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Direct NP- A cost-effective extraction-free RT-qPCR based test for SARS-CoV-2
Rasesh Y Parikh1, Satish N Nadig2, Shikhar Mehrotra2,3
1Department of Biochemistry and Molecular Biology, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC 29425, USA.
Heliyon
|June 24, 2022
Summary
Direct NP is a new, cost-effective test for SARS-CoV-2 that skips RNA extraction. This method reduces testing costs to $2 per test, improving accessibility for widespread detection of the virus.
Area of Science:
- Molecular Biology
- Virology
- Public Health
Background:
- High demand for SARS-CoV-2 testing strains supply chains.
- Current common tests necessitate RNA extraction, a costly and time-consuming process.
- RNA extraction bottlenecks hinder widespread SARS-CoV-2 detection.
Purpose of the Study:
- To develop and evaluate Direct NP, an extraction-free RT-qPCR test for SARS-CoV-2.
- To assess the cost-effectiveness and performance of Direct NP compared to existing methods.
- To provide a scalable solution for SARS-CoV-2 diagnostics.
Main Methods:
- Direct NP utilizes a dualplex RT-qPCR assay on heat-denatured Nasopharyngeal (NP) swab specimens.
- The assay directly detects SARS-CoV-2 viral RNA without an RNA extraction step.
- Performance was evaluated against the established CDC assay.
Main Results:
- Direct NP demonstrated 92.5% positive percentage agreement (PPA) with the CDC assay.
- Negative percent agreement (NPA) for Direct NP was 97% compared to the CDC assay.
- The cost per Direct NP test was reduced to $2.
Conclusions:
- Direct NP offers a cost-effective, extraction-free alternative for SARS-CoV-2 detection.
- The assay's performance is comparable to the CDC method, supporting its clinical utility.
- Direct NP can alleviate healthcare system costs and facilitate broad-scale testing.
