COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2859

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

Specimen

Other biological fluids, Sputum, Throat secretion

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

The rTEST COVID-19 qPCR Rapid kit is a qualitative in vitro diagnostic test designed to detect the presence of SARS-CoV-2 genetic material in biological samples obtained by gargling without RNA extraction. The rTEST COVID-19 qPCR Rapid kit is an innovative, improved, and re-designed version of the WHO- recommended Charite, Berlin protocol. The kit contains three sets of primers and hydrolysis probes (TaqMan®) in a single multiplexed reaction targeting the SARS-CoV-2 specific E and RdRP genes together with human RNase P. TaqMan probes for E, RdRP, and RNase P genes are conjugated to YY, FAM, and Cy5, respectively. This enables multiplexed detection of SARS-CoV-2 and human RNase P as an internal control to validate proper sample collection and performance of the test. For E and RdRP genes, we developed proprietary dual TaqMan® probes to increase the sensitivity and specificity of our 1-Step RT-qPCR method. The RT and qPCR reactions are conducted in a one tube, one-step fashion. 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

Reader Required

Yes

Method

RT-PCR

Measurement

Quantitative

Time

52 minutes

LOD

1000 cpm

Positive control

RNA isolated from cell cultured SARS-CoV-2

Negative control

PCR water

Analytical Sensitivity

95 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %