A rapid, easy, and scalable whole blood monocyte CD169 assay for outpatient screening during SARS-CoV-2 outbreak, and potentially other emerging disease outbreaks
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Abstract
The COVID-19 corona virus disease outbreak is globally challenging health systems and societies. Its diagnosis relies on molecular methods, with drawbacks revealed by mass screening. Upregulation of neutrophil CD64 or monocyte CD169 has been abundantly reported as markers of bacterial or acute viral infection, respectively. We evaluated the sensitivity of an easy, one-step whole blood flow cytometry assay to measure these markers within 10 min, as a potential screening test for COVID-19 patients.
Methods:
Patients ( n = 177) with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were tested on 10 µL blood and results were compared with reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR).
Results:
We observed 98% and 100% sensitivity in early-stage ( n = 52) and asymptomatic patients ( n = 9), respectively. Late-stage patients, who presented for a second control RT-qPCR, were negative for both assays in most cases. Conversely, neutrophil CD64 expression was unchanged in 75% of cases, without significant differences between groups.
Conclusion:
Monocyte CD169 evaluation was highly sensitive for detecting SARS-CoV-2 infection in first-presentation patients; and it returns to basal level upon infection clearance. The potential ease of fingerprick collection, minimal time-to-result, and low cost rank this biomarker measurement as a potential viral disease screening tool, including COVID-19. When the virus prevalence in the tested population is usually low (1%−10%), such an approach could increase the testing capacity 10 to 100-fold, with the same limited molecular testing resources, which could focus on confirmation purposes only.
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SciScore for 10.1101/2020.10.22.20215749: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Français du Sang”, Marseille, France) The study was approved by the institutional ethics and GDPR committee, with the reference number PJ4BQH.
Consent: According to French law, the patients were informed and retained the right to oppose the use of their anonymized medical data for research purposes, but formal consent was not required for this non-interventional study.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data analysis and statistics: Flow cytometry data files were analyzed using the Kaluza software, version 2.1 (Beckman … SciScore for 10.1101/2020.10.22.20215749: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Français du Sang”, Marseille, France) The study was approved by the institutional ethics and GDPR committee, with the reference number PJ4BQH.
Consent: According to French law, the patients were informed and retained the right to oppose the use of their anonymized medical data for research purposes, but formal consent was not required for this non-interventional study.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data analysis and statistics: Flow cytometry data files were analyzed using the Kaluza software, version 2.1 (Beckman Coulter Life Sciences). Kaluzasuggested: (Kaluza, RRID:SCR_016182)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Prospective studies fulfilling this criterion and including further categories of patients (pediatric, comorbidities) are now required to fully assess the capabilities and possible limitations of this assay.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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