Viral diagnostics
Viral Diagnostics
Cube Dx’ suite of products for respiratory viruses combines multiplex screening for Influenza A and B, Respiratory Syncytial Virus (RSV) and SARS-Cov-2 with a comprehensive follow-up mutational analysis of SARS-Cov-2. Mutations, especially in the receptor binding domain (RBD) of the S-gene, are relevant as these changes might hamper the effectiveness of currently approved vaccines, the clinical presentation of the disease, and diagnostic tools.
The combination of a comprehensive screening kit and the immediate analysis of mutations of positive samples enables a swift reaction to new variants seen in a region for the first time. The detailed mutation overview allows for a targeted selection of samples for further sequencing. The simple handling, the comprehensive mutation panel, and the automated analysis of variants drastically reduce the need for personnel for mutation diagnostics. The mutation analysis is performed by means of the compact sequencing process.
Compact sequencing is a two-step process. The first step is a standard RT- PCR reaction (in this case of a single S-gene amplicon). This first step provides single-stranded fluorescence-labeled DNA for the second step and allows for a quantitative estimate of viral load. The second step is the identification of mutations and data analysis in the hyborg.
The whole process takes less than two hours and the sequencing step in the hyborg utilizes a patented, extremely fast heating and cooling method.
88 mutations / All relevant Omicron variants
EPIDEMIOLOGICAL SURVEILLANCE OF SARS-COV-2 MUTATIONS/VARIANTS:
Cube Dx’ fast and comprehensive examination of mutations of SARS-Cov-2 quickly singles out virus phenotypes with altered mutation patterns to take swift action to contain an outbreak of new variants.
The multiplex RT-PCR CuPCR SARS-Cov-2 Mutations is the first step for the mutation analysis and is based on a one-step reaction of reverse transcription (RT) combined with real-time PCR for the detection of the RNA of SARS-Cov-2 (S gene). The test is based on the principles of TaqMan-PCR and uses a single fluorescence dye to indicate amplification of the S-gene.
Positive amplicons are immediately examined for relevant mutations in the receptor binding domain (RBD) of the S gene of SARS-Cov-2 with hybcell SARS-Cov-2 Mutations using Cube Dx’s proprietary compact sequencing. In just 15 minutes, 88 SNPs (single nucleotide polymorphism = mutations) can be distinguished by identifying bases (A, C, G, T) of +ssRNA at specific nucleotide positions. The resulting mutation patterns are translated into likely variants of concern (or interest) by the software.
The test is periodically updated to cover the currently most relevant mutations and variants. Different samples can be tested, for example human samples or wastewater samples. The test is an epidemiological tool and is not intended to serve as an in-vitro diagnostic tool.
Advantages:
-
Screening of 1 amplicon (S-gene)
-
Minimum hands-on time, and direct use of positive amplicons, fast results, and "easy" read-out of results (report)
-
Limit of detection > 10 RNA copies per reaction
-
Analysis of 88 SARS-Cov-2 SNPs in 20 minutes
-
Automated reporting of known variants without any user intervention
-
Ability to show different variants simultaneously in aggregate samples (e.g. wastewater)
-
Validated for human and (waste) water samples
1 test, 4 targets: SARS-COV-2, INFLUENZA A, INFLUENZA B, RSV
DIAGNOSING VIRAL INFECTIONS OF THE RESPIRATORY TRACT:
SARS-Cov-2, influenza viruses and the respiratory syncytial virus (RSV) are the main causes of clinically relevant infections of the upper respiratory tract during the cold season. Cube Dx offers multiplex screening of these pathogens in a single test. Patients suffering from typical symptoms can be diagnosed rapidly and efficiently with the test.
Influenza viruses cause infections in the respiratory tract. From the known strains A, B, C, and D, only A and B are clinically relevant. Influenza A causes the most severe cases of disease and is mostly responsible for seasonal outbreaks resulting on about 500,000 deaths per year.
An infection with the Respiratory Syncytial Virus (RSV) is the second most frequent cause of death in infants. An analysis estimated between 66,000 and 160,000 deaths of children under the age of five is associated with an infection of RSV.
The multiplex real-time RT-PCR test CuPCR Respiratory xB is an in-vitro diagnostic test based on Reverse Transcription (RT). It transcribes viral RNA into DNA for the subsequent Polymerase Chain Reaction (PCR) of the target sequences of SARS-Cov-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) types A and B, and human control. TaqMan probes are used for four different channels (fluorescent dyes) to read out successful amplification. As a sample, eluted RNA extracted by common RNA extraction methods is used.
Advantages:
-
Screening of SARS-Cov-2, Influenza A, Influenza B, RSV subtype A/B, and human control in one RT-PCR test.
-
Optimized to suppress RT-PCR inhibitors
-
One-step reverse transcription and Realtime PCR
-
Sensitive and specific
