. 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 This article is protected by copyright. All rights reserved.

Clinical evaluation of the Cue's COVID-19 diagnostic test to detect SARS-CoV-2 in the upper respiratory tract 1 

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 pandemic, the pandemic phase of COVID-19 looks to be ending in many regions; however, several parts of the world are still experiencing health crisis due to a new variant emergence. Timely and widespread diagnostic testing for SARS-CoV-2 remains critical for patient care, and it is an essential part of a comprehensive COVID-19 control and preparedness strategy. 5, 6 POCT has been in high demand for COVID-19, and one significant reason is that it helps to address the SARS-CoV-2 testing backlog in clinical laboratories. 7, 8 In the United States, the Cue's COVID-19 test (Cue Health Inc.) which was similar to our data (95.0%). In addition, their invalid rate seemed lower than ours (8.6% vs. 10.7%), and their false positive rate seemed higher than ours (1.7% vs. 0%), however, these discrepancies are minor. While this study group showed a good positive agreement (95.7%, 22 of 23) of the Cue's COVID-19 test, 11 our result was much lower (76.5%, 13 of 17). The falsenegative result occurred in one specimen with a high Ct value (35.0), which was also seen in our evaluation. The substantial difference in the reported positive agreement between two studies could be explained by the different collection designs.

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