Viral RNA level, serum antibody responses, and transmission risk in discharged COVID-19 patients with recurrent positive SARS-CoV-2 RNA test results: a population-based observational cohort study

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1. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.07.21.20125138: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study was approved by the Ethics Committee of Shenzhen CDC (QS2020060007). Consent: As data collection is part of the public health investigation of an emerging outbreak, individual informed consent was waived.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   From March 18, serum specimens were collected on the 1st, 3rd, 7th, and 14th days for antibody assays (n=499, 2–8 per person), and some RP-DC patient blood specimens (n=147, 1–4 per person) were collected for SARS-CoV-2 RNA detection by RT-qPCR.	7th sugge…

   SciScore for 10.1101/2020.07.21.20125138: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study was approved by the Ethics Committee of Shenzhen CDC (QS2020060007). Consent: As data collection is part of the public health investigation of an emerging outbreak, individual informed consent was waived.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   From March 18, serum specimens were collected on the 1st, 3rd, 7th, and 14th days for antibody assays (n=499, 2–8 per person), and some RP-DC patient blood specimens (n=147, 1–4 per person) were collected for SARS-CoV-2 RNA detection by RT-qPCR.	7th suggested: None
   Serum immunoglobulin (Ig) antibody against the SARS-CoV-2 surface spike protein receptor-binding domain (RBD) was measured using a chemiluminescence kit (IgM, IgG, and total antibody, Beijing Wantai Biotech, measured by cut-off index [COI]) or enzyme-linked immunosorbent assay kit (IgA, Beijing Hotgen Biotech, measured by optical density at 450/630 nm [OD450/630]) in accordance with the manufacturer’s instructions.	SARS-CoV-2 surface spike protein receptor-binding domain (RBD suggested: None
   Specimens with COI>1 (IgM, IgG, or total antibody), OD450/630>0.3 (IgA), or an NAb titre of ≥1:4 were considered positive.	IgM, IgG suggested: (Bio-Rad Cat# MCA630, RRID:AB_322183)
   Experimental Models: Cell Lines
   Sentences	Resources
   Vero-E6 cells were used for virus isolation in a BSL-3 laboratory.	Vero-E6 suggested: None
   Software and Algorithms
   Sentences	Resources
   WGS was performed after specifically amplifying SARS-CoV-2 RNA.	WGS suggested: None

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Our study has several limitations. First, this was a single-centre study conducted on all DC patients from Shenzhen. Because there are differences in the discharge criteria and SARS-CoV-2 RNA testing methods among different cities and counties, our RP incidence needs to be verified by multicentre studies. Second, we collected only nasopharyngeal swab, anal swab, and serum specimens based on current sampling policies; other specimen types with generally higher viral loads, such as lower respiratory tract and sputum specimens, were not collected. Thus, the RP incidence in this study represents a conservative estimation. Third, the systemic collection of serum specimens started mid-study, and serum specimens from RP-DC patients during their hospitalization were not available, which limited further investigations on the antibody level dynamics of RP-DC patients. Finally, due to the strict management of DC patients, most DC patients were identified during quarantine and consequently had few close contacts. This study included the close contacts of only 23 RP-DC patients; larger scale epidemiologic studies are needed to further confirm the transmission risk posed by RP-DC patients. In conclusion, our study found that intermittent detection of low levels of SARS-CoV-2 RNA in DC patients is not rare and that the timing of RP detection varies (up to 90 days post-discharge). The transmission risk posed by RP-DC patients is likely low. To better balance COVID-19 prevention and control w...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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2. 

   ScreenIT

   Jul 26, 2020

   SciScore for 10.1101/2020.07.21.20125138: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement

   The study was approved by the Ethics Committee of Shenzhen CDC (QS2020060007).

   Randomization

   not detected.

   Blinding

   not detected.

   Power Analysis

   not detected.

   Sex as a biological variable

   There were more female (57/93, 61%) than male RP-DC patients (36/93, 39%, Table 1).

   Cell Line Authentication

   not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   From March 18, serum specimens were collected on the 1st, 3rd, 7th, and 14th days for antibody assays (n=499, 2–8 per person), and some RP-DC patient blood specimens (n=147, 1–4 per person) were collected for SARS-CoV-2 RNA detection by RTqPCR.	7th suggested: None …

   SciScore for 10.1101/2020.07.21.20125138: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement

   The study was approved by the Ethics Committee of Shenzhen CDC (QS2020060007).

   Randomization

   not detected.

   Blinding

   not detected.

   Power Analysis

   not detected.

   Sex as a biological variable

   There were more female (57/93, 61%) than male RP-DC patients (36/93, 39%, Table 1).

   Cell Line Authentication

   not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   From March 18, serum specimens were collected on the 1st, 3rd, 7th, and 14th days for antibody assays (n=499, 2–8 per person), and some RP-DC patient blood specimens (n=147, 1–4 per person) were collected for SARS-CoV-2 RNA detection by RTqPCR.	7th suggested: None
   Serum immunoglobulin (Ig) antibody against the SARS-CoV-2 surface spike protein receptor-binding domain (RBD) was measured using a chemiluminescence kit (IgM, IgG, and total antibody, Beijing Wantai Biotech, measured by cut-off index [COI]) or enzyme-linked immunosorbent assay kit (IgA, Beijing Hotgen Biotech, measured by optical density at 450/630 nm [OD450/630]) in accordance with the manufacturer’s instructions.	SARS-CoV-2 surface spike protein receptor-binding domain ( RBD suggested: None
   To investigate the antibody responses of RP-DC and NRP-DC patients, their SARS-CoV-2-specific anti-RBD IgM, IgG, IgA, total antibody, and NAb were assessed.	anti-RBD IgM , IgG suggested: None
   Together, these results indicate that the SARS-CoV-2-specific anti-RBD antibody levels (excluding IgM) are similar in RP-DC and NRP-DC patients and in RP-DC patients regardless of current RP detection.	anti-RBD suggested: None
   None showed clinical symptoms during the twoweek follow-up, and all had negative SARS-CoV-2 RNA test results; 20 were tested for serum SARS-CoV-2-specific anti-RBD antibodies (IgM, IgG, and total antibody), and the results were also negative.	IgM , IgG suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Vero-E6 cells were used for virus isolation in a BSL-3 laboratory.	Vero-E6 suggested: None
   Software and Algorithms
   Sentences	Resources
   WGS was successful for six of the nine specimens, but only genome fragments were obtained.	WGS suggested: None

   Data from additional tools added to each annotation on a weekly basis.

   About SciScore

   SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.

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3. 

   Version published to 10.1101/2020.07.21.20125138 on medRxiv

   Jul 26, 2020
4. Version published to 10.1080/22221751.2020.1837018

   Jan 1, 2020