COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3117

CE Marking

✓Yes

HSC common list (RAT)

×No

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Rhinovirus

Pathogens detected

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

At the beginning of the pandemic, Laborant SARS CoV-2 RT-PCR Kits performed over 200 laboratory and generate satisfying results from all comparison studies. There is no need to additional extraction step with SINAT-100 collection tubes that manufactured by Ant Medical Company. With combining Laborant SARS CoV-2 RT-PCR Kits, sampling to reports take 40 minutes for 96 samples.

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Measurement

Qualitative

Time

34 minutes

LOD

400 cpm

Positive control

Human RPP30 as internal control, SARS CoV-2 for positive control template

Negative control

DNase RNase free water

Analytical Sensitivity

100 %

Clinical Sensitivity

100 %

Throughput

96 samples per run

Notes

We targeted 3 different SARS CoV-2 gene (ORF1ab, E and N genes) in a single channel (FAM). Combined probes leads cumulative signal and also accurate results. We are conducting sequencing controls in some periods. There have been any mutation on our targets. In this way, this kit could detect all the lineages so far. The specificity and sensitivity for all lineages are 100, 100, respectively.