SARS-CoV-2 2.0

2nd generation of COVID-19 test takes usability and sensitivity to a new level. The assay provides fast and reliable detection of SARS-CoV-2 using RT-PCR, the golden standard for COVID-19 diagnostics. The easy-to-use GenomEra platform combines the simplicity of rapid testing and the superior sensitivity of PCR methods in one reliable system.

 

 

Key facts of the test

  • Rapid PCR test results with excellent sensitivity (98.3%) and high specificity (99.8%)
  • No extensive safety measures nor dedicated PCR facilities are required
  • Only a short and simple sample preparation is needed, after which the assay is fully automated
  • Test result is automatically interpreted as positive, negative or borderline with Ct values in just 50 minutes

Basics of the test

The GenomEra SARS-CoV-2 2.0 is a rapid and highly sensitive multiplex RT-qPCR test for the detection of SARS-CoV-2 from respiratory samples. Only a short and simple sample preparation is needed, after which the assay is fully automated and the qualitative result will be automatically interpreted with Ct values after 50 minutes. Due to the simplicity of the system, no prior experience in PCR nor dedicated PCR facilities are required.

The assay is compatible with a wide range of commercial sample collection media available, including inactivating media. If the sample is collected to an inactivating media, it allows safe handling of the sample without the need for extensive biosafety measures and minimizes the hands-on time. Additionally, the new assay includes an integrated sample processing control targeting a specific human housekeeping gene mRNA.

Clinical performance

The GenomEra SARS-CoV-2 2.0 was evaluated in a multi-center study. In total, 915 samples were tested and compared to another RT-PCR method.

Positive Percent Agreement: 98.3%
Negative Percent Agreement: 99.8%

Table 1. The GenomEra SARS-CoV-2 2.0 Assay Kit is highly sensitive and specific.

Reference assay

GenomEra SARS-CoV-2 2.0

Positive

Negative

Positive

350

1

Negative

6

558

Ordering information

To place an order, please contact your local distributor.

Product name

Product code

GenomEra SARS-CoV-2 2.0 Assay Kit, 20 pcs

CDX-150-01-20

GenomEra SARS-CoV-2 2.0 Assay Kit, 100 pcs

CDX-150-01-100

GenomEra CDX system

CDX-10-020