A 1-minute blood test detects decreased immune function and increased clinical risk in COVID-19 patients

  1. Chirajyoti Deb
  2. Allan N. Salinas
  3. Tianyu Zheng
  4. Aurea Middleton
  5. Katelyn Kern
  6. Daleen Penoyer
  7. Rahul Borsadia
  8. Charles Hunley
  9. Bassam Abomoelak
  10. Vijay Mehta
  11. Laura Irastorza
  12. Devendra I. Mehta
  13. Qun Huo

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Abstract

Upon infection with SARS-CoV-2, the virus that causes COVID-19, most people will develop no or mild symptoms. However, a small percentage of the population will become severely ill, and some will succumb to death. The clinical severity of COVID-19 has a close connection to the dysregulation of the patient’s immune functions. We previously developed a simple, nanoparticle-enabled blood test that can determine the humoral immune status in animals. In this study, we applied this new test to analyze the immune function in relation to disease severity in COVID-19 patients. From the testing of 153 COVID-19 patient samples and 142 negative controls, we detected a drastic decrease of humoral immunity in COVID-19 patients who developed moderate to severe symptoms, but not in patients with no or mild symptoms. The new test may be potentially used to monitor the immunity change and predict the clinical risk of patients with COVID-19.

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  1. Version published to 10.1038/s41598-021-02863-2
  2. Version published to 10.21203/rs.3.rs-635353/v2 on Research Square
  3. Version published to 10.21203/rs.3.rs-635353/v1 on Research Square
  4. ScreenIT

    SciScore for 10.1101/2020.09.30.20203844: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: According to NIH policy on human subject research, the use of these samples is considered as non-human subject research, therefore Institutional Research Board (IRB) approval is not needed.
    Consent: Informed consent was obtained from each patient.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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:
    Patients who were tested positive, but exhibited no or only mild symptoms were assigned with a scale 1 (ambulatory with no limitation of activities) or 2 (ambulatory with limitation of activities). These patients were either not hospitalized or were hospitalized for unrelated conditions and found to be positive. From scale 3 and above, all patients were hospitalized and treated in various hospitals at Orlando Health. Blood samples were collected during patients’ stay in the hospital. The documented clinical symptoms were the symptoms exhibited by the patient when the blood sample was collected. According to the clinical symptom severity, the patient was assigned with the Ordinal Scale from 3 – 7: 3 – patients were hospitalized, but no oxygen therapy; 4 – patients require oxygen by mask or nasal prongs; 5 – patients require non-invasive ventilation or high flow mask; 6 – patients require intubation and mechanical ventilation; 7 – patients require ventilation and additional organ support such as vasopressors, RRT, and ECMO. We did not include samples from patients who died of COVID-19 in our study, which would be scale 8. In keeping with the Eight Category Ordinal Scale, patients with scale 1-2 were further grouped as asymptomatic/mild cohort (38 samples); patients with scale 3-4 are grouped as moderate cohort (54 samples); and patients with scale of 5 and above are group as severe cohort (61 samples). Figure 2 is the D2Dx immunity test scores of the six study cohorts. P values...

    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.

    About SciScore

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  5. Version published to 10.1101/2020.09.30.20203844v1 on medRxiv