COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3132

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated

Physical Support

Strip

Target type

Nucleic acid

Specimen

Anterior nasal swab, Nasal swab

Cross-reactivity (pathogens tested)

Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The abCyclerQd is a small, fast, easy-to-use point-of-care-testing (PoCT) system, suitable for on-site rapid nucleic acid detection and testing. It is highly sensitive and can achieve a rapid thermal cycle by moving the consumables tube between two high precision temperature zones, greatly reducing the detection time. A test on the abCyclerQd can be completed within 20 minutes.

Assay Type

Nucleic acid-PCR

Self Test

Yes

Reader Required

Yes

Method

RT-PCR

Measurement

Qualitative

Time

20 minutes

LOD

1000 cpm

Positive control

COVID-19

Negative control

Nuclease free water

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

Single tubes