COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2950

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1a polyprotein/gene, ORF1b polyprotein/gene

Specimen

Saliva

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The TaqPath COVID-19 Fast PCR Combo Kit 2.0 is a CE-IVD marked, multiplexed, highly sensitive, fast RT‐PCR assay for the qualitative detection and characterization of SARS-CoV-2 RNA (N, ORF 1a, and ORF 1b genes) in raw saliva collected in sterile containers from individuals suspected of COVID-19 by their healthcare provider. The multigene SARS-CoV-2 assays target three different viral genomic regions, reducing the risk of failure when new viral strains arise. The RNase P assay run in the same well is used to help assess sample quality and also serves as an internal process control. The kit is designed to provide reliable and sensitive results from raw saliva samples.

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Time

53 minutes

LOD

750 GCE/ml specimen

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

97.1 %

Clinical Specificity

100 %

Throughput

Higher than 96 samples per run