SARS-CoV-2 Testing

The novel coronavirus SARS-CoV-2 has created an enormous challenge for laboratories and communities worldwide. To address the crisis presented by COVID-19, labs need an accurate testing method capable of cost-effectively processing large numbers of samples.

iPLEX Pro SARS-CoV-2 Panel

The SARS-CoV-2 Panel from Agena Bioscience^® enables high-throughput, low-cost detection of COVID-19 caused by SARS-CoV-2 infection. The single-well, multiplexed assay targets 5 highly conserved regions of the viral genome, providing high accuracy and low limit of detection.

Main characteristics of the panel

• ACCURATE DETECTION: Five SARS-CoV-2 assays multiplexed into one well targeting the nucleocapsid (N) gene, ORF1, and ORF1ab regions.
• MAXIMIZE THROUGHPUT: Process up to thousands of samples in a day with a single MassARRAY® System.
• RELIABLE SUPPLY – Overcome instrument and reagent shortages with a reliable supply.

Assay components

The iPLEX® Pro SARS-CoV-2 Panel is a single well, qualitative in vitro diagnostic assay containing the following:

• ◊ Three assays probing the viral nucleocapsid (N) gene
• ◊ One assay probing open reading frame 1, ORF1.
• ◊ One assay probing ORF1ab.
• ◊ One MS2 phage quality control assay to control for all steps from RNA extraction through to results.

Specimens

The iPLEX Pro SARS-CoV-2 Panel is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

Assay workflow

The combined RT-PCR reaction together with high-throughput processing on the MassARRAY System enables testing up to hundreds or thousands of samples per day.

• ◊ RT-PCR / SAP / Extension. Multiplex end-point RT-PCR followed by a single base extension reaction.
• ◊ Target sequence detection. Automated analyte transfer and data acquisition.
• ◊ Results reporting. Simple, user-friendly reports.