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AddMedi SARS-CoV-2 RT-qPCR Kit

 

Detection of SARS-CoV-2 virus through one-step real-time polymerase chain reaction (PCR)

from human respiratory samples

CE-IVD

All Components for Diagnosis

UDG System for Protection of Contamination

Use the Specific Primer/Probe for RdRp and S gene Detection

Highly Stable RT-qPCR Kit

Fast and Reliable Results in Less Than 2 hours

Detection All Variants included Delta and Omicron

CE IVD Marked

Detection of New SARS-CoV-2 Variants

Research Use Only.

Not for Use in Diagnostic Procedures.

FDA announced (updated 8 Jan 2021) that the mutation in S-gene may cause some RT-PCR assays targeting the S gene to produce a negative result (S-gene target failure). Whereas, the primer/probe used in our diagnosis kit is located in highly conserved site, so can detect all new variants without false negatives. 

SARS-CoV-2 RT-qPCR Kit S gene target loc

Performance

Sensitivity: 96.00%

Specificity: 100.00% in 80 samples (50 Positive samples, 30 Negative samples)

Limit of Detection: 50.0 copies/reaction for both S and RdRp gene targets

SARS-CoV-2 RT-qPCR Kit PCR data

Documents

IFU (EN)

IFU (DE)

Brochure

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