COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

GenomtecSARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit

Manufactured by Genomtec SA, Poland - https://genomtec.com/en/

Device identification number

2000

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual

Physical Support

Microplate, Strip

Target type

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Lineages detected

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.1.617.1 (Kappa), B.1.617.2 (Delta), 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

Kit contains also Inhibition Control - Amplification mix and control primers (target reference sequence of a human genome) with added patient’s extracted RNA sample. Both, the PPV and NPP were also obtained at 100% as well as the test accuracy (probability that a patient is correctly classified) was obtained at 100% (95% CI: 90.97%-100.00%). None of the 30 pathogens tested had any effect on RT-LAMP assay performance and cross-reacted.

Assay Type

Nucleic acid-Other

Reader Required

Yes

Method

LAMP

Measurement

Qualitative

Time

30 minutes

Subclass

JRC-S

LOD

20 cpr

Positive control

Positive Control in the form of a synthetic SARS CoV-2 cDNA.

Negative control

Negative SARS-CoV-2 Control

Clinical Sensitivity

100 %

Clinical Specificity

100 %

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements