Evaluation of SARS-CoV2 antibody Rapid Diagnostic Test kits (RDTs) and Real Time-Polymerase Chain Reaction (Rt-PCR) for COVID-19 Diagnosis in Kaduna, Nigeria

  1. Oluwafemi Ige
  2. Ayuba Sunday Buru
  3. Tanko Zainab Lamido
  4. Tahir Mohammed
  5. Livingstone Dogara
  6. Ijei Ifeoma Patience
  7. Bello-Manga Halima
  8. Audu Reward
  9. Ige Samuel
  10. Nmadu Grace

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Abstract

The emergence of the RNA virus SARS-CoV2, the causative agent of COVID-19 and its declaration by the World Health Organization (WHO) as a pandemic has disrupted the delicate balance in health indices globally. Its attendant immune dysregulation and pathobiology is still evolving. Currently, real time PCR is the gold standard diagnostic test, however there are several invalidated antibody-based tests available for possible community screening. With ongoing community transmission in Nigeria, neither the true burden of COVID-19 nor the performance of these kits is presently known. This study therefore, compared the performance of the SARS CoV2 antibody test and the real time Polymerase Chain Reaction (Rt-PCR) in the diagnosis of COVID-19. For the purpose of this evaluation, we used the diagnostic test kit by Innovita® Biological Technology CO., LTD China, a total of 521 venous blood samples were collected from consenting patients for the SARS COVID-19 rapid diagnostic kit and Oral and Nasopharyngeal swabs were collected and analyzed using the real time Polymerase chain reaction technique for nucleic acid detection and quantification.

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  1. ScreenIT

    SciScore for 10.1101/2020.11.24.20231324: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Eligibility: Patients who present for community testing and those confirmed positive for SARS-CoV2 virus by RT PCR at the Isolation centers who give consent Assuming a confidence (accuracy) of 0.95%, reliability (precision) of 0.90% and a sample size of 521, True positive value, true negative value and positive and negative predictive value of the antibody was assessed using the formula:

    Acceptability criterion = accuracy of ≥95%

    Data Analysis: Data was analyzed using SPSS data analysis package ver. 23.

    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    For the purpose of this evaluation, the diagnostic test kit by Innovita® Biological Technology CO., LTD China, will be used on Venous whole blood samples (4.0mls) dispensed into Ethylene diamine tetra-acetic acid (EDTA) anticoagulated bottles.
    Innovita® Biological
    suggested: None
    Eligibility: Patients who present for community testing and those confirmed positive for SARS-CoV2 virus by RT PCR at the Isolation centers who give consent Assuming a confidence (accuracy) of 0.95%, reliability (precision) of 0.90% and a sample size of 521, True positive value, true negative value and positive and negative predictive value of the antibody was assessed using the formula:

    Acceptability criterion = accuracy of ≥95%

    Data Analysis: Data was analyzed using SPSS data analysis package ver. 23.

    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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

    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 checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2020.11.24.20231324v1 on medRxiv