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

abTES™ Flu/COVID-19 qPCR I Kit

Manufactured by AITBIOTECH PTE Ltd., Singapore - www.aitbiotech.com

Device identification number

3129

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Lab-based, Semi-automated

Physical Support

Strip

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene

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), Hemophilus Influenzae, 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

Influenza A, Influenza B, SARS-CoV

Lineages detected

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), P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The abTES™ Flu/COVID-19 qPCR I Kit is a qualitative real-time polymerase chain reaction (qPCR) kit which enables simultaneous detection of SARS-CoV-2 (orf1a), Flu A and Flu B in a single reaction. It also includes detection of human housekeeping gene, GAPDH, as an Internal Control (IC) to monitor RNA extraction efficiency and potential PCR inhibitions from sample processing. The kit contains all the necessary PCR reagents for rapid, sensitive and reproducible real-time detection of four Influenza types using highly specific primer pairs and double-dye hydrolysis probes. The recommended human sample types are nasal and throat swabs.

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Self Test

Reader Required

Yes

Subcategory

Other ()

Method

RT-PCR

Measurement

Quantitative

Time

114 minutes

LOD

2.377 cpu (Influenza A)

LOD

3.206 cpu (Influenza B)

LOD

2.193 cpu (SARS-CoV-2)

Positive control

Influenza A, Influenza B, SARS-CoV-2

Negative control

nuclease-free water

Analytical Sensitivity

95 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

96 samples per run

Notes

performances Delta (100;99.8); Omicron (100;100)

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