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

REALQUALITY RQ-SARS-CoV-2

Manufactured by AB ANALITICA, Italy - www.abanalitica.com

Device identification number

2091

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual, Semi-automated

Target type

Nucleic acid

Targets

non-structural protein/gene NSP12, non-structural protein/gene NSP7, non-structural protein/gene NSP8, spike protein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Coronaviruses (HCoV), MERS-CoV, SARS-CoV

Lineages detected

A.23.1, AT.1, 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.1.621 (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

Kit for detection of RdRp and S genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab Oropharyngeal swabs; Target: S, RdRP genes and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses; Diagnostic specificity = 100% Diagnostic sensitivity = 100% Accuracy = 100%

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

100 minutes

LOD

3.57 cpr

Positive control

Positive control SARS-CoV-2 (DNA containing part of the SARS-CoV-2 genome and RNaseP gene)

Clinical Sensitivity

98.1 %

Clinical Specificity

100 %

Type of antigen

S, RdRP genes

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