COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2361

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual, Semi-automated

Specimen

Bronchoalveolar lavage fluid, Deep (cough) sputum, Nasal aspirate, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, 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), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The INFET-002 kit allows the qualitative determination of the SARS-CoV-2 viral genome (genes N-nucleocapsid, ORF1ab-polyprotein and E-envelope) and of the human Rnase P gene. The method consists of a molecular technique called "NAT" (Nucleic Acid Testing): it uses the RNA retro-transcription technique to synthesize the cDNA and a subsequent polymerase chain reaction PCR (Polymerase Chain Reaction) with oligonucleotides and specific probes. The detection occurs in a Real-Time PCR system by sensing the fluorescence. The retro-transcription reaction is performed on the total RNA obtained from nasopharyngeal and/or oropharyngeal cellular contents.

Assay Type

Unknown

Reader Required

Yes

Subcategory

Other ()

Method

RT-PCR

Measurement

Qualitative

Time

71 minutes

LOD

10 cpr (cpr)

Positive control

Syntetic control containing Orf1ab, N, E, RdRp, S Viral genes and RNase P human gene as control.

Negative control

Buffer

Analytical Sensitivity

95 %

Analytical Specificity

99 %

Clinical Sensitivity

98 %

Clinical Specificity

100 %