COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

Manufactured by Shanghai BioGerm Medical Technology Co. Ltd., China - http://en.bio-germ.com/

Device identification number

2019

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual

Physical Support

Cassette, Strip

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Sputum

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This kit is an in vitro diagnosis test, for qualitative detection of Novel Coronavirus RNA (2019-nCoV, also known as SARSCoV2) in nasopharyngeal swab, oropharyngeal swabs and sputum samples from patients with suspected 2019-nCoV infection, by targeting ORF1ab and N gene of the virus.

Assay Type

Nucleic acid-PCR

Self Test

Reader Required

Yes

Subcategory

Validity test kit

Method

RT-PCR

Measurement

Qualitative

Time

39 minutes

Detection Principle

Fluorescence

LOD

150 copies/ml

Positive control

Plasmid harboring 2019- nCoV (ORF1ab/ N genes) and virus-like particles containing RNaseP specific fragment.

Negative control

Normal saline

Analytical Sensitivity

0 %

Analytical Specificity

100 %

Clinical Sensitivity

99.24 %

Clinical Specificity

99.14 %

Throughput

96 samples per run

Notes

CV Value could reach 3%

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements