COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1160

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Target type

Nucleic acid

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

45 minutes

LOD

10 virus-copies

Positive control

The positive control contains the SARS-CoV-2 E gene, RdRP gene and RNase P RNA fragments

Negative control

Nuclease-free water

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Throughput

96 samples/run

Notes

Information provided by the manufacturer: COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx kit is a multiplexed assay designed for simple, reliable and rapid qualitative detection of SARS-CoV-2 specific RNA using TaqMan technology (FAM and HEX/VIC). The kit includes 2x One-Step RT-PCR Master Mix and 2 primer/probe mixes, a positive control and a negative control (nuclease-free water). The first primer/probe mix is the E gene/RP that targets the SARS-CoV-2 – specific Envelop gene (E gene - FAM) in addition to the human RNase P transcript (RP - HEX/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The second Primer/Probe Mix is for the RdRP gene and detects two RNA-dependent RNA Polymerase (RdRP) targets where the first RdRP target is SARS-CoV-2 specific (FAM) while the second RdRP target is to detect SARS-CoV and bat-SARS-related CoVs (HEX). The use of the second RdRP gene Primer/Probe Mix is only required as a discriminatory/confirmatory step with samples showing positive amplification of the E gene. The provided E gene/RdRP/RP Positive Control contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control).