Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucleic acid amplification) test at a community drive through collection center

Donato, Leslie J.; Trivedi, Vipul A.; Stransky, Angie M.; Misra, Avanish; Pritt, Bobbi S.; Binnicker, Matthew J.; Karon, Brad S.

doi:10.1016/j.diagmicrobio.2020.115307

Cited by 50 publications

(55 citation statements)

References 14 publications

(13 reference statements)

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“…Searches of PubMed, Google Scholar, medRxiv, and bio-Rxiv yielded 15 unique studies after de-duplication. [36][37][38][39][40][41][42][43][44][45][46][47][48][49][50] Studies identified can be found in Appendix 2. Fourteen of the studies examined the BinaxNOW platform, and 1 examined the Cue COVID-19 Test.…”

Section: Resultsmentioning

confidence: 99%

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

Kepczynski¹,

Genigeski²,

Koski³

et al. 2021

Journal of the American Pharmacists Association

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Objectives Home-based rapid diagnostic testing can play an integral role in controlling the spread of COVID-19. This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUA) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. Methods Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as well as linked resources from the FDA’s webpages. Homepages of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed literature searches were performed, most recently in May 2021, to locate literature about the identified home tests, as were searches of Google Scholar, medRxiv, and bioRxiv. Literature Selection Studies were included if they were performed at home or were self-collected (or collected by a parent or guardian for patients under 18 years of age), and evaluated the positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of SARS-CoV-2 virus. Results Limited data has been published for these home tests given that they are available through EUAs that do not require clinical trials. Fifteen studies were located from searching the literature, but only 2 met the inclusion criteria. Review of the home-tests' websites yielded a single study for each test with the 3 BinaxNow platforms using the same study for their EUAs. The 9 COVID-19 home tests with EUAs as of May 7, 2021 include 3 molecular tests and 6 antigen tests. These tests had similar performance based on positive percent agreement ranging from 83.5% to 97.4% and negative percent agreement ranging from 97% to 100%. Conclusions The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison to laboratory real time reverse-transcription polymerase chain reaction (RT-PCR) tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.

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Section: Resultsmentioning

confidence: 99%

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

Kepczynski¹,

Genigeski²,

Koski³

et al. 2021

Journal of the American Pharmacists Association

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“…For the Corbas Liat system 200 µl sample is loaded directly into the assay cartridge, whereas for the Egoo system 20 µl sample is 10-fold diluted before 20 µl of the diluted sample is loaded into the Egoo capsule, meaning that there is a 100-fold difference in sample input between the two systems. Compared to the Roche Flow/MGI-BGI RT-PCR reference method which include a NA puri cation, an up concentration (180 µl to compared to a reference NAAT test using standard nasopharyngeal swab 25 which is comparable to our sensitivity and speci city of 91.8% and 98.2% respectively when testing 1154 oropharyngeal swabs.…”

Section: Discussionmentioning

confidence: 73%

“…Simpli ed RT-PCR work ows has been developed using nucleic acid (NA) extraction free methods such as direct lysis or heat [5][6][7][8][9] or alternative NAAT tests such as loop-mediated isothermal ampli cation (RT-LAMP) [10][11][12][13][14][15][16][17] , CRISPR-Cas12 and CRISPR-Cas13a based systems 18,19 , recombinase polymerase ampli cation (RT-RPA) [20][21][22] , and nicking-endonuclease ampli cation reactions (RT-NEAR) 23,24 which can reduce the overall reaction time to approximately 20-30 minutes. However only a few of these NAAT tests can be performed outside specialized laboratories such as the Cue COVID-2 test 25 , the Visby medical SARS-CoV-2 test 26 and the DNAnudge Covid-19 test 27 .…”

Section: Read Full License Introductionmentioning

confidence: 99%

SARS-CoV-2 Detection Using Reverse Transcription Strand Invasion Based Amplification And A Portable Compact Size Instrument

Rosenstierne¹,

Joshi²,

Danielsen³

et al. 2021

Preprint

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Rapid nucleic-acid based tests that can be performed by non-professionals outside laboratory settings could help the containment of the pandemic SARS-CoV-2 virus and may potentially prevent further widespread lockdowns. Here, we present a novel compact portable detection instrument (the Egoo Health System) for extraction-free detection of SARS-CoV-2 using isothermal Reverse Transcription Strand Invasion Based Amplification (RT-SIBA). The SARS-CoV-2 RT-SIBA assay can be performed directly on crude oropharyngeal swabs without nucleic acid extraction with a reaction time of 30 minutes. The Egoo health system uses a capsule system, which is automatically sealed tight in the Egoo instrument after applying the sample, resulting in a closed system optimal for molecular isothermal amplification. The performance of the Egoo Health System is comparable to the PCR instrument with an analytical sensitivity of 25 viral RNA copies per SARS-CoV-2 RT-SIBA reaction and a clinical sensitivity and specificity between 87.0-98.4% and 96.6-98.2% respectively.

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“…Donato et al compared the Cue™ COVID-19 test (Cue Health Inc., CA, USA) to the Aptima SARS-CoV-2 on a Hologic Panther instrument. In a community drive through collection setting including both symptomatic and asymptomatic outpatients the overall PPA and NPA were 91.7 and 98.4%, respectively [48].…”

Section: Poc Naatsmentioning

confidence: 97%

Detection of Sars-Cov-2At the Point of Care

Loeffelholz¹,

Tang

2021

Bioanalysis

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of COVID-19. Testing for SARS-CoV-2 infection is a critical element of the public health response to COVID-19. Point-of-care (POC) tests can drive patient management decisions for infectious diseases, including COVID-19. POC tests are available for the diagnosis of SARS-CoV-2 infections and include those that detect SARS-CoV-2 antigens as well as amplified RNA sequences. We provide a review of SARS-CoV-2 POC tests including their performance, settings for which they might be used, their impact and future directions. Further optimization and validation, new technologies as well as studies to determine clinical and epidemiological impact of SARS-CoV-2 POC tests are needed.

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Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucleic acid amplification) test at a community drive through collection center

Cited by 50 publications

References 14 publications

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information

SARS-CoV-2 Detection Using Reverse Transcription Strand Invasion Based Amplification And A Portable Compact Size Instrument

Detection of Sars-Cov-2At the Point of Care

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