COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2465

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Target type

Nucleic acid

Specimen

Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), Other, P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The C4Covid-19 HumanTM kit is a rapid SARS-CoV-2 ribonucleic acid (RNA) amplification test. It is based on RT-LAMP technology to detect the 2 target genes of the virus (one target gene common to the family of ß-coronaviruses: the RdRp gene, and a specific target of SARS-CoV-2: the N gene) which are tested for in 2 separate wells. The RdRp and N genes must be amplified so that the test can be considered as positive (see Interpretation of results). A third well containing a control reaction, makes it possible to ensure that the LAMP reaction has been properly carried out (control reaction). The test consists of 2 stages: pre-analytical processing of the sample by the operator for a 10-minute duration followed by a genetic material amplification by the reader during a maximum of 20 minutes’ duration. The total time to yield results is at most 30 minutes.

Assay Type

Unknown

Reader Required

Yes

Subcategory

Sample preparation

Method

LAMP

Measurement

Qualitative

Time

30 minutes

LOD

210000 AU ((2.10E5))

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

2.3 %

False negatives

2.4 %

Precision

Evaluated

Accuracy

95 % ( (ribonucleic acid (RNA) amplification test))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

85 % ((ribonucleic acid (RNA) amplification test))

Clinical Specificity

97 % ((Aribonucleic acid (RNA) amplification test))

Type of antigen

Other