COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2899

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated

Physical Support

Cartridge

Target type

Nucleic acid

Targets

non-structural protein/gene NSP15, ORF1a polyprotein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The Analyzer and its consumables (the Test Cartridge from the Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method) are intended for in vitro diagnostics, i.e. a virus detection in the patient's nasopharyngeal, oropharyngeal, or combined oro- and nasopharyngeal swabs sampled from individuals suspected of COVID-19. The Analyzer is designed to perform the viral RNA extraction from the patient's nasopharyngeal, oropharyngeal or combined oro- and nasopharyngeal swab, and subsequent real-time amplification. The Analyzer's operating principle is based on three main procedures: Lysis - viral envelope destruction in chaotropic salts. RNA extraction from a specimen - RNA binding to the glass filter. Detection - real-time amplification. Note: Analyzer is operable only with the Test Cartridge from Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method (Mirai Genomics, Japan). The system is completely closed. The Test Cartridge contains all the required reagents. The Analyzer does not interact with the reagents inside the Test Cartridge in any way. Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method are not supplied with the system and must be purchased separately. For ordering information, contact Mirai Genomics. The Analyzer is intended for use in clinical diagnostic laboratories, as well as research institutes laboratories. The Analyzer is intended for in vitro diagnostics only. The Analyzer is intended for trained staff use only.

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Measurement

Qualitative

Time

35 minutes

LOD

1000 cpm

Positive control

Dry mixture of an in vitro synthesized fragment of the SARS-CoV-2 RNA genome 4x107 cpm

Negative control

Guanidine Thiocyanate, Sodium polyacrylate, Tris-HCl buffer solution, pH 7.4, Triton X-100, Ethanol

Analytical Sensitivity

% 100.00

Analytical Specificity

% 100.00

Clinical Sensitivity

% 98.04

Clinical Specificity

% 100.00

Throughput

other