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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: nasal, nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of SARS-CoV-2 by their healthcare provider.

The CellInsightTM SARS-CoV-2 RT-PCR test (REF#CM9001) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test. The test is multiplexed (two viral targets and one internal control target) into a single reaction and amplification set up. The test uses two primers and probes sets to detect two regions in the SARS COV-2 N gene and one primer and probe set to detect RP. RNA isolated from upper and lower respiratory specimens is reversed transcribed to cDNA and subsequently amplified using real-time PCR instrument. During the amplification process, the probe anneals to specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5’-exonuclease activity of Taq polymerase degrades the bound probe, causing the reporter dye to separate from the quencher dye, generating a fluorescent signal. Fluorescence intensity is monitored at each PCR cycle by the real-time PCR instrument.

Controls to be used with the CellInsightTM SARS-CoV-2 RT-PCR test

  • A negative (no template) control is needed to eliminate the possibility of samples contamination on the assay run and is used on every assay plate. This control is molecular grade, nuclease-free water.
  • A positive control is needed to verify that the assay is performing as intended and is used on in every assay-run. The positive control does not include RNase P target and will result as “undetermined” for the RNase P marker
  • An internal control targeting RNase P is included to verify that nucleic acid is present in every sample and is used for every sample processed. The internal control also serves as the extraction control to ensure that samples resulting as negative contain nucleic acid for testing.
  • A negative extraction control is a previously characterized negative patient sample. It serves both as a negative extraction control to monitor for any cross-contamination during the extraction process, as well as an extraction control to validate extraction reagents and successful RNA extraction. The negative extraction control will need to screen positive for RNase P target.

Analytical sensitivity of the CellInsightTM SARS-CoV-2 RT-PCR test

The Limit of Detection (LoD) study established the lowest concentration of SARS-Cov-2 expressed in genome copies that can be detected by the CellMade SARS-CoV-2 RT-PCR tests at least 95% of the time.

The analytical sensitivity was established by testing 20 replicates of 2-fold dilutions (50 cp/µL, 25 cp/µL, 12.5 cp/µL, 6.25 cp/µL, 3.125 cp/µL and 1.25 cp/µL) of SARS-CoV-2 synthetic RNA. The samples were prepared by spiking the quantified SARS-CoV-2 synthetic RNA into negative respiratory clinical matrices.

The study results showed that the LoD of the CellInsightTM SARS-CoV-2 RT-PCR test is 1 cp/µL (20/20 positive).

A contrived (surrogate clinical samples) clinical study was performed to evaluate the performance of the CellInsightTM SARS-CoV-2 RT-PCR test. A total of 40 individual nasal swap respiratory samples were used in this study. 40 negatives and 40 contrived (surrogate) positives were tested.  Contrived positive Nasal Swap Samples were spiked with AccuPlex™ SARS-CoV-2 at 8x, 4x, 2x and 1x LoD. AccuPlex™ SARS-CoV-2 virus products are non-replicative recombinant viruses that are intended to assess the performance of the full process. AccuPlex™ SARS-CoV-2 virus products were used to evaluate test proficiency and accuracy through the full process because they are encapsulated viruses which require extraction and amplification. 

The positive and negative percent agreement between the CellInsightTM SARS-CoV-2 RT-PCR is 100%.

CellInsightTM SARS-CoV-2 RT-PCR test (REF#CM9001) is intended for Research Use Only (RUO).

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

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Products

Ref Products Associated Products Price
CM9001 SARS-CoV-2 real-time RT-PCR detection kit (respiratory samples) for 100 reactions 0.00 €