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SARS-CoV-2 RT-PCR kits

The CellInsightTM SARS-CoV-2 RT-PCR test (REF#CM9001) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as: nasopharyngeal swabs or oropharyngeal swabs) collected from individuals suspected of SARS-CoV-2 by their healthcare provider.

CellInsightTM SARS-CoV-2 RT-PCR test (REF#CM9001) is intended for in vitro diagnostic use.

The CellInsightTM SARS-Cov-2 detection kit (REF#CM9001) is a multiplex real-time reverse transcriptase polymerase chain reaction (PCR) assay for use on the Agilent AriaMX Real-time PCR System for the qualitative detection of RNA from the nucleocapsid phosphoprotein gene (N-gene)  of the SARS-Cov-2 virus and the human RNase P gene. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for the detection of SARS-Cov-2 by amplifying two unique regions of the N Gene (i.e., N1 and N2). Detection of the human RNase P serves as an endogenous Sample Processing Control (SPC) and allows to verify the nucleic acid extraction procedures and serves as an internal amplification control. No external addition of SPC is required.

Laboratories must establish the number, type, and frequency of testing of control materials according to guidelines or requirements of local, provincial, state, and federal and/or country regulations or accreditation organizations in order to monitor the e?ectiveness of the entire analytical process. Process Controls available from CellMade (REF#CM9202) are treated as if they were patient samples. It is required to run at least one (1) External Positive Control and one (1) External Negative Control on a daily basis.

The analytical sensitivity for the CellInsightTM SARS-Cov-2 detection kit (REF#CM9001) N1, N2 & RNase P Multiplex was determined as follows: 

  • Contrived positive samples (n=20) were generated using AccuPlexTM standards;
  • Dilution series of AccuPlexTM standards were analyzed.  

 

Target

LoD / mL

(200 µL sample input)

LoD/reaction (RNA copies per RT-PCR reaction)

Expected Cycle threshold (Ct)

N1 target

~1000

7.5

34-36

N2 target

~1000

7.5

34-36

*LOD established using AccuPlexTM viral particles that underwent lysis, nucleic acid extraction and rtRT-PCR.

**Extraction was automated on KingFisherTM Flex Magnetic Particle Processor using the CellInsightTM Total Nucleic Acid Extraction Kit – Pathogens (Ref#CM9100) kit.

 

CellInsightTM SARS-CoV-2 RT-PCR test (REF#CM9001) is intended for in vitro diagnostic use.

 

For further information on our SARS-CoV-2 RT-PCR test, please refer to the Documents Centre of this page.


Products

Ref Products Associated Products Price
CM9001 SARS-CoV-2 real-time RT-PCR detection kit (respiratory samples) for 96 reactions 0.00 €