COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1077

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual

Target type

Nucleic acid

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

qualitative assay; targeting the E gene, SARS-CoV-2 specific RdRP gene, and human RNase P https://www.multiplexdx.com/product/vdetect-covid-19-rt-qpcr-diagnostic-kit;

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Measurement

N.A.

Time

90 minutes

LOD

2 copies/reaction

LOD

0.4 copies/μl

Positive control

full genomic RNA of coronavirus SARS-COV-2 + human RNA

Negative control

nuclease-free water (PCR water

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

96 samples/run (96 samples per run)

Notes

https://uploads-ssl.webflow.com/58bcee1de9c6693a0278d729/5f105a60f24778ff0fb3e223_07-2020_MultiplexDX_A4_User%20Information.pdf; One package of the kit is sufficient for 400 testing reactions. Testing flexibility: either single gene screening or precision dual gene diagnostics. E or RdRP gene (based on the end-user preference) can be exclusively used for 400 screening tests. This option is recommended when manysymptomatic patients have to be screened at once. The precision dual gene option is based on running 200 screening assays first (E or RdRP gene) followed by 200 confirmation assays to confirm positive screening results (E or RdRP gene) or eliminate false-positive results. In addition, conducting an internal control assay for human RNase P assesses appropriate swab and RNA extraction, the presence of human RNA within the extracted sample, while eliminating false-negative results. Thus, for the precision dual gene diagnostics workflow, two testing reactions(screening and confirmation) should be performed per one patient and this option is recommended when precision testing is essential.