CoVClear

CoVClear

The MiRXES CoVClear is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirate, nasal wash/aspirate and anterior/mid-turbinate nasal swabs samples from patients suspected of COVID-19 by a healthcare provider.

Key Features

Two-target
multiplex RT-PCR

Detection of the ORF1ab and N regions of the SARS-CoV-2 genome in one reaction.

Fast
results

1h 30min turnaround time after RNA extraction.

Reliable
performance

High sensitivity and specificity. Zero cross-reactivity with 31 different respiratory tract-associated organisms.

Lab
ready

Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.

Quality
assured

End-to-end process validated.

Details

MiRXES CoVClear is a real-time RT-PCR intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirate, nasal wash/aspirate and anterior/mid-turbinate nasal swabs samples from patients suspected of COVID-19 by a healthcare provider.

The RNA from SARS-CoV-2 is generally detectable in upper respiratory during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

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.

Detects all variants of concern, as of 6 August 2021.

Regulatory Status

MiRXES CoVClear has received CE Mark and is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. 

Detection Target
Channel
1
SARS-CoV-2 ORF 1ab gene
FAM
2
SARS-CoV-2 N gene
HEX/VIC
3
Human RNase P gene
Cy5
Specifications
Values
Limit of Detection
0.25 GE/µL
Inclusivity
>99.8% have 100% homology to either N or ORF1ab target as of 16th February 2021 including B.1.1.7 lineage and B.1.351 lineage.
Cross reactivity
No cross-reactivity with 31 respiratory tract-associated organisms
Clinical sensitivity
96.8% (CI: 89.0% – 99.1%)
Clinical specificity
96.2% (CI: 87.0% – 98.9%)

Ordering Information

Product
Pack Size
Contents
Catalogue No.
CoVClear
200 reactions/kit
Primers-Probes Mix, Reverse Transcriptase, Universal Probes Reaction Mix, Positive Control, Negative Control
FGS0006R (RUO), FGS0006

The test is only provided for use by clinical laboratories or Research Use Only (RUO).

Contact Us

Singapore (Global HQ)
Tel: +65 6816 2931
Email: sales@mirxes.com

Available Downloads:

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