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SARS-CoV-2 Detection RT-PCR Testing Kit

For rapid detection of SARS-CoV-2
QuantuMDx’ SARS-CoV-2 RT-PCR Detection assay is a real-time reverse transcriptase (rtRT)-PCR assay that has been developed using advanced bioinformatics to maximise performance. The assay has been designed with the most up-to-data sequence information to ensure 100% inclusivity of all known SARS-CoV-2 sequences. The assay is also re-evaluated in silico on a periodic basis to ensure 100% inclusivity versus all available SARS-CoV-2 sequences.
Our SARS-CoV-2 assay has been CE-IVD marked under the in vitro Diagnostics Directive (98/79/EC). We have also applied to the US Food and Drug Administration (FDA) for Emergency Use Authorisation and to the WHO for Emergency Use Listing.

FIND Diagnostics have independently evaluated our assay at the University Hospitals of Geneva, to verify the limit of detection (LOD) and the clinical performance in comparison to an in-house PCR protocol.
Key Features & Benefits
Speed
Amplification & Detection Only

Result in 75 mins or less
(instrument dependent)

Exclusivity
No Cross-reactivity or Interference

No cross-reactivity or interference due to common commensal or infectious organisms found in the respiratory tract, both in silico and standard bench testing

Inclusivity
100% Coverage

100% coverage of all known SARS-CoV-2 sequences at the date of analysis

Sensitive
Amplification & Detection Only

Highly sensitive, targeting three loci

Versatile
Multiple Platforms
Validated to run on multiple platforms
Cost Effective
Competitive

Competitive cost per sample

Our test kits are fully lyophilised allowing for ease of shipment and can be run on properly calibrated standard real-time instruments.

Our SARS-CoV-2 test targets three SARS-Cov-2 genomic loci; the S and N gene and the Orf1 region. The assay has been designed and developed to run on multiple high- and low-throughput PCR platforms that can be calibrated for the fluorophores FAM and HEX.
Intended Use

The QuantuMDx Severe Acute Respiratory Syndrome Virus coronavirus-2 (SARS-CoV-2) real-time reverse transcription polymerase chain reaction (RT-PCR) Detection Assay is a qualitative RT-PCR assay for the detection of SARS-CoV-2 genomic RNA from upper respiratory specimens (e.g. nasopharyngeal or oropharyngeal swabs, etc.) collected from individuals who meet criteria for SARS-CoV-2 testing.

Results are for the presumptive detection and identification of SARS-CoV-2 targeted genomic RNA sequences. SARS-CoV-2 genomic RNA is detectable in upper respiratory specimens during the acute phase of the infection and for a time after symptoms have abated.

Positive results are indicative of active infection with SARS-CoV-2 but do not rule out co-infections with other viruses or bacteria. Clinical correlation with patient history and other diagnostic information is necessary to determine an individual’s infection status. The detection of SARS-CoV-2 genomic RNA may not indicate the definitive cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as a sole basis for treatment or other care management decisions. Negative results must be combined with clinical observations, the individual’s history and epidemiological data and information.

Testing with the QuantuMDx SARS-CoV-2 Detection Assay is intended for use by trained laboratorians who are proficient in performing molecular based tests.

Download the Introductory Brochure & Data Sheet for QuantuMDx SARS CoV-2 assay.
Download the User Instructions for QuantuMDx SARS CoV-2 assay.
Download the Safety Data Sheet for QuantuMDx SARS CoV-2 assay.

Our SARS-CoV-2 detection assay is available now for purchase and we have capacity to produce 2m tests per week.
If you’re interested in partnering with us, please contact our sales team.
Customer or technical support

Please email us at: moc.xdmutnauq@troppusremotsuc

You can also ring us at +44 (0) 870 803 1234
Monday to Friday 9am – 5pm GMT or BST

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