COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2949

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1a polyprotein/gene, ORF1b polyprotein/gene

Specimen

Anterior nasal swab, Mid-turbinates swab, Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The TaqPath COVID-19 RNase P Combo Kit 2.0 is used for real-time PCR detection of SARS-CoV-2 viral RNA. The RT-PCR assay detects SARS-CoV-2 with multiple target regions while compensating for emerging variants and mutations. The assay includes the RNase P control and is used in combination with the included control, control dilution buffer, and master mix for RT-PCR detection.

Assay Type

Nucleic acid-PCR

Method

RT-PCR

LOD

75 GCE/ml specimen

Analytical Sensitivity

% 100

Analytical Specificity

% 100

Clinical Sensitivity

% 96.7

Clinical Specificity

% 95

Throughput

Higher than 96 samples per run

Notes

The TaqPath COVID-19 diagnostic tests can detect all currently known SARS-CoV-2 variants among patients’ samples.