COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3119

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Lab-based, Semi-automated

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Influenza A, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The abTES™ COVID-19 Variant Kit is a real-time polymerase chain reaction (qPCR) kit for the detection of the spike protein (S) of SARS-CoV-2 Variants together with COVID-19 non-structural polypeptide (orf1ab) and nucleocapsid protein (N). It also includes detection of human housekeeping gene, GADPH, as Internal control (IC) to identify the possible for PCR inhibition. The kit contains all the necessary PCR reagents for rapid, sensitive, and reproducible real-time detection of using highly specific primer pairs and double-dye hydrolysis probes. The recommended human sample types of nasopharyngeal and oropharyngeal swabs.

Assay Type

Nucleic acid-PCR

Self Test

No

Reader Required

Yes

Subcategory

Other ()

Method

RT-PCR

Measurement

Quantitative

Time

47 minutes

LOD

550 cpm

Positive control

Orf1ab gene, N gene, S gene and IC (GAPDH)

Negative control

nuclease-free water

Analytical Sensitivity

95 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

96 samples per run

Notes

lineages_performances Delta(98.24%), Omicron (99.06%)