COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2855

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Semi-automated

Target type

Nucleic acid

Specimen

Mid-turbinates swab, Nasal swab, Nasopharyngeal swab

Cross-reactivity (pathogens tested)

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.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Method = Test Kit for real time isothermal helicase depending amplification of SARS CoV-2 RNA on the Solana Analyzer Platform '(closed platform system); Target within the non-structural polyprotein 13 (nsp 13); Direct molecular detection of SARS CoV-2 RNA on heat-lyzed specimens; Compatible with transportation medium; Run-Time 25 min + 10-15 min specimen preparation (= about 45 min total time to result): Data for clinical Sensitivity and Specificity for combined nasal and nasophyrngeal specimen; for differentiated data for nasal and nasopharyngeal specimen please refer to package insert

Assay Type

Nucleic acid-Other

Reader Required

Yes

Method

Other ()

Measurement

Qualitative

Time

25 minutes

LOD

11600 cpm

Positive control

Internal Process Control (ICP) included

Negative control

not included

Analytical Specificity

100 %

Clinical Sensitivity

97.8 %

Clinical Specificity

99.5 %

Notes

China-CDC-ORF1ab