COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1825

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Strip

Target type

Nucleic acid

Specimen

Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Throat swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

INTENDED TO USE LAMPIGEN® RT-LAMP KIT is a screening assay with Fluorometric detection for SARS-CoV-2 viral RNA. A Point of Care diagnostic solution with Fluorometric RT-LAMP portable devices (Genie® II, III, and HT). LAMPIGEN® RT-LAMP KIT does not require RNA extraction and can be used directly on oropharyngeal/nasopharyngeal swab dilutions. The causative agent of COVID-19, SARS-CoV-2, is an enveloped, positive-sense RNA virus belonging to the Coronaviridae family. Regular and reliable detection of SARS-CoV-2 RNA is required to monitor the spread of the virus and screen clinical samples from patients displaying relevant symptoms of COVID-19. LAMPIGEN® RT-LAMP KIT is an in-Vitro diagnostic point of care test based on Reverse Transcription Loop-mediated isothermal AMPlification (RT-LAMP) technology for the detection of SARS-CoV-2 viral RNA. The detection is a one-step process, a closed-tube format where the reverse transcription and subsequent amplification of the specific target sequence occur in the same reaction well. The processing detects the amplified outcome in real-time using fluorescence exposure. It automatically runs an anneal curve at the end of amplification, where the reaction is heated to 98°C and slowly cooled. This final step acts as a secondary confirmatory check - ensuring LAMP amplicons are specific to SARS-CoV-2. The result is exact, and it reports automatically a positive (+) from both the amplification timeslot and the annealing temperature at which the test detects the virus

Assay Type

Nucleic acid-PCR

Reader Required

Yes

Method

LAMP

Time

30 minutes

Subclass

HKU-ORF1b-nsp14

LOD

3 cpu

Positive control

yes

Negative control

yes

Analytical Sensitivity

99 %

Analytical Specificity

100 %

Clinical Sensitivity

94 %

Clinical Specificity

100 %

Notes

Transcription Loop-mediated isothermal AMPlification (RT-LAMP)