Evaluation of Four Point of Care (POC) Antigen Assays for the Detection of the SARS-CoV-2 Variant Omicron

Hardick, Justin; Gallagher, Nicholas; Sachithanandham, Jaiprasath; Fall, Amary; Siddiqui, Zishan K.; Pekosz, Andrew; Manabe, Yukari C.; Mostafa, Heba H.

doi:10.1128/spectrum.01025-22

Cited by 16 publications

(25 citation statements)

References 25 publications

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“…While RT-PCR is the gold standard, RAT was developed to address the need for faster turnaround as well as widespread scaling of testing to the public for those both asymptomatic and symptomatic. However, the transition of COVID-19 from the Delta variant to the Omicron variant has been demonstrated to significantly reduce the accuracy of RATs, thus presenting significant challenges in their ability to maintain accuracy which are critical to decision making [1][2][3][4] .…”

Section: Introductionmentioning

confidence: 99%

Portable Breath-Based Volatile Organic Compound Monitoring for the Detection of COVID-19: Challenges of Emerging Variants

Sharma

Zang

Tabartehfarahani

et al. 2022

Preprint

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Importance Breath analysis has been explored as a noninvasive means to detect COVID19. However, the impact of the emerging variants such as Omicron on the exhaled breath profile and hence the accuracy of breath analysis is unknown. Objective To evaluate the diagnostic accuracies of breath analysis on detecting COVID19 patients in periods where Delta and Omicron were most prevalent. Design, Setting, and Participants A convenience cohort of patients testing positive and negative for COVID19 using reverse transcriptase polymerase chain reaction (RTPCR) were studied and included 167 COVID and nonCOVID patients recruited between April 2021 and May 2022, which covers the period when Delta (and other variants prior to Delta) was the dominant variant (April to December 2021) and when Omicron was the dominant variant (January to May 2022). The breath from those patients were collected and analyzed for volatile organic compounds (VOCs) with a newly developed portable gas chromatography based breath analyzer. Diagnostic patterns and algorithms were developed. Results A total of 205 breath samples were analyzed from 167 COVID and nonCOVID patients. The RTPCR was conducted within 18 hours of the breath analysis to confirm the COVID status of the patients. Among 94 COVID positive samples, 41 samples were collected from the patients in 2021 who were assumed to be infected by the Delta variant (or other variants occurring in 2021) and 53 samples from the patients in 2022 who were assumed to be infected by the Omicron variant (BA.1 and BA.2). Breath analysis using a set of 4 VOC biomarkers was able to distinguish between COVID (Delta and other variants in 2021) and nonCOVID with an overall accuracy of 94.7%. However, the accuracy dropped significantly to 82.1% when the same set of biomarkers were applied to the Omicron variant with and 21 out of 53 COVID positive being misidentified. A new set of 4 VOC biomarkers were found to distinguish the Omicron variant and non-COVID, which yielded an overall accuracy of 90.9%. Breath analysis was also found to be able to distinguish between COVID (for all the variants occurring between April 2021 and May 2022) and nonCOVID with an overall accuracy of 90.2%, and between the Omicron variant and the earlier variants (Delta and other variants occurring in 2021) with an overall accuracy of 91.5%. Conclusions and Relevance Breath analysis of VOCs using point of care gas chromatography may be a promising diagnostic modality for detection of COVID and similar diseases that result in VOC production. However, similar to other diagnostic modalities such as rapid antigen testing, challenges are posed by the dynamic emergence of viral variants. The results of this study warrant additional investment and evaluation on how to overcome these challenges and to exploit breath analysis to improve the diagnosis and care of patients.

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Section: Introductionmentioning

confidence: 99%

Portable Breath-Based Volatile Organic Compound Monitoring for the Detection of COVID-19: Challenges of Emerging Variants

Sharma

Zang

Tabartehfarahani

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…Most published studies evaluated RAT performance with different SARS-CoV-2 variants (including Alpha, Beta, Gamma, Delta and Omicron) using different specimens from different countries ( Galliez et al, 2022 ; Kyritsi et al, 2022 ; Hardick et al, 2022 ; Weishampel et al, 2022 ). Sporadic worldwide studies compared NAATs and RATs during the Omicron surge ( Schrom et al, 2022 ; Lin et al, 2022 ).…”

Section: Discussionmentioning

confidence: 99%

Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China

Xu¹,

Ying²,

Cai³

et al. 2022

Virologica Sinica

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“…Leading commercially available rapid antigen tests in the United States are able to detect previous variants of concern. (31) However, currently circulating BA.1, BA.2, BA.2.12.1, BA.4, and BA.5 have shown reduced sensitivity in existing rapid antigen tests. (32) The use of SARS-CoV-2 specific mAbs may prove beneficial for the detection of current and future variants.…”

Section: Discussionmentioning

confidence: 99%

Comparison of a prototype SARS-CoV-2 lateral flow immunoassay with the BinaxNOW™ COVID-19 Antigen CARD

Hill

Uppal

Hau

et al. 2022

Preprint

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Background Robust diagnostics, capable of detecting multiple variant of SARS-CoV-2 are necessary to mitigate the COVID-19 pandemic. In this study we directly compare the diagnostic capabilities of an LFI engineered with monoclonal antibodies (mAbs) originating from SARS-CoV-2 NP immunizations to the Abbott BinaxNOW™ COVID-19 Antigen CARD. Methods Here we established a library of 18 mAbs specific to SARS-CoV-2 NP and used two of these mAbs (1CV7 and 1CV14) to generate a prototype antigen-detection lateral flow immunoassay (LFI). Samples consisting of remnant RT-PCR positive patient nasopharyngeal swabs preserved in viral transport media (VTM) were tested on the 1CV7/1CV14 LFI and the commercially available BinaxNOW™ test. Assays were allowed to resolve and results were recorded by two observers. Findings A total of 98 remnant SARS-CoV-2 positive patient specimens were tested on both the 1CV7/1CV14 LFI and the BinaxNOW™ test. The 1CV7/1CV14 LFI detected 71 of the total 98 specimens, while the BinaxNOW™ test detected 52 of the 98 specimens. Additionally, the 1CV7/1CV14 LFI consistently detected samples with higher RT-PCR cycle threshold values than the BinaxNOW™ test. Interpretation The 1CV7/1CV14 LFI outperformed the BinaxNOW™ test in the detection of BA.2, BA.2.12.1, and BA.5 Omicron sub-variants when testing remnant RT-PCR positive patient nasopharyngeal swabs diluted in viral transport media. BA.1 and BA.4 detection was comparable. The data suggest that mAbs derived from SARS-CoV-2 NP can aid in a more sensitive diagnostic immunoassay for COVID-19.

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Evaluation of Four Point of Care (POC) Antigen Assays for the Detection of the SARS-CoV-2 Variant Omicron

Cited by 16 publications

References 25 publications

Portable Breath-Based Volatile Organic Compound Monitoring for the Detection of COVID-19: Challenges of Emerging Variants

Portable Breath-Based Volatile Organic Compound Monitoring for the Detection of COVID-19: Challenges of Emerging Variants

Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China

Comparison of a prototype SARS-CoV-2 lateral flow immunoassay with the BinaxNOW™ COVID-19 Antigen CARD

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