Analysis of factors associated early diagnosis in coronavirus disease 2019 (COVID-19)

  1. Jinwei Ai
  2. Junyan Gong
  3. Limin Xing
  4. Renjiao He
  5. Fangtao Tian
  6. Juan Wang
  7. Jun Wang
  8. Shengduo Pei
  9. Dongxuan Chen
  10. Guoxin Huang
  11. Meiling Zhang
  12. Gaojing Qu
  13. Wufeng Fan
  14. Hongming Lin
  15. Desheng Li
  16. Bin Pei

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Abstract

Background

The pandemic of coronavirus disease 2019 (COVID-19) has become the first concern in international affairs as the novel coronavirus (SARS-CoV-2) is spreading all over the world at a terrific speed. The accuracy of early diagnosis is critical in the control of the spread of the virus. Although the real-time RT-PCR detection of the virus nucleic acid is the current golden diagnostic standard, it has high false negative rate when only apply single test.

Objective

Summarize the baseline characteristics and laboratory examination results of hospitalized COVID-19 patients. Analyze the factors that could interfere with the early diagnosis quantitatively to support the timely confirmation of the disease.

Methods

All suspected patients with COVID-19 were included in our study until Feb 9 th , 2020. The last day of follow-up was Mar 20 th , 2020. Throat swab real-time RT-PCR test was used to confirm SARS-CoV-2 infection. The difference between the epidemiological profile and first laboratory examination results of COVID-19 patients and non-COVID-19 patients were compared and analyzed by multiple logistic regression. Receiver operating characteristic (ROC) curve and area under curve (AUC) were used to assess the potential diagnostic value in factors, which had statistical differences in regression analysis.

Results

In total, 315 hospitalized patients were included. Among them, 108 were confirmed as COVID-19 patients and 207 were non-COVID-19 patients. Two groups of patients have significance in comparing age, contact history, leukocyte count, lymphocyte count, C-reactive protein, erythrocyte sedimentation rate (p<0.10). Multiple logistic regression analysis showed age, contact history and decreasing lymphocyte count could be used as individual factor that has diagnostic value (p<0.05). The AUC of first RT-PCR test was 0.84 (95% CI 0.73-0.89), AUC of cumulative two times of RT-PCR tests was 0.92 (95% CI 0.88-0.96) and 0.96 (95% CI 0.93-0.99) for cumulative three times of RT-PCR tests. Ninety-six patients showed typical pneumonia radiological features in first CT scan, AUC was 0.74 (95% CI 0.60-0.73). The AUC of patients’ age, contact history with confirmed people and the decreased lymphocytes were 0.66 (95% CI 0.60-0.73), 0.67 (95% CI 0.61-0.73), 0.62 (95% CI 0.56-0.69), respectively. Taking chest CT scan diagnosis together with patients age and decreasing lymphocytes, AUC would be 0.86 (95% CI 0.82-0.90). The age threshold to predict COVID-19 was 41.5 years, with a diagnostic sensitivity of 0.70 (95% CI 0.61-0.79) and a specificity of 0.59 (95% CI 0.52-0.66). Positive and negative likelihood ratios were 1.71 and 0.50, respectively. Threshold of lymphocyte count to diagnose COVID-19 was 1.53×10 9 /L, with a diagnostic sensitivity of 0.82 (95% CI 0.73-0.88) and a specificity of 0.50 (95% CI 0.43-0.57). Positive and negative likelihood ratios were 1.64 and 0.37, respectively.

Conclusion

Single RT-PCR test has relatively high false negative rate. When first RT-PCR test show negative result in suspected patients, the chest CT scan, contact history, age and lymphocyte count should be used combinedly to assess the possibility of SARS-CoV-2 infection.

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  1. ScreenIT

    SciScore for 10.1101/2020.04.09.20059352: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the ethics review board at Xiangyang No.1 People’s Hospital (No. 2020GCP012).
    Consent: Conventional informed consent was not necessary in this study, due to the emergency outbreak and bidirectional nature of the study, informed consent was waived.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    1.4 Statistical analysis: SPSS 22.0 and MedCalc were applyed for statistical analysis.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)

    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:
    However, this study has certain limitations. Firstly, this study’s sample size is limited, which may lead to some bias in the research result. Secondly, this study only studies on patient’s chest CT results before hospitalization, blood routine test results and first routine laboratory test results after hospitalization. Other indicators that may have diagnostic value for early diagnosis might be missed. Thirdly, previous research(15) shows few patients can have longest time period of 38 days from symptom onset to nucleic acid tested positive. While in this study the follow up lasted for 30 days, therefore it is possible of miss diagnosis in the cases that are included in this study. However, this study is a two-way cohort study, from the aspects of etiology and diagnostic accuracy test, the study result is still reliable. Moreover, this study mainly focuses on patient’s epidemiological characteristics, chest CT result and blood routine test result before hospitalization, and first routine laboratory test result after hospitalization, which can reflect the early status of patients after symptom onset more accurately. And it is of high reference value for early diagnosis. Currently, previously established cohort is still under further follow up, which will provide more detailed information for early diagnosis, disease characteristics and prognosis, in order to have a more in-depth understanding of COVID-19. 4 Conclusion: Single RT-PCR test has relatively high false negative di...

    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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  2. Version published to 10.1101/2020.04.09.20059352v2 on medRxiv
  3. Version published to 10.1101/2020.04.09.20059352v1 on medRxiv