SARS-CoV-2 RT PCR Multiplex Diagnostic Kit

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.

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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.

Specifications

Components	Tube Vol (μl)	Reagent Vol (μl)
NAR-01 PCR Master Mix	1500	1000
NAR-02 PCR Enzyme Mix	500	100
NAR-03 PCR Multiplex Mix	500	400
NAR-04 PCR Positive Control	500	50
NAR-05 PCR Negative Control	1500	1000

Target Gene Fluorophores

Target gene	Fluorophore (λemm)
N gene	FAM (520 nm)
E gene	HEX (556 nm)
ORF1ab gene	ROX (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

Product	Cat. 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