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Development and validation of an RNA extraction kit for the molecular diagnosis of SARS-CoV-2 infection in Nigeria
Journal of Public Health in Africa ; 13:74, 2022.
Article in English | EMBASE | ID: covidwho-2006823
ABSTRACT
Introduction/

Background:

The COVID-19 pandemic has impacted public health laboratories with shortages and an increase in the cost of RNA extraction kits. The aim of this project was to develop and validate an RNA extraction kit for use in the diagnosis of SARS-CoV-2 infection to improve COVID-19 testing and surveillance in Nigeria.

Methods:

The developed kit is based on the spin-column method and named the NIMR Biotech Total RNA Extraction Kit. The kit is intended for RNA extraction from different specimens, including blood, animal tissues, cell lines, bacteria, viruses, and swabs. Analytical validation of the kit for COVID-19 diagnosis was done at six different COVID-19 testing sites on 20 different nasopharyngeal and oropharyngeal specimens, with the results compared using NIMR Biotech. Kit and another commercial RNA extraction kit (spin-column and magnetic-bead based).

Results:

Validation results showed an average correlation of 93% when compared to other spin-column based kits. When compared with the Qiagen RNA extraction kit, the performance indices of the kit were sensitivity of 94%, specificity of 100%, positive predictive value of 100%, negative predictive values of 94.7%, and accuracy of 95%. The NIMR Biotech total RNA kit showed a good correlation with the DaanGene and the Geneaid extraction kits. In both instances, there was only one disparity between the NIMR Biotech kit and these two kits. Impact The developed RNA extraction kit from this study provides a suitable and cheaper alternative to high-end, commercially available RNA extraction kits. The adoption of this kit in all COVID-19 testing laboratories in Nigeria, and Africa, will help scale-up COVID-19 testing in Africa.

Conclusion:

NIMR Biotech's Total RNA extraction kit is sufficiently robust for the extraction of viral and human RNA from oropharyngeal and nasopharyngeal samples. The kit correlates better with the spin-columnbased RNA extraction method when compared to the magnetic-bead-based method and will be useful for monitoring SARS-CoV-2 infection and other RNA viruses.
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Collection: Databases of international organizations Database: EMBASE Type of study: Diagnostic study / Prognostic study Language: English Journal: Journal of Public Health in Africa Year: 2022 Document Type: Article

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Collection: Databases of international organizations Database: EMBASE Type of study: Diagnostic study / Prognostic study Language: English Journal: Journal of Public Health in Africa Year: 2022 Document Type: Article