SARS-CoV-2 RT PCR Multiplex Diagnostic Kit

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Product Description

The HA TECH SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit is a real time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 virus in upper respiratory specimens such as nasopharyngeal swabs and oropharyngeal swabs. The real-time RT-PCR test is intended for use by qualified clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.

This product uses well characterised primers and probes for the N gene, E gene and Orf1ab and combines them into an optimised multiplex that reduces reagent use, sample volume needed and improves detection as samples may be picked up that were otherwise missed with a single gene target. Our primers and probes have also been aligned with sequences of the new UK B1.1.7, South African B1.351, UK/South Africa B1.525, California B1.429/B1.427, Brazil B1.1.28 and India B1.617 variants.  There were no mismatches which suggests our assays will not miss the new variants. RNaseP internal control (RNaseP gene) provides a nucleic acid extraction procedural control and a secondary negative control. Positive control (purified SARS-CoV-2 genomic RNA) provides a reverse transcription and PCR control to validate the post extraction procedure and reagent integrity.

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Features

Rapid

- Multiplex of 3 target genes in one tube for simultaneous screening.
- Results within ~45 mins after extraction.

Sensitive

- Limit of Detection is 0.8-4 copies per µL.
- Less chance of false negatives as all 3 assays must fail
- Reduces the risk of missing the virus due to mutations in one gene.
- Will detect the new UK and South African variants which have mutations causing failure of S gene assays

Specific

- WHO recommended targets (N gene, E gene and ORF1ab gene).
- No cross-reactivity with SARS-CoV-1 and common respiratory pathogens

Reliable

- Internal control (RNaseP gene) to verify sample quality
- Positive (purified SARS-CoV-2 RNA) control included
- No template control to verify the procedure and reagent integrity

Compatible

- Compatible with most multichannel Real-Time PCR Thermal Cyclers
- Compatible with any RNA extraction method
- Direct PCR after virus inactivation is possible. However, RNA extraction is still recommended for the best performance.
– See IFU for details

Specifications

Kit Components

ComponentsTube Vol (μl)Reagent Vol (μl)
NAR-01 PCR Master Mix15001000
NAR-02 PCR Enzyme Mix500 100
NAR-03 PCR Multiplex Mix500400
NAR-04 PCR Positive Control50050
NAR-05 PCR Negative Control 15001000

Target gene fluorophores

Target gene Fluorophore (λemm)
N geneFAM (520 nm)
E geneHEX (556 nm)
ORF1ab geneROX (602 nm)
Internal control – RNaseP Cy5 (670 nm)

Storage and Shelf life

Shipping temperature 2~8°C.

  • All reagents should be stored at -20±5°C with protection from light. Avoid multiple freeze-thaw cycles. The reagents are stable for 6 months when stored at the recommended condition.
  • Expiration date is 12 months after production date.
  • The expiration date will not change if the kit is opened and stored at the recommended conditions.
  • The expiration date will not change if the kit is transported with ice-packs for 4 days and/or treated with 10 freeze-thaw cycles.

Ordering Information

ProductCat. No.
SARS-CoV-2 RT PCR Multiplex Diagnostic Kit (100 Reactions)NAT-01

Analytes: N gene, E gene, Orf1ab, RnaseP gene

Specimens: Nasopharyngeal and Oropharyngeal swabs