Potential applications of the rapid COVID-19 antibody test kit screening in comparison to the RT-PCR in patients and personnel at the Department of Obstetrics and Gynecology

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Abstract

Objective

To explore potential applications of the rapid antibody test for COVID-19 screening, in comparison to RT-PCR, for emergency obstetric and gynecological procedures, and medical personnel in the Department of Obstetrics and Gynecology.

Methods

A cross-sectional study was conducted in expected 290 participants: 230 patients and 60 medical staff, during the four-month national COVID-19 outbreak period (Aug – Sep 2020, and Dec 2020 - Jan 2021). All participants underwent both rapid antibody tests and RT-PCR (at admission for patients).

Results

A total of 270 participants completed the study. Fever and URI symptoms were present in 6/210 patients (2.8%) while one patient (0.5%) had a history of traveling to a high-risk area. However, only two (1%) asymptomatic patients had positive IgM results. Concerning the medical personnel, 10% fell into the ‘patient under investigation (PUI)’ category. 4/60 (6.7%) IgM positive was observed in the staff cohort in which 3/4 came from non-PUI participants. Neither participant had RT-PCR positive demonstrating a 1.9% total false positive rate.

Conclusion

Rapid point-of-care antibody test can be used to screen either a pregnant coming for delivery, a patient who requires urgent/emergency operative procedures, or medical personnel, at least in the defined lower-prevalence COVID-19 situation.

Trial registration

This study was approved by the Institutional Review Board of Srinakharinwirot University (IRB SWUEC119/2563F) and was registered at the Thai Clinical Trials Registry (TCTR20210613001).

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  1. SciScore for 10.1101/2021.07.16.21259725: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study received ethical approval from the institutional review board (SWUEC119/2563F).
    Consent: Informed consent was obtained from the participants.
    Sex as a biological variableA total of 290 participants were expected; i) 230 patients and pregnant women visiting the hospital for either an emergency medical procedure or an elective unpostponable surgery including vaginal delivery, cesarean section, uterine curettage for miscarriage, and exploratory laparotomy, ii) 60 medical personnel, comprising physicians, nursing staffs, technicians, in the department.
    Randomizationnot detected.
    BlindingThe RT-PCR tests were analyzed by a molecular pathologist (WJ) who was blinded from the rapid test results.
    Power Analysisnot 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:
    In the pandemic, the RT-PCR is suggested with limitations regarding access and duration of the result as previously described. The rapid test could guide the management concerning the prioritization of PPE equipment and facilities, i.e., negative pressure theatre or cohort ward, which shall be limited during the pandemic. However, the rapid antibody test should be interpreted with caution also due to the odds of false-negative results especially during the early clinical course [5, 13]. In our current practice, we perform both rapid antibody test and RT-PCR in symptomatic patients (fever, URI symptoms) at admission for a patient who requires an urgent/emergency procedure including childbirth delivery. The research also studied the seroprevalence of SARS-Cov-2 antibodies among the medical personnel, who were considered healthy and active, thus possess a risk to become a ‘silence spreader’. We included 74.07% of all staff in the department. All frontline people including residents, interns, nursing staff, and technicians participated in the study. While only 10% of consultants took part in the study. The Thai government also considers healthcare workers with URI symptoms as one of the PUI criteria. In the current study cohort, 21.6% (12/60) were at risk for COVID-19 infection. About half of these high risk were symptomatic (6/20) while the others were either indirectly contacting the COVID-19 patient or recently traveling to the high-risk area. Contracting the disease from outs...

    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.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.


    About SciScore

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