COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2446

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Microplate, Strip

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), 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 kit also includes Inhibition Control (IC) constituting of AmpMix and control primers ( targeting human reference gene) with added patient’s extracted RNA sample. Kit detects also variant Breton (hCoV-19/France/BRE- IPP04233/2021). Cliinical validation was perfomrmed on 63 samples. The PPV and NPP were 100% and 93.94%, respectively, whereas the test accuracy was obtained at 96.83% (95% CI: 89.00%-99.61%). The Kit retained all diagnostic properties against SARS-CoV-2 virus identification in contrived positive saliva samples spiked with interfering substances. Thirty tested pathogens had any effect on RT-LAMP assay performance and cross-reacted.

Assay Type

Unknown

Rapid Diagnostic

No

Reader Required

Yes

Method

LAMP

Measurement

Qualitative

Time

40 minutes

LOD

2 cpr ((saliva))

LOD

10 cpr ((dry swab))

LOD

10 cpr ((dry swab))

Positive control

Positive Control in the form of a synthetic SARS CoV-2 cDNA fragments.

Negative control

Two types: Negative SARS-CoV-2 Control & Negative Human Control

Clinical Sensitivity

93.75 %

Clinical Specificity

100 %