Why choose our test?

The second generation GenomEra^® SARS-CoV-2 2.0 Assay Kit is an improved version of Uniogen’s GenomEra^®SARS-CoV-2 assay. The GenomEra^® SARS-CoV-2 2.0 Assay Kit takes usability and sensitivity to the next level, providing fast and reliable detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using reverse transcriptase polymerase chain reaction (RT-PCR), which is the gold standard for COVID-19 diagnostics. The easy-to-use GenomEra CDX System combines the simplicity of rapid testing and the superior sensitivity of PCR methods in one reliable system.

SARS-CoV-2 belongs to the family of Coronaviridae within  the Betacoronaviruses genus and is an enveloped, positive-sense single-stranded RNA (+ssRNA) virus of zoonotic origin.¹ SARS-CoV-2 is closely related to the members of a viral species termed severe acute respiratory syndrome-related CoV (SARSr-CoV), a species defined as the agent of the 2002/03 outbreak of SARS in humans.^2,3 SARS-CoV-2 is the cause of the COVID-19 pandemic that was designated a public health emergency  by the World Health Organization (WHO) in March 2020.^4,5

Human-to-human transmission occurs primarily via respiratory droplets from coughs and sneezes.⁶ Indirect contact via contaminated surfaces is another possible cause of infection⁷, and viral RNA has also been found in the stool of infected people.⁸ Most infected people develop mild to moderate symptoms of fever, cough, tiredness, and shortness of breath, and recover without requiring special treatment. Individuals with underlying medical conditions and those over 60 years of age have a higher risk of severe, even life-threatening, complications.⁹

Although home tests are needed to accelerate clinical decision-making and to alleviate the workload of centralized test laboratories, RT-PCR is the standard approach for COVID-19 screening in symptomatic patients and also the one recommended by the WHO.¹⁰

Key facts

• Rapid RT-PCR diagnostics of SARS-CoV-2 with excellent sensitivity and specificity
• Safe and easy-to-use with no need for extensive safety measures or dedicated PCR facilities
• A fully automated assay procedure, preceded by a short and simple manual sample preparation process
• Automatic interpretation of test results by the intuitive GenomEra® Software in just 50 minutes

Assay principle

The GenomEra SARS-CoV-2 2.0 Assay Kit is a rapid and highly sensitive real-time RT-PCR  test for the qualitative detection of SARS-CoV-2 nucleic acids from respiratory specimens. The assay utilizes RT-PCR and hydrolysis probes to detect unique sequence regions of SARS-CoV-2 envelope (E) and RNA-dependent RNA polymerase (RdRP) protein-coding genes.

The GenomEra SARS-CoV-2 2.0 Assay Kit is compatible with a wide range of commercially available sample collection media, including inactivating media. Collecting the sample directly into inactivating media allows safe handling of the sample with no need for extensive biosafety measures, simultaneously minimizing the hands-on time for laboratory personnel. Additionally, our upgraded assay includes internal sample processing, amplification, and sufficiency control, targeting the mRNA of a specific human housekeeping gene.

After the respiratory swab specimens are collected to a sample collection media, preferably to eNAT, only a short and simple sample preparation process is needed, following a fully automated assay procedure. Qualitative test results are automatically reported with cycle threshold (Ct) values after 50 minutes. Due to the simplicity of the system, no prior experience in PCR diagnostics or dedicated PCR facilities are required.

The GenomEra SARS-CoV-2 2.0 Assay Kit is intended to aid the diagnosis of SARS-CoV-2 infection in humans when used in conjunction with clinical evaluation, patient history, and epidemiological information. Positive results are indicative of a SARS-CoV-2 infection, while negative results do not preclude infections by SARS-CoV-2 or other viral or bacterial pathogens and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Clinical performance

The clinical performance of the GenomEra SARS-CoV-2 2.0 Assay Kit was evaluated at five institutions across Europe during October–December 2021 (Table 1). Study specimens consisted of fresh (prospective) and frozen (retrospective) respiratory swab samples collected in Copan eSwab™, Universal Transport Medium (UTM), VTM, phosphate-buffered saline (PBS) or similar transport media, or fresh saliva samples from patients with signs and symptoms of respiratory infection. The reference assays used were standard RT-PCR methods developed for SARS-CoV-2 detection.

Table 1. The GenomEra SARS-CoV-2 2.0 Assay Kit is highly sensitive and specific in prospective and retrospective clinical specimens. NPA, negative percent agreement; PPA, positive percent agreement.

Specimen type	Sample size, n	PPA, % (CI 95%)	NPA, % (CI 95%)
Fresh	566	98.2 (94.7–99.6)	99.8 (98.6–100)
Frozen	349	98.5 (95.5–99.7)	100 (97.7–100)
Total	915	98.3 (96.4–99.4)	99.8 (99.0–100)

Ordering information

To place an order, please contact your local distributor.

Product name	Product code
GenomEra SARS-CoV-2 2.0 Assay Kit
20 tests	CDX-150-01-20
100 tests	CDX-150-01-100
GenomEra CDX System	CDX-10-020

 

The GenomEra SARS-CoV-2 2.0 Assay Kit has received the European CE marking for In Vitro Diagnostic (IVD) medical devices according to the requirements of EU Directive 98/79/EC (IVDD) and is available in European markets. In other markets, please contact your local distributor for availability. The product is manufactured by Uniogen, Finland.

GenomEra 2.0 kits: preparation of sample in eNAT

GenomEra 2.0 Assay Kits – Getting started with the kit

GenomEra 2.0 kits: preparation of sample in other media than eNAT

References

1. Zhang Y-Z. Novel 2019 coronavirus genome. [Accessed 25 Mar 2020].
2. de Groot RJ, Baker SC, Baric R, Enjuanes L, Gorbalenya AE, Holmes KV, et al. Family Coronaviridae. In: King AMQ, Adams MJ, Carstens EB, Lefkowitz EJ. Virus taxonomy: classification and nomenclature of viruses: ninth report of the International Committee on Taxonomy of Viruses. London; Waltham: Academic Press; 2012. p. 806-820.
3. Peiris JS, Yuen KY, Osterhaus AD, Stöhr K. The severe acute respiratory syndrome. N Engl J Med. 2003;349(25):2431-2441.
4. Wee SL, McNeil Jr DG, Hernández JC (30 January 2020). “W.H.O. Declares Global Emergency as Wuhan Coronavirus Spreads”. The New York Times. Retrieved 25 Mar 2020.
5. Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J et al. (February 2020). “A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster”. The Lancet. 395 (10223): 514–523.
6. “How COVID-19 Spreads”. U.S. Centers for Disease Control and Prevention (CDC). 4 March 2020. Retrieved 25 March 2020.
7. “Getting your workplace ready for COVID-19″ (PDF). World Health Organization (WHO). 3 March 2020. Retrieved 25 March 2020.
8. Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H et al. (March 2020). “First Case of 2019 Novel Coronavirus in the United States”. The New England Journal of Medicine. 382(10): 929–936.
9. “Coronavirus disease (COVID-19)”. World Health Organization (WHO). 2022. Retrieved 5 January 2022.
10. Recommendations for national SARS-CoV-2 testing strategies and diagnostic capacities. World Health Organization (WHO). Interim guidance 25 June 2021. WHO REFERENCE NUMBER: WHO-2019-nCoV-lab-testing-2021.1-eng. Retrieved 5 January 5, 2022.