COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3156

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Fully automated (robot), Lab-based, Manual, Semi-automated

Physical Support

Microplate, Strip

Target type

Nucleic acid

Targets

envelope protein/gene, ORF1b polyprotein/gene

Specimen

Other biological fluids, Sputum, Throat secretion

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

rTEST COVID-19 qPCR SuperRapid kit is a diagnostic kit designed to detect SARS-CoV-2 genomic RNA from samples obtained by gargling without prior RNA extraction. The rTEST COVID-19 qPCR SuperRapid kit is an innovative, improved, and re-designed version of the WHO-recommended Charitè, Berlin protocol. The kit contains three sets of primers and hydrolysis probes (TaqMan®) for multiplex detection of SARS-CoV-2 specific E gene and RdRP gene, together with human RNase P. TaqMan® probes for E gene are conjugated to fluorophore YY, TaqMan® probes for the RdRP gene they are conjugated to the fluorophore FAM and the TaqMan® probe for RNase P is conjugated to the fluorophore Cy5. Such labelling allows for multiplexed detection of SARS-CoV-2 and human RNase P, which serves as an internal control to verify proper sampling and assay performance. To detect the SARS-CoV-2 E gene and the RdRP gene, we have developed patented dual TaqMan® probes, the use of which increases the sensitivity and specificity of our 1-step RT-qPCR. The kit is intended exclusively for use in a diagnostic laboratory with the appropriate equipment, safety standards and properly trained personnel. One package of the kit is sufficient for 400 tests.

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Time

45 minutes

LOD

1000 cpm

Positive control

RNA isolated from cell cultured SARS-CoV-2

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %