Analites

SARS-COV-2

Specimen

Nasopharyngeal, nasal swabs, saliva

Description

The assay is intended for the qualitative detection of RNA from SARS-CoV-2 in clinician-collected nasopharyngeal swab specimens from patients with signs and symptoms suggestive of COVID-19 (e.g., fever and/or symptoms of acute respiratory illness).
Results are for the detection of SARS-CoV-2 RNA that is detectable in nasopharyngeal swab and saliva samples during infection. Positive results are indicative of SARS-CoV-2 RNA detection, but may not represent the presence of transmissible virus. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. CoronaMelt is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

CoronaMelt uses a multi-target design to compensate for emerging SARS-CoV-2 variants and mutations. None of the mutations in B.1.351, P.1 and B.1.1.7, Delta and Omicron BA.1/BA.2 are known to affect our COVID-19 portfolio of tests.*

*as at 15th January 2022.

Features and advantages

CoronaMelt is based on a single step real-time RT-PCR test able to detect two different SARS-CoV-2 loci through melting fingerprinting analysis, thus ensuring unique specificity and sensitivity.
The analysis of samples using the CoronaMelt assay can be performed either following an RNA extraction, or in combination with Ulisse Faster (UBM0008) or Ulisse Faster light (UBM0019) which allow use without extraction.
CoronaMelt does not contain materials of animal or human origin.

Content

Includes ready-to-use reagents for amplification, endogenous internal control (GAPDH) and positive control.

Order information

Licenced to Menarini Diagnostics

Product code Product name Size
UBM0007 CoronaMelt 100 test

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